Bracing for FDA review, Gloucester bags $29M round

With an expert panel review looming at the FDA for its cancer drug romidepsin, an HDAC inhibitor, Cambridge, MA-based Gloucester Pharmaceuticals announced that it has raised $29 million in a fourth round of venture capital. Novo A/S led the round, which included current investors Apple Tree Partners, ProQuest Investments, Prospect Venture Partners and Rho Ventures.

The money gives Gloucester enough cash to get through the NDA process on its lead indication--cutaneous T-cell lymphoma--and complete a pivotal trial and file for approval on a second indication without being forced into a marketing pact on someone else's terms, CEO Alan Colowick tells FierceBiotech. "This gives us flexibility to do a deal when the deal makes the most sense."

There are a number of HDAC inhibitors in development, Colowick concedes, but most are in early-stage development with only a handful in late-stage trials. And he believes that Gloucester's therapy has distinguished itself in the trial process. Last June, Gloucester revealed that 41 percent of evaluable patients with refractory CTCL achieved an overall response rate in a trial, with seven percent achieving a complete response and 33 percent demonstrating a partial response.

All of Gloucester's eggs are in the romidepsin basket. The company was formed six years ago when it acquired the program from Fujisawa Pharmaceuticals. Researchers at the company have been pursuing clinical trials for three cancer indications. The drug is also being studied as a combo therapy in two programs, including one study with Velcade.

- check out the press release

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