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Fierce Biotech Names Amphista Therapeutics as One of its “Fierce 15” Biotech Companies of 2022

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

 

Cambridge, UK – September, 12, 2022 – Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, today announced that Fierce Biotech has named it as one of 2022’s Fierce 15 biotechnology companies, designating it as one of the most promising early-stage biotechnology companies in the industry.

Amphista is a world leading next-generation Targeted Protein Degradation (TPD) company with the mission to unlock the full therapeutic potential of TPD by addressing the limitations of first-generation approaches. Amphista advantages include: targeting of a non-cereblon component with a more consistent expression profile that enables increased tissue reach, broader disease applicability and potentially greater clinical efficacy. This mechanistic approach, leveraging an essential protein, offers the potential for reduced clinical resistance.  Amphista’s TPD therapeutics are designed to be drug-like molecules with oral bioavailability and the potential for CNS penetration.  Amphista has built a strong IP foundation for the platform including its proprietary warheads, forming the basis of a true platform approach to TPD.

Nicki Thompson, CEO of Amphista, said

“We are delighted to be selected as a ‘Fierce 15’ company in a year where we have made outstanding progress in advancing our proprietary Eclipsys™ platform and therapeutic portfolio and in expansion of our world-leading team.  This also comes in a year where our technology has been further recognized and validated by our strategic collaborations with global pharmaceutical companies Merck Healthcare, a division of Merck, and Bristol Myers Squibb worth more than $2 billion. We remain dedicated to advancing our ground-breaking science with the potential to open up this exciting modality by delivering medicines to patients across a wider range of diseases.”

Every year Fierce Biotech evaluates hundreds of early-stage companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.  The Fierce 15 celebrates the spirit of being “fierce” – championing innovation and creativity, even in the face of intense competition.

About Fierce Biotech
Fierce Biotech is the biotech industry’s daily monitor, an email newsletter and web resource providing the latest biotech news, articles, and resources related to clinical trials, drug discovery, FDA approval, FDA regulation, patent news, pharma news, biotech company news and more. More than 450,000 top biotech professionals rely on Fierce Biotech for an insider briefing on the day’s top stories. Signup is free at www.fiercebiotech.com/signup.

About Amphista Therapeutics

Amphista Therapeutics is focused on transforming the lives of patients with severe diseases including cancer. The company is applying its proprietary Amphista degrader platform to advance new approaches in targeted protein degradation (TPD) that  address the challenges faced by earlier stage TPD research and to realise the full therapeutic potential of this transformational approach. 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 over $60M to date and is funded by leading life science investors including Forbion, Gilde Healthcare, Novartis Venture Fund, Advent Life Sciences, BioMotiv and Eli Lilly & Company.

For more information, please visit: https://amphista.com/

CONTACTS:
Lynn Granito
Berry & Company Public Relations
lgranito@berrypr.com
212 253 8881

AviadoBio selected by Fierce Biotech as a ‘Fierce 15’ 2022 winner

By AviadoBio, Press Release, Private Companies
Press Release.

 

AviadoBio selected by Fierce Biotech as a ‘Fierce 15’ 2022 winner

Award reinforces AviadoBio’s position as one of the most promising early-stage biotech companies in the gene therapy industry

London, UK; Monday, September 12, 2022 — AviadoBio, a pioneering, pre-clinical stage gene therapy company focused on developing and delivering transformative medicines for people with neurodegenerative disorders, today announced that it has been selected by Fierce Biotech as a ‘Fierce 15’ 2022 winner, designating it one of the most promising early-stage biotechnology companies in the industry.

The award validates AviadoBio’s progress over the past year and recognizes the mission of the company, and its aspiration to develop gene therapy treatments for patients living with neurodegenerative diseases such as frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS) who currently have few-to-no therapeutic options.

“This award acknowledges the immense progress AviadoBio has made this year, and is a testament to the hard work of everyone at the company,”

said Lisa Deschamps, Chief Executive Officer.

“This year has marked some important milestones, including securing orphan drug designation from the FDA and EMA, as we move AVB-101, our investigational AAV gene supplementation therapy AVB-101 for frontotemporal dementia (FTD), into the clinic in late 2022.”

The Fierce 15 celebrates biotech companies who champion innovation and creativity. Every year Fierce Biotech evaluates hundreds of early-stage companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of technology, partnerships, venture backers and a competitive market position.

 

About Aviadobio

At AviadoBio, our mission is to transform the lives of people living with neurodegenerative disorders by developing and delivering transformative gene therapies for diseases including frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS). The Company’s technology is based on pioneering research from King’s College London and the UK Dementia Research Institute. AviadoBio’s unique platform combines next-generation gene therapy design with deep neuroscience expertise and a novel neuroanatomy-led approach to drug delivery. AviadoBio’s investors include New Enterprise Associates (NEA), Monograph Capital, Advent Life Sciences, EQT Lifesciences, Dementia Discovery Fund (DDF), F-Prime Capital, Johnson & Johnson Innovation – JJDC, Inc. (JJDC), and LifeArc.

