PIPELINE

LiPlaCis

Oncology Venture - LiPlaCis
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.
Therapeutic Target Annual Diagnoses (est.)
Metastatic breast cancer
Prostate cancer 1.3 million (worldwide)
Lung cancer 2.1 million (worldwide)
Head and neck cancer 865,000 (worldwide)
Bladder cancer 549,000 (worldwide)
Ovarian cancer 295,000 (worldwide)

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.

Clinical Trials

A Phase 2 clinical trial of LiPlaCis is ongoing in Denmark for the treatment of metastatic breast cancer. In October 2018 this trial was expanded to include prostate cancer patients, 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. 

Response to a registration route has been received by FDA (505(b)(2)). OV has received IDE approval and are in discussions of the clinical trial design of the IND.

References
  1. 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%).

Equipment from Oncology Venture’s labs.

LiPlaCis DRP

The Cisplatin DRP was validated in multiple studies, including:

On 15 August 2018, the LiPlaCis DRP was granted IDE approval by the FDA.

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.