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Sep 12
Love0

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.

Aug 04
Love0

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.

Jun 28
Love0

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

Jun 14
Love0

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
May 16
Love0

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

May 11
Love0

Artax Biopharma Closes Financing to Advance Clinical Stage First-in- Class Oral Immunomodulator to Treat T Cell-Mediated Diseases

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

  • Close of $26 Million Funds Immunomodulation Candidate AX-158 Development
  • Adds New Investors Eli Lilly and Company and Sound Bioventures

 

Cambridge, MA, May 11, 2022 – Artax Biopharma, Inc., a clinical stage
biotechnology company focused on transforming the treatment of T Cell-mediated pathologies, today announces the close of a $26 million financing round to develop AX-158, the Company’s first oral small molecule immunomodulating agent. New investors, Eli Lilly and Company and Sound Bioventures, participated alongside existing investors Advent Life Sciences, Columbus Venture Partners, Belinda Termeer and other Company shareholders.

Artax will use these funds to support the clinical development of AX-158 in
autoimmune diseases, including the addition of key clinical development personnel. AX-158 employs a first-in-class mechanism of action that selectively modulates inappropriate T cell activation, a cause of autoimmune disease. AX-158 has the potential to treat T Cell-mediated diseases without the risk of immunosuppression.

Artax’s ongoing Phase 1 clinical trial is assessing the safety, exposure, and
pharmacokinetics of AX-158 in healthy volunteers and includes ex vivo stimulated measures of its pharmacodynamic activity. In preclinical studies, AX-158 demonstrated potential to treat T Cell-mediated diseases by decreasing key cytokines including INFγ, TNFα, IL-2, IL-1 and IL-6 in whole human blood samples.

“We are pleased to welcome Lilly and Sound Bioventures as new investors as we continue to develop our unique immunomodulating agent for patients with T Cell-driven conditions, including autoimmune diseases. We believe AX-158’s immunomodulating effect has the potential to make a transformative difference for patients living with T Cell-driven conditions, without impacting healthy immune system function,”

said Joseph Lobacki, Chief Executive Officer of Artax Biopharma.

“We are also excited to welcome Casper Breum, Managing Partner of Sound Bioventures, who will join the Artax Board of Directors,”

said Mr. Lobacki.

“Mr. Breum’s experience will be a valuable asset to guide the Company’s strategy.”

 

About Artax Science and Immunomodulation

A healthy immune system eliminates harmful foreign pathogens, while being
tolerant of self-tissues and organs. The T Cell Receptor (TCR) is central to healthy T Cell function and a well-functioning immune system. When TCR signaling becomes dysregulated, T Cells behave abnormally. This behavior results in T Celldriven conditions, including autoimmune diseases, T Cell malignancies (lymphomas), and induced T Cell pathologies in which medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-hostdisease or immuno-oncology treatments resulting in immune related-adverse events). Artax believes immunomodulation – a mechanism through which our investigational agents assist in rebalancing the immune system and eliminating a cause of T Cell-mediated diseases, while not impacting patients’ ability to effectively fight foreign pathogens – holds great potential.

 

About AX-158

AX-158 is a first-in-class, oral small molecule immunomodulating agent in
clinical development for the treatment of T Cell-mediated diseases. AX-158
employs a novel mechanism of action that selectively modulates, or adjusts, T Cell responses that play a critical role in immune system function. AX-158 is a Nck SH3.1 domain inhibitor which selectively counteracts the role of Nck in T Cells. Nck is a protein that naturally amplifies T Cell signaling directly at the TCR, contributing to T Cell mediated disease. This process of  immunomodulation assists the immune system to maintain healthy control and eliminates a direct contributor to T Cell-mediated diseases. Importantly, Artax believes that preclinical data suggests AX-158 will not be immunosuppressive and so will not impact the immune system’s ability to mount a strong response to foreign pathogens and infections.

 

About Artax Biopharma

Artax Biopharma is a clinical-stage biotechnology company transforming
T Cell-mediated disease treatment by developing innovative small molecules that modulate the immune system. Artax science holds broad potential to treat T Cellmediated diseases such as autoimmune diseases; induced T cell pathologies (such as acute graft-versus-host disease and immune-oncology treatment-related adverse events); and T Cell malignancies, while simultaneously allowing the body to fight foreign pathogens. For more information, please visit: www.artaxbiopharma.com.

