Other pipeline assets
Besides Dovitinib, 2X-121, and Ixempra, Oncology Venture has several other pipeline assets as listed on this page.
LiPlaCis® is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapeutic agents, cisplatin, which has documented efficacy in numerous tumor types.
The specific LiPlaCis formulation allows delivery of LiPlaCis directly to the tumor site where is it needed.
How it Works
LiPlaCis, a target controlled liposome, enables a more selective up-take of cisplatin at the tumor site. Once it has accumulated in the cancer tissue, the drug is broken down by secretory phospholipase A2 (sPLA2), an enzyme present on tumors. The lipid composition of LiPlaCis is tailored to be specifically sensitive to degradation by the sPLA2 enzyme and thereby for release of the encapsulated cisplatin.
A Phase 2 clinical trial of LiPlaCis is ongoing in Denmark for the treatment of metastatic breast cancer. In October 2018 this trial , increasing the planned study cohort from 30 to 50 patients. The aim of this study is to identify the breast and prostate patient populations relevant for submitting a Marketing Authorization application.
- A partial remission is defined as a >30% reduction in tumor size as measured in one dimension by CT scan. A 30% reduction measured in only one dimension is equivalent to an estimated 66% reduction in total tumor size, since the tumor will not only have been reduced in length (one dimension) but also in height and depth. Thus, on average the tumor is reduced to 34% of its initial size, or less (0.7 x 0.7 x 0.7 * 100% = 34%).
History and Funding
Oncology Venture in-licensed LiPlaCis from LiPlasome Pharma in 2016. The technology behind this product candidate was originally developed by scientists from Danish Technical University (DTU).
Development of LiPlaCis is funded in part by a 2016 EUROSTARS grant, with additional funding from Smerud Medical Research.
Jakobsen EH et al. Liposomal cisplatin response prediction in heavily pretreated breast cancer patients: A multigene biomarker in a prospective phase 2 study. J Clin Oncol 36, 2018 (suppl; abstr e13077)
Equipment from Oncology Venture’s labs.
How it Works
This novel drug candidate is designed for the liposomal delivery of the anti-cancer drug doxorubicin directly to a tumor, with a glutathione coating added to exploit active endogenous transporters, allowing the drug to cross the blood-brain barrier.
Doxorubicin is an anthracycline that inhibits the growth of many cancerous cell lines, including glioblastoma and breast cancer cell lines. It is among the most widely used anti-cancer agents.
Phase 2 clinical studies have been prepared, using a validated DRP companion diagnostic in patients with brain metastases from breast cancer and recurrent glioblastoma multiforme (GBM).
2X-111 has been granted orphan drug designation by the U.S. Food and Drug Administration.
In a prior clinical trial conducted without a DRP, 2X-111 demonstrated encouraging efficacy and safety. Observed response rates in this Phase 2 study in brain metastases from breast cancer included 67% disease control. Use of the validated DRP for 2X-111 in future trials is expected to result in improved efficacy.
A molecular model of doxorubicin. 2X-111 is is designed for the liposomal delivery of doxorubicin directly to a tumor.
This drug candidate is a synthetic drug candidate based on a naturally occurring substance that exploits a deficiency in the DNA repair mechanism of cancer cells in a manner similar to a PARP inhibitor.
How it Works
Irofulven alkylates DNA and protein macromolecules, forms adducts, and arrests cells in the S-phase of the cell cycle. This agent requires NADPH-dependent metabolism by alkenal/one oxidoreductase for activity.
The compound is more active in vitro against tumor cells of epithelial origin, and is more resistant to deactivation by p53 loss and MDR1 than other alkylating agents.
OV is running a single arm, open label Phase 2 Study of Irofulven for treatment of metastatic castration-resistant prostate cancer. This study aims to enroll up to 27 men with metastatic castration-resistant prostate cancer who have previously been treated with docetaxel and who have been identified by the DRP as having a high likelihood of response to Irofulven.
Irofulven has been evaluated in 19 clinical trials, predominantly in refractory prostate and ovarian cancer patients and all conducted without DRP-guided patient selection. Results were positive, including a 10% response rate in patients with prostate cancer previously treated with docetaxel and 13% in ovarian cancer patients relapsing between 6 and 12 months after standard treatment with carboplatin and paclitaxel, but were not deemed sufficient for regulatory approval by the previous owner of the drug.
The ongoing and planned studies using the Irofulven DRP are expected to significantly improve response rates seen in prior studies.
A molecular model of irofulven. Irofulven is a semisynthetic sesquiterpene derivative of illudin S, a natural toxin isolated from the fungus Omphalotus illudens.