Gene therapy start-up already one of the largest manufacturers in its field … and in full expansion

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

COLUMBUS, Ohio (COLUMBUS BUSINESS FIRST) – Although it has been around for a little over a year, Forge Biologics Inc. is already one of the top five such manufacturers in the growing field of gene therapy. .

And he’s starting an expansion next week that will likely propel him to the top.

The Drive Capital-backed startup has fielded a dozen clients, but raising a total of $ 160 million in venture capital to date has dramatically accelerated the schedule to build a lab space in a facility. of 175,000 square feet in Grove City, which once housed a motor vehicle. manufacturer’s warehouse and bookstore.

Four laboratories are operational and construction begins Monday on a row of seven laboratories, which will be followed by seven more according to market requirements.

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

Forge was launched in July 2020, in the midst of a pandemic, to create a dual model: the company develops gene therapies for rare and often fatal diseases, while also serving as a subcontractor for other researchers and pharmaceutical companies in the field. .

Revenue from manufacturing helps fuel the costly process of obtaining therapy through regulatory approval.

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

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

Co-founder and COO Jaysson Eicholtz had led the manufacture of gene therapy 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 spin-off acquired in 2019.

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

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

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

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

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

Forge Internal Therapy is licensed by the University of Pittsburgh for childhood Krabbe disease, a rare inherited condition that almost always kills before the age of 2 or 3. The therapy is given at the same time as a bone marrow transplant.

Andelyn Biosciences Inc., a children’s spin-off company, is also building a gene therapy manufacturing plant, but started out from a green field on the west campus of Ohio State University. Building inside an existing shell building allowed Forge to start operations faster, Eicholtz said.

Columbus-based BHDP Architecture designed the facility and Skanska, a Swedish company specializing in building the pharmaceutical industry, is the prime contractor.

“It’s been floating around in my head for a decade, wanting to build something like this,” Eicholtz said.

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