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Apr 01
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Eloxx Pharmaceuticals Acquires Zikani Therapeutics

By Eloxx Pharmaceuticals, Press Release, Publicly Listed
Press Release.

 

Combined Company to be Leader in Ribosomal RNA-Targeted Genetic Therapy Bringing Together Complementary Platforms

Maximizes Potential for ELX-02 for Cystic Fibrosis in Phase 2 Development

Adds Preclinical Stage Pipeline in Rare Diseases and Oncology Targeting RNA
and Ribosomal Mutations

Expect to File IND for First Oral Drug to Treat Patients with Recessive Dystrophic
and Junctional Epidermolysis Bullosa (RDEB and JEB)

Sumit Aggarwal, Zikani President and CEO, to Lead the Combined Company

Eloxx to Issue Approximately 7.6 Million Shares to Zikani Stockholders

Company to Host Investor Call at 8:30 a.m. ET, April 1

WALTHAM, MA and WATERTOWN, MA – APRIL 1, 2021 – Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) today announced it has acquired Zikani Therapeutics, Inc. in an all-stock transaction, with the potential to create a leader in ribosomal RNA-targeted therapies for treatment of rare diseases and oncology. Sumit Aggarwal, previously the President and Chief Executive Officer of Zikani, has been named President and Chief Executive Officer of Eloxx, and Vijay Modur, M.D., Ph.D., who was Zikani’s Chief Scientific and Medical Officer, has been named Eloxx’s Head of Research and Development.

“With the strength of our ELX-02 program for cystic fibrosis, this acquisition provides us with the opportunity to amplify the potential of our innovative science by developing a new class of therapies to treat diseases with limited to no treatment options under the stewardship of leaders with a proven ability to translate technology into treatments for patients,”

said Tomer Kariv, Eloxx Chairman.

“We are excited about the potential of ELX-02 and combining the companies opens the door to build a leadership position in genetic therapy by rapidly developing treatments that can restore functional proteins in patients with nonsense mutations in their RNA,”

said Aggarwal.

“The combined capabilities of Eloxx and Zikani in chemistry, biology, regulatory and drug development, including Zikani’s TURBO-ZMTM synthetic chemistry platform for designing macrolide-based Ribosome Modulating Agents (RMAs), along with a committed leadership team and talented employees, will further accelerate our ability to impact the lives of those who have rare diseases with the type of urgency and novel thinking that they deserve,”

added Aggarwal.

ELX-02 is currently in Phase 2 clinical trials in Cystic Fibrosis (CF) patients affected by nonsense mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The investigational therapy has shown strong activity across a full range of mutations in CF preclinical models. In Phase 1 testing, ELX-02 was generally well- tolerated and demonstrated high bioavailability with consistent pharamacokinetics across both single and multiple-dose studies.

“The Phase 2 trials are designed to validate the safety of ELX-02 and assess its biological activity. We look forward to completing enrollment in the first four treatment arms by mid-year and reporting data from these treatment arms in the second half of this year,”

said Dr. Modur.

In addition to CF, the company plans to file an IND in 2022 for what could potentially become the first oral therapy for protein restoration for patients with nonsense mutations in Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional Epidermolysis Bullosa (JEB). RDEB is an incurable, extremely painful and often fatal skin blistering condition caused by a lack of collagen type VII that is estimated to affect more than 3,000 people worldwide. JEB is the most severe form of EB, with most patients dying in infancy.

By extending the application of ribosomal RNA modulation to the readthrough of nonsense mutations in tumor suppressor genes, the company is also rapidly advancing preclinical research for familial adenomatous polyposis (FAP), an inherited pre-cancerous colorectal disease frequently caused by nonsense mutations in the adenomatous polyposis coli (APC) gene.

Nonsense mutations cause approximately 10-12 percent of rare inherited diseases. ELX-02 along with the TURBO-ZMTM library of compounds are anticipated to significantly expand to include the treatment of many other rare diseases and certain cancers.

Acquisition Terms

Under the terms of the merger agreement, stockholders of Zikani received approximately 7.6 million Eloxx common shares and own approximately 16 percent of the combined company.

Board and Management Changes

In connection with the acquisition, Silvia Noiman, Ph.D., and Martijn Kleijwegt have stepped down from the Eloxx Board. Alan Walts, Ph.D., and Raj Parekh, Ph.D., who have both served as Zikani directors, were appointed to fulfill the vacancies and serve out the remaining terms of office.

“We’re pleased to welcome Sumit and Vijay to the Eloxx leadership team. They demonstrated their ability to transform Zikani by following the science and pursuing the creation of a new class of therapies on behalf of patients with unmet medical need. We want to extend our thanks and appreciation to Dr. Greg Williams for his stewardship of Eloxx and his commitment to advancing the critical work of the company. We are pleased that Greg will continue to advise Eloxx to facilitate a smooth transition” said Kariv.

Conference Call Information

Date: Thursday, April 1, 2021

Time: 8:30 a.m. ET

Domestic Dial-in Number: (866) 913-8546

International Dial-in Number: (210) 874-7715

Conference ID: 8180169

Live Webcast: accessible from the Company’s website at www.eloxxpharma.com under Events and Presentations or by clicking here. A replay of this conference call will be available on the Eloxx and Zikani websites.

Leadership Profiles

Sumit Aggarwal

Sumit Aggarwal served as Zikani’s President and CEO. He has led the transformation of Zikani from an early-stage technology company to a development-stage rare disease and oncology focused organization. Under Aggarwal’s leadership, Zikani has concentrated its focus on demonstrating pre-clinical proof of efficacy across several disease states using its TURBO-ZM™ technology platform.

In his more than 20 years in pharmaceutical and biotechnology commercial operations, investment management and management consulting, Aggarwal has been successful in transforming companies by re-invigorating innovation, growth and profitability, and raising capital for promising technology companies.

Prior to joining Zikani, he reinvigorated growth and profitability at Progenity, raised $125 million in capital and built a novel drug delivery-based GI pipeline. He also held leadership roles in healthcare and biotechnology at Adage Capital and as an Associate Partner at McKinsey & Company in its healthcare practice.

Aggarwal has an MBA with distinction from the Johnson School, Cornell University, and a Bachelor of Technology with Honors in Chemical Engineering from the Indian Institute of Technology, Kharagpur.

Vijay Modur, M.D., Ph.D.

Vijay Modur, M.D., Ph.D., served as Zikani’s Chief Scientific and Medical Officer and has led the scientific efforts to transform medicines based on ribosomal modulation using Zikani’s proprietary TURBO-ZM™ technology platform.