The company is developing AVB-101 for patients with FTD-GRN. AVB-101 is an investigational AAV gene therapy designed to slow or stop disease progression by delivering a functional copy of the GRN gene throughout the central nervous system to restore progranulin levels.

For more information, please visit www.aviadobio.com and follow us at Twitter @AviadoBio and LinkedIn AviadoBio.

F2G Announces $70 Million Financing to Advance Development and Commercialization of New Antifungal Agent Olorofim

By F2G, Press Release, Private Companies
Press Release.

 

MANCHESTER, UK, 4 August 2022 – F2G Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal infections with a high unmet medical need, today announces a $70 million financing. The financing was co-led by new investors Forbion and Sofinnova Partners with strong participation from existing investors, Novo Holdings, Morningside Ventures, Cowen Healthcare Investments and Advent Life Sciences. The proceeds from the financing in addition to the $480 million from the recent strategic collaboration with Shionogi & Co., Ltd., will enable F2G to advance late-stage development and commercialization in the US of olorofim, a novel oral antifungal therapy to treat invasive aspergillosis (IA) and other rare mold infections. Nanna Lüneborg of Forbion and Joe Anderson of Sofinnova Partners will join the F2G Board of Directors.

Olorofim represents the first novel class of antifungals developed in the past 20 years and is the only antifungal medication to be awarded a Breakthrough Therapy Designation for multiple indications by the US Food and Drug Administration (FDA). Olorofim works through a unique mechanism of action, different from existing classes of antifungals, exerting fungicidal activity through inhibition of the pyrimidine synthesis pathway. It is anticipated to be used to treat patients with a serious invasive, rare fungal disease where existing treatments are inappropriate or no longer effective. Data from F2G’s open Phase 2b study in patients with rare and resistant molds, who have limited treatment options, will be presented at ID Week annual conference in October.

Francesco Maria Lavino, Chief Executive Officer of F2G, said:

“We are delighted to attract this additional capital from such high caliber late-stage investors to F2G, and welcome Nanna and Joe to the Board. Their experience will be invaluable as we move to our next stage of growth. This is a pivotal year for the Company. We are building a world class team with commercial, operational and dealmaking experience as we prepare for final development and commercialization of olorofim in the US. If approved, olorofim is expected to be the first new class of anti-fungal with a novel, differentiated mechanism of action in more than 20 years and will address genuine unmet needs in conditions with high morbidity and mortality.”

Nanna Lüneborg, General Partner at Forbion, commented:

“The Forbion Growth Opportunities Fund II focuses on promising late-stage European life sciences companies like F2G. We have been very impressed with the significant progress achieved to date and we are pleased to support this highly impactful Company in its next stage of growth as it pursues commercialization of olorofim in the US.”

Joe Anderson, Partner at Sofinnova Partners, said:

“We aim to support outstanding companies developing innovative treatments for life-threatening disease. With its highly experienced team, F2G has made significant progress over recent years and is now close to bringing its breakthrough product to market for patients with limited treatment options. We look forward to working with management, the board and our co-investors as the company moves into this important phase in its development and growth.”

In May 2022, F2G entered a $480million strategic collaboration with Shionogi & Co., Ltd. to develop and commercialize olorofim in Europe and Asia which included $100 million in upfront payment and $380 million in regulatory and commercialization milestones plus double-digit royalties on sales.

END

For further information please contact:

F2G Ltd
Francesco Maria Lavino | Chief Executive Officer
Ralf Schmid | Chief Financial Officer
Tel: +44 (0)161 785 1271 (UK) / +43 (0)1 997 4267 (A)

Optimum Strategic Communications
Mary Clark / Charlotte Hepburne-Scott / Manel Mateus / Zoe Bolt
Email: F2G@optimumcomms.com
Tel: +44 (0) 203 882 9621

Notes to Editors

About F2G

F2G is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit: www.f2g.com

About olorofim

Olorofim (formerly, F901318) is F2G’s leading candidate from the orotomide class and is currently in a Phase 2b open-label study (ClinicalTrials.gov Identifier: NCT03583164) in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. F2G has initiated a global Phase 3 trial (“OASIS”)2 to compare treatment with olorofim versus AmBisome® followed by standard of care (SOC) in patients with lower respiratory tract invasive fungal disease caused by proven or probable infection with Aspergillus species. Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has also received orphan drug status from the FDA for the treatment of coccidioidomycosis scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis.

About invasive aspergillosis

Aspergillosis is a fungal infection caused by Aspergillus species of mold which are commonly found all over the world. Most of these molds, in most people, are harmless. However, aspergillus is transmitted to humans through inhalation and may cause a broad spectrum of disease ranging from hypersensitivity reactions to direct invasion and destruction of tissue. Invasive aspergillosis is a rare disease that can occur in over 10% of some high-risk immunosuppressed populations with mortality exceeding 80%.

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 €2 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion’s current team consists of over 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with successful investments in 92 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 well-being 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 Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage. The firm actively partners with ambitious entrepreneurs as a lead or cornerstone investor to develop transformative innovations that have the potential to positively impact our collective future.

Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners has over €2.5 billion under management. For more information, please visit: www.sofinnovapartners.com.

