Forge Biologics Launches with $40 Million Series A Financing to Manufacture and Develop Gene Therapies

Proceeds to expand Contract Development and Manufacturing Organization (CDMO) capacity to deliver GMP adeno-associated viruses (AAV) product for clients by mid-2021 and to develop a proprietary pipeline of novel gene therapies

Company is advancing development candidates for rare disease with lead product FBX-101 for the treatment of Krabbe disease expected to enter the clinic later this year

Series A financing led by the Perceptive Xontogeny Venture Fund

COLUMBUS, OH, USA I July 21, 2020 IForge Biologics, a viral vector gene therapy manufacturing and development company with the dual platform of CDMO capabilities and the development of proprietary gene therapy products, today announced the closing of a $40 million Series A financing led by the Perceptive Xontogeny Venture Fund (“PXV Fund”) with participation from Drive Capital. Forge will use the proceeds of this financing to expand AAV manufacturing CDMO capabilities in 2020, with cGMP production capacity available by mid-2021, and for the development of a novel gene therapy pipeline.

“Importantly, we believe our combination approach has the potential to address some of the immunological safety challenges recently observed in gene therapy clinical trials.”

Forge Biologics is a viral vector CDMO and therapeutics developer, located in a 175,000 ft2 facility in Columbus, Ohio. This facility, referred to as The Hearth, is home to a custom-designed cGMP facility dedicated to AAV viral vector manufacturing, currently capable of up to 50L scale research and toxicology grade AAV manufacturing. By mid-2021, The Hearth will host end-to-end cGMP AAV manufacturing services at 500L scale, enabling biotech and pharma clients the ability to accelerate their gene therapy programs from pre-clinical development through clinical and commercial stage manufacturing.

“Forge is a true gene therapy development engine, bringing together access to viral vector design expertise, quality AAV manufacturing, a management team with significant gene therapy experience, and an exciting pipeline of new therapies for patients,” said Timothy J. Miller, Ph.D., Co-founder, President and CEO of Forge Biologics. “As gene therapy programs continue to demonstrate clinical success, the need for AAV manufacturing has never been greater. Our mission is to enable access to potentially life-saving therapies and help bring them from idea into reality. Furthermore, we are pleased to welcome Perceptive Advisors and their PXV Fund as lead investor in this financing and look forward to benefiting from their deep expertise in the gene therapy and rare disease space.”

In addition to its CDMO capabilities, Forge is developing its own pipeline of innovative gene therapies aimed at treating patients with genetic diseases. Today, Forge announces its lead program, a novel AAV and umbilical cord transplant combination approach to treat infantile Krabbe disease, a devastating neurodegenerative disorder. Krabbe disease has a predicted incidence of about 1 in 12,000 people in the U.S. with symptoms developing in babies and rapidly progressing to death by age two. The combination treatment was pioneered at the University of Pittsburgh in the lab of Maria Escolar, M.D., who joins Forge as Chief Medical Officer. Dr. Escolar is currently a Professor of Pediatrics and Director, Program for the Study of Neurodevelopment in Rare Disorders (NDRD) at University of Pittsburgh and brings a wealth of rare disease and clinical gene therapy experience to the team.

“It is a true privilege to join Forge as Chief Medical Officer to advance FBX-101 as an important treatment for Krabbe patients. The development approach of FBX-101 combines a Umbilical Cord Bone marrow Transplant (UCBT) and AAV gene therapy to comprehensively address both central and peripheral nerve degeneration associated with this disease,” said Dr. Escolar, who also holds equity in Forge. “Importantly, we believe our combination approach has the potential to address some of the immunological safety challenges recently observed in gene therapy clinical trials.” Data from research at the University of Pittsburgh, recently presented data at the American Society for Gene and Cell Therapy annual meeting, demonstrated this combination approach significantly improved efficacy compared to a single AAV administration alone in canines affected with Krabbe disease.

In conjunction with the Series A financing, Chris Garabedian, Manager of the PXV Fund for Perceptive Advisors and CEO of Xontogeny will be joining the Forge Board of Directors as Chairman. “We are excited to have Forge represent the PXV Fund’s first investment in the gene therapy space as we are confident that the Forge team’s previous gene therapy experience will make them a capable and trusted partner for gene therapy drug developers,” said Chris Garabedian. “Given the overwhelming demand for a CDMO that can successfully take a gene therapy program from inception through commercialization, we believe Forge serves the industry in filling this important gap and has the team that can do this successfully.”

Timothy J. Miller, Ph.D. leads a well-established management team of gene therapy veterans with a track record of success. In addition to Maria Escolar, M.D. joining as CMO, the management team includes co-founders Jaysson Eicholtz, Chief Operations Officer, and Erandi De Silva, Ph.D., Chief Strategy Officer. Most notably, Dr. Miller was previously President, CEO and co-founder of Abeona Therapeutics, Jaysson Eicholtz was previously responsible for Nationwide Children’s Hospital’s gene therapy manufacturing facility, and Dr. Silva was previously head of Program Management at Myonexus Therapeutics.

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

About Forge Biologics

Forge Biologics is a gene therapy development engine, focused on enabling access to life changing gene therapies. Forge aims to bring a patients-first approach to accelerate transformative medicines for those who need them most and is building capacity to address the growing demand for gene therapy manufacturing. Through its state-of-the-art, 175,000 ft2 cGMP facility, dedicated to AAV viral vector production, Forge offers end-to-end capabilities to accelerate gene therapy programs from preclinical stage through clinical, and on to commercial-scale production. With this facility as its foundation, Forge is developing a proprietary pipeline of disease-modifying AAV-based therapies to potentially help patients with rare genetic diseases.

About Perceptive Xontogeny Venture Fund

Established in 2018, the Perceptive Xontogeny Venture Fund (PXV Fund) focuses purely on private investments in early stage life sciences companies. A primary source of investments for the PXV Fund are companies that are seeded, incubated, and/or actively managed by Xontogeny, a life sciences accelerator that provides experienced operational support to successfully and efficiently advance early stage companies. The PXV Fund is an affiliate of Perceptive Advisors, a New York City-based investment management firm founded in 1999 and focused on supporting the progress of the life sciences industry by identifying opportunities and directing financial resources to the most promising technologies in healthcare. For more information about Perceptive, visit www.perceptivelife.com.

SOURCE: Forge Biologics

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