 

About Sound Bioventures

Sound Bioventures is a biotherapeutics focused venture fund, with a strong
foundation in the Nordic biotech ecosystem, that invests in clinical stage companies in EU, UK and USA. The fund invests in projects addressing significant unmet medical needs having the potential for a profound impact on human health and healthcare systems. Sound Bioventures was founded by a team of experienced life science investors and is backed by a strong investor syndicate comprising Novo Holdings, Saminvest, Vaekstfonden, the European Investment Fund, Ramsbury Invest and the founders. Sound Bioventures Fund I AB is a registered alternative investment fund, under the Swedish Alternative Investment Funds Managers Act.

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

 

Contacts:
Karen LaRochelle, MBA
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

May 04
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Amphista Therapeutics Enters Strategic Collaboration with Merck for Discovery and Development of Targeted Protein Degradation Therapeutics

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

 

  • Amphista and Merck will collaborate to leverage Amphista’s proprietary EclipsysTM TPD platform and generate novel protein degrading therapeutics in oncology and immunology
  • Collaboration includes  up to €39 million ($44 million*) in combined upfront and R&D funding payments for an initial three programs
  • Amphista will potentially receive up to €893.5 million ($1.0 billion*) in total payments across three programs plus mid-single digit royalties

 

Cambridge, England, May 4th, 2022 – Amphista Therapeutics, a global leader in the discovery and development of next generation targeted protein degradation (TPD) therapeutics, today announced a strategic collaboration with Merck Healthcare, a division of Merck. Under the terms of the agreement, Merck and Amphista will work collaboratively to discover and develop small molecule protein degraders for an initial three targets in oncology and immunology indications. Amphista will receive an upfront payment, R&D funding and success-based milestone payments of up to €893.5 million ($1.0 billion*) as well as royalties in the mid-single digit range. Completion of the transaction is subject to the parties obtaining any necessary regulatory clearances or approvals.

Nicola Thompson, CEO of Amphista, said,

“We are extremely pleased to enter into this collaboration with Merck. This is a significant validation of the progress we have made in TPD research and the potential of our Eclipsys next-generation TPD platform. We look forward to working with the Merck team, using our combined expertise to develop new TPD therapies to treat cancers and immuno-inflammatory diseases.”

TPD therapies are designed to use physiological mechanisms to remove pathogenic protein from the body, offering the potential to access many disease targets previously considered “undruggable.” Amphista’s technology is specifically designed to develop next generation TPD therapeutics based on mechanistic insights and novel chemistry approaches that enable the company to develop novel protein degrading therapeutics with superior levels of efficacy and broad therapeutic applicability.

About Amphista Therapeutics

Amphista Therapeutics is a global leader in the discovery and development of next generation targeted protein degradation (TPD) medicines, addressing the challenges faced by the field to realise the full potential of this transformational modality.

The company’s proprietary EclipsysTM Platform supports development of multiple innovative therapeutic candidates able to overcome the limitations associated with traditional TPD approaches with superior levels of efficacy and broad therapeutic applicability. The Amphista team includes pioneers and established leaders in TPD research and all phases of drug discovery and development. The company is supported 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: http://www.amphista.com/.

Media Contacts:

Amphista Therapeutics
CEO Nicola Thompson
+44 (0) 7436102411
nicki@amphista.com

Berry & Company Public Relations
Doug Haslam
dhaslam@berrypr.com
+1 212 253 8881

May 04
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Amphista Therapeutics Enters Strategic Collaboration with Bristol Myers Squibb for Discovery and Development of Targeted Protein Degradation Therapeutics

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

 

Amphista and Bristol Myers Squibb to collaborate and leverage Amphista’s proprietary Eclipsys™ targeted protein degradation platform to develop novel protein degrading therapeutics
Collaboration includes an upfront payment of $30 million, the potential for up to $1.25 billion in performance-based milestone payments and payments for a limited expansion of the collaboration, as well as royalties on global net sales of products

 

Cambridge, England, May 4th, 2022 – Amphista Therapeutics, a global leader in the discovery and development of next generation targeted protein degradation (TPD) therapeutics, today announced a strategic collaboration and license agreement with Bristol Myers Squibb.

Under the terms of the agreement, Bristol Myers Squibb and Amphista will work collaboratively to discover and develop small molecule protein degraders.  Bristol Myers Squibb will be granted a global exclusive license to the degraders developed and will be responsible for further development and commercialization activities.  Amphista will receive a $30 million upfront payment, the potential for up to $1.25 billion in performance-based milestone payments and payment for a limited expansion of the collaboration, as well as royalties on global net sales of products. The closing of the transaction is subject to the parties obtaining regulatory clearances or approvals.

