BioWorld International Correspondent

COPENHAGEN, Denmark - Norwegian firm GemVax AS is seeking €12 million in a private financing round to support further clinical development of its collection of peptide-based tumor vaccines.

The Oslo-based company, which was spun out of the industrial group Norsk Hydro ASA last year, is based on more than a decade of research at the Norwegian Radium Hospital, and it has three products in clinical trials.

GemVax CEO Mona Møller told BioWorld International she aims to close the financing round by year's end. Talks with Scandinavian investors are under way, she said. Pareto Securities ASA of Oslo is managing the transaction.

GemVax previously received seed funding from Norwegian investors and from the national research fund. Its product pipeline has already been the subject of more than €20 million of investment since 1989. Its roots lie in a research collaboration between Oslo-based Norsk Hydro's life sciences business and Gustav Gaudernack, head of immunotherapy at the Norwegian Radium Hospital, the largest cancer center in Scandinavia. The company also has research links with David Kerr at the University of Oxford and H kan Mellstedt at the Karolinksa Institute in Stockholm. Its aim is to develop vaccines that target the key processes that make cancer cells immortal.

So far, some 200 patients have participated in clinical trials involving the company's vaccine candidates. They include GV 1001, a peptide derived from the human telomerase catalytic subunit (hTERT), which is in Phase I/II trials in patients with advanced pancreatic cancer, lung cancer and malignant melanoma; a mutant Ras peptide, which is in a Phase II trial for pancreatic cancer; and a vaccine that targets the microsatellite instability phenotype found in about 15 percent of colorectal cancers, which is in Phase I/II trials.

The company is planning to combine its hTERT and Ras vaccines in a trial in pancreatic cancer patients. "Having two targets is good because tumor cells are quite good at escaping [the immune response]," M ller said. It also wants to test the vaccine in combination with Gemzar, the only FDA-approved drug for pancreatic cancer, which is marketed by Eli Lilly and Co., of Indianapolis.

Its telomerase-derived vaccine has already yielded promising efficacy data. In one ongoing trial of GV 1001, 12 of 16 patients with non-resectable pancreatic cancer developed an immune response following vaccination. As of October, median survival was 7.5 months, according to GemVax, whereas in Gemzar's registration study, median survival was 5.7 months.

GemVax has adopted a heavily outsourced business model and, Møller said, maintains a tight cost structure. "We have worked for more than 10 years in something that was a non-core business to the owner," she said. Norsk Hydro, Norway's largest company, is a diversified energy and materials group and decided to exit the life sciences arena last year as part of a wider restructuring. Prior to establishing GemVax, Møller was a research director at Norsk Hydro and headed its department of organic chemistry and biotechnology.