LiPlaCis

About LiPlaCis

Cisplatin is one of the most widely used drugs in the treatment of cancer due to its documented efficacy in a number of tumour types. Cisplatin is used in the treatment of large indications as lung cancer EU+US ≈ 480,000 new cases annually), head and neck cancer (500,000 cases annually worldwide) bladder cancer (EU+US ≈ 170,000 annually) and ovarian cancer (EU+US ≈ 71,000 annually). The lipid formulation is the answer to a well-established need for improving cisplatin therapy and improving the formulation of the drug, so that a more selective up-take of cisplatin administered takes place at the tumour sites. LiPlasome Pharma from whom Oncology Venture has in-licensed LiPlaCis™ has identified and incorporated a mechanism into the liposomes – called LiPlasomes – designed to trigger the release of an encapsulated drug specifically in the tumour tissue. An enzyme especially present on tumors called secretory phospholipase A2 (sPLA2), is utilised to break down the LiPlaCis once it has accumulated in the cancer tissue. The lipid composition of the LiPlasomes is tailored to be specifically sensitive to degradation by the sPLA2 enzyme and thereby for release of the encapsulated drug. The technology behind LiPlaCis™ was originally developed by scientists from Danish Technical University – DTU.

 

LiPlaCis Phase 2 for metastatic Breast Cancer (mBC)

LiPlaCis has finalized the dose escalation part of the trial in November 2016 and has demonstrated promising activity in patients already in the dose escalation part. LiPlaCis is administered intravenously in 3 week cycles on day 1 and day 8. Upon the investigator’s judgement, the patient may continue treatment for more than 3 cycles when benefitting from the study. Response (confirmed PR = Partial Response) has been published for the first DRP-screened patient with a hard to treat metastatic Breast Cancer. LiPlaCis has received status as a phase 2 study by the Danish authorities and 2 more (i.e. 3 out of 4 in total) Danish centers are now active in recruiting 12-15 metastatic Breast Cancer patients screened and expected to be highly likely responders to LiPlaCis. We expect to finalize the study in Q3 2017. The first regulatory approach has been to register LiPlaCis together with its DRP™ companion diagnostic for an EU-marking. Next step in the regulatory strategy is building a data package for a ‘Pre-Submission meeting’ with the FDA. This is done in collaboration with US-experts.

Liplacis

Collaboration agreement with Cadila Pharmaceuticals

Oncology Venture entered a collaboration agreement with Cadila Pharmaceuticals LTD in September 2016. Cadila invest in kind in research and development activities of 310 cancer patients and DRP screening of more than 1400 patients. Cadila will perform four (4) Phase 2 trials in Prostate, Head & Neck, Skin and Esophageal Page 2 of 3 cancers and a pivotal randomized clinical Phase 3 trial in metastatic breast cancer. In the consortium of owners now including Cadila Pharmaceuticals, LiPlasome, MPI and Oncology Venture – Oncology Venture owns 29% of the total value of the LiPlaCis project after Phase 3. Further information about the development with Cadila is presented in a separate press release from 20 September 2016. The phase 2 part of the OV trial will take approximately 12 months which is Q3 2017, with interim data expected during the period. Together with our CRO Smerud LiPlaCis obtained a EUROSTARS grant (EU grant) in December 2016 supporting the development of LiPlaCis with a total value of 18 mSEK.