In his more than 20 years in pharmaceutical and diagnostic roles in R&D, he has successfully translated research discovery efforts into products that have impacted medical practice.

Prior to joining Zikani, Dr. Modur led the venglustat rare disease program at Sanofi across multiple rare disease indications into Phase 2 and Phase 3 clinical development along with leading other early development programs. Prior to Sanofi, he held leadership roles in HTG Molecular, Novartis Oncology and Merck Research Labs.

Dr. Modur obtained his MBBS from Karnatak University and his Ph.D. from the University of Utah. He was a resident in Clinical Pathology at Washington University School of Medicine where he also completed his post-doctoral fellowship.

About Eloxx Pharmaceuticals

Eloxx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA. As a consequence, patients with premature stop codon diseases have reduced or eliminated protein production from the mutation bearing allele accounting for some of the most severe phenotypes in these genetic diseases. These premature stop codons have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is focused on extending mRNA half-life and increasing protein synthesis by enabling the cytoplasmic ribosome to read through premature stop codons to produce full-length proteins. Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis. ELX-02 is an investigational drug that has not been approved by any global regulatory body. Eloxx’s preclinical candidate pool consists of a library of novel drug candidates designed to be eukaryotic ribosomal selective glycosides identified based on readthrough potential. Eloxx also has preclinical programs focused on kidney diseases including autosomal dominant polycystic kidney disease, as well as rare ocular genetic disorders. Eloxx is headquartered in Waltham, MA, with operations in Rehovot, Israel, and Morristown, NJ. For more information, please visit www.eloxxpharma.com.

About Zikani Therapeutics

Zikani Therapeutics is an emerging leader in the science of ribosome modulation, leveraging its innovative TURBO-ZMTM chemistry technology platform to develop novel Ribosome Modulating Agents (RMAs) as therapeutics for people with limited treatment options. Zikani’s TURBO-ZMTM platform allows rapid synthesis of novel compounds that can be optimized to modulate the ribosome in a disease specific manner. As the company evolves its focus from early-stage to clinical-stage research, Zikani is actively moving into pre-clinical development to target select rare diseases including inherited diseases and cancers caused by nonsense mutations. For more information, visit zikani.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, including: the development of the Company’s readthrough technology; the approval of the Company’s patent applications; the Company’s ability to successfully defend its intellectual property or obtain necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the Company’s ability to obtain applicable regulatory approvals for its current and future product candidates; the acceptance by the market of the Company’s products should they receive regulatory approval; the timing and success of the Company’s preliminary studies, preclinical research, clinical trials, and related regulatory filings; the ability of the Company to consummate additional financings as needed; the impact of global health concerns, such as the COVID-19 global pandemic, on our ability to continue our clinical and preclinical programs and otherwise operate our business effectively, including successfully integrating the combined companies; as well as those discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

Contact

Investors
John Woolford
john.woolford@westwicke.com
443.213.0506

Media
Laureen Cassidy
laureen@outcomescg.com

Mar 24
Love0

Aura Biosciences Expands Executive Leadership Team with the Appointment of Mark De Rosch, Ph.D., as Chief Operating Officer

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

March 24, 2021

CAMBRIDGE, MA – March 24, 2021 – Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the appointment of Mark De Rosch, Ph.D. as Chief Operating Officer. In his role, he will be responsible for leading Aura’s global operations and regulatory strategy.

Dr. De Rosch brings to Aura more than 30 years of experience in leading global regulatory and development strategies across many therapeutic areas, including oncology and ophthalmology. He has expertise in transitioning companies from early-stage to late-stage and in building effective teams to achieve clinical and corporate objectives.

“Mark joins our team during an exciting time at Aura. His decades of experience with global regulatory strategy, as well as building successful teams and pipelines, will be invaluable as we work to realize the full potential of our VDC technology platform,” said Elisabet de los Pinos, Ph.D., founder and CEO of Aura. “His proven track record and strong scientific acumen aligns well with our goals as we advance AU-011 toward late-stage pivotal development.”

“I am delighted to join Aura at this important time in the Company’s history and I look forward to being part of its promising future, as we work to become a leader in ocular oncology,”

said Dr. De Rosch.

“Aura’s experienced team and the novel VDC technology make this a compelling opportunity. I look forward to contributing my global regulatory, operational and organizational expertise to grow the Company and advance this leading technology to transform the outcomes for cancer patients.”

Dr. De Rosch joins Aura from Epizyme, where he served as Chief Regulatory Officer and led regulatory efforts for their first approved product, TAZVERIK® (tazemetostat). Prior to Epizyme, Dr. De Rosch served as Senior Vice President, Regulatory Affairs and Quality Assurance for Nightstar Therapeutics (acquired by Biogen in 2019), where he developed and implemented global regulatory roadmaps for their gene therapy programs in choroideremia and retinitis pigmentosa. Prior to Nightstar, he served as Senior Vice President, Regulatory Affairs, Quality Assurance and CMC at Akebia Therapeutics.  Before that, Dr. De Rosch served in roles of increasing responsibility at several life science and healthcare consulting firms. Dr. De Rosch holds a Ph.D. and an M.S. in inorganic chemistry from the University of California, San Diego and a B.S. in chemistry/biochemistry from the University of Wisconsin-Parkside.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the pioneering discoveries of NIH distinguished investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases that have no drugs approved. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation including patients with tumors close to the fovea and optic disk, along with a favorable safety profile. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer.  Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

Investor and Media Contact:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

Mar 18
Love0

Aura Biosciences Announces Oversubscribed $80 Million Financing

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

Proceeds to Support Pivotal Program of AU-011 for the First Line Treatment of Choroidal Melanoma and Expansion of Virus-like Drug Conjugate (VDC) Platform in additional Ocular Oncology Indications and Solid Tumors

Lead Investors Matrix Capital Management and Surveyor Capital (a Citadel company) are Joined by New Investors Rock Springs Capital and Adage Capital Management LP, Along with All Existing Institutional Investors

CAMBRIDGE, MA – March 18, 2021 – Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the closing of an oversubscribed $80 million financing. The financing was led by Matrix Capital Management and Surveyor Capital (a Citadel company) with participation from new investors, including Rock Springs Capital, Adage Capital Management LP and Velosity Capital. Existing investors Medicxi, Advent Life Sciences, Lundbeckfonden Ventures, Arix Bioscience, Chiesi Ventures, Ysios Capital and Columbus Venture Partners also participated in the round.

