On April 30, 2019 Oncology Venture A/S reported news on DRP based analyses of biopsies from clinical trials with dovitinib (Press release, Oncology Venture, APR 30, 2019, View Source [SID1234535457]). . In addition to renal, endometrial and GIST tumors Oncology Venture has now also shown in two new indications liver cancer and breast cancer that the DRP can predict the responding patients. Moreover, the first patient has been dosed with 2X‑121 at the Dana Farber Cancer Institute. Boston, US for the treatment of advanced ovarian cancer. Also, Oncology Venture has submitted an IND (Investigational New Drug Application) for LiPlaCis and its DRP to the FDA, with the intention to start a pivotal study in metastatic breast cancer.

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Dovitinib
Oncology Venture’s dovitinib DRP (Drug Response Predictor) has previously proved its ability to identify the best responders based on patient biopsies from clinical trials in renal, endometrial and GIST cancer. New analyses of biopsies from clinical trial cohorts of liver and breast cancer patients resulted in equally good predictability. Oncology Venture has thereby been able to confirm its DRP for dovitinib in five out of five of Novartis’ clinical trials and this without having to invest in own studies.

Oncology Venture aims to apply for a first FDA marketing approval of dovitinib and its companion DRP based on existing data from a pivotal study done by Novartis in patients with renal cancer.

2X-121/PARPi
The first U.S. patient has now been dosed at Dana-Farber Cancer Institute Boston with 2X-121, a PARP inhibitor in development for advanced ovarian cancer. 2X-121 has previously shown promising results in ovarian cancer patients in a phase 1 study performed by EISAI. The DRP selection aimed to find the best responding patients is expected to lift the response rate to outperform currently marketed drugs for the same indication. 2X-121 is also in development for the treatment of metastatic breast cancer.

LiPlaCis
An IND (Investigational New Drug Application) for LiPlaCis in metastatic breast cancer has been submitted to the FDA for the purpose of performing a pivotal study of LiPlaCis and its DRP in patients with metastatic breast cancer. An IDE (Investigational Device Exemption) will follow in this quarter.

In metastatic breast cancer patients with the highest DRP score (top 20%), LiPlaCis treatment resulted in a response rate of 40%. In comparison, the latest product approved by the FDA in this patient group, Halaven, showed a response rate of 12%. LiPlaCis is also being evaluated in an ongoing Phase 2 study in patients with prostate cancer.

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 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 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.