Gilead Sciences to Acquire Mirobio

By MiroBio, Press Release
Press Release.

 

Acquisition Provides Gilead with MiroBio’s Pipeline of Immune Checkpoint Agonists and Proprietary Discovery Platform

MiroBio’s Scientific Approach to Restoring Immune Balance for the Treatment of Autoimmune Diseases Complements Gilead’s Inflammation Research and Development Strategy

Foster City, Calif. and Oxford, U.K., August 4, 2022 – Gilead Sciences, Inc. (Nasdaq: GILD) and MiroBio, a privately-held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, today announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in cash, subject to customary adjustments.

The acquisition will provide Gilead with MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed earlier this week. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.

MiroBio’s I-ReSToRE platform (REceptor Selection and Targeting to Reinstate immune Equilibrium) has the potential to be used to develop best-in-class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases. The I-ReSToRE platform supports identification and development of therapeutics that utilize inhibitory signaling networks with the goal of restoring immune homeostasis for patients. Gilead anticipates advancing additional agonists derived from MiroBio’s I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programs, over the next several years.

“The team at MiroBio has spearheaded foundational research for agonist antibodies following a rigorous scientific approach,”

said Flavius Martin, Executive Vice President, Research, Gilead Sciences.

“We believe that MiroBio’s unique platform technology has the potential to produce best-in-class agonist antibodies targeting immune inhibitory receptors.”

“We are excited to be joining Gilead,”

said Eliot Charles, Chairman of MiroBio.

“MiroBio has a deep understanding of checkpoint receptor signaling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead’s drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease.”

Under the terms of the agreement, Gilead will acquire all of the outstanding share capital of MiroBio for a total of $405 million in cash consideration, subject to customary adjustments, which is payable at closing. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with MiroBio to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.30-$0.35. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

Cowen is acting as financial advisor to Gilead. Centerview Partners is acting as financial advisor to MiroBio. Davis Polk & Wardwell LLP, Mayer Brown LLP, and Mishcon de Reya LLP are serving as legal counsel to Gilead and Goodwin Procter LLP and Wilson Sonsini Goodrich & Rosati are serving as legal counsel to MiroBio.

 

About MiroBio

MiroBio is a clinical-stage private biotechnology company whose mission is to develop a new class of therapeutic agents, checkpoint agonist antibodies, to restore immune balance in autoimmune patients. MiroBio has developed I-ReSToRE, a proprietary discovery platform, combining its Checkpoint Atlas™, a cutting-edge receptor mapping database and visualization tool, with proprietary antibody engineering. It was spun out of Oxford University in 2019 and is based on more than 15 years of foundational research from the labs of Professor Simon Davis and Professor Richard Cornall with the potential to create safer and more efficacious medicines for patients with autoimmune disease. MiroBio is backed by a strong group of international investors including Oxford Science Enterprises, Samsara BioCapital, SR One, Medicxi, Advent Life Sciences, OrbiMed and Monograph.

For more information on MiroBio, please visit the company website: www.mirobio.com

 

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

 

Gilead Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of the parties to complete the transaction in a timely manner or at all; the possibility that various closing conditions for the transaction may not be satisfied or waived, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; uncertainties relating to the timing or outcome of any filings and approvals relating to the transaction; difficulties or unanticipated expenses in connection with integrating the companies, including the effects of the transaction on relationships with employees, other business partners or governmental entities; the risk that Gilead may not realize the expected benefits of this transaction; the ability of Gilead to advance MiroBio’s product pipeline and successfully commercialize MiroBio’s products; the ability of the parties to initiate and complete clinical trials involving such products in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such products; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not approve any such products in the anticipated indications or on the timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use; any assumptions underlying any of the foregoing; and other risks and uncertainties detailed from time to time in Gilead’s periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Gilead Contacts:

Jacquie Ross, Investors
investor_relations@gilead.com

Hayley Home, Media
Hayley.Home@gilead.com

MiroBio Contact:

Tom Donovan, Media
tom@tenbridgecommunications.com

Aura Biosciences Receives FDA Fast Track Designation for Belzupacap Sarotalocan (AU-011) for the Treatment of Non-Muscle Invasive Bladder Cancer

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

 

CAMBRIDGE, Mass. — (BUSINESS WIRE) — Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for belzupacap sarotalocan (AU-011), Aura’s first VDC product candidate, for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).

“We are pleased that belzupacap sarotalocan has been granted Fast Track designation. We believe that, given that NMIBC presents such a high unmet medical need, the opportunity for more frequent interactions with Division of Oncology at FDA and the potential for Priority Review will be valuable as we advance further into clinical development in patients with NMIBC,”

said Dr. Mark De Rosch, Chief Operating Officer and Head of Regulatory Affairs of Aura.

“NMIBC has no approved targeted therapies, and patients experience high levels of recurrence and progression, ultimately leading to cystectomy or the removal of the entire bladder,”

said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura.

“This milestone supports our goal to advance the development of belzupacap sarotalocan for patients with NMIBC in need of better and earlier targeted treatment options with the potential to help preserve the bladder.”