Nicola Thompson, CEO of Amphista, said,

“Our collaboration with Bristol Myers Squibb is a powerful validation of our advances in TPD research and the capabilities of our Eclipsys next-generation TPD platform.  Combining our expertise with Bristol Myers Squibb’s strong legacy and experience in the protein degradation space brings new promise to the potential of delivering more effective new treatment to patients seeking treatment options.”

TPD therapies are designed to use physiological mechanisms to remove pathogenic protein from the body, offering the potential to access many disease targets previously considered “undruggable.” Amphista’s technology is specifically designed to develop next generation TPD therapeutics based on advanced mechanistic insights and novel chemistry approaches that enable the development of novel protein degrading therapeutics.

“Bristol Myers Squibb continues to build its leadership and scientific expertise in the protein degradation space,”

said Rupert Vessey, M.A., B.M., B.Ch., FRCP, D.Phil., Executive Vice President, Research & Early Development, Bristol Myers Squibb.

“We look forward to collaborating with Amphista and using its TPD platform to potentially develop new targeted protein degradation therapies.”

 

About Amphista Therapeutics

Amphista Therapeutics is a global leader in the discovery and development of next generation targeted protein degradation (TPD) medicines, addressing the challenges faced by the field to realise the full potential of this transformational modality.

The company’s proprietary EclipsysTM Platform supports development of multiple innovative therapeutic candidates able to overcome the limitations associated with traditional TPD approaches with superior levels of efficacy and broad therapeutic applicability. The Amphista team includes pioneers and established leaders in TPD research and all phases of drug discovery and development. The company is supported 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: http://www.amphista.com/.

 

Media contacts:

Amphista Therapeutics
CEO Nicola Thompson
+44 (0) 7436102411
nicki@amphista.com

Berry & Company Public Relations
Doug Haslam
dhaslam@berrypr.com
+1 212 253 8881

May 04
Love0

AviadoBio to Present Pre-clinical Data on its Gene Therapy Candidate for Frontotemporal Dementia at ASGCT 2022

By AviadoBio, Press Release, Private Companies
Press Release.

 

  • Intrathalamic delivery of AVB-101 shows promising efficacy in a pre-clinical disease model
  • Gene therapy candidate also demonstrated broad cortical expression in a large animal biodistribution study

 

London, UK, May 4th, 2022 – AviadoBio, a pioneering, pre-clinical stage gene therapy company focused on developing and delivering transformative medicines for people with neurodegenerative disorders, announces that it will be presenting preclinical data at the upcoming ASGCT 25th Annual Meeting (American Society of Gene & Cell Therapy) on 16-19 May, 2022. The data are from studies it has conducted with its investigational, one-time, adeno-associated virus (AAV) gene therapy, AVB-101 (AVB-PGRN), for the treatment of frontotemporal dementia with GRN mutations (FTD-GRN).

The oral presentation, entitled “Intrathalamic Delivery of AVB.PGRN Rescues Pathology in Grn Null Mice and Achieves Widespread Cortical Expression in a Large Animal Model without Expression in the Liver”, will be presented by AviadoBio Co-Founder and Chief Scientific and Clinical Advisor, Professor Chris Shaw, on Tuesday 17 May at 3:45pm (EST). The presentation will form part of the session “Applications of Improved Gene Therapy Methods in Neurologic Disorders” and will be followed by a Q&A discussion.

The abstract number 468 can be viewed here.

In addition, AviadoBio CEO Lisa Deschamps will be presenting at the conference, on Monday 16 May at 12:00pm (EST), in a session entitled: “Startup Showcase: AviadoBio – A revolution in gene therapy for neurodegenerative disorders”.

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.

About Frontotemporal Dementia and AVB-101

Frontotemporal dementia (FTD) is of the second most common form of dementia in people under the age of 65 after Alzheimer’s disease. It affects 50,000 to 60,000 patients in the U.S. and over 100,000 in the E.U. Approximately one third of FTD cases are familial and linked to autosomal dominant mutations in three genes including the granulin gene (GRN) and FTD-GRN represents 5-10% of all patients with FTD. Progressive degeneration of the frontal and temporal lobes of the brain is characteristic of FTD, and is associated with progressive decline of behaviour, decision-making, language and emotion, typically leading to death within 7-10 years of diagnosis. There are currently no approved treatments to stop or slow the progression of FTD or FTD-GRN.

