Chris Garabedian's incubator leads Series A funding for gene therapy manufacturer/developer combo
Back in December, longtime industry investor Chris Garabedian helped launch a $210 million VC fund for early-stage biotechs. On Tuesday, Garabedian and the Perceptive Xontogeny Venture Fund introduced its latest startup.
The ex-Sarepta CEO has teamed with former Abeona chief Tim Miller to create Forge Biologics, a gene therapy company focusing on both manufacturing and development of GMP adeno-associated viruses, with $40 million in Series A funding. Forge is the eighth biotech in which the PXV Fund has invested — but only the sixth announced — and the first in the gene therapy area, Garabedian told Endpoints News.
Drive Capital also participated in the funding. Because Forge will serve as both a contract development and manufacturing organization (CDMO) and a producer of its own pipeline, Garabedian sees upside here.
“That combination CDMO and proprietary pipeline is rare to find, that capability in one shop,” Garabedian, who will serve as Forge’s chairman, said.
Owning and contracting out its manufacturing facility, a 175,000-square-foot former warehouse space dubbed “The Hearth” in Columbus, Ohio, will allow Forge to create a network of clients encompassing not only biotechs but academic institutions and research foundations. There is huge demand for such specialty sites in the gene therapy field, and Miller said Forge has already secured some potential clients.
The high demand, combined with having the capacity to develop AAVs on-site, makes for “a very compelling business model,” Garabedian said. Earlier this year, Deerfield Management invested $1.1 billion in a new CDMO facility while two other big players, Catalent and Thermo Fisher, had previously spent over $1 billion each on gene therapy manufacturers.
Forge’s challenge in meeting that demand will be upscaling its production capabilities, and the company plans to have services at the 500-liter scale by mid-2021, up from 50 liters currently.
“We’re using what we consider to be a relatively standard way of approaching using a suspension culture, but with an experienced team who can take those cultures and scale those for the masses,” Miller said.
In terms of its own pipeline, Forge is initially researching an AAV in combination with umbilical cord bone marrow (UCBM) transplants as a treatment for Krabbe disease, a genetic disorder that in many cases causes death by age 2. The program, labeled FBX-101, is expected to be in early clinical trials by the end of 2020.
Miller specifically mentioned Philadelphia-based Passage Bio, whose Krabbe disease treatment will hit Phase I/II clinical trials in the first half of 2021, as a potential competitor. While Passage Bio focuses solely on AAV delivery, Forge aims to prove that its UCBM and AAV combo will ultimately be safer and efficacious.
“What this [combination] does is it gives the patients a reset, or a new immune system,” Miller said, “so they don’t have an immune response against the protein that would be expressed during this gene therapy, and it suppresses any immune response to the actual AAV.”
Of course, Krabbe disease treatments are just the first in what Forge hopes is a long future of servicing and developing gene therapy. The biotech has two other in-house projects it’s currently working on, one of which is related to oncology.
Looking forward, Forge intends to be a “development engine” that uses Garabedian’s seed fund background with Miller’s vast network to service early-stage manufacturing while also taking on new projects itself.
“Between the two of us, we’re pretty plugged in to the emerging gene therapy research projects,” Garabedian said.