Oncology Venture Up-date
Hoersholm, Denmark; November 9th, 2015 – Oncology Venture Sweden AB (OV:ST) up-dates information about drug candidates in the pipeline.
Irofulven: The screening part of the trial is expected to include its first patients in Q4 2015. Following the production of Irofulven, which has already been initiated, first patient treated is expected in late Q2-Q3 2016. Production of Irofulven has been initiated.
APO010: old drug on stock may be useful in the planned trial of Multiple Myeloma (MM) and Chronic Lymphocytic Leukemia (CLL). This causes potential large initial savings on production costs. 5 mg of APO010 from stock has been sold to non-competing undisclosed company for 176.000 USD.
Furthermore, OV has acquired yet two Drug Response Prediction DRP™ licenses from MPI A/S on two undisclosed promising anticancer products.
Background: Irofulven is an anticancer drug in-licensed from Lantern Pharma. The two companies received a grant of 800t USD from Massachusetts Life Sciences Center to develop Irofulven in prostate cancer. An Irofulven DRP™, a gene expression data based Irofulven responsive predictor, has been developed by MPI A/S and in-licensed into OV.
Irofulven has been studied in 38 clinical trials (19 published) between 1995 and 2007, in which it has demonstrated promising single agent activity in a range of indications, including prostate cancer, ovarian, liver and pancreatic cancer, and clinical activity. For example, Irofulven demonstrated a 10% response rate in prostate cancer patients previously treated with docetaxel.
Up-date: A clinical phase 2 trial including a screening process is now to be initiated in selected patients with castration – and docetaxel resistant prostate cancer by using the Irofulven DRP™. 150 (possibly later extended to 600) patients are expected to be screened and 10% of the patients with the highest likelihood of benefit from Irofulven will be offered to participate in the trial. The aim is to improve the response rate to a clinical relevant and approvable level. The screening part of the trial is expected to include its first patient in Q4 2015. Following the production of Irofulven which has already been initiated first patient treated is expected in late Q2-Q3 2016.
License agreement: In October 2015 OV prolonged its license agreement with Onxeo regarding APO010. The license agreement gives OV global rights, royalties etc. in line with the previous communicated.
Production of APO010: OV has existing APO010 product that was produced in 2007 which is still active and stable. Currently OV has an expert team investigating whether the product can be approved for use in clinical trials. This will save a substantial amount of money and allow OV to commence an APO010 trial faster than if OV has to produce a new batch. If it is possible to use the old batch OV may initiate the first trial in Q2 2016.
Phase 2 clinical trial: APO010 was previously run in Switzerland at two sites. Two cohorts of 3 patients will initially in the current trial be included to establish the recommended phase 2 dose. The phase 2 trial has been designed to include MM and CLL patients and hematology experts on two sites in Denmark are interested in participation in the testing of APO010 in these two blood cancer diseases. The screening part of the trial is expected to begin as soon as OV has a green light from its production. In the MM/CLL all patients have the FAS-receptor. The APO010 is a FAS-ligand drug
and only works when the FAS-receptor is there but this is not enough and OV use its DRP to find the high likelihood responders. It is anticipated that 50% of the patients will respond when the recommended APO010 dose is found. Accordingly the top 50% will be included in the trial and more than 50 patients will therefore be screened in order to be able to include 20 – 25 patients in the trial.
Sales of APO010: OV has in November 2015 sold 5 mg of their current stock of APO010 for 176.000 USD to an undisclosed company developing APO010 for a non-competing project which uses APO010 outside the body i.e. not competing with OVs plans. The product may also be sold in the future for this purpose if tests pan out as expected.
New drugs in the pipeline
Up-date: Oncology Venture has acquired DRP license to two new promising anticancer drugs and work and discussions with drug owners is ongoing to further evaluation of the business potential. For business reasons the identity of the drugs cannot be revealed. The details of the license are explained in the OV Memorandum from summer 2015. The price of a DRP™ report is 120.000 DKK.
Oncology Venture has built an expert team of part time oncologists and hematologist researching the area of promising drugs to support the US team in Boston and Arizona to find the best products and help negotiate deals.
For further information concerning Oncology Venture please contact:
Peter Buhl Jensen, CEO
Telephone: +45 21 60 89 22
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. The business enterprise is based on “rescuing” anti-cancer drugs whose development has been interrupted in the clinical development stage. DRP™ has proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment in cancer patients in 26 of the 32 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.