H3 Pharma Inc., a Montreal based Pharmaceutical Development Company, announced that it has finalized a licensing and an investment undertaking with OncoMab GmbH, a start-up biotech drug discovery company based in Wurzburg, Germany. The deal is a multimillion-dollar transaction including an exclusive royalty-bearing license for the first product and its molecular target, an exclusive option for a license on three other products targeting other forms of cancer and the purchase of an equity stake in the company. H3 Pharma will take charge of the clinical development and worldwide registration for the four products.
The first product, SC-1, is a fully human monoclonal IgM antibody targeting a specific isoform of CD55 present in 60 per cent of stomach carcinomas. In a prospective study, the antibody was administered prior to surgery in 51 patients and was shown to specifically induce tumour apoptosis. Moreover, two-year survival after SC-1 treatment and curative resection was 75 per cent versus less than 60 per cent in a comparable patient population. This statistically significant survival benefit was further increased after three years.
"Most patients diagnosed with stomach cancer fail to be cured by gastric resection, and most trials of pre- or post-surgery chemotherapy show no improvement in survival rates. Preliminary clinical results with SC-1 suggest a remarkable increase in survival with SC-1 administration being extremely well tolerated," stated Dr. Didier Coquoz, vice president research and development at H3 Pharma. Coquoz further added, "SC-1 will likely be the first human antibody of the IgM class to be registered. IgM antibodies like SC-1 directly induce cell death; these antibodies could, therefore, be more potent than IgGs in classical oncology settings in addition they could be effective in more aggressive cancers."
The company envisages a fast track designation for SC-1 given the considerable unmet medical need and the positive preliminary results. Orphan Drug status will also be pursued in the United States where there are 25,000 new cases of stomach cancer out of the 300,000 occurring every year worldwide.
"OncoMab products are the result of more than 15 years of research at the University of Wurzburg, Germany to harness the innate immune response of cancer patients to their tumours. The founders, Professor Heinz-Peter Vollmers, Professor Hans-Konrad Muller-Hermelink, and myself are extremely happy to partner with H3 Pharma for the development of our products, and to have H3 Pharma actively taking part as investors in building our company," said Dr. Frank Hensel, CEO of OncoMab GmbH.
Dr. Loic Maurel, president and CEO of H3 Pharma commented on the announcement with enthusiasm, "We are delighted with this deal. H3 Pharma has screened a very large number of projects since its inception. We have been extremely strict in our choice of products. Many projects have not survived our due diligence process including critical criteria based on product development and commercial potential. I am very happy to join forces with OncoMab, they have superb science which no doubt will mark the beginning of a new era of both well-tolerated and life saving oncology treatments."