"This is a very important part of our strategy to protect Irofulven and its Companion diagnostic DRP™ via the FDA Orange Book," said CEO Peter Buhl Jensen. "This ensures a new 20 year patent protection for our combined Irofulven response predictor and Irofulven," Irofulven has already demonstrated good clinical effects and we will use the Drug Response Predictor to include the prostate cancer patients that are most likely to benefit from Irofulven The aim is to increase the response rate and get Irofulven approved.” Peter Buhl Jensen, M.D., CEO of Oncology Venture further commented.
Oncology Venture is developing the phase 2 drug candidate Irofulven, together with a companion diagnostic technology (Irofulven DRP™) to identify patients highly likely to respond to Irofulven therapy. The Irofulven DRP™ companion diagnostic is derived from the Drug Response Predictor (DRP™) Platform of Medical Prognosis Institute (MPI) wherefrom the Irofulven DRP™ has been in-licensed. Previous substantial clinical investigations in 38 clinical trials (19 published) of Irofulven by US biotech company MGI Pharma and pharmaceutical company Eisai led to objective responses in subsets of patients, including for a range of hard to treat cancers; such as prostate, ovarian, liver and pancreatic cancer. Utilizing the DRP Platform, Oncology Venture has identified the genetic signatures associated with response to Irofulven, and has secured rights to the drug for focused development in patient populations with a high likelihood of response. Oncology Venture will run a focused phase 2 trial of Irofulven in likely patient responders with castration-resistant prostate cancer as the next step towards the commercialization of Irofulven as a precision therapy for a range of hard to treat cancers.
Irofulven is in-licensed from Lantern Pharma. Oncology Venture and Lantern received a grant of 800.000 USD from Massachusetts Life Sciences Center to develop Irofulven in prostate cancer.
Irofulven (6-hydroxymethylacylfulvene) is a semi-synthetic derivative of illudin S, a natural toxin isolated from the Jack O’lantern mushroom (Omphalotus illudens). A pro-drug, Irofulven requires catalysis by prostaglandin reductase 1 to become active.
Created at the University of California, San Diego (UCSD), Irofulven was exclusively licensed to US biotech company MGI Pharma, which was acquired by Eisai in 2007. After being returned to UCSD in 2009, Lantern Pharma licensed Irofulven in 2015, and subsequently sub-licensed Irofulven to Oncology Venture.
Irofulven is more active in vitro against tumour cells of epithelial origin and is more resistant than other alkylating agents to deactivation by p53 loss and MDR1. Irofulven exhibits impressive anti-cancer results in xenograft models in vivo, shows synergy with topoisomerase I inhibitors, and has demonstrated activity against cell lines that are resistant to other therapies. Irofulven has significant scope for combination with other therapies, including standard chemotherapeutic regimes.
About The Orange Book
The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product.
The Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them. In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that they will not launch their generic until after the expiration of the Orange Book-listed patent, or that the patent is invalid, unenforceable, or that the generic product will not infringe the listed patent.
About the Drug Response Predictor - DRP™ screening tool
Oncology Venture uses the MPI multi gene DRP™ to select those patients that by the gene signature in their cancer is found to have a high likelihood of response to the drug. The goal is to develop the drug for the right patients and by screening patients before treatment the response rate can be significantly increased.
This DRP™ method builds on the comparison of sensitive vs. resistant human cancer cell lines including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. The DRP™ is based on messenger RNA from the patients’ biopsies.
The DRP™ platform i.e. the DRP™ and the PRP™ tools can be used in all cancer types, and is patented for more than 60 anti-cancer drugs in the US. The PRP™ is used by MPI for Personalized Medicine. The DRP™ is used in Oncology Venture for drug development.
For further information, please contact
|Ulla Hald Buhl, COO and Chief IR & CommunicationsMobile: +45 2170 firstname.lastname@example.org
||Peter Buhl Jensen, CEOMobile: +45 21 60 89 22E-mail: email@example.com
This information is information that Oncology Venture Sweden AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on May 31th 2016.
About Oncology Venture Sweden AB
OV is engaged in the research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS. Oncology Venture has a license to use Drug Response Prediction – DRP™ – in order to significantly increase the probability of success in clinical trials. DRP™ has proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment in cancer patients in 29 of the 37 clinical studies that were examined. The Company uses a model that alters the odds in comparison with traditional pharmaceutical development. Instead of treating all patients with a particular type of cancer, patients’ tumors genes are screened first and only those who are most likely to respond to the treatment will be treated. Via a more well-defined patient group, the risk and costs are reduced while the development process becomes more efficient.
The current product portfolio: LiPlaCis for Breast Cancer in collaboration with Cadila Pharmaceuticals, Irofulven developed from a fungus for prostate cancer and APO010 – an immuno-oncology product for Multiple Myeloma.
Oncology Venture has spun out 2X Oncology Inc. a company focused on developing precision medicine for women’s cancer with three anticancer products in pipeline and OV-SPV2 which will test and potentially develop an oral Tyrosine Kinase inhibitor from a Big Pharma the treatment of cancers.