Oncology Venture Up-date
Hoersholm, Denmark; August 25, 2016 – Oncology Venture Sweden AB (OV:ST) up-dates information about its drug candidates APO010, Irofulven and LiPlaCis in the pipeline and informs about potential drugs in a US Special Purpose Vehicle (SPV) focusing on Women’s Cancers using the Drug Response Predictor -DRP- to select high likely responding patients. At the IPO in July 2015 Oncology Venture set out to in-license and evaluate 5 products in a three-year period. OV has already now in-licensed and started development on three of these and is on an overall schedule ahead of its initial timelines.
APO010 - All stability tests up till now have been satisfactory and only one single test is outstanding before we can send the application for the clinical proof of concept study in MM. Three sites are included in the screening. OV hopes to begin inclusion of patients in the proof of concept study with APO010 during the next quarter or early 2017. Previously communicated timelines were that the study could include patients at the earliest in Q3, 2016. The expenses are likewise postponed and therefore the financial impact is minimal.
The production of Irofulven is ongoing, two expert manufactures are working together. Three sites are including patients in the screening protocol. The Company hopes to initiate the Phase 2 study of Irofulven in January 2017. Previously OV has communicated that it hoped to initiate the trial at the earliest Q3 2016. The expenses are likewise postponed and therefore the financial impact is minimal.
More than 1100 metastatic breast cancer patients have now given informed Consent to partake in the DRP screening study that forms a registry wherefrom DRP positive patients can be offered to enter the LiPlaCis trial if and when this becomes relevant. The number of LiPlaCis trial sites will be increased by 2-4 to accelerate inclusion of patients due to the positive start of the extension Phase of LiPlaCis.
APO010 - an immuno oncology product
As previously announced the APO010 drug on stock which was produced by the earlier drug owner may be used in the planned trial of Multiple Myeloma (MM – a Bone Marrow Cancer) if APO010 is still a stable drug. This causes potential large initial savings on production costs.
All stability tests up till now have been satisfactory and only one single test is outstanding before we can send the application for the clinical proof of concept study in MM.
If the APO010 product in stock is approved, OV hopes to begin inclusion of patients during the next quarter or early 2017. Previous OV communicated that initiation of the first trial was expected in Q3 2016. The expenses are likewise postponed and therefore the financial impact is minimal.
Two more centres were included and started screening Multiple Myeloma patients in the Oncology Venture APO010 study. Three out of four scheduled Danish hematology centers are thereby partaking in the study and patients with a high likelihood to respond as per Drug Response Predictor analysis are expected to be ready for inclusion at the time we receive approval from the Danish Authorities. Approximately 150 patients will be screened using OV’s DRP™ (Drug Response Predictor). The screening study aims to identify 15 Multiple Myeloma patients to be included in a focused phase 2 multi-center study. Response data will be available during the clinical trial.
Through our partner Smerud Medical Research International AS (SMERUD) we have received a grant from the Norwegian Research Board within the EUROSTARS program for development of our immune oncology product APO010. This grant supports the clinical proof-of-concept study to investigate early signs of efficacy from APO010 in Multiple Myeloma patients.
The grant was received from SMERUD who co-finance the study and also contribute with private investments. The total value of the EUROSTARS grant, and the contribution from SMERUD amounts to 13 MSEK.
Irofulven
Irofulven is an anticancer drug in-licensed from Lantern Pharma. The two companies have received a grant of 800t USD from Massachusetts Life Sciences Center and Medicon Valley (Copenhagen and Skåne regions) to develop Irofulven in prostate cancer.
The production of Irofulven is ongoing, two expert manufactures are working together. First and most critical step where cell lines produces illudin S has successfully been completed with high yields and the second manufacturer is now working on producing Irofulven from illudin S. Oncology Venture is awaiting the timelines from the US manufacturer – and we hope to start the phase 2 study in January 2017. Previously OV has communicated that the start was expected to start at the earliest during Q3, 2016. As the expenses are likewise postponed the financial impact is minimal.
OV will communicate this as soon as we know the timelines. In the meantime Swedish and Danish prostate cancer patients are being screened by the DRP so that top 10% in a register of Prostate Cancer patients who are expected to be high likelihood responders to Irofulven are ready to enter the study. Response data will be available during the clinical trial.
An Irofulven DRP™, a gene expression data based Irofulven responsive predictor, has been developed by MPI 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.
LiPlaCis
The Phase 1 dose escalation + extension phase study to evaluate the safety and tolerability of LiPlaCis in patients with advanced tumours has been conducted at two Oncology sites at University Hospitals in Copenhagen. 20 patients have been included in the dose escalation part in solid tumors. The LiPlaCis program has now moved into the extension proof of concept phase and the first metastatic Breast Cancer patient with a positive DRP has responded with a Partial Remission (ie. >30% reduction of tumor). Patients are dosed with 75mg LiPlaCis™/patient and administered intravenously in weekly cycles on day 1 and day 8 in 3 weeks cycles. More than 1100 metastatic Breast Cancer patients have consented to have their tumor tissue analysed whereof 15 patients in the top 10% high likelihood responders will be offered to enter the proof of concept study. To further accelerate the inclusion Oncology Venture is in the process of opening 2-4 more sites in Denmark – in total 4-6 sites.
Special Purpose Vehicle/Women’s Cancer Company
Oncology Venture is in the process of establishing a New Company in the US – a so called Special Purpose Vehicle (SPV). This initiative is launched to increase the number of shots on goal with our DRP technology without having to go to OV investors and funding will primarily come from US investors. This company will focus on developing drugs for the treatment of Women’s Cancers using the Drug Response Predictor – DRP. Drugs relevant for breast and ovarian cancers with very good DRPs have been identified by our oncology specialist search team and Term Sheets are currently being negotiated with the drug owners. We Expect that this initiative will give a strong and interesting news flow.
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 Ulla Hald Buhl, COO, IR & Communication
Telephone: +45 21 60 89 22 Telephone +45 21 70 10 49
E-mail: pbj@oncologyventure.com E-mail: uhb@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 25 august 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 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.