Status up-date and planned rights issue
Hoersholm, Denmark September 20th 2016 – Oncology Venture Sweden AB:s (OV:ST) daughter company Oncology Venture ApS announces the entering of a co-development agreement with Cadila Pharmaceuticals Ltd. (“Cadila”) to advance the anticancer product LiPlaCis® in combination with its Drug Response Predictor – DRP™. The aim is to evaluate the LiPlaCis efficacy in several different indications and perform a randomized phase 3 trial as corner stone and part of the data package study for marketing approval by the FDA, EMA, CDSCO (Central Drugs Standard Control Organization of India). Cadila will invest in kind in research and development activities regarding 310 cancer patients and DRP screening of more than 1400 patients. Cadila will perform four (4) clinical Phase 2 trials and a pivotal randomized clinical Phase 3 trial during a period of three years. 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.
Oncology Venture has also identified a fourth drug candidate - an oral tyrosine kinase inhibitor that has proven effect and where tumor tissue is available from clinical phase 3 trials for DRP testing before entering into full agreement. OV is negotiating with an undisclosed Big Pharma, who has the full rights to the project.
Furthermore, OV intends to secure rights to three promising drug candidates for the treatment of women’s cancers via 2X Oncology Inc., an American spinout from Oncology Venture. Oncology Venture is as a consequence of the above mentioned new projects seeking new capital why the Company plans a rights issue of approximately 22 MSEK with a relatively low rebate in the near future. A number of parties, among which there are major shareholders, have through subscription rights signed up for 55% of the volume of the emission. Information about the planed rights issue will be communicated in the near future.
”Oncology Venture has until now in-licensed three anticancer drugs LiPlaCis®, APO010 and Irofulven and is ahead of its initial timelines. We now have the opportunity – in a focused way – to move the Company to next level why Oncology Venture seeks new capital. In-licensing of the fourth drug candidate in OV accelerates the pace and the number of shots of goals (the likelihood of success) considerably and the development deal with Cadila Pharmaceuticals means that we can take a big step ahead with LiPlaCis®. If we can also initiate the work with the products in 2X Oncology Inc., our American spinout for treatment of Womens Cancers we can further increase the number of promising drug candidates”, said Peter Buhl Jensen, Adjunct professor, M.D., PhD and CEO for Oncology Venture.
Goals and prioritized activities
At the time of going public in July 2015, it was stated the over-all goal amongst others was to in-license 5 drugs and with these drugs perform 5 focused Phase 2 studies in a three-year period. In addition, the goal is within a three-year period to generate at least two drug candidates for out-licensing (or sale).
The Company’s activities on the earlier in-licensed drug candidates APO010, Irofulven and LiPlaCis is running according to plans. The Company has capital from the emission from the time of the listing in 2015 to run focused clinical phase 2 trials for APO010 and Irofulven. The LiPlaCis-program has moved from the dose escalation part to an extension phase of the proof-of-concept-study. Through the capital raise at the time of the rights issue during spring 2016 it is possible to keep a high pace of development of LiPlaCis®.
Planed Rights Issue
Oncology Venture is focused on development of anticancer drugs in combination with its Drug Response Predictor – DRP – and has now the possibility to increase the pace of the company and as a consequence of this seeks capital. To raise capital, the Company plans to do a rights issue of approximately 22 MSEK with a relatively low rebate. The raised capital will primarily be used to finance the in-licensing and the development of a fourth anticancer drug candidate an oral tyrosine kinase inhibitor, manufacturing of LiPlaCis for the clinical studies in accordance with the Cadila agreement and to secure the rights for three highly interesting products for development in women’s cancers for 2X Oncology Inc. – an US spinout (Special Purpose Vehicle) from Oncology Venture. A number of parties, amongst these some of the major shareholders have through subscription rights ensured 55 % of the volume issued. More information about he planned right issue will be communicated in the near future. +
Development deal with Cadila Pharmaceuticals Ltd.
In accordance with the agreement Cadila Pharmaceuticals will finance and conduct studies with a total of 310 cancer patients including those who have the highest likelihood of success with the LiPlaCis® treatment. The drug development is planned as follows:
1. Screening by the use of the LiPlaCis-DRP™ of 1 250 metastatic breast cancer patients to identify 250 patients with high likelihood to respond to LiPlaCis treatment and perform a randomized phase 3 trial in these 250 patients comparing standard therapy with LiPlaCis.
2. Through Cadilas strong network and Cadials CRO run four (4) clinical Phase 2 trials in 20 patients (out of 100 screened) with Head & Neck cancer, 20 prostate cancer patients (out of 100 screened), and 10 skin cancer patients and 10 esophagus cancer patients – the two latter indications are in a high frequency sensitive to cisplatin – of which LiPlaCis® is an improved formulation – why the patients will not be screened. Cadila has commercialization rights in India, Russia, Africa and South East Asia (ASEAN countries only), Oncology Venture has the commercialization rights to America, Europe and China and RoW. Oncology Venture will be responsible for the manufacturing and pay for manufacturing of the product. Estimated costs for product in 2017-2018 is 0,6 MUSD. 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. When developed parties may choose to market themselves in their own territories or out license or sell to a third party.
An oral Tyrosine Kinase Inhibitor-project
A fourth OV product – an oral Tyrosine Kinase Inhibitor (TKI)– has been identified and terms are under negotiation with a non-disclosed Big Pharma company who owns all rights to the drug. The product has been tested in Phase 2 and Phase 3 studies and biopsies are available. Oncology Venture has the possibility to run a quick proof-of-concept DRP test on the biopsies to see if Oncology Venture can identify responders from the clinical trials why this – according to the board – is a de-risked and unique investment case. The test can be run in two months.
Oncology Venture has the opportunity to acquire rights to DRP-test the biopsies for 500,000 USD and the Company has an investor who intends to invest in the rights from the drug owner, a Big Pharma Company. If this proof of concept testing falls out positively it is likely that the drug will be spun out in a Special Purpose Vehicle (SPV), in which Oncology Ventures investors and institutional investors will be offered to invest.
Special Purpose Vehicle (SPV) – gives the opportunity to increase the product pipeline
The Company has incorporated an oncology product spin-out, 2X Oncology Inc. for Womens Cancers i USA. The company focusses on precision medicine for cancer indications specific for women with the aim to develop promising cancer drugs in clinical phase by the use of the DRP-tool. The initial therapeutic focus will be directed towards unmet medical needs in breast and ovarian cancer. Oncology Venture has identified three products for which the company planes to secure rights for 2X Oncology Inc. The plan is to test the products in proof-of-concept-studies in Scandinavia with the help of the Drug Response Prediction tool and thereafter move the most promising candidate to a randomized possibly pivotal Phase 2-study in the US.
For further information, please contact
Ulla Hald Buhl, COO and
Chief IR & Communications
Mobile: +45 2170 1049
uhb@oncologyventure.com
or
Peter Buhl Jensen, CEO
Mobile: +45 21 60 89 22
E-mail: pbj@oncologyventure.com
This information is information that Oncology Venture Sweden AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on September 20th 2016.
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’ tumors genes 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: LiPlaCis for Breast Cancer, Irofulven developed from a fungus for prostate cancer and APO010 – an immuno-oncology product for Multiple Myeloma.