Timothy J. Miller, PhD, Forge Biologics CEO, president, and co-founder,

Gene therapy-focused CDMO Forge Biologics has closed on a $120 million Series B financing, saying the proceeds will accelerate its planned expansion of adeno-associated virus (AAV) manufacturing capabilities.

The company operates a 175,000-square-foot cGMP facility in Columbus, OH, dedicated to AAV viral vector manufacturing, which the company has nicknamed “The Hearth.”

“Forge will use these proceeds to speed up the expansion of our buildout in Columbus,” Timothy J. Miller, PhD, Forge’s CEO, president, and co-founder, told GEN. “We will be expanding existing AAV manufacturing capabilities with additional FDA- and [European Medicines Agency] EMA-compliant GMP commercial suites in the next 12–18 months.”

AAV manufacturing is part of the end-to-end manufacturing services offered by Forge—services that include research and toxicology grade AAV production, to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.

Forge said it also plans to use the financing proceeds toward operating its subsidiaries that advance the company’s novel AAV gene therapy programs from preclinical through clinical and commercial stage manufacturing.

Targeting Krabbe disease

Those programs start with Forge’s lead program FBX-101 for the treatment of patients with Krabbe disease. The first-in-human gene therapy uses an AAV after hematopoietic stem cell transplant (HSCT) to deliver a functioning copy of the GALC gene intravenously to cells in the central nervous system (CNS) and peripheral organs.

FBX-101 will be studied in a planned six-patient Phase I trial (NCT04693598) that had yet to recruit patients as of the study’s most recent update on ClinicalTrials.gov in January. During the nonblinded, nonrandomized dose escalation study of intravenous AAVrh10 after HSCT, subjects will receive standard of care hematopoietic cell transplantation for Krabbe disease, followed by a single infusion of FBX-101.

Forge employs more than 75 people, with plans to more than double its workforce to about 200 people by the end of 2022.

“We are pulling in talent from the coasts as well as the incredible workforce that comes out of the universities in Ohio,” Miller said.

RA Capital Management led the Series B financing, with participation from Perceptive Advisors and related entities/affiliates, Surveyor Capital (a Citadel company), Octagon Capital, and Marshall Wace. Existing investors Perceptive Xontogeny Venture Fund and Drive Capital also participated.

In connection with the financing, Matthew Hammond, PhD, of RA Capital, and Fred Callori of the Perceptive Xontogeny Venture Fund will join Forge’s Board of Directors.

In July 2020, Forge emerged from stealth mode with a $40 million Series A financing.

“We have built Forge into a focused gene therapy development engine with a firm commitment to helping our clients provide potentially life-saving gene therapies to patients,” Miller said. “We believe that focusing entirely on gene therapy will allow us to best serve our clients and patients by efficiently delivering high-quality products.

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