Aura intends to use the proceeds from this financing to advance the clinical development of its VDC technology platform, including the pivotal Phase 3 program for AU-011, the Company’s lead candidate in development for the first line treatment of choroidal melanoma, and ongoing research for additional programs in ocular oncology, as well as expanding the VDC technology into bladder cancer, the first non-ophthalmic solid tumor indication.

“Aura is pioneering the development of a new class of targeted therapies for life-threatening cancers with our novel VDC technology platform. This funding from a syndicate of distinguished investors enables us to advance AU-011 into a pivotal Phase 3 program for the first line treatment of choroidal melanoma, a rare, life- and vision-threatening form of cancer with no drugs approved. It also allows us to continue to expand the reach of our VDC technology in additional ocular oncology indications and in the treatment of solid tumors like bladder cancer where there is a high unmet medical need for better targeted therapies to treat early and reduce the incidence of metastasis,”

said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

In connection with this financing, Karan Takhar, Senior Managing Director of Matrix Capital Management, will join Aura’s Board of Directors.

Mr. Takhar said,

“Matrix believes in the long-term potential of Aura’s VDC technology to further strengthen the Company’s position as a leader in ocular oncology and beyond within other types of cancers in need of better treatment options. We look forward to supporting Aura’s leadership team through this next stage of pipeline growth and transition into late-stage development with the commencement of the AU-011 pivotal program.”

About AU-011 (belzupacap sarotalocan)

AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparan sulphate proteoglycans (HSPGs) that are modified and overexpressed on the tumor cell surface of choroidal melanoma cells (and other tumors) and delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant melanoma cells with a pro-immunogenic cell death that is believed to activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. The possibility of early treatment intervention and the activation of the immune system could lead to a reduction in the metastatic rate for patients with this life-threatening disease. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration and is currently in Phase 2 clinical development.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the pioneering discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases that have no drugs approved. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. Aura has demonstrated the efficacy and safety of AU-011 in a Phase 1b/2 trial, including high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

Investor and Media Contact:
Joseph Rayne
Argot Partners
617.340.6075 | joseph@argotpartners.com

Mar 17
Love0

Amphista Therapeutics raises $53M in oversubscribed Series B round to advance next generation targeted protein degradation assets

By Amphista Therapeutics, Press Release, Private Companies
Press Release.

 

Financing includes leading life-science investors Gilde Healthcare, Forbion, Novartis Venture Fund and Eli Lilly and Company

 

Glasgow, UK, 17 March 2021 – Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, today announced the closing of a $53 million (£38 million) Series B financing round. The round was co-led by Forbion and Gilde Healthcare. Additional investors in this round include Novartis Venture Fund, and Eli Lilly and Company, joining existing investor BioMotiv and founding investor Advent Life Sciences. The proceeds will be used to accelerate the company’s growing pipeline of potent and selective bifunctional molecules, known as ‘Amphistas’ to the clinic and to extend its proprietary TPD platform.

Amphista’s CEO Nicola Thompson said,

“This financing round, led by an outstanding investor syndicate, is a strong endorsement of our world class team and our novel approach. Amphista will now accelerate its oncology pipeline towards the clinic and extend our portfolio into indications largely inaccessible by traditional TPD approaches, such as diseases of the central nervous system (CNS). This oversubscribed Series B supports our ambition as a world-leading next generation protein degradation company delivering ground-breaking new medicines to patients in areas of high unmet need.”

Rogier Rooswinkel, Partner at co-lead investor, Forbion said,

“We are delighted to have selected Amphista as the first company to invest in from our fifth fund that closed late last year. Amphista combines several attributes we typically look for: a world-class team, innovative science, and a disruptive technology that has the potential to improve treatment options and thus impact many patients’ lives.”

Stefan Luzi, Partner at co-lead investor Gilde, said,

“Amphista emerged as the best-in-class protein degradation company in our comprehensive landscaping effort. We believe this team, who are pioneers in this field, combined with a truly unique platform, will unlock the full therapeutic potential of a broad range of disease targets. Amphista represents a strong fit with Gilde’s longstanding strategy of identifying Europe’s leading science and of engaging with experienced drug developers to build and support high growth (bio)pharma companies.”

Amphista’s TPD approach offers a greatly improved way of treating disease and modulating drug targets, using synthetic small molecule degraders. Amphista’s next generation bifunctional degraders use a novel set of mechanisms that make use of a wider range of the body’s own innate protein degrading proteins, instead of the very narrow set of ubiquitin E3 ligase-based mechanisms used by most other TPD companies. This proprietary approach offers the potential to overcome many of the limitations seen with current TPD approaches, providing the opportunity to treat a wider range of diseases. Amphista is focused on biological targets with a high level of clinical or genetic validation, allowing the team to focus on the translation of their novel TPD approach for clinical benefit in areas of high unmet need.

In association with this financing, Amphista has added the following leading life science executives to the Board: Stefan Luzi, Partner at Gilde Healthcare; Rogier Rooswinkel, Partner at Forbion; and Florian Muellershausen, Managing Director at Novartis Venture Fund.

–    Ends   –

 

Media contacts:

Amphista Therapeutics
CEO Nicola Thompson
+447464974714
nicki@amphista.com

Scius Communications
Katja Stout
+447789435990
katja@sciuscommunications.com

About Amphista Therapeutics

Amphista Therapeutics is a biopharmaceutical company creating first-in-class therapeutics that harness the body’s natural processes to selectively and efficiently degrade and remove disease-causing proteins. The company’s pipeline of novel targeted protein degradation (TPD) based medicines is focused on challenging diseases including cancer. Founded by Advent Life Sciences, Amphista is a spin-out of TPD expert Professor Alessio Ciulli’s labs at the University of Dundee. The company has raised approximately £45M to date and is funded by leading life science investors including Forbion, Gilde Healthcare, Novartis Venture Fund, Advent Life Sciences, BioMotiv and Eli Lilly and Company.

For more information, please visit: http://www.amphista.com/

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the UK, the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.

For more information, please visit www.AdventLS.com

About Forbion

Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space.

Forbion manages well over EUR 1.7 billion across multiple fund strategies that cover all stages of (bio)pharmaceutical drug development. Forbion’s current team consists of 20 life sciences investment professionals that have built an impressive performance track record since the late nineties with successful investments in over 69 companies.

The firm is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and wellbeing of patients. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, “ERP – Venture Capital Fonds investments”. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany.