Aura’s planned Phase 1 clinical trial with belzupacap sarotalocan in this indication will evaluate the safety and early proof of mechanism, assess distribution, local necrosis and evidence of immune activation. Aura expects to initiate the trial in the second half of 2022, with initial Phase 1 data expected in 2023.

Fast Track designation is an FDA process designed to facilitate the development of products that address high unmet medical needs and may expedite the review of drugs intended to treat serious or life-threatening diseases. Features of Fast Track designation include opportunities for more frequent interactions with the FDA review team and, if supported by clinical data, eligibility for Priority Review. Belzupacap sarotalocan has also been previously granted Fast Track and Orphan Drug designations by the FDA for the treatment of choroidal melanoma and is currently in Phase 2 clinical development in this indication.

 

About Aura Biosciences

Aura Biosciences, Inc., is a clinical-stage biotechnology company developing virus-like drug conjugates (VDCs), a novel class of therapies, for the treatment of multiple oncology indications. Aura’s lead VDC candidate, belzupacap sarotalocan (AU-011), consists of a virus-like particle conjugated with an anti-cancer agent. Belzupacap sarotalocan is designed to selectively target and destroy cancer cells and activate the immune system with the potential to create long-lasting anti-tumor immunity. Belzupacap sarotalocan is currently in development for ocular cancers, with an ongoing Phase 2 dose escalation clinical trial evaluating it as a first-line treatment of choroidal melanoma, a vision- and life-threatening form of eye cancer where standard of care with radiotherapy leaves patients with severe comorbidities, including major vision loss. Aura plans to pursue development of belzupacap sarotalocan across its ocular oncology franchise including for the treatment of patients with choroidal metastases. In addition, leveraging Aura’s technology platform, Aura is developing belzupacap sarotalocan more broadly across multiple cancers, starting with a planned Phase 1 clinical trial in patients with non-muscle invasive bladder cancer (NMIBC). Aura is headquartered in Cambridge, MA.

For more information, visit aurabiosciences.com, or follow us on Twitter and LinkedIn.

 

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward looking statements. Words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of belzupacap sarotalocan for the treatment of cancers including choroidal melanoma and NMIBC and expectations with respect to the clinical development of belzupacap sarotalocan, including expectations regarding the potential benefits conferred by Fast Track designation and initiation of a Phase 1 clinical trial.

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, an improved quality of life of patients after treatment with belzupacap sarotalocan; a potential paradigm shift in the approach to the treatment of choroidal melanoma; the urgent need for a vision preserving targeted therapy; the potential of belzupacap sarotalocan compared to the existing standard of care for patients with choroidal melanoma; uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s clinical trials may not be predictive of future results in connection with future clinical trials; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated development and review timelines; Aura’s ongoing and planned pre-clinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220630005254/en/

 

Contacts
Investor and Media Contact:
Matthew DeYoung
Argot Partners
212-600-1902 | aura@argotpartners.com

Wondr Medical raise £12 million in Seed round to accelerate global collaboration across the medical community

By Press Release, Private Companies, Wondr
Press Release.

 

London, UK, 28th June, 2022: Digital health start-up Wondr Medical, which helps doctors and medical professionals across the world collaborate, connect and discover medical information, has raised £12 million. The seed funding round was co-led by Advent Life Sciences and Sonder Capital with participation from existing shareholders. Wondr Medical, founded in 2020, is the enabler for a new age of medical discovery, connectivity and collaboration. The digital health platform recently on-boarded its 200,000th member.

An encrypted and HIPAA compliant web and mobile software platform – the first of its kind – Wondr Medical offers a secure way for healthcare users to share and discuss clinical information, such as sensitive patient data, between colleagues and across the global healthcare system.

 

Interventional Cardiologist, Founder and CEO, Dr. Justin Davies said:

“The pace of change in global healthcare is accelerating, and we are handing out the shovels. Our mission is to enable the world’s medical professionals to come together as a truly connected community for the first time. After a successful beta in Cardiology, this investment will drive our expansion with the launch of our key strategic product, the ‘Wondr Medical Rooms’ mobile app; a transformative software for Healthcare Professional (HCP) collaboration. Greater access to expertise through better communication is the key that lets every doctor be the best they can be, for patients across the world.”

 

An early-adopter of the platform has been Manesh Patel, Chief of Cardiology at Duke University Hospital:

“As doctors and healthcare providers across the medical field, the more we can pool and access our collective knowledge base in real-time, the more effective we can be. For too long our communications have been siloed and analogue, often in our own hospitals, let alone globally. Wondr Medical has shown us how becoming a fully connected community can be transformative to our clinical work.”

 

Executive Chair of Wondr Medical, Scott Huennekens:

“Global Healthcare is responding to societal needs with an explosion of innovation; from devices and robotics, to drug and vaccine development, to diagnostics and AI. But all of these exciting new technologies benefit incrementally from greater inter-connectivity of the human capital across the market. Wonder Medical is building the operating system that will allow innovation and adoption to flow. That’s why we are so excited to start expanding our member base across all of healthcare.”

