Hoersholm, Denmark and Cambridge, MA, US – September 27, 2018 – Oncology Venture A/S (OV:ST) and Oncology Venture US Inc. today announced that its collaboration with the NCI Pediatric Preclinical Testing Consortium (“PPTC”), funded by the National Cancer Institute (“NCI”), part of the National Institutes of Health (“NIH”) has passed the first feasibility steps for the 2X-121 DRP, the drug response predictor for its investigational, orally-available, targeted PARP inhibitor, 2X-121.
“This NCI collaboration provides a long-term opportunity, assuming 2X-121 demonstrates activity in the PPTC models, to evaluate our novel PARP and tankyrase inhibitor in pediatric cancers, including rare cancer types seen by the NCI”, said Dr Marie Foegh, CMO of Oncology Venture.
Under the collaborative agreement, the PPTC will provide Oncology Venture with confidential access to RNA-Seq data from PPTC models. Oncology Venture will use its novel drug response predictor (DRP®) mRNA biomarker technology to analyze this data with the goal of identifying sequences that may predict responses to 2X-121 in childhood cancers.
2X-121 has a novel dual-inhibitory action against both PARP 1/2 and Tankyrase 1/2. The molecule is also active in P-glycoprotein expressing cells, suggesting it may overcome PARP inhibitor resistance.
Positive response prediction signals have been identified, and preclinical studies are underway to evaluate 2X-121 against in vivo panels of certain pediatric tumors including neuroblastoma, sarcoma and renal tumors using different mouse models like SCID or other immunodeficient mice strains.
Additional studies may be conducted to determine the sensitivity in vitro of cell lines representing many of these same tumor types, and pharmacokinetic and pharmacodynamic testing may also be conducted to further explore mechanism of action and mechanism of resistance.
About the NCI Pediatric Preclinical Testing Consortium
The NCI-supported Pediatric Preclinical Testing Consortium (PPTC) is a comprehensive program to systematically evaluate new agents against childhood solid tumor and leukemia models. The PPTC is funded through a National Cancer Institute (NCI) cooperative agreement with five institutions and one coordinating center.
About Oncology Venture A/S
Oncology Venture A/S, a merger between Oncology Venture A/S (formerly MPI A/S) and Oncology Venture Sweden AB, is engaged in the research and development of anti-cancer drugs via its wholly-owned subsidiary, Oncology Venture Product Development ApS. Oncology Venture uses 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 and is currently demonstrating promising results in an ongoing phase 2 study prospectively using LiPlaCis® and its DRP® to track, match and treat patients with metastatic breast cancer. The DRP® 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 OV product portfolio includes: LiPlaCis®, a liposomal formulation of cisplatin in an ongoing Phase 2 trial for breast cancer; 2X-121 a PARP inhibitor in an ongoing Phase 2 for breast cancer; dovitinib, which will enter Phase 2 trials for indications dependent on further Dovitinib-DRP retrospective/prospective analysis of studies completed by Novartis. 2X-111, a liposomal formulation of doxorubicin under manufacturing for Phase 2 in breast cancer; irofulven, for which a Phase 2 is planned for prostate cancer; and APO010, an immuno-oncology product in Phase 1/2 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 on developing 2X-121 and 2X-111, and OV-SPV 2, a Danish company that will test and develop dovitinib. Oncology Venture A/S has an ownership of 98% in Oncology Venture US and 55% of dovitinib with an opportunity to acquire further 30%.
Learn more at oncologyventure.com.
DRP® is a registered trademark of Oncology Venture A/S.
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 undertakes 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.
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