For more information, please visit www.forbion.com.

About Gilde Healthcare

Gilde Healthcare is a specialized healthcare investor with $1.8 billion under management across two fund strategies: Venture & Growth and Private Equity. The firm operates out of offices in Utrecht (The Netherlands), Frankfurt (Germany) and Cambridge (United States).

Gilde Healthcare Venture & Growth invests in innovative companies active in (Bio)Pharmaceuticals, HealthTech and MedTech. The portfolio of the Venture & Growth fund is balanced with fast growing life science companies from Europe and North America.

For more information, please visit www.gildehealthcare.com.

About Novartis Venture Fund

Novartis Venture Fund is a financially driven corporate life science venture fund whose purpose is to foster innovation, drive significant patient benefit and generate superior returns by creating and investing in innovative life science companies at various stages of their development.

For more information, please visit www.nvfund.com.

About Eli Lilly and Company

Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. They were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today they remain true to that mission in all their work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

For more information, please visit www.lilly.com and www.lilly.com/newsroom.

About BioMotiv

BioMotiv is a mission-driven accelerator associated with The Harrington Project for Discovery & Development, a $340 million initiative focused on advancing early stage breakthrough discoveries from research institutions into medicines. Led by a highly accomplished and passionate team of veteran biopharma experts, BioMotiv’s innovative model efficiently aligns resources and capital to select, fund, manage and advance a portfolio of drug development programs.

For more information, please visit: www.biomotiv.com

Mar 17
Love0

Advent Life Sciences’ founded Amphista Therapeutics raises $53M in oversubscribed Series B round to advance next generation targeted protein degradation assets

By Advent Life Sciences, Press Release
Press Release.

 

This investment will fund Amphista Therapeutics’  growing pipeline of potent and selective bifunctional molecules, known as ‘Amphistas’ to the clinic and extend its proprietary platform.

London, UK, 17 March 2021 – Advent Life Sciences (“Advent”) a leading transatlantic venture investor focused on building innovative life science companies in the UK, Europe and the US, today announces that Amphista Therapeutics, an Advent founded biotech and leader in next generation targeted protein degradation (TPD) approaches, has closed a $53 million (£38 million) Series B financing round. Advent Life Sciences, and existing investor BioMotiv, will be joined by a strong syndicate of new investors:  Forbion, Gilde Healthcare, the Novartis Venture Fund and Eli Lilly & Company.

Amphista’s TPD approach offers a greatly improved way of treating disease and modulating drug targets, using synthetic small molecule degraders. Amphista’s next generation bifunctional degraders use a novel set of mechanisms that make use of a wider range of the body’s own innate protein degrading proteins, instead of the very narrow set of ubiquitin E3 ligase-based mechanisms used by most other TPD companies. This proprietary approach offers the potential to overcome many of the limitations seen with current TPD approaches, providing the opportunity to treat a wider range of diseases. Amphista is focused on biological targets with a high level of clinical or genetic validation, allowing the team to focus on the translation of their novel TPD approach for clinical benefit in areas of high unmet need.

Raj Parekh, General Partner, Advent Life Sciences commented:
“Advent over the last 20 years has continued to found and invest in the highest quality life science companies. With its exceptional  academic and medical science base, many of these companies  have originated from the UK. Amphista is another example of Advent’s continuing strategy to identify innovative and differentiated science as the basis of world-leading companies that will address areas of high unmet medical need. The Advent team have worked closely with Professor Alessio Ciulli, the University of Dundee and the Amphista team to found and to grow the company. We are delighted to be joined by this strong syndicate of experienced investors and pharmaceutical companies for the next stage in Amphista’s growth.”

Nicola Thompson, CEO, Amphista Therapeutics commented:

“This financing round, led by an outstanding investor syndicate, is a strong endorsement of our world class team and our novel approach. Amphista will now accelerate its oncology pipeline towards the clinic and extend our portfolio into indications largely inaccessible by traditional TPD approaches, such as diseases of the central nervous system (CNS). This oversubscribed Series B supports our ambition as a world-leading next generation protein degradation company delivering ground-breaking new medicines to patients in areas of high unmet need.”

In addition to Amphista, Advent has founded over 20 new biotech companies. Recent examples include Arrakis Therapeutics that struck an $190 million partnership deal with Roche in the first half of 2020, and KaNDy Therapeutics which was acquired by Bayer Pharmaceuticals for over $875 million also last year. Advent continues to invest at seed, series A and beyond, backing companies to develop new therapeutics and high-potential medical technologies. Advent’s team includes 16 investment professionals with a track record of supporting entrepreneurs to deliver innovative new medicines and products. In the last 15 years, Advent’s portfolio companies have discovered 14 first- or best-in-class medicines and products that have successfully achieved regulatory approval, each for a different and unmet medical need.

The full announcement from Amphista can be found here: Amphista Therapeutics raises $53M

–    Ends   –

Media contacts:

Advent Life Sciences
Laura Lane
+ 44 (0) 7795 469 847
pr@adventls.com

Amphista Therapeutics
CEO Nicola Thompson
+44 (0) 7464 974714
nicki@amphista.com

Scius Communications for Amphista
Katja Stout
+44 (0) 7789 435990
katja@sciuscommunications.com

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the UK, the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.

For more information, refer to: www.adventls.com

About Amphista Therapeutics
Amphista Therapeutics is a biopharmaceutical company creating first-in-class therapeutics that harness the body’s natural processes to selectively and efficiently degrade and remove disease-causing proteins. The company’s pipeline of novel targeted protein degradation (TPD) based medicines is focused on challenging diseases including cancer. Founded by Advent Life Sciences, Amphista is a spin-out of TPD expert Professor Alessio Ciulli’s labs at the University of Dundee. The company has raised approximately £45M to date and is funded by leading life science investors including Forbion, Gilde Healthcare, Novartis Venture Fund, Advent Life Sciences, BioMotiv and Eli Lilly and Company.

For more information, refer to: www.amphista.com

Mar 12
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Advent Life Sciences Becomes Latest Partner of One Nucleus

By Advent Life Sciences, Press Release
Press Release.

 

Cambridge and London UK: 12th March 2021

Advent Life Sciences, one of the sector’s leading Trans-Atlantic venture investors has become the latest Partner to join One Nucleus. The One Nucleus Partner Programme is tailor-made to meet the needs of the Partner and One Nucleus members.