 

Shahzad Malik, General Partner of Advent Life Sciences:

“We are excited by Wondr Medical’s vision. The powerful ecosystem they are building will not only enable Medical Professionals to improve care, but also creates an effective channel-to-market for hundreds of medical startups. The last few years have challenged how HCPs and industry interact, with the big physical medical conferences and events cancelled, Wondr Medical have filled the gap impressively. We’re proud to help them in the next phase of their development to expand their capability for all medical professionals.”

 

Andy McGibbon, Managing Partner of Sonder Capital:

“We always look for big ideas that will change lives around the world in healthcare. We couldn’t be happier to be partnering with Wondr Medical and helping them change the way medical professionals engage and collaborate forever. We believe the platform is set to enhance patient outcomes, for decades to come. We are looking forward to working with Dr. Davies and the senior management team.”

 

Wondr Medical have recently strengthened their leadership team with the appointment of David Ellam as Chief Financial Officer, Leyla Pope as Chief Operating Officer, Max Peters as Chief Technology Officer and Stephen Taylor as Chief Revenue Officer. David Ellam, the new CFO who has over 20 years of experience within life science companies said:

“I am excited to join Wondr Medical at such an important inflection point for the company, particularly as the global medical community seeks to realise the benefits to patients of greater inter-connectivity for healthcare participants everywhere.”

 

About Wondr Medical
Wondr Medical helps doctors and medical professionals across the world collaborate, connect and discover medical information,. We believe medical knowledge starts with curiosity. From breakthrough research to advances in best practice, from meeting collaborators to learning from mentors and peers – it all starts with the drive to discover more. Wondr exists to drive and feed that curiosity, pushing medicine forward, for medics and patients everywhere. Our mission is to accelerate medical learning and discovery by creating the world’s most connected medical network. Find out more here.

 

Editor’s Notes
For more information, imagery or to arrange an interview with Dr. Justin Davies, please contact Nigel Brown on Nigel.Brown@DirtandGloryMedia.com

Proximie Raises $80 Million in Series C Funding to Accelerate Product Expansion of Full-Service Connected Surgical Platform

By Press Release, Private Companies, Proximie
Press Release.

 

Funding round led by Advent Life Sciences. New investors include Emerson Collective, SoftBank Vision Fund 2, British Patient Capital, Mubadala and the Minderoo Foundation.
Proceeds to accelerate development and scale of Proximie’s Operating System for the Operating Room – a centralized platform delivering connected surgical care.

London – 14th June 2022 – Proximie, the global health technology platform digitally connecting operating rooms (OR) announces it has successfully raised $80 million in a Series C equity financing. The investment follows a year in which Proximie saw a significant increase in its Total Contracted Value, supported over 13,000 surgeries, and expanded their global footprint to 100 countries.

The funding round was led by Advent Life Sciences – one of the leading trans-Atlantic venture investors building innovative life sciences businesses, with participation from new investors Emerson Collective – the impact investor founded by Laurene Powell Jobs, SoftBank Vision Fund 2, British Patient Capital, Mubadala Investment Company, and the Minderoo Foundation. Existing investors F-Prime Capital, Eight Roads, Questa Capital, Global Ventures, and Maverick Ventures also participated in the round.

Proceeds will be used to accelerate development of key products and services, build out Proximie’s marketplace ecosystem and scale their Operating System of the OR – a centralized platform delivering connected surgical care. Hospitals and surgical centers who leverage Proximie’s technology will have access to preoperative data that can help inform patient care, real time collaborative tools to record, train, and deliver care, and postoperative content management tools to capture and distribute content to their colleagues. Taken together, Proximie will allow health systems to establish an intelligent, digital layer to the OR, enabling them to save time, money, and more lives.

Proximie has been used for cases in surgical specialities at over 500 hospitals worldwide. Hospitals have applied Proximie’s technology to drive efficiencies in the surgical backlog following COVID-19, increased the speed of training surgeons while maintaining costs, and built hub and spoke models concentrating surgical care and expertise in central locations to reduce the time and costs associated with travel.

 

Dr. Nadine Hachach-Haram, CEO and Founder of Proximie, said:

“Our vision is to democratize surgery through better data by connecting every OR and Cath Lab in the world.  We began this journey enabling surgeons to virtually join any OR.  Now, we’re using this capability to digitize the operating room, bringing patients the collective expertise of the best surgeons in the world – where data collected and shared on Proximie can help them receive life-saving care, no matter where they live.”

 

Five billion people currently lack access to safe surgery, with over 18 million people dying every year from lack of access to surgery. Launched in 2016, Proximie is a tool allowing surgeons to virtually “scrub in” to any operating room in the world, extending the capabilities of top surgeons to areas without access to top surgical care. With the COVID-19 pandemic inhibiting travel and access, Proximie has grown rapidly, scaling to five continents and over 100 countries, helping surgeons deliver lifesaving care during a time of healthcare disruption.

Dr. Shahzad Malik, General Partner Advent Life Sciences, said:

“We are delighted to partner with Proximie and a world class group of investors as the company expands its global footprint and product capabilities. The company is a perfect fit for our ethos of backing best-in-class innovative life sciences businesses that have the capability to positively impact human health and healthcare delivery in paradigm changing ways.”

