Sunday, March 27, 2022

Gene therapy ‘development engine’ scores $120M to beef up contract manufacturing


Less than a year after launch, gene therapy biotech-CDMO hybrid Forge Biologics has scored another round of investor cash to grow its viral vector ambitions.

The self-styled gene therapy “development engine” raised $120 million to quickly expand capacity for its adeno-associated virus (AAV) contract manufacturing services—and triple its workforce along the way.

Forge will also use the cash to manage its subsidiaries as they push their own AAV gene therapy hopefuls through the clinic, the company said Thursday.

RA Capital led the funding round, and Matthew Hammond, Ph.D., will join Forge’s board. Perceptive Xontogeny Venture Fund’s Fred Callori will also join after not only participating in the series B, but pitching in with first-round funding as well.

RELATED: Biogen cements gene therapy ambitions with $200M factory in Research Triangle

Forge already tackles AAV vector production from its home base in Columbus, Ohio, dubbed “The Hearth,” where it can handle projects from 1 to 50 liters in research grade work and 50 to 500 liters in GMP, co-founder and CEO Tim Miller, Ph.D., said in an interview. Armed with the series B financing, the company is “moving upwards to 1,000 to 2,000 liter bioreactors.”

The company’s 175,000-square-foot facility has four GMP rooms now, and the latest cash infusion will hasten build-out of “a number of additional suites” that should be FDA and EMA compliant by mid-2022, Miller said. 

The company will look to grow the plant’s 75-person workforce by around 150 over the next 18 months, he added.

The company debuted last year with an impressive roster of gene therapy veterans at the helm. Miller himself comes from AAV specialist Abeona Therapeutics, while Forge’s chief operating officer, Jaysson Eicholtz, previously managed gene therapy manufacturing for Nationwide Children’s Hospital. Erandi De Silva, Ph.D., previously in charge of program management at Myonexus Therapeutics, helped found the company and joined as its VP of product development.

Coming up one its one-year anniversary this July, Forge is now manufacturing for clients and negotiating with more than two dozen potential manufacturing customers, Miller said.

RELATED: AbbVie sells biologics plant to Pharmaron, fueling the China company’s cell and gene therapy ambitions

With gene therapy’s star on the rise, Forge set out last year aiming to develop its own treatments and shore up gene therapy manufacturing as growth in the field threatened to outstrip the industry’s capacity.

To put it simply, gene therapy production “takes a lot of bioreactors, it takes a lot of space, it takes a lot of expertise,” Miller explained. 

Putting that capacity squeeze into context, Miller pointed to a bioprocessing push that’s dominated headlines in recent months: The COVID-19 vaccines “were made in very similar bioreactors to what we use.” But to get the equivalent of a single gene therapy dose, especially if it’s intravenous, “you’d have to get 220 vaccines a day for a year straight,” Miller said. 

Forge isn’t sticking with manufacturing alone, either. The company’s lead program, FBX-101, which it’s developing for infants with Krabbe disease, combines an AAV gene therapy with an umbilical cord bone marrow transplant. This approach could help circumvent certain patients’ immunity to AAVs, which in turn render the therapies ineffective. 

The series B was spearheaded by RA Capital Management alongside contributions from Perceptive Advisors, Surveyor Capital, Octagon Capital and Marshall Wace. The Perceptive Xontogeny Venture Fund and Drive Capital, which helped Forge reel in a $40 million series A in July, also chipped in, Forge said in a release.



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