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GEN News Highlights : Sep 20, 2011

FKD Therapies Acquires Exclusive License to Merck & Co.’s Gene Therapy Portfolio

Pipeline is headed by Phase II-ready recombinant adenoviral interferon alfa 2b for treating superficial bladder cancer.

Merck & Co. has taken an equity stake in newly established Finnish gene medicines firm, FKD Therapies, in return for granting the latter an exclusive license to develop its gene therapy portfolio. The agreement includes candidates for bladder cancer, glaucoma surgery failure, and solid tumors.

Recombinant adenoviral p21 (rAd-p21) is being tested as a treatment of glaucoma surgery failure and conditionally replicating adenoviral technology CRAV) for the treatment of solid tumors. The lead candidate is recombinant adenoviral interferon alfa 2b (rAd-IFN) for the treatment of superficial bladder cancer.

rAD-IFN has completed a 14-pateint Phase I trial. The study showed that a single therapeutic dose of rAd-IFN administered into the bladder after tumor resection led to a 43% complete response rate at three months, which was maintained for an average duration of 23 months among patients receiving one repeat dose of the therapy.

FKD was founded in February 2010 with a $16 million pot of working capital secured through private fundraising supported by the Finnish Funding Agency for Technology and innovation. The firm is headed by chairman and CEO Nigel Parker, Ph.D., who from 1997–2010 was CEO at Ark Therapeutics. Dr. Parker stepped down from his position at Ark shortly after the firm’s then lead brain cancer product, Cerepro, failed to get regulatory approval. He says development of the acquired Merck portfolio will start with a Phase II trial for rAD-IFN.