The successful completion of today’s fundraise means Proximie has raised a total of $130 million since inception.

John Cassidy, Investment Director at SoftBank Investment Advisers said,

“The pandemic has rapidly accelerated the adoption of virtual clinical care globally. Proximie’s technology platform combines AI, machine learning, and augmented reality to facilitate live sharing of the operating room, creating a connected surgical care ecosystem to better support patients and hospitals. We are pleased to partner with Dr. Nadine Hachach-Haram and the Proximie team to support their mission of saving lives by sharing the world’s best clinical practices.”

Further information

Thoburns

Jamie Pudge
proximie@thoburns.com
+44 7557 771 703

 

Notes to Editors

About Proximie

  • Proximie is a global health technology platform focused on digitizing operating and diagnostic rooms;
  • Proximie’s mission is to deliver a connected surgical platform to help provide quality surgical care around the globe. Every Proximie procedure can be recorded, analysed and leveraged for future use to help inform best practice;
  • By connecting operating rooms globally, Proximie is facilitating a rich, insightful data set which naturally feeds best practices into the entire healthcare ecosystem;
  • Founded by Dr Nadine Hachach-Haram, Proximie has now conducted tens of thousands of surgical procedures and been deployed in over 500 hospitals in across 100 countries in five continents;
  • Proximie has contracts with over 35 major medical device companies – with access to 90% of operating rooms and diagnostic suites in the U.K., U.S., and E.U – and been published in over 20 medical journals;

 

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 investment team consists of experienced professionals, each with extensive scientific, medical and operational experience, and a long-standing record of entrepreneurial and investment success in the US and Europe
  • The firm invests in a range of sectors within life sciences, including drug discovery, enabling technologies, digital health, and med tech, with an emphasis on innovative, paradigm-changing approaches
  • Advent Life Sciences has a presence in the UK, US and France

Aura Biosciences Announces Publication of Preclinical Data of the Combination of VDCs with Immune Checkpoint Inhibitors at the 2022 ASCO Annual Meeting

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

 

CAMBRIDGE, Mass.(BUSINESS WIRE)— Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the publication of preclinical data on AU-011, its first VDC product candidate, in combination with immune checkpoint inhibitors. AU-011 is being developed for the treatment of life-threatening cancers with high unmet need, including primary choroidal melanoma and non-muscle invasive bladder cancer (NMIBC). The abstract has been published online as part of the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 3-7, 2022, in Chicago, IL.

“These data show that AU-011, a first in class VDC, in combination with immune checkpoint inhibition is effective against both primary tumors and distant metastases in a preclinical model, demonstrating its clinical potential for the treatment of choroidal melanoma and certain other cancers. This includes the potential to treat both the primary tumor in early-stage disease and to treat metastatic lesions, whether clinically present or not at initial treatment.”

“We are so appreciative of our collaboration with the scientists and clinicians at Leiden University Medical Center in The Netherlands, one of the top European clinical and research centers in ocular oncology,”

said Dr. Cadmus Rich, Chief Medical officer and Head of R&D of Aura Biosciences.

 

“It is promising to see the results of these experiments, as we have shown that in murine models, the previously observed positive effects of AU-011 as a single agent could be enhanced with the addition of immune checkpoint inhibitors,”

said Dr. Martine Jager, Professor of Ophthalmology at Leiden University.

“In addition, we show that not only the primary tumor, but also distant lesions, are targeted. Our survival data in murine models show that the combination of VDCs with immune checkpoint inhibitors is a potential new treatment modality that may generate a potent targeted cytotoxicity on local tumors as well as potential metastases.”

 

Abstract details:

Title: A novel Virus-Like-Drug Conjugate (VDC) in combination with immune checkpoint inhibitors for the treatment of primary tumors and distant metastasis
Authors: Ruben Victor Huis in ‘t Veld1, Sen Ma1, Rhonda Kines2, Anneli Savinainen2, Cadmus Collins Rich2, Ferry Ossendorp3, Martine Jager1; 1Leiden University Medical Center, Leiden, Netherlands; 2Aura Biosciences, Cambridge, MA; 3Department of Immunology, Leiden University Medical Center, Leiden, Netherlands
Session Category: Publication – 2022 ASCO Annual Meeting Proceedings
Session Title: Developmental Therapeutics – Immunotherapy
Abstract Number: e14544
The published abstract is available here.

 

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage biotechnology company developing virus-like drug conjugates (VDCs), a novel class of therapies, for the treatment of multiple oncology indications. Aura’s lead VDC candidate, AU-011 (belzupacap sarotalocan), consists of a virus-like particle conjugated with an anti-cancer agent. AU-011 selectively targets and destroys cancer cells and activates the immune system with the potential to create long-lasting anti-tumor immunity. AU-011 is currently in development for ocular cancers, with an ongoing Phase 2 dose escalation clinical trial evaluating first-line treatment of choroidal melanoma, a vision- and life-threatening form of eye cancer where standard of care with radiotherapy leaves patients with severe comorbidities, including major vision loss. Aura plans to develop AU-011 across its ocular oncology franchise including for the treatment of patients with choroidal metastases. In addition, leveraging Aura’s technology platform, Aura is developing AU-011 more broadly across multiple cancers, starting with a planned Phase 1 clinical trial in patients with non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA.
For more information, visit aurabiosciences.com, or follow us on Twitter and LinkedIn.

