OV in-licensed LiPlaCis™ as third drug in OV pipeline

Hoersholm, Denmark; February 19th, 2016 – Oncology Venture Sweden AB (OV:ST) announces that it has in-licensed LiPlaCis™ from LiPlasome Pharma ApS, Denmark. LiPlaCis is the third drug in OV’s pipeline and will be the first prospective trial using the Drug Response Predictor - DRP™. LiPlaCis™ is the lead product in LiPlasome Pharma – mainly owned by Vecata Invest A/S an investment company managing the Bagger-Sorensen Group's investments in the venture segment. LiPlaCis™ - a liposomal formulation of cisplatin - is just finalizing the dose escalation part of a phase 1 study in solid tumors and is on the verge of moving into the extension phase where screened breast cancer patients with metastatic disease will be treated. Using analysis of patients own biopsies by the DRP™ patients are screened beforehand for high likelihood of effect of the LiPlaCis™ drug. The DRP™ should thereby enable a high response rate and give breast cancer patients a new effective treatment opportunity. There is no sign on fee and no up-front payment to LiPlasome. The License agreement is based on a revenue split between the parties once the LiPlaCis™ product is commercialized. It is anticipated that more capital will be needed to take LiPlaCis the whole way to outlicensing/exit. OV will raise money when it is needed and as previously announced each product including LiPlaCis is budgeted to cost approximately 2 mUSD on average.

"This is a key step for OV – the team in OV has the last three years worked with MPI and LiPlasome on LiPlaCis™ and the fact that OV can now take over the responsibility for this promising project is indeed a major step forward for OV”, Said Adjunct professor Peter Buhl Jensen, MD, PhD and CEO of Oncology Venture. ”We know the project well and we are proud that Vecata Invest as the major owner has let us include LiPlaCis™ in the OV portfolio. We trust we can develop LiPlaCis™ into a new effective treatment opportunity for breast cancer patients”, Dr. Buhl Jensen further commented."

“We are very happy to out-license the lead product LiPlaCis™ to Oncology Venture which we believe is a better home for a product progressing into a more advanced level in clinical development”, Said Hans-Henrik Eriksen CEO of Vecata Invest. “Oncology Venture has a proven team and in our joined advisory board we look forward to a continued collaboration bringing LiPlaCis to cancer patients.”

LiPlaCis™ is a liposomal formulation of cisplatin. LiPlaCis™ is finalizing a promising clinical phase 1-studie with early responses in non-screened patients with solid tumors (one patient with esophageal cancer and one patient with skin cancer) and is on the verge of entering an extension phase 2 design study in which 12 breast cancer patients will be treated based on screening using the DRP™ and where efficacy will be measured. LiPlaCis™ is thereby the most advanced drug in the Oncology Venture pipeline. The team responsible for running the phase 1 trial is the OV team which is an advantage as OV is therefore very familiar with the product manufacturing, regulatory communication as well as the conduct of the study at the clinical site. Thus, there will be no time wasted in the takeover period.

In a collaboration with the Danish Breast Cancer Cooperative Group (DBCG) including nine Danish breast cancer sites more than 900 patients with metastatic breast cancer have participated in the screening for high likelihood responders to LiPlaCis™. Biopsies from the patients have been analyzed by the LiPlaCis DRP™ and the project is very soon to start include patients. The LiPlaCis active ingredient is cisplatin and the Cisplatin DRP™ has been previously validated retrospectively in a lung cancer study and now also in a prospective lung cancer study (Abstract submitted to ASCO). OV therefore prioritize this proof of concept study with LiPlaCis in breast cancer patients. This is the fastest possible first prospective trial using the DRP method.

The LiPlaCis™ deal
There is no sign on fee and no up-front payment to LiPlasome. The License agreement is based on a revenue split between the parties once the LiPlaCis™ product is commercialized. It is anticipated that more capital will be needed to take LiPlaCis the whole way to outlicensing/exit. OV will raise money when it is needed and as previously announced each product including LiPlaCis is budgeted to cost approximately 2 mUSD on average.

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 from LiPlasome 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 ApS has identified and incorporated a mechanism into their 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.

More about LiPlaCis™ and the clinical testing
The Phase 1 study to evaluate the safety and tolerability of LiPlaCis in patients with advanced tumours is running at a Phase 1 Unit at a University Hospital in Copenhagen and has included 18 patients in the dose escalation part of a phase 1 study in solid tumors. The LiPlaCis program is now on the verge of moving into the extension phase 2 designed trial (part of the phase 1 application where patients with a specific disease – here metastatic breast cancer - are included to investigate early Proof of Concept – i.e. effect of the drug. LiPlaCis™ is administered intravenously in cycles weekly on day 1, day 8 Upon the investigator’s judgement the patient may continue treatment for more than 3 cycles when benefiting from the study drug.

About the Drug Response Predictor -DRP™ - screening tool
Oncology Venture uses the MPI DRP™ to select those patients that by the gene signature in their cancer is found to have a high likelihood of response to the drug. The goal is to develop the drug for the right patients and by screening patients before treatment the response rate can be significantly increased.

This 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. The DRP™ based on microRNA is used on certain products where the DRP™ based on messenger RNA is more broadly useable and more validated.

For further information, please contact
CEO Peter Buhl Jensen, Adjunct professor, MD, PhD
Telephone: +45 21 60 89 22
E-mail: pbj@oncologyventure.com

About Oncology Venture Sweden AB
Oncology Venture Sweden AB is engaged in the research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS. Oncology Venture has a license to use Drug Response Prediction – DRP™ – in order to significantly increase the probability of success in clinical trials. DRP™ has proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment in cancer patients in 29 of the 37 clinical studies that were examined. The Company uses a model that alters the odds in comparison with traditional pharmaceutical development. Instead of treating all patients with a particular type of cancer, patients are screened first and only those who are most likely to respond to the treatment will be treated. Via a more well-defined patient group, the risk and costs are reduced while the development process becomes more efficient.

The current product portfolio: Irofulven developed from a fungus for prostate cancer and APO010 – an immuno- oncology product for Multiple Myeloma.