Proceeds to develop Contract Development and Manufacturing Organization (CDMO) capability to ship GMP adeno-associated viruses (AAV) product for purchasers by mid-2021 and to develop a proprietary pipeline of novel gene therapies
Company is advancing growth candidates for uncommon illness with lead product FBX-101 for the therapy of Krabbe illness anticipated to enter the clinic later this yr
Series A financing led by the Perceptive Xontogeny Venture Fund
COLUMBUS, Ohio–(BUSINESS WIRE)–July 21, 2020–
Forge Biologics, a viral vector gene remedy manufacturing and growth firm with the twin platform of CDMO capabilities and the event of proprietary gene remedy merchandise, at the moment introduced 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 develop AAV manufacturing CDMO capabilities in 2020, with cGMP manufacturing capability obtainable by mid-2021, and for the event of a novel gene remedy pipeline.
Forge Biologics is a viral vector CDMO and therapeutics developer, situated in a 175,000 ft2 facility in Columbus, Ohio. This facility, known as The Hearth, is residence to a custom-designed cGMP facility devoted to AAV viral vector manufacturing, at the moment able to as much as 50L scale analysis and toxicology grade AAV manufacturing. By mid-2021, The Hearth will host end-to-end cGMP AAV manufacturing providers at 500L scale, enabling biotech and pharma purchasers the power to speed up their gene remedy applications from pre-clinical growth via medical and business 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,” stated 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 growing its personal pipeline of modern gene therapies aimed toward treating sufferers with genetic illnesses. Today, Forge declares its lead program, a novel AAV and umbilical twine transplant mixture strategy to deal with childish Krabbe illness, a devastating neurodegenerative dysfunction. Krabbe illness has a predicted incidence of about 1 in 12,000 individuals within the U.S. with signs growing in infants and quickly progressing to loss of life by age two. The mixture therapy was pioneered on the University of Pittsburgh within the lab of Maria Escolar, M.D., who joins Forge as Chief Medical Officer. Dr. Escolar is at the moment 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 uncommon illness and medical gene remedy expertise to the crew.
“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,” stated Dr. Escolar, who additionally holds fairness 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 analysis on the University of Pittsburgh, just lately offered knowledge on the American Society for Gene and Cell Therapy annual assembly, demonstrated this mix strategy considerably improved efficacy in comparison with a single AAV administration alone in canines affected with Krabbe illness.
In conjunction with the Series A financing, Chris Garabedian, Manager of the PXV Fund for Perceptive Advisors and CEO of Xontogeny shall be becoming a member of 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,” stated 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 administration crew of gene remedy veterans with a monitor report of success. In addition to Maria Escolar, M.D. becoming a member of as CMO, the administration crew contains co-founders Jaysson Eicholtz, Chief Operations Officer, and Erandi De Silva, Ph.D., Chief Strategy Officer. Most notably, Dr. Miller was beforehand President, CEO and co-founder of Abeona Therapeutics, Jaysson Eicholtz was beforehand answerable for Nationwide Children’s Hospital’s gene remedy manufacturing facility, and Dr. Silva was beforehand head of Program Management at Myonexus Therapeutics.
For extra info, please go to www.forgebiologics.com.
About Forge Biologics
Forge Biologics is a gene remedy growth engine, centered on enabling entry to life altering gene therapies. Forge goals to deliver a patients-first strategy to speed up transformative medicines for individuals who want them most and is constructing capability to handle the rising demand for gene remedy manufacturing. Through its state-of-the-art, 175,000 ft2 cGMP facility, devoted to AAV viral vector manufacturing, Forge gives end-to-end capabilities to speed up gene remedy applications from preclinical stage via medical, and on to commercial-scale manufacturing. With this facility as its basis, Forge is growing a proprietary pipeline of disease-modifying AAV-based therapies to doubtlessly assist sufferers with uncommon genetic illnesses.
About Perceptive Xontogeny Venture Fund
Established in 2018, the Perceptive Xontogeny Venture Fund (PXV Fund) focuses purely on personal investments in early stage life sciences firms. A major supply of investments for the PXV Fund are firms which might be seeded, incubated, and/or actively managed by Xontogeny, a life sciences accelerator that gives skilled operational assist to efficiently and effectively advance early stage firms. The PXV Fund is an affiliate of Perceptive Advisors, a New York City-based funding administration agency based in 1999 and centered on supporting the progress of the life sciences trade by figuring out alternatives and directing monetary sources to essentially the most promising applied sciences in healthcare. For extra details about Perceptive, go to www.perceptivelife.com.