Gene therapy startup already one of largest manufacturers in its field … and expanding

Columbus Business First

Timothy Miller, CEO of Forge Biologics Inc. Photo: Columbus Business First

COLUMBUS, Ohio (COLUMBUS BUSINESS FIRST) — Although it has been around just over a year, Forge Biologics Inc. already is one of the five largest manufacturers of its type in the fast-growing gene therapy field.

And it starts an expansion next week that likely will vault it to the top.

The Drive Capital-backed startup has lined up about a dozen clients, but raising a total $160 million in venture capital to date greatly sped up the timeline to build out lab space in a 175,000-square-foot Grove City facility that once housed an automotive manufacturer and bookstore warehouse.

Four labs are up and running, and construction starts Monday on a row of seven labs, which will be followed by seven more as the market demands.

“Forge is really on that hockey-stick inflection point (of rapid upward growth),” said co-founder and CEO Timothy Miller. “We’ve probably moved two to three years ahead of our competitors. It’s not really the money – it’s the people.”

Forge launched in July 2020, mid-pandemic, to create a dual model: The company is developing gene therapies for rare and often fatal conditions, while also serving as a contract manufacturer for other researchers and pharmaceutical companies in the field.

Revenue from the manufacturing helps fuel the expensive process of getting a therapy through regulatory approval.

The company has already grown to 115 employees and will likely surpass 200 over the coming year, Miller said.

Miller previously was CEO of Abeona Therapeutics Inc., a publicly traded gene therapy spinoff of Nationwide Children’s Hospital.

Co-founder and COO Jaysson Eicholtz had led gene therapy manufacturing at the Columbus hospital. Erandi De Silva, the third co-founder and vice president of product development, had led program management at Myonexus Therapeutics, another Children’s spinoff acquired in 2019.

Perceptive Xontogeny Venture Fund led its first $40 million round and RA Capital Management led this spring’s $120 million Series B. Columbus-based Drive Capital LLC was a participant in both.

Gene therapy uses modified viruses – called vectors – to deliver copies of missing or defective genes to the body’s cells. Forge chose to specialize in one particular vector called adeno-associated viruses or AAV, which cannot replicate themselves and do not cause any known human diseases.

AAV is used in about 8% of all active gene therapy trials, according to the Journal of Gene Medicine, but a roundup on the field this year in the journal Nature called it one of the most promising vectors.

But growing demand created a manufacturing bottleneck – researchers have to wait 18 to 24 months just to get their production run queued up.

By next year, Miller said, Forge will have the most capacity to produce AAV of any contract manufacturer in the world. Shorter waits for production could mean getting life-saving treatments on the market faster.

Forge’s in-house therapy is licensed from University of Pittsburgh for infantile Krabbe disease, a rare, inherited condition that almost always kills by age 2 or 3. The therapy is delivered at the same time as a bone marrow transplant.

Children’s spinoff Andelyn Biosciences Inc. also is building a manufacturing facility for gene therapy, but started from a green field on Ohio State University’s west campus. Building inside of an existing shell building helped Forge get to operations faster, Eicholtz said.

Columbus-based BHDP Architecture designed the facility, and Skanska, a Swedish firm that specializes in pharmaceutical industry construction, is the lead contractor.

“This has been floating around my head for a decade, wanting to build something like this,” Eicholtz said.

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