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First Patient Dosed in Phase 2 Study of PARP/Tankyrase Inhibitor 2X-121 for Metastatic Breast Cancer

/EIN News/ --

CAMBRIDGE, Mass. and HOERSHOLM, Denmark, June 26, 2018 (GLOBE NEWSWIRE) -- Oncology Venture US Inc., Oncology Venture AB (OV:ST) (“OV”) and Medical Prognosis Institute A/S (MPI:ST) today announced dosing of the first patient in a Phase 2, open-label clinical trial to investigate the anti-tumor effect and tolerability of 2X-121 in patients with metastatic breast cancer selected by a novel drug response predictor (DRP®) mRNA-driven multiple biomarker, the 2X-121 DRP®.  The drug is being developed by Oncology Venture US Inc. (formerly 2X Oncology Inc.).

“This targeted Phase 2 study will enable us to rapidly evaluate the efficacy of our Tankyrase and PARP inhibitor in heavily pre-treated metastatic breast cancer patients, using the 2X-121 DRP® to prospectively select likely responders to this differentiated therapy,” said George Elston, CEO of Oncology Venture US Inc.

2X-121 is an orally-available small molecule PARP and tankyrase inhibitor. This clinical trial is designed to enroll 30 metastatic breast cancer patients regardless of hormone receptor, HER2 status and BRCA1 or 2 status, who have relapsed on two or more different prior therapies and who are identified by the 2X-121 DRP® as highly likely to respond to treatment with 2X-121.

The 2X-121 DRP is a novel, tumor-agnostic (i.e. independent of tumor site) molecular biomarker based on expression of 414 genes predictive of response to 2X-121.  In a study presented at ASCO, the 2X-121 DRP correctly identified responders and non-responders to treatment irrespective of BRCA mutation status. Although a patient’s BRCA status is used to identify potential responders for treatment with approved PARP inhibitors, other likely responders are excluded. The 2X-121 DRP biomarker is expected to identify those patients who are likely responders while excluding the likely non-responders.

In this clinical trial, patients will receive oral treatment with 600 mg of 2X-121, as a single agent, in a 21-day cycle. The primary endpoint of this study is clinical benefit rate, defined as complete response, partial response, or stable disease at greater than 24 weeks post-treatment using the RECIST criteria. Secondary endpoints include progression free survival, duration of response (from first response to progression), and overall survival.

2X-121 Phase 2 study in metastatic Breast Cancer (mBC)
2X-121 is an investigational, orally-available small molecule targeted inhibitor of Poly ADP ribose polymerase (PARP), a key enzyme involved in DNA damage repair in cancer cells. The drug candidate has a novel dual-inhibitory action against both PARP 1/2 and Tankyrase 1/2.  The molecule is also active in P-glycoprotein expressing cells, suggesting it may overcome PARP inhibitor resistance. Patients will receive oral treatment with 600 mg 2X-121, as a single agent, in a 21-day cycle. The primary endpoint of this study is clinical benefit rate defined as complete response, partial response, or stable disease at greater than 24 weeks post-treatment using the RECIST criteria. Secondary endpoints include progression free survival, duration of response (from first response to progression), and overall survival.

Separate, targeted Phase 2 studies of 2X-121 are planned using the validated DRP® biomarker in recurrent ovarian cancer, castration resistant prostate cancer, and pancreatic cancer to identify patients likely to respond to and benefit from treatment with the drug. 

About the Drug Response Predictor - DRP® Companion Diagnostic 
Oncology Venture uses the Medical Prognosis Institute (MPI) multi gene DRP® to select those patients who by the genetic signature of their cancer are found to have a high likelihood of responding to the drug. The goal is developing the drug for the right patients, and by screening patients before treatment the response rate can be significantly increased. The 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. DRP® is based on messenger RNA from the patient’s biopsies. 

The DRP® platform, i.e. the DRP® and the PRP™ tools, can be used in all cancer types and is patented for more than 70 anti-cancer drugs in the US. The PRP® is used by MPI for Personalized Medicine. The DRP® is used by Oncology Venture for drug development. 

DRP® is a registered trademark of Medical Prognosis Institute A/S.

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 the clinical outcome from drug treatment in cancer patients in 29 out of 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 first screened, and only the patients most likely to respond to the treatment will be treated. Via a more well-defined patient group, risks 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 as Special Purpose Vehicles: Oncology Venture US Inc,  a US based company focusing on precision medicine, currently with a pipeline of promising phase 2 product candidates, and OV-SPV 2, a Danish company that will test and potentially develop an oral phase 2 Tyrosine Kinase inhibitor. 

About Oncology Venture US Inc. (previously named 2X Oncology Inc.)
Oncology Venture US Inc. (OV US) is a clinical stage precision medicine company developing targeted therapeutics addressing significant unmet needs in hard-to-treat cancers.  Our pipeline leverages a proprietary Drug Response Predictor (DRP®) technology generating drug specific companion diagnostics to identify patients who are most likely to respond and benefit from treatment.  DRP® also identifies likely non-responder patients, providing a precision medicine approach for the treatment of patients who can benefit from our therapies. 

The OV US pipeline of product candidates, including a PARPi, are focused on the treatment of breast, ovarian, prostate and pancreatic cancers and primary and secondary brain tumors.  These programs have demonstrated clinical efficacy and safety and are positioned to enter focused Phase 2 studies with study data and potential accelerated approval filings expected in 2H 2018.

The Cambridge, MA based spin-out from Oncology Venture ApS, recently rebranded as Oncology Venture US Inc. to reflect that its product candidates and the DRP® technology aim to benefit cancer patients of all genders.

For further information, please contact: 
                    Oncology Venture US
                    George Elston
                    CEO, Oncology Venture US
                    george.elston@2xoncology.com
                    
                    Oncology Venture AB
                    Ulla Hald Buhl, COO and 
                    Chief IR & Communications 
                    +45 2170 1049 
                    uhb@oncologyventure.com 
                    
                    Or 
                    
                    Peter Buhl Jensen, CEO 
                    +45 21 60 89 22 
                    pbj@oncologyventure.com 

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