Lack of AAV capacity drives $120m investment for Forge Biologics

Forge Biologics has closed $120 million in Series B financing to expand its AAV manufacturing capabilities and develop gene therapies.

The gene therapy contract development manufacturing organization (CDMO) Forge Biologics has raised $120 million with finances led by RA Capital Management, Octagon Capital, Surveyor Capital (a Citadel company), and Marshall Wace.

According to Forge, the funding will fast-track the expansion of its adeno-associated virus (AAV) manufacturing CDMO capabilities and capacity and work with its subsidiaries that are developing AAV gene therapy programs.

“This funding will allow Forge to take on almost 4x the number of clients with the accelerated expansion of our existing cGMP suites to more than triple our capacity [by] the end of 2022,” a spokesperson for Forge told BioProcess Insider.

Furthermore, it is able to ramp up its hiring and the CDMO told us it has “grown from four to over 75 full time employees in less than a year, and we will add roughly 200 by the end of 2022.”

Image/iStock: Evgen_Prozhyrko

“We are very pleased to be working with RA Capital and a strong syndicate of top-tier life sciences investors who share our vision as we now advance our growth as a global gene therapy manufacturing and development company,” said CEO, president and co-founder of Forge Biologics, Timothy Miller.

He added: “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.”

Forge has a 175,000 square-foot manufacturing plant in Columbus, Ohio that is dedicated to AAV viral vector production and aims to move gene therapy programs from preclinical through to commercialization.

Matthew Hammond, principal at RA Capital Management said the production of AAV drugs has drained manufacturing capacity across the industry. However, “this financing will help to address this industry-wide capacity shortage by properly capitalizing an emerging gene therapy focused CDMO.”

In relation to the $120 million funding, Hammond and Fred Callori from the Perceptive Xontogeny Venture Fund will Join Forge’s Board of Directors.

Forge’s pipeline

In its own clinical pipeline, the firm is actively advancing its lead program FBX-101 which aims to treat patients with Krabbe disease.

Typically, Krabbe disease affects infants and causes problems such as trouble eating, delayed mental and physical development, and muscle weakness with most patient’s dying before reaching two years old.

Gene therapy candidate, FBX-101 is a first-inhuman gene therapy using an AAV to send a working copy of the GALC gene to cells in the central nervous system and organs. It is currently in Phase I/11 trials to evaluate its safety and efficacy.

Forge bagged $40 million in Series A funding in July 2020 to expand its model and develop FBX-101.