Shahzad Malik, General Partner, Advent Life Sciences commented

“Advent is committed to investing in outstanding, early-stage science and to establish and nurture innovative companies in the UK, Europe and US. We greatly value partnerships in supporting this, as exemplified by the our new Advent-Harrington Impact Fund, in conjunction with the transatlantic not-for-profit drug development group, Harrington Discovery Institute. Joining the Partner Programme brings further opportunities to our multinational portfolio of companies available through One Nucleus membership, and leveraging that ecosystem as they grow.”

Tony Jones, CEO of One Nucleus expands further

“We are delighted to welcome Advent Life Sciences to the One Nucleus Partner Programme. Their track record of funding and nurturing high growth Life Science companies illustrates the value to our members and wider network of engaging them and their portfolio. One Nucleus is entirely focussed on how we bring great innovation, leadership and investment together to enable translation of world class science to patient benefit and returns for all stakeholders. Advent Life Sciences bring immense expertise, connectivity and capacity to help us in that endeavour.”

ENDS

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France. For more information, please visit www.AdventLS.com

About One Nucleus
Established in 1997, One Nucleus is an award winning not-for-profit Life Sciences & Healthcare membership organisation centred on the Greater London-Cambridge-East of
England corridor. Headquartered in Cambridge, at the heart of Europe’s largest Life Sciences & Healthcare cluster, we support those institutions, companies and individuals undertaking activity in or with the above region.

Through providing the local, UK-wide and international connectivity, One Nucleus seeks to enable our members to maximise their performance. This support helping them achieve, or better still exceed, the goals they have set for themselves. Biomedical and Healthcare R&D have always been impactful in driving social and economic progress. In an increasingly outsourced, collaborative and multi-disciplinary sector, bringing the best people together is key to translating great innovation into great products that markedly improve patient outcomes and drive economic development. Attracting and enabling the best people to engage with is at the heart of the One Nucleus team ethos and what we continually strive to deliver.

For further information, please contact:

Tony Jones, CEO

Email: Tony@onenucleus.com
Tel: +44 (0)1223 896463
Web: www.onenucleus.com

Email: pr@adventls.com
Tel:+44 (0)20 7932 2100
Web: www.adventls.com

Mar 02
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Highlight Therapeutics and Pivotal work together on Melanoma therapy and launch a Phase IIa trial to examine BO-112 efficacy and safety

By Highlight Therapeutics, Press Release, Private Companies
Press Release.

 

  • Trial will examine administration of Highlight’s BO-112 in combination with an anti-PD1 in unresectable or metastatic melanoma patients
  • Recruitment has already begun across 19 top-level centers in Spain and France
  • No delays to recruitment despite the persistent challenges encountered during the COVID-19 pandemic

Madrid, Spain, 2 March, 2021 – Highlight Therapeutics, (“Highlight”), a clinical-stage biopharmaceutical company developing RNA-based therapies against cancer, and Pivotal, a Europe-wide full-service CRO, today announced that the first patients have been recruited in a Phase IIa study to assess Highlight’s lead program BO-112 in combination with an anti-PD1 therapy, in patients with unresectable or metastatic melanoma that have previously progressed to checkpoint inhibitors

Melanoma is the most malignant tumor of the skin although it can be seldom found in other organs. Incidences of this tumor are rapidly increasing in western countries and, once disseminated, it has been considered an incurable disease with limited therapeutic options. Recently, immunotherapy with anti-PD1 (checkpoint inhibitors) showed encouraging results with 30-36% patients alive at 5 years. Unfortunately, the median PFS (progression free survival) is less than 12 months, mainly due to primary or acquired resistance to anti-PD1 treatment, and most of those patients will die due to the tumor or its complications.

“This Phase IIa study is an important step forward in our strategy to develop effective cancer therapies which can be used in combination with checkpoint inhibitors. We are looking to produce a better immunological response in anti-PD1 therapy-sensitive patients, and to induce or maintain responses for those patients that progress or are initially treatment-resistant. BO-112 has the potential to be employed from the beginning of disease treatment and we believe it offers patients a resistant status after immunological treatment,”

said Dr. Marisol Quintero, PhD, CEO of Highlight Therapeutics.

“We are encouraged by the effectiveness already seen in previously treated melanoma patients in the phase I study with BO-112 and we are pleased to be working once more with the highly experienced and dedicated team at Pivotal.”

This Phase IIa, open-label clinical study is a non-comparative trial implemented in 19 sites across Spain and France. The protocol will include a minimum of 40 non-resectable melanoma patients. This is the third trial with BO-112, following initiation of the phase I trial in 2016. In 2020, a second trial was initiated in gastrointestinal tumors from which the first cohorts have already been successfully completed, and the recruitment of this phase IIa trial has now been initiated in melanoma despite the obstacles presented due to the COVID-19 pandemic.

The study will evaluate the anti-tumoral activity and systemic exposure of repeated intratumoral injections of BO-112 into a tumoral lesion, in combination with intravenously administered anti-PD1. BO-112 has intrinsic anti-tumoral effects, but interestingly acts on several mechanisms involved in resistance to Checkpoint inhibitors.

“The excellence in clinical research of the clinical investigators´ teams, together with Pivotal’s infrastructure and vast experience in the implementation and performance of innovative early phases clinical trials, will allow us to accelerate the research and to quickly test this new treatment regimen,”

said Dr. Lourdes Huarte, PhD, Senior Vice President of Regulatory and Clinical Operations at Pivotal.

“The challenge of this trial was to swiftly implement the study and activate its recruitment in a period negatively impacted by the COVID-19 pandemic. We are delighted to have diligently achieved our first milestone with the recruitment of the first patients in this trial.”

