New Compound for the Treatment of Pancreatic Cancer

Ascenion Receives Equity in Oncology Start-up MBiotec

February 20, 2009 Munich, Germany - Ascenion GmbH announces today that it is taking an equity position in MBiotec GmbH, a biopharmaceutical company that has recently been founded in order to develop and commercialize the compound MALP-2S for the treatment of cancer. MALP-2 is a lipopeptide originating from mycoplasma that was discovered by Prof. Mühlradt and his team at the Helmholtz Centre for Infection Research (HZI). During 20 years of intensive research, the scientists have characterized the compound in detail, established a process for the production of a synthetic analogue, MALP-2S, and built an extensive set of data demonstrating that MALP-2S can effectively stimulate the human immune system - innate as well as adaptive immunity. Moreover, preclinical studies and a physician sponsored phase I/II trial (1) indicate safety as well as anti-tumour activity of the compound in pancreatic cancer patients.

It was during BioVaria 2008, a life-science showcasing event initiated by Ascenion, that these data triggered interest from experienced industry managers. In follow-on discussions with Prof. Mühlradt and Ascenion, the idea was born of setting up a new company to exploit the potential of MALP-2 for cancer treatment. The founding team includes, besides Prof. Mühlradt, four seasoned executives with many years of industry experience in drug development, marketing and financing.

Ascenion, the HZI's commercialization partner, has mediated a licensing contract between the HZI and MBiotec providing the start-up company with the exclusive right to develop and commercialize MALP-2 and derivatives thereof for oncology applications.

"We are most impressed by the founding team," Christian Stein, CEO of Ascenion comments. "They have developed a convincing business plan within a remarkably short period of time. With their combined expertise and industry experience they are in an ideal position to advance MALP-2 efficiently through clinical trials and towards the market."

MBiotec has already filed an orphan drug application for MALP-2S in pancreatic cancer with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). Upon successful completion of the first financing round, the company aims to perform a fast-track clinical programme, which could result in market approval within an exceptionally short period of time.

"I am looking forward to working with the team and making MALP-2S available for cancer patients," says Prof. Mühlradt. "Pancreatic cancer has a poor prognosis. The disease is frequently diagnosed at late stages, when complete surgical removal of the tumour is impossible. Therapies such as chemotherapy or radiation have severe limitations. Currently, median survival is as low as 4-6 months. By stimulating the patient's own immune response, MALP-2S could provide a new treatment option for these patients when combined with conventional chemotherapy. Our data indicate that the application of MALP-2S in addition to traditional treatment schemes could significantly improve the therapeutic outcome."

MALP-2 also holds potential for a range of other applications. Besides cancer immunotherapy, these include vaccination, wound healing and sepsis prophylaxis. An exclusive licence for MALP-2 as vaccine adjuvant was granted to Swiss-based AmVac in 2007. For all other indications, MALP-2 is still available for licensing. ###

(1) Br J Cancer 2007; 97(5): 598-604