 

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward looking statements. Words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of AU-011 for the treatment of cancers including choroidal melanoma and NMIBC and expectations with respect to the clinical development of AU-011.

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s clinical trials may not be predictive of future results in connection with future clinical trials; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated timelines; Aura’s ongoing and planned pre-clinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20220526005604/en/

 

Contacts
Investor and Media Contact:
Matthew DeYoung
Argot Partners
212-600-1902 | aura@argotpartners.com

Advent Life Sciences Announces Growth of Investment Team with Three Senior Appointments

By Advent Life Sciences, Press Release
Press Release.

 

26 May 2022, London, UK: Advent Life Sciences, a leading transatlantic venture and growth investor focused on building innovative life science companies in the UK, Europe, and the US, announced today that it has appointed three senior members to its team, all sector investment specialists, and adept at building companies and supporting them in translating ideas into transformative medicines. Dominic Schmidt, based in the UK, and Satish Jindal, based in Boston, USA, have been appointed General Partners. Katrine Bosley, based in Boston, USA, joins as Venture Partner.  Advent’s investment team now includes 18 professionals with a track record of nurturing entrepreneurs and companies to deliver innovative new medicines.

Dominic previously spent eight years as a Partner in the investment team of Syncona, where he was involved in the founding, funding, and building of several life science businesses and served on the Boards of Anaveon, Orbit Biomedical, Gyroscope Therapeutics (acquired by Novartis), Purespring Therapeutics and Forcefield Therapeutics. Dominic has a degree in Biochemistry from the Free University of Berlin and the Max Planck Institute for Molecular Genetics, and a PhD from the Department of Oncology at the University of Cambridge. Dominic was a Cancer Research UK scholar, and his award-winning research has been published in Cell, Nature, and Science.

Satish was previously serving as CEO of BioMotiv, an early-stage investment fund. Satish was a co-founder and CEO of NeoGenesis (acquired by Schering-Plough, now Merck), co-founder and President of Verastem (NADAQ: VSTM) and co-founder of Elicio Therapeutics. He also served as Vice President and Site Head at Schering-Plough Research Institute in Cambridge, Massachusetts, and Vice President at Bristol-Myers Squibb. Satish’s PhD in Biochemistry is from Punjab University in India. He did his postdoctoral research at MIT’s Whitehead Institute.

Katrine is an entrepreneur with over 30 years biotech industry experience. She is Chair of the Board of Arrakis Therapeutics, founding CEO of DaCapo Brainscience, and a Board member of Genocea Biosciences. Katrine was CEO of Editas Medicine, the first company established to develop CRISPR-based gene editing therapeutics. Before that she was CEO of Avila Therapeutics, and held various roles at The Broad Institute, Adnexus Therapeutics, Biogen, Highland Capital Partners, and Alkermes. Katrine has been recognized as one of the 100 Most Creative People in Business by Fast Company, as CEO of the Year by Xconomy, as one of 30 Global Game Changers by Forbes, as Entrepreneur of the Year by the New England Venture Capital Association, and as one of the Top Ten Women in Biotech by Fierce Biotech.

Shahzad Malik, General Partner, Advent Life Sciences said:

“I’m delighted to welcome Dominic, Satish, and Katrine. They bring a wealth of expertise to our talented team. 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-potential innovations that can deliver important new medicines for unmet medical needs. The last few years have reinforced the vital need to translate world class science into the discovery and development of new medicines to tackle devasting diseases.”

Dominic Schmidt, General Partner, Advent Life Sciences said:

“Advent is one Europe’s leading venture capital firms in the life sciences space with a long successful track record resulting in an impressive 14 approved medicines and products to the benefit of patients. I am looking forward to working with such a hands-on and entrepreneurial team supporting Advent’s long-standing successful strategy of backing high-potential life sciences companies.”

Satish Jindal, General Partner, Advent Life Sciences said:

“It’s a great pleasure to join the stellar team at Advent, who have founded over 35 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 we have extensive experience in supporting new companies through the critical early years.”

Katrine Bosley, Venture Partner, Advent Life Sciences said:

“I’m delighted to join the Advent team and provide on-the-ground in-market support in Boston, USA, right at the heart of the world’s biggest cluster of biotech expertise. Venture financing is critical to the development of new medicines, more so than ever in these turbulent public market times, and it will continue to deliver real impact to patients in addition to strong financial returns.”

–    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

 

Contacts:

Katja Stout, Scius Communications
Daniel Gooch, Scius Communications
katja@sciuscommunications.com
daniel@sciuscommunications.com
+44 (0) 7747 875 479

Shionogi & Co., Ltd. and F2G Ltd., Enter Strategic Collaboration to Develop and Commercialize the New Antifungal Agent Olorofim in Europe and Asia

By F2G, Press Release, Private Companies
Press Release.

