On December 18, 2018 Oncology Venture A/S ("OV" or the Company) reported that the US Food and Drug Administration, FDA has responded positively on questions posed by the company in a Pre-IND/IDE package for the approval pathway for LiPlaCis and its companion diagnostic DRP – Drug Response Predictor – in metastatic breast cancer (Press release, Oncology Venture, DEC 18, 2018, View Source [SID1234532169]).

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The FDA agreed that the 505(b)(2) pathway is an acceptable registration route for LiPlaCis and that no further toxicology studies are needed. Based on current good data the number of patients to be treated is in line with previous guidance in the upcoming pivotal phase 3 trial of LiPlaCis and its DRPÒ for the treatment of patients with advanced breast cancer.
The FDA accepts objective response rate (ORR) as the primary endpoint but asked for further characterization of sub-groups in the breast cancer population aimed for treatment with LiPlaCis.
LiPlaCis is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin. The specific LiPlaCis formulation allows delivery of LiPlaCis directly at tumor site. The specific LiPlaCis DRP selects the patients whom are expected to benefit from the treatment. LiPlaCis has shown very promising results in an ongoing phase 2 trial, a study that will continue as planned. Recruitment timelines of the pivotal phase 3 study will be updated following the FDA approval of the Investigational New Drug Application (IND) and the Investigational Device Exemption (IDE) expectedly in H1 2019.

"Oncology Venture in-licensed LiPlaCis as a phase 1 project in 2016. The 505(b)(2) strategy allows us to refer to data for a listed drug and will save us important time and resources. Our team has done a remarkable job by moving this project from an early stage to a late stage project in only two years. The discussions with the FDA gave no barrier for proceeding with our pivotal development plans for a fast route to commercialization and we can now increase our partnering activities with pharma," comments Peter Buhl Jensen, M.D., CEO of Oncology Venture.

Data from the ongoing Phase 2 LiPlaCis study in patients with metastatic breast cancer shows a
50% objective response rate (five out of ten patients) in the upper one third of DRP selected patients and a 24% objective response rate (6 out of 25 patients) in the upper two thirds of DRP selected patients. These data should be compared with historical response rates to the established cancer drugs in metastatic breast cancer with a 10-12% objective response rate of eribulin, vinorelbine and gemcitabine and 10% of conventional cisplatin.

If the ongoing phase 2 study will continue to show strong efficacy data, Oncology Venture aims for a Break through designation. This application is planned for filing shortly after the IND and its IDE application for LiPlaCis.

Oncology Venture’s regulatory strategy is to first obtain approval in the US. The aim is then to run randomized pivotal studies in Europe and Asia.