About Highlight Therapeutic

Highlight Therapeutics, formerly known as Bioncotech Therapeutics, is a private, clinical-stage company dedicated to unlocking the full potential of immuno-oncology. Our lead drug candidate BO-112 is a best-in-class RNA-based therapy which has been demonstrated to initiate a powerful immune response, leveraging a unique multi-target approach to turn ‘cold’ tumors ‘hot’ and therefore visible to the immune system. It has the potential to rescue patients who are resistant to current checkpoint inhibitor therapy, a very large market opportunity. BO-112 is currently being investigated in a range of clinical trials as a monotherapy and in combination with checkpoint inhibitors. In addition to in-house research, Highlight Therapeutics has a number of external collaborators, including Merck & Co and UCLA
For more information, please visit www.highlighttherapeutics.com; or

Contacts Dr. Marisol Quintero CEO at Highlight Therapeutics     info@highlighttherapeutics.com
Mo PR Advisory    Tel: +44 (0) 7876 444977 / 07860 361746
Mo Noonan/Jonathan Birt

About Pivotal

Pivotal was founded in 2001 by Dr. Ibrahim Farr on the principle that strategic medical advice and support should be the backbone of all clinical trials. After working for over two decades in the pharmaceutical industry, Dr. Farr recognized the need for a medium-sized CRO with a solid internal medical franchise that could act not only as the “doers” but also as the “co-thinkers” for their clients, through its strategic scientific advice. To date, we are the trusted adviser and counsellor for many companies to deliver maximum value in their drug and medical devices development programs. We are a leading privately held European CRO and, since inception, we have experienced a fast and steady organic growth in Europe.
Pivotal´s client portfolio spans major pharmaceutical, biotechnological, medical device and nutrition companies, as well as independent investigators and cooperative groups. We have long-standing relations with over 200 clients. Pivotal has extensive experience across major therapeutic areas and phases I to IV. Our highly customized teams bring to each client a combination of broad industry knowledge and operational excellence, to offer our clients fresh perspectives and breakthrough business insights. Additionally, we have built a strong oncology, innovative therapies, infectious diseases, vaccines, rare diseases and early phases hub that enables us to tackle our customers most difficult challenges, turning recommendations into concrete actions. By remaining true to our core principles and values, our vision is to become our client’s preferred outsourcing solution partner.
For more information, please visit www.pivotalcr.com; or
Contact Ms Natalia Farr at Pivotal natalia.farr@pivotalcr.com

Feb 18
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Advent Life Sciences Announces Close of Two New Funds Totalling $215 million

By Advent Life Sciences, Press Release
Press Release.

 

18 February 2021, London, UK: Advent Life Sciences, a leading transatlantic venture investor focused on building innovative life science companies in the UK, Europe and the US, announced today that it has closed two new funds with commitments totalling $215 million.

Advent Life Sciences Fund III is the firm’s third dedicated life sciences venture capital fund raised from new Limited Partners (LPs), including British Patient Capital, as well as existing LPs.

The Advent-Harrington Impact Fund is a new type of fund raised in collaboration with the Harrington Discovery Institute to translate innovative drug discoveries into novel treatments for the benefit of patients and society, otherwise known as ‘impact’ investing.

Investing at seed, series A and beyond, the funds will primarily support companies to develop new therapeutics but will also continue Advent’s successful strategy of backing high-potential medical technology companies.

Since its launch, Advent Life Sciences has invested at the interface of academic research and commercial drug development with a focus on identifying and backing high-impact, high-potential innovations that can deliver important new medicines for unmet medical needs. The partnership with Harrington Discovery Institute expands this paradigm by increasing access to world-class academic science with high medical and commercial promise.

Shahzad Malik, General Partner, Advent Life Sciences said:

“The last year has reinforced the vital need to translate world class science into the discovery and development of new medicines to tackle devasting diseases.  Advent has continued its successful strategy to invest in outstanding, early-stage science and to establish and nurture  innovative companies for patients and investors alike.  We are delighted that British Patient Capital joins as a new cornerstone investor in our third fund.

We are also delighted to have partnered with the transatlantic not-for-profit drug development group, Harrington Discovery Institute to raise the new Advent-Harrington Impact Fund.  This new collaboration will allow us to both broaden the quality of the investment opportunities across the globe and increase the amount of capital available to support them. We believe this translational financing is critical to the development of new medicines, and that it will deliver real impact to patients in addition to strong financial returns.”

Judith Hartley, CEO, British Patient Capital, said:

“Our cornerstone commitment to Advent Life Sciences’ latest fund is a key part of our strategy to invest with fund managers that can leverage the UK’s world leading position in life sciences. Developing new life science technologies from research through to new medicines is crucial. Long-term patient capital can support our high-potential, high growth life science companies to reach their full potential and deliver compelling returns.”

Advent’s portfolio company success stories over the last year include the sale of Advent-founded KaNDy Therapeutics to Bayer Pharmaceuticals for over $875 million bringing a non-hormonal treatment for symptoms of the menopause closer to patients; Advent-founded Arrakis’ $190 million partnership deal with Roche to develop small molecule modulators of RNA; the NASDAQ IPO of Acutus Medical launching a best-in-class mapping technology and future ablation therapies for cardiac arrythmias; and notable follow-on financings including participating in a $60 million round for F2G Therapeutics, that also received Breakthrough Therapy Designation from the FDA for its novel class of anti-fungal treatments that address a very high unmet need.

Advent’s team includes 16 investment professionals with a track record of nurturing entrepreneurs to deliver innovative new medicines. In the last 15 years alone, Advent has supported its portfolio companies in developing 14 new approved medical products.  Advent has founded over 20 new biotech companies that are focused on translating academic research into the next generation of medicines.  This stage of development in life sciences is underserved and Advent’s team has extensive experience in supporting new companies through the critical early years.

–    ENDS   –

Notes to Editors:

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.  For more information, please visit www.AdventLS.com

About British Patient Capital
British Patient Capital is the trading name of British Patient Capital Limited, a wholly-owned commercial subsidiary of British Business Bank plc, the UK government’s economic development bank. It forms part of the British Business Bank’s commercial arm.

Its mission is to enable long-term investment in innovative firms led by ambitious entrepreneurs who want to build large scale businesses. Launched in June 2018, British Patient Capital has £2.5bn to invest over 10 years in venture and venture growth capital to support high growth potential innovative UK businesses in accessing the long-term financing they require to scale up. Find out more at britishpatientcapital.co.uk

Contacts:
Katja Stout, Scius Communications
katja@sciuscommunications.com
+44 7789 435990

Laura Lane, Advent Life Sciences
laura@adventls.com
+44 207 932 2159

Feb 16
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Centessa Pharmaceuticals Launches with $250 Million Series A Financing and Unveils a New Kind of Pharmaceutical R&D Model

By Centessa Pharmaceuticals, Press Release, Publicly Listed
Press Release.