 

  • Shionogi to conduct clinical trials, subsequent registration and commercialization of olorofim for invasive aspergillosis IA in Europe and Asia
  • F2G to receive u pfront payment of $100 m and share development costs
  • F2G will also be eligible for additional regulatory and commercial milestones of up to $380 m , as well as double digit royalties on net sales

OSAKA, Japan, and MANCHESTER, UK, May 16, 2022 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) and F2G Ltd.(Head Office: Manchester, UK; CEO: Francesco Maria Lavino; hereafter “F2G”)today announced that they have entered a strategic collaboration to develop and commercialize the new antifungal agent olorofim for invasive fungal infections in Europe and Asia.

Olorofim is a novel oral antifungal therapy developed by F2G to treat invasive aspergillosis (IA) and other rare mold infections. Olorofim works through a unique mechanism of action, different from existing classes of antifungals, exerting fungicidal activity through inhibition of the pyrimidine synthesis pathway. Olorofim represents the first novel antifungal class developed in the past 20 years and is the only antifungal medication to be awarded a Breakthrough Therapy Designation (BTD) for multiple indications by the FDA.

Under the terms of the agreement, Shionogi will conduct the clinical trials and subsequent registration and commercialization of olorofim for IA in Europe and Asia. Shionogi will make an upfront payment to F2G of $100 million and share development costs in global studies. F2G will also be eligible to receive additional regulatory and commercial milestones of up to $380 million, as well as double-digit royalties on net sales.

 

“We are delighted to announce this partnership. By joining forces with Shionogi, we will be able to progress the development of olorofim with a partner which has a proven track record in both global drug development and business development to effectively deliver a potentially life-saving therapy to patients globally,”

said Francesco Maria Lavino, Chief Executive Officer of F2G.

 

“As F2G prepares to commercialize olorofim in the US, we are excited to work closely together with Shionogi to address the unmet medical need caused by invasive aspergillosis and other rare mold diseases around the world.”

“Shionogi is committed to ‘Protect people worldwide from the threat of infectious diseases’ as our key focus. We are pleased to partner with F2G, which is boldly tackling fungal infections where new drug development is difficult.”

said Isao Teshirogi, Ph.D., CEO of Shionogi.

“We will continue to address unmet medical needs in infectious diseases, and to work towards total care for this area. As part of this mission and through our partnership with F2G, we hope to be able to provide new antifungal drugs to patients to protect people’s health from life-threatening, invasive fungal infections.”

 

Invasive aspergillosis is a rare disease that can be fatal, occurring primarily in immunocompromised patients, including those having received cancer chemotherapy or hematopoietic stem cell transplantation. Other rare fungi, such as scedospurium or lomentospora, may also infect patients with compromised immunity. Existing antifungal therapies may not be appropriate treatments due to drug-drug interactions, tolerability or other serious side-effects, or are not effective due to resistance. For these patients, treatment options are limited.

Olorofim is anticipated to be used to treat patients with serious invasive fungal disease where existing treatments are inappropriate or no longer effective. Both companies believe olorofim provides hope to patients with, and physicians treating, serious invasive fungal infections.

 

About Shionogi

Shionogi & Co., Ltd. is a leading global research-driven pharmaceutical company based in Japan, dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.”

The company has discovered and developed novel medicines for HIV, influenza and antimicrobial resistance, and currently markets products in several therapeutic areas including anti-infectives with the first siderophore cephalosporin, cefiderocol. For more information, please visit https://www.shionogi.com/global/en

 

About F2G

F2G is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more details, please visit the F2G web site.

 

About olorofim

Olorofim (formerly, F901318) is F2G’s leading candidate from the orotomide class and is currently in a Phase 2b open-label study1. F2G is currently initiating a global Phase 3 trial (“OASIS”)2 to compare treatment with olorofim versus AmBisome® followed by standard of care (SOC) in patients with lower respiratory tract invasive fungal disease caused by proven or probable infection with Aspergillus species. Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has also received orphan drug status from the FDA for the treatment of coccidioidomycosis scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis.

 

About invasive aspergillosis

Aspergillosis is a fungal infection caused by Aspergillus species of mold which are commonly found all over the world. Most of these molds, in most people, are harmless. However, aspergillus is transmitted to humans through inhalation and may cause a broad spectrum of disease ranging from hypersensitivity reactions to direct invasion and destruction of tissue. Invasive aspergillosis is a rare disease that can occur in over 10% of some high-risk immunosuppressed populations with mortality exceeding 80%.

 

Forward-Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

References
1.  https://clinicaltrials.gov/ct2/show/NCT03583164
2.  https://clinicaltrials.gov/ct2/show/NCT05101187

For Further Information, Contact:
SHIONOGI Website Inquiry Form https://www.shionogi.com/global/en/contact.html.

For F2G, contact Petra Taylor-Stadler
Email: ptaylor@f2g.com
Tel: +43 (0)1 997 4267

Optimum Strategic Communications
Mary Clark/ Charlotte Hepburne-Scott/ Supriya Mathur/ Zoe Bolt
Email: F2G@optimumcomms.com
Tel: +44 (0) 203 882 9621