On August 15, 2019 Oncology Venture A/S (Nasdaq First North Stockholm: OV.ST) reported that the US Food & Drug administration & Drug administration (FDA) has approved an IDE (Investigational Device Exemption) application for use of the company’s drug response predictor LiPlaCis DRP in a planned pivotal Phase 3 study (Press release, Oncology Venture, AUG 15, 2019, View Source [SID1234538784]). In parallel, the FDA is evaluating Oncology Venture’s IND (Investigational New Drug) application for the drug substance LiPlaCis, which is primarily being developed as a potential new treatment of metastatic breast cancer in heavily pre-treated patients.

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Oncology Venture’s drug candidate LiPlaCis is a third-generation intelligent liposomal formulation of cisplatin, enabling direct delivery to the tumour site. LiPlaCis is being developed in combination with a specific drug response predictor, LiPlaCis DRP, which includes 205 genes and predicts the treatment response in individual patients based on a pre-treatment biopsy. Treatment of patients with LiPlaCis selected by the DRP continues to deliver encouraging results in an ongoing Phase 2 study.

The FDA is currently evaluating Oncology Venture’s IND (Investigational New Drug) application for the drug substance LiPlaCis. Oncology Venture has recently provided the authority with supplementary information on the characteristics of LiPlaCis and has an ongoing dialogue with the authority on the details of the pivotal Phase 3 study design.

"The FDA approval to use Oncology Venture’s drug response prediction technology, DRP, in a pivotal Phase 3 study of LiPlaCis in the US is a major step forward in establishing our unique concept of precision medicine", says Peter Buhl Jensen, M.D., CEO of Oncology Venture.

For further information, please contact:

For investor inquiries
Ulla Hald Buhl, IR & Communications
E-mail: [email protected]
Telephone +45 21 70 10 49

For media inquiries
Thomas Pedersen, Carrotize PR & Communications
E-mail: [email protected]
Telephone +45 60 62 93 90

About the Drug Response Predictor – DRP Companion Diagnostic
Oncology Venture uses its 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 patients’ biopsies.
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 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 Oncology Venture for Personalized Medicine. The DRP is used by Oncology Venture for drug development.