 

Merger of 10 Privately Held Biotech Companies with Highly Validated Programs Led by Industry Leading Teams to Operate Under Centessa Umbrella

Company Founded by Medicxi with Financing Led by General Atlantic, and Co-led by Vida Ventures and Janus Henderson Investors

Saurabh Saha, M.D., Ph.D., Former Senior Vice President, R&D, and Global Head of Translational Medicine at Bristol Myers Squibb, Appointed as Chief Executive Officer

Moncef Slaoui, Ph.D., Former Chief Scientific Advisor of Operation Warp Speed, Former Chairman of R&D at GlaxoSmithKline, Partner at Medicxi, Appointed as Chief Scientific Officer, Advisor
February 16, 2021 06:30 AM Eastern Standard Time

CAMBRIDGE, Mass. & LONDON–(BUSINESS WIRE)–Centessa Pharmaceuticals (“Centessa”) launched today as a novel asset-centric pharmaceutical company designed and built to advance a portfolio of highly validated programs. Centessa’s asset-centric R&D model applied at scale has assembled best-in-class or first-in-class assets, each of which is led by specialized teams committed to accelerate development and reshape the traditional drug development process. The company was founded by Medicxi and raised $250 million in an oversubscribed Series A financing led by General Atlantic and co-led by Vida Ventures and Janus Henderson Investors. Additional blue-chip investors participated in the financing, including Boxer Capital, Cormorant Asset Management, T. Rowe Price Associates, Inc., Venrock Healthcare Capital Partners, Wellington Management Company, BVF Partners L.P., EcoR1 Capital, Franklin Templeton, Logos Capital, Samsara BioCapital, LifeSci Venture Partners and an undisclosed U.S.-based, healthcare-focused fund.

“This approach encourages an environment where scientific teams are incentivized to maintain an unwavering focus on advancing medicines to key go/no-go inflection points based on data-driven decisions.”

In conjunction with its launch, Centessa has completed the merger of 10 private biotech companies (“Centessa Subsidiaries”) that will each continue to develop its assets with oversight from the Centessa management team. Each Centessa Subsidiary team is asset-focused, in that it prosecutes a single program or biological pathway, with leadership provided by subject matter experts who are given a high degree of autonomy to advance each program. With a singular focus on advancing exceptional science, combined with proprietary capabilities, including structure-based drug discovery and design, the subsidiary teams enable Centessa to potentially develop and deliver impactful medicines to patients.

“The vision of Centessa is to build a pharmaceutical company with a unique operational framework that aims to reduce some of the key R&D inefficiencies that classical pharmaceutical companies face because of structural constraints,”

said Francesco De Rubertis, Ph.D., Co-Founder and Partner at Medicxi and Chairman of the Centessa Pharmaceuticals Board of Directors.

“Our operations will be driven by an asset-centric approach, whereby each Centessa Subsidiary is solely focused on the execution of its programs with oversight from the highly experienced Centessa management team. The ambition of applying asset centricity at scale is to be able to deliver life altering medicines to patients with improved efficiency by boosting R&D productivity.”

Our Approach
Centessa brings together 10 companies from Medicxi’s portfolio with 15 high conviction programs led by experienced teams. Each Centessa Subsidiary is led by industry leaders and subject matter experts with deep experience directly related to key biological pathways that underpin the programs being advanced. These entrepreneurs who have catalyzed the creation of subsidiary companies will continue to advance novel science within the Centessa enterprise.

The Centessa Subsidiaries are comprised of ApcinteX, Capella BioScience, Janpix, LockBody, Morphogen-IX, Orexia Therapeutics, Palladio Biosciences, PearlRiver Bio, Pega-One and Z Factor. The current Centessa Pharmaceuticals portfolio consists of four clinical stage programs, including two that are in late-stage clinical development, and more than 10 additional programs spanning diseases with high unmet need across oncology, hematology, immunology, inflammation, neuroscience and rare diseases.

“With this first-of-its-kind model, we are bringing together programs with robust genetic and biological validation under one new pharmaceutical company that provides centralized resources to enable and empower asset-focused teams to advance highly impactful programs for patients,”

said Saurabh Saha, M.D., Ph.D., Centessa’s Chief Executive Officer.

“This approach encourages an environment where scientific teams are incentivized to maintain an unwavering focus on advancing medicines to key go/no-go inflection points based on data-driven decisions.”

Centessa will have the flexibility to deploy capital by adhering to a “follow-the-data” philosophy and will support each Centessa Subsidiary with centralized capabilities that enable advancement of its respective programs. These include manufacturing, regulatory and operational support to enable and expedite scientific prosecution of programs by subsidiary teams. Each team is uniquely incentivized to expeditiously interrogate key scientific hypotheses.

Moncef Slaoui, Ph.D, Chief Scientific Officer, Advisor of Centessa added,

“In creating Centessa, we have strategically assembled our subsidiary portfolio to include programs with strong biological validation, mechanistic diversification, and teams with proprietary capabilities and insights. This high-quality portfolio aims to deliver enhanced diversification, reduced risk and asymmetric upside with a view to withstanding the inherent low probability of success associated with drug development.”

Meet the Team
The Centessa Pharmaceuticals management team consists of biotech and pharmaceutical industry leaders who oversee decisions related to capital allocation, development plans and strategic transactions in partnership with the Centessa Subsidiaries.

Saurabh Saha, M.D., Ph.D., former Senior Vice President, R&D, and Global Head of Translational Medicine at Bristol Myers Squibb, has been appointed as the company’s Chief Executive Officer and a member of the Board of Directors. In addition, Moncef Slaoui, Ph.D., former Chief Scientific Advisor of Operation Warp Speed, former Chairman of R&D at GlaxoSmithKline, and Partner at Medicxi, has been appointed as Chief Scientific Officer, Advisor.

The Centessa Board of Directors includes Francesco De Rubertis, Ph.D., Medicxi, who will serve as the company’s Chairman; Aaron Kantoff, Medicxi; Brett Zbar, M.D., General Atlantic; and Arjun Goyal, M.D., M.Phil., Vida Ventures.

“We believe Centessa represents a unique opportunity in our sector,”

said Brett Zbar, M.D., Managing Director and Global Head of Life Sciences at General Atlantic.

“The high-quality science and entrepreneurial drive within each of the Centessa Subsidiaries, combined with this deeply experienced leadership team, has the potential to bring important medicines to patients with speed and efficiency.”

“Centessa’s bold vision and unique operating model are supported by compelling clinical programs, strong data and a stellar team,” said Arjun Goyal, M.D., M.Phil., Co-Founder and Managing Director at Vida Ventures. “We believe Centessa’s approach can ultimately lead to impactful medicines that will benefit patients globally.”

ABOUT THE CENTESSA SUBSIDIARIES

ApcinteX
ApcinteX is developing SerpinPC, a specific inhibitor of the anticoagulant protease activated protein C (APC), for the treatment for hemophilia A and hemophilia B, with or without inhibitors.

