Press release from Companies
Publicerat: 2018-08-27 17:00:00
Hoersholm, Denmark, August 27, 2018 - Oncology Venture AB (OV:ST) ("OV" or the "Company"), Oncology Venture US and Medical Prognosis Institute (MPI.ST) today announced that the US Food and Drug Administration (FDA) has accepted its Investigational Device Exemption (IDE) and its Investigational New Drug Application (IND) to begin a Phase 2 clinical trial in advanced ovarian cancer with 2X-121 -a PARP inhibitor- using it's Drug Response Predictor - DRP® - to select patients with high likelihood of responding to the treatment. The 2X-121 DRP has a gene signature consisting of more than 400 genes. This multi-gene technology captures the complexity of cancer to provide more precise guidance in identifying patients with high likelihood of responding to treatment as well as identifying patients that are likely resistant to the treatment The study is an international multicenter trial to be conducted in the US and Germany. Initially the study is expected to include up to 30 patients who will receive 2X-121 600 mg orally daily until progression. The primary endpoint is antitumor efficacy (Complete Remission (CR) or Partial Remission (PR)). Secondary endpoints are other efficacy parameters as well as safety evaluation. This study follows a study of 2X-121 in metastatic breast cancer initiated (https://www.spotlightstockmarket.com/sv/market-overview/nyheter/nyhets-artikel?id=45498) in Denmark in Q2 2018. That study also uses the 2X-121 DRP to select patients with high likelihood of responding. Oncology Venture in-licensed (https://www.dropbox.com/s/t0ml3bk7ac2uatc/Press%20release%20OV%20-%20OV%20and%20Eisai%20Forge%20Agreement%20PARP%20Inhibitor%20E7449.pdf?dl=0) the active PARP inhibitor from Eisai in Q2 2017. Clinical data (https://www.dropbox.com/s/lanebkx5zu00qu8/Press%20Release%20OV%20-%20OVs%20clinical%20data%20on%20PARPi%202X-121%20and%20DRP%20validation%20to%20be%20presented%20on%20ASCO.pdf?dl=0) were presented at the world's largest cancer congress ASCO 2018. The presentation included validation of Oncology Ventures novel 2X-121 DRP®s ability to identify the patients who will benefit from the 2X-121 therapy as well as identifying patients that were resistant to the treatment.
“I’m proud to obtain this first Oncology Venture prepared FDA IND and IDE approval to run trials with our PARP inhibitor in the US and look forward to initialize study in ovarian cancer to prove the patient benefit of our PARP inhibitor and it’s DRP for precision treatment”, says Chief Medical Officer of Oncology Venture Marie Foegh, M.D. “Our Drug Response Prediction – DRP technology to track, match and treat patients with our PARP inhibitor enables us to be precise in selecting patients who will benefit from PARP inhibitor treatment. We expect the results of the clinical trials will confirm the DRP technology advantage and will position us very favorably in the market,” said Peter Buhl Jensen M.D., CEO of Oncology Venture.
For further information, please contact
| Ulla Hald Buhl, COO and Chief IR & CommunicationsMobile: +45 2170 1049E-mail: uhb@oncologyventure.com | Or | Peter Buhl Jensen, CEOMobile: +45 21 60 89 22E-mail: pbj@oncologyventure.com |
About the Drug Response Predictor - DRP® Companion Diagnostic
Oncology Venture uses the Medical Prognosis Institute (MPI) multi gene DRP® to select those patients who by the genetic signature of their cancer are found to have a high likelihood of responding to the drug. The goal is developing the drug for the right patients, and by screening patients before treatment the response rate can be significantly increased. The 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. DRP® is based on messenger RNA from the patient’s 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 70 anti-cancer drugs in the US. The PRP® is used by MPI for Personalized Medicine. The DRP® is used by Oncology Venture for drug development.
DRP® is a registered trademark of Medical Prognosis Institute A/S.
About Oncology Venture AB
Oncology Venture Sweden AB 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® –to significantly increase the probability of success in clinical trials. DRP® has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 29 out of 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 first screened, and only the patients most likely to respond to the treatment will be treated. Via a more well-defined patient group, risks and costs are reduced while the development process becomes more efficient. ?
The current product portfolio includes: LiPlaCis® for breast cancer in collaboration with Cadila Pharmaceuticals; irofulven for prostate cancer; and APO010, an immuno-oncology product for multiple myeloma.
Oncology Venture has spun out two companies as Special Purpose Vehicles: Oncology Venture U.S. Inc. (previously 2X Oncology Inc.), a US-based precision medicine company focusing developing two promising phase 2 product candidates, and OV-SPV 2, a Danish company that will test and potentially develop a Phase 2 oral Tyrosine Kinase inhibitor.
On the May 30, 2018, MPI and Oncology Ventures respective general assemblies decided to merge. Trading in the Oncology Venture share continues the next couple of months and all OV shares will - when the merger is finalized - give 1,8524 MPI shares.
Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of OV’s control and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning OV’s plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. OV undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
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 August 27, 2018.
