Press release Oncology Venture receives feedback from U.S. FDA on potential approval pathway for Dovitinib.

Hørsholm, Denmark (20 March 2020) – Oncology Venture A/S (“OV” or the “Company”) today announced that it has received feedback from its recent pre-NDA meeting with the U.S. FDA regarding a potential path to approval for Dovitinib, one of its top priority programs.
The Company attended a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss a potential path to approval for Dovitinib used to treat Renal Cell Carcinoma (RCC) (kidney cancer), the current lead indication for the drug. The Company’s proposal is to seek approval based on “non-inferiority” against the already approved compound Sorafenib (Bayer), based on prior Phase 3 trial results (by Novartis).  In the pre-NDA meeting and the subsequent Meeting Memorandum, the FDA indicated that they would accept the NDA filing if submitted, and provided additional guidance regarding the submission, including that the NDA would likely be referred to an Oncologic Drugs Advisory Committee (ODAC)¹  for review and recommendation.  The FDA provided input on the “non-inferiority” margin against Sorafenib, which had not been pre-defined in the protocol for the prior Phase 3 trial in RCC, and discussed progression free survival (PFS) as an endpoint for “non-inferiority.”  No other substantive issues were raised by the FDA.  In addition, the FDA stated that no additional pre-clinical studies are required, no safety issues were raised, no additional pharmacokinetics (PK), pharmacology, and/or human toxicity studies are required, and no new manufacturing (CMC) requests are necessary.Oncology Venture plans to use the data from the prior Phase 3 trial to prove that Dovitinib is in fact “non-inferior” to Sorafenib for the treatment of RCC, and expects that Dovitinib will be approved by the FDA as a safe and efficacious drug beneficial to RCC patients as a third line treatment.  However, the FDA’s feedback provides guidance only and the review process is unpredictable and may or may not lead to a formal approval. Given the additional guidance, Oncology Venture now plans to file a New Drug Aplication (NDA) for the approval of Dovitinib for the treatment of RCC late in the second half of 2020.Dovitinib, a pan-tyrosine kinase inhibitor (TKI) originally developed by Novartis, addresses a significant unmet need for improved therapies for the treatment of Renal Cell Carcinoma. Annual sales of Sorafenib, under the trade name Nexavar^®, were approximately USD $715 million in 2018. The global RCC market is projected to grow to USD $6.3 billon by 2022.  In addition to the RCC market, Dovitinib has promising potential as a monotherapy in a number of other indications, including metastatic breast cancer, hepatocellular cancer, endometrial cancer and gastrointestinal stromal tumors, as well as in combination therapy with other approved drugs, including immune checkpoint inhibitors.Steve Carchedi, CEO of Oncology Venture, stated “We are excited to move towards U.S. submission of our first oncology portfolio asset and appreciate FDA guidance in the filing process.  Mr. Carchedi further noted that “Renal Cell cancer continues to have a high unmet need and we hope that Dovitinib, alone or together with a DRP® companion diagnostic that we are validating for the drug, will provide patients with a more effective treatment.”For further information, please contact:Henrik Moltke, CFO
E-mail: hm@oncologyventure.com
Telephone +45 53 63 96 37About Oncology Venture A/S
Oncology Venture A/S (Nasdaq First North Growth Market Stockholm: OV.ST) develops drugs for personalized treatment of cancer guided by its proprietary drug response predictor technology, DRP®. The company has a mature portfolio of six drug candidates, including compounds in the pre-registration stage. The product portfolio includes: 2X-121, a PARP inhibitor in Phase 2 for Ovarian cancer; Dovitinib, a pan-TKI in post-Phase 3  for Renal Cell Carcinoma; IXEMPRA ® (Ixabepilone), a microtubulin inhibitor approved in the U.S. for the treatment of breast cancer;  LiPlaCis®, a liposomal formulation of cisplatin in Phase 2 trials for breast and prostate cancer;  2X-111, a liposomal formulation of doxorubicin under manufacturing for Phase 2 in breast cancer; and Irofulven, a DNA damaging agent in Phase 2 for prostate cancer.About the Drug Response Predictor – DRP® Companion DiagnosticOncology Venture uses its drug specific DRP® to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. 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 prior clinical trial outcomes. DRP® is based on messenger RNA from the patient’s biopsies. DRP® has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP® platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs in the U.S.Follow us on social media:
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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.Certified Adviser:
Svensk Kapitalmarknadsgranskning AB, Email: ca@skmg.se. Tel: +46 11 32 30 732This information is information that Oncology Venture A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication on March 20, 2020.¹ The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner of Food and Drugs.  The ODAC consists of a number of independent members, selected by the Commissioner, from among key opinion leaders (KOLs) and authorities knowledgeable in the fields of general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics, and other related professions.