Oncology Venture Updates on Pipeline and Business

Hoersholm, Denmark -- October 23rd  2017 – Oncology Venture Sweden AB:s (OV:ST) (“Oncology Venture” or “OV”) announces a pipeline and business update: Oncology Venture has within the last six months signed agreements for two product candidates – a PARP/tankyrase inhibitor from Eisai and a tyrosine kinase inhibitor (TKI) from Novartis. We know thar there is fierce competition to acquire these types of assets, and we believe that the  the differentiated DRP™ companion diagnostic technology enabled us to secure these high profiled products licenses. Accordingly these two new products will be of highest priority of the company. The TKI data on biopsies from Novartis will be available in 6-8 weeks and OV will know if the DRP can predict responders on this important Phase 3 product. Oncology Venture has commenced regulatory activities for first FDA discussions on the TKI the 2X Oncology PARP inhibitor and LiPlaCis,. Irofulven clinical trial application is three weeks delayed and expected to be submitted in week 43.

As previously announced, the DRP™ correctly predicted both the responder and non-responder patients treated with Eisai’s PARP, now being developed by our US subsidiary 2X Oncology, Inc. as 2X-121. The copany believes that the 2X-121 DRP will provide a competitive advantage, as it should significantly improve patient response rates in the planned clinical study and position this program for accelerated approval studies next year. PARP inhibitors have demonstrated success in ovarian cancer and hold promise for other cancer types as well and 2X-121, paired with its DRP, is well positioned to potentially be an important treatment in this space.

Clinical phase 3 data combined with data from biopsies from in excess of 150 of patients treated with our second big pharma product candidate, a TKI from Novartis, are currently being analyzed by a Novartis service provider; within the next months we will know if OV’s TKI DRP predictor can find the responders. This is a very important milestone for the company, and if positive OV will initiate discussions with regulatory authorities - FDA - this winter for a potential fast route to approval and a stronger competitive profile of this important product.

OV is confident in the DRP and have already announced that the DRP can identify patients that respond to LiPlaCis and supporting data has previously been announced in metastatic breast cancer in the ongoing Phase 2 study. Please see press release of September 19th, 2017. Historic literature shows a response rate of 10% to standard cisplatin (http://ascopubs.org/doi/abs/10.1200/jco.2012.46.2408), compared to which OV’s first results on LiPlaCis holds promis of signicant improvement of this result.

Retrospective prospective validations on epirubicin, cisplatin, and 2X-121 DRPs have been completed. In OV’s combined six-product pipeline the 2X-121, 2X-111, LiPlaCis and potentially the TKI candidates are prioritized, as the DRP has already shown its effectiveness in prediction the companyhas already demonstrated that it can find the responding patients in real practice for these product candidates.

OV have recently initiated the business development process as it plan to sell the products after succesfull focused phase 2 trials. At this early stage there is as expected interest from potential partners and product buyers who look forward to see the data before materializing the interest. Timing and closure of a transaction is always difficult and subject to a range of factors including product data, partner priorities and deal terms however OV plan to actively advance these discussions to a conclusion.

The progress of the screening trials and clinical trials of the pipeline projects are all on time except for a delay in irofulven manufacturing which has been resolved. The irofulven vials are now in Denmark, and the irofulven prostate cancer protocol will be submitted with three weeks delay due to technical update from the successful manufacturing of Irofulven to authorities in October.  

On the financing front, OV is working on different routes to attract capital and advance our pipeline for long-term value creation. OV’s clinical trial partner, Smerud, is investing in-kind in the projects and Smerud is securing a cost-effective operation that can handle the projects. OV is also pursuing, with Smerud, continued grant support. Financing is, as always, a balance between securing funding and minimizing dilution

The 2X Oncology team also continues to make progress with its planned financing, with a focus on U.S based healthcare investors.

Oncology Venture is working on obtaining coverage of the company by equity analysts – this is a timing issue that will be aligned with other ongoing activities.

“The DRP technology is a new way of identifying patients who will benefit from a drug. We know that precision medicin is prioritized by the FDA. I look very much forward to the meetings discussing our promising products developed together with their Drug Response Predictor – DRP™,” Said Dr. Marie Foegh, M.D., DMSc. and CMO of 2X Oncology Inc. 

Regulatory Strategy

The U.S. is the most important commercial market for pharmaceuticals, and briefing packages will be submitted to the FDA for two OV products before year end: an End-Of-Phase 2 meeting request for the TKI, and a Special Protocol Assessment for the LiPlaCis randomized Phase 2 clinical trial. Additionally, 2X Oncology expects to meet with the FDA and file an IND for 2X-121 and an IDE for the 2X-121 DRP™ with the FDA in the fourth quarter of the year. For more detailed information please see https://www.fda.gov/downloads/drugs/guidances/ucm153222.pdf 

Traditionally a drug is approved when a randomized study (where one directly compares the old and the new drug(s), or the new drug(s) vs. placebo) has demonstrated that the new drug has better data than standard therapy. This is still the case at the European health authorities EMA.

However, this classic regulatory pathway is under change. The FDA in particular is focused on rapidly bringing new effective treatments to cancer patients, and may approve drugs if Phase 2 data are strong. This is exactly the regulatory approach that OV and 2X Oncology are pursuing, since the DRP allows us to run small focused Phase 2 studies with a significantly increased benefit for the patients.

In cases with strong data, the drug will be positioned for approval on the basis of the already ongoing/planned focused phase 2 studies – in other cases there may be a rationale for further inclusion of patients and in a third category there may be a need for a randomized Phase 2 or 3 study to demonstrate superiority.

For further information, please contact:

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 October 23rd 2017.

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 an exclusive license to use the Drug Response Predictor (DRP™) technology 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 with DRP™ 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 in collaboration with Cadila Pharmaceuticals; Irofulven developed from a fungus for prostate cancer; and APO010 – an immuno-oncology product for multiple myeloma.

Oncology Venture has spun out two companies in Special Purpose Vehicles: 2X Oncology Inc. a US-based company focusing on precision medicine for women’s cancers with a pipeline of three promising Phase 2 product candidates, and Danish OV-SPV 2 which will test and potentially develop the Novartis small molecule kinase inhibitor. Oncology Venture currently owns 92% of 2X Oncology Inc. and 40% of OV-SPV2 ApS.