References:

  • Boxer AL. Miller BL.  Alzheimer Dis Assoc Disord. 2005;19 Suppl 1:S3-6
  • Hogan DB, et al. Can J Neurol Sci. 2016;43 Suppl 1:S96-S109
  • Olney NT, et al. Neurol Clin. 2017;35(2): 339–374
  • Greaves CV, et al. J Neurol. 2019;266(8):2075–2086

CONTACT

For media enquiries:
Consilium Strategic Communications
Chris Gardner, Angela Gray, Isabelle Abdou
+44 (0) 20 3709 5700
AviadoBio@consilium-comms.com

May 02
Love0

Orphalan announces FDA approval of Cuvrior™ for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine

By Orphalan, Press Release, Private Companies
Press Release.

 

Paris, France 2 May 2022 – Orphalan SA (“Orphalan” or “the Company”), an international orphan drug development and commercialisation company, today announces approval of Cuvrior™, a new salt of trientine (trientine tetrahydrochloride) by the United States Food and Drug Administration (FDA). Cuvrior™ is approved for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine. Penicillamine is currently approved as a first-line treatment of Wilson’s disease in the US with about one third of patients developing intolerance1.

Orphalan recently completed a global phase III trial, CHELATE, which met its primary efficacy endpoint by demonstrating that Cuvrior™ was non-inferior to penicillamine as measured by non-ceruloplasmin copper (NCC). In consultation with the FDA, an assay based on total serum copper protein speciation was used for measuring this primary efficacy endpoint.

Wilson’s disease is a rare inherited disorder of copper transport primarily affecting the liver and brain. Orphalan commercializes its trientine tetrahydrochloride product in Europe under the name of Cuprior® and expects to launch Cuvrior™, which has been granted Orphan Drug Designation by the FDA, in the US by early 2023. The approval follows the New Drug Application (NDA) submission for the company’s product last year.

Dr. Naseem Amin, Chief Executive Officer at Orphalan, commented:

“We are delighted with the approval of our product, Cuvrior™, which provides a well-tolerated and effective option for Wilson’s disease patients. At Orphalan, we are committed to delivering innovative therapies, with our drug Cuprior® already approved and launched in European countries, and we look forward to launching Cuvrior™ in the United States. We also plan further national submissions to make our product available to patients globally.”

Mary L Graper, Vice President of Scientific Affairs, Wilson Disease Association, added:

“Wilson’s disease is a devastating disorder affecting patients worldwide and for which there has remained a significant need for innovative new treatments. The approval of Orphalan’s Cuvrior™ is extremely promising and is reflective of Orphalan’s patient-driven approach. This marks the culmination of many years of work and is an important moment, offering new hope for patients affected by this disease.”

Professor Michael Schilsky, MD, Director, Center for Excellence for Wilson Disease at Yale University, said:

“As a physician, I have seen first-hand how Wilson’s disease impacts the lives of patients and, until now, there have been few effective long-term treatment options available. The approval of Orphalan’s Cuvrior™ by the FDA is backed by positive data from Orphalan’s multicenter, multinational CHELATE trial – the first head-to-head controlled study of a new trientine salt versus penicillamine. For patients in need, Cuvrior™ represents a well-tolerated and effective alternative to penicillamine, the current standard of care.”

1 Weiss KH, et al. Efficacy and Safety of Oral Chelators in Treatment of Patients With Wilson Disease. Clin Gastroenterol Hepatol. 2013 Aug;11(8):1028-35.e1-2.
– ENDS –

About Trientine Tetrahydrochloride
Trientine tetrahydrochloride is an oral trientine formulation. In the US, trientine tetrahydrochloride has been granted with Orphan Drug Designation for the treatment of Wilson’s disease excluding patients intolerant of penicillamine. It has been approved under the 505(b)(2) pathway for the treatment of adult stable Wilson’s disease patients who are successfully de-coppered and tolerant to penicillamine. The 505(b)(2) regulatory pathway is a type of New Drug Application (NDA).

About Orphalan
Orphalan is an international orphan drug development and commercialisation company. The company delivers worldwide innovative therapies for people living with orphan diseases and is a pioneer in the space. Orphalan was founded in 2011 and has launched Cuprior®. across Europe with its own commercial organization. For more information visit www.orphalan.com and follow us on LinkedIn.

For more information, please contact:
Orphalan Tel: +33 (0)1 42 49 82 64
info@orphalan.com

Consilium Strategic Communications:
Mary-Jane Elliott, Davide Salvi, Genevieve Wilson
Tel: +44 (0) 203 709 5700
orphalan@consilium-comms.com