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motor function, life span, and body weight compared to the gene therapy alone. Scientists also reported an improvement in the formation of myelin on nerve cells. The research also revealed potential risks and side effects, such as tremors. The paper says that those tremors are most likely due to the radiation treatment used to condition the body for the bone marrow transplant.
Miller says Forge’s combination approach is a platform technology that the company can apply to other gene therapies. It has two additional gene therapies in the pipeline that Miller isn’t yet ready to discuss. But he adds that a different combination—Forge’s pairing of contract manufacturing with R&D—enables Forge to finance work on multiple gene therapies.
Forge is preparing to test the combination Krabbe treatment in a clinical trial expected to start later this year. The new capital will support that research, as well as the expansion of Forge’s manufacturing capabilities. Miller says the 175,000-square-foot site is about 10 years old; Forge has occupied it for six months. The startup currently has capacity to do contract manufacturing for toxicology and preclinical testing. It’s building additional clean rooms to handle manufacturing according to cGMP standards, which Miller expects will be ready by the middle of next year. Miller says Forge will handle manufacturing work for a wide range of clients: non-profit groups, academic labs, small biotechs, and even large pharmaceutical companies. Eventually, he says the site will have the capacity to handle commercial-scale manufacturing.
Forge isn’t the only company trying to address gene therapy manufacturing needs. Last year, Waltham MA-based ElevateBio raised $150 million in financing to back its plans for a contract manufacturing facility. The company also invests in cell and gene therapy startups.
In January, Nationwide Children’s Hospital formed Andelyn Biosciences, a contract gene therapy manufacturer. Though Andelyn is a for-profit company, Nationwide Children’s, a hub of gene therapy R&D, says the startup’s revenue will be reinvested in the hospital’s Abigail Wexner Research Institute. Though Forge is also headquartered in Columbus, the company has no affiliation with Nationwide Children’s. But Miller says that the emergence of gene therapy startups in the region makes it a good place to set up shop.
“Ohio, and Columbus in particular, is becoming a hot bed of biotech development,” Miller says.
The Forge financing was led by Perceptive Xontogeny Venture Fund (PXV), with additional participation from Drive Capital. Chris Garabedian, manager of the PXV fund, said in an email that he sees Forge as offering “beautiful synergies” for the manufacturing and development of gene therapies. Garabedian, who is joining Forge’s board as chairman, also sees the company’s model as the source of potential alliances involving Xontogeny, a startup accelerator he also leads, or financing from PXV Fund.
Photo by Forge Biologics
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