Capella BioScience
Capella BioScience is developing CBS001, a neutralizing therapeutic monoclonal antibody to the inflammatory membrane form of LIGHT (known as TNFSF14), for the treatment of idiopathic pulmonary fibrosis. Capella BioScience is also developing CBS004, a therapeutic monoclonal antibody to blood dendritic cell antigen 2 (BDCA2), for the treatment of lupus erythematosus (systemic and cutaneous) and systemic sclerosis.

Janpix
Janpix is developing a novel class of selective dual-STAT3/5 small molecule monovalent degraders for the treatment of various hematological malignancies, including leukemias and lymphomas.

LockBody
LockBody is pioneering a platform technology to develop LockBody CD47 (LB1) and LockBody CD3 (LB2) for optimal targeting of solid tumors by the innate immune system.

Morphogen-IX
Morphogen-IX is developing MGX292, a protein-engineered variant of human bone morphogenetic protein-9 (BMP9), for the treatment of pulmonary arterial hypertension.

Orexia Therapeutics
Orexia Therapeutics is developing oral and intranasal orexin receptor agonists using structure-based drug design approaches. These agonists target the treatment of narcolepsy type 1, where they have the potential to directly address the underlying pathology of orexin neuron loss, as well as other neurological disorders characterized by excessive daytime sleepiness.

Palladio Biosciences
Palladio Biosciences is developing lixivaptan, an oral non-peptide, new chemical agent that works by selectively suppressing the activity of the hormone vasopressin at the V2 receptor, as a treatment for autosomal dominant polycystic kidney disease with the goal of slowing the progression of kidney function decline and avoiding the liver safety issues associated with tolvaptan.

PearlRiver Bio
PearlRiver Bio is developing ​potent and selective oral exon20 insertion mutation inhibitors intended to have ​minimal activity on wild-type EGFR and optimal pharmacokinetic properties, ​for the treatment of EGFR exon 20 insertion (with potential to target and treat Her2 exon 20 insertions) non-small cell lung cancer (NSCLC). PearlRiver Bio is also developing oral inhibitors targeting C797S-mutant EGFR and undisclosed next generation EGFR inhibitors for NSCLC.

PegaOne
PegaOne is developing imgatuzumab, a humanized, non-fucosylated, anti-EGFR monoclonal antibody for the treatment of cutaneous squamous cell carcinoma and other solid tumor indications.

Z Factor
Z Factor is developing ZF874, a small molecule chemical chaperone intended to rescue folding of the Z variant of alpha-1-antitrypsin, increasing serum levels of active protein and reducing accumulation in the liver, for the treatment of alpha-1-antitrypsin deficiency.

ABOUT CENTESSA PHARMACEUTICALS

Centessa Pharmaceuticals Limited is a next-generation biopharmaceutical company that aims to reshape the traditional drug development process. The company applies an asset-centric R&D model at scale to advance a portfolio of highly validated programs led by industry leading teams. Each program is developed by an Centessa Subsidiary and supported by a centralized infrastructure and the Centessa management team. The company is headquartered in Cambridge, Mass. For more information, visit www.centessa.com

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “estimates,” “expects,” “intends,” “anticipates,” “believes,” “may,” “should,” “will,” “plans,” “projects,” “seeks,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans and prospects regarding the clinical development plans and timing, clinical trial designs, clinical and therapeutic potential, and strategy for any of our programs reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of clinical trials, regulatory filings, and approvals. These forward-looking statements are based upon the current expectations and beliefs of Centessa’s management team as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Furthermore, Centessa operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Media:
Dan Budwick, 1AB
dan@1abmedia.com

UK/European media enquiries
Optimum Strategic Communications
Mary Clark, Shabnam Bashir
centessa@optimumcomms.com

Swiss media enquiries
VEITHing Spirit
Marcus Veith
marcus@vspirit.ch
Cellphone: +41 79 20 75 111

Jan 25
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Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem

By Iterum, Press Release, Publicly Listed
Press Release.

 

If approved, First Oral Penem in the U.S. and First New Oral Treatment for uUTIs in Over 20 Years

PDUFA goal date of July 25, 2021

DUBLIN, Ireland and CHICAGO, Jan. 25, 2021 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a quinolone non-susceptible pathogen. The FDA has designated this application as a priority review and consequently assigned a PDUFA (Prescription Drug User Fee Act) goal date for completion of the review of oral sulopenem of July 25, 2021. The agency currently plans to hold an advisory committee meeting to discuss the NDA.

“The FDA acceptance of our NDA for review is an important milestone for Iterum. If approved, oral sulopenem would be the first penem available orally in the U.S. with the ability to treat multi-drug resistant infections in the community,”

said Corey Fishman, Chief Executive Officer.

“Specifically, this important antibiotic is one step closer to relieving the growing problem of quinolone resistance found in over six million uncomplicated urinary tract infections in the U.S. each year.”

The NDA includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated. The SURE-1 clinical trial (uUTIs) demonstrated statistical superiority of oral sulopenem to the widely used comparator, ciprofloxacin, for the primary efficacy endpoint of clinical and microbiologic response at the test-of-cure visit for patients with a quinolone non-susceptible pathogen.

About Iterum Therapeutics plc

Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding, among other things, timing of the review of regulatory filings and the market opportunity for, and potential market acceptance of, oral sulopenem for uUTIs, and the Company’s plans, strategies and prospects for its business. In some cases, forward-looking statements can be identified by words such as “may,” “believes,” “intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “would,” “will,” “future,” “potential” or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside the Company’s control, including the uncertainties inherent in the initiation and conduct of clinical trials,  availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, the timing of approval of any submission, changes in public policy or legislation, commercialization plans and timelines, if oral sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of the Company’s expectations regarding how far into the future the Company’s cash on hand will fund the Company’s ongoing operations, the sufficiency of the Company’s cash resources and the Company’s ability to continue as a going concern, the impact of COVID-19 and related responsive measures thereto, the Company’s ability to maintain listing on the Nasdaq Capital Market, risks and uncertainties concerning the outcome, impact, effects and results of the Company’s evaluation of corporate, organizational, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, organizational, strategic, financial or financing alternative and the Company’s ability to complete one at all, the price of the Company’s securities and other factors discussed under the caption “Risk Factors” in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Investor Contact:
Judy Matthews
Chief Financial Officer 312-778-6073
IR@iterumtx.com

Source: Iterum Therapeutics plc