Oncology Venture AB (“Oncology Venture”) and 2X Oncology, Inc. (“2X Oncology”), today announced that Oncology Venture has entered into an exclusive global license agreement with Eisai Inc. for Eisai’s Phase 2 PARP inhibitor E7449 – now called 2X-121. 2X-121 will be developed by 2X Oncology, a precision medicine company developing targeted therapeutics to address significant unmet needs in women’s cancer.
2X-121 is a small molecule targeted inhibitor of Poly ADP ribose polymerase (PARP), a key enzyme involved in DNA damage repair in cancer cells. The PARP inhibitor demonstrated clinical activity in a prior Phase 1 study in a number of cancers, including ovarian and breast. The drug also has potential to treat brain metastases and primary brain tumors based on its ability to pass through the blood-brain barrier.
“We are excited to in-license this promising PARP-inhibitor from Eisai. The cutting-edge science and compelling clinical data behind 2X-121 in combination with our unique Drug Response Predictor (DRP™) biomarker technology provide an exceptional risk-reduced opportunity to develop effective treatments for hard to treat cancers,” said Peter Buhl Jensen, M.D., CEO of Oncology Venture.
Oncology Venture successfully validated its DRP™ biomarker for 2X-121 using clinical biopsy materials and blinded patient response data provided by Eisai under a prior agreement between the companies.
The drug will be developed in the pipeline of 2X Oncology, a Cambridge, MA-based spin-out of Oncology Venture focused on developing precision medicines for unmet needs in women’s cancers.
“We plan to initiate a focused Phase 2 trial of 2X-121 for the treatment of metastatic breast cancer later this year, using a DRP™ biomarker to identify patients who are most likely to respond to and benefit from treatment with this promising therapeutic,” said George O. Elston, CEO of 2X Oncology, Inc. “Positive data from this study will position this program for a pivotal Phase 2 study initiation in 2018,” Mr. Elston added.
Under the terms of the agreement, Oncology Venture will be responsible for the development and commercialization of 2X-121 in oncology. Oncology Venture will, through 2X Oncology, Inc., execute a mutually agreed upon clinical development plan, which includes an initial Phase 2 clinical study in patients with metastatic breast cancer using the DRP™ biomarker. Further terms of the agreement were not disclosed.
2X-121 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.
A Phase 2 study (>20 patients) is planned using a DRP™ biomarker in metastatic breast cancer patients to identify patients likely to respond to and benefit from treatment with 2X-121. Positive data from this study will position the program for a pivotal Phase 2 study initiation in 2018.
In a prior Phase 1 study conducted without a DRP™, two patients had a durable partial response (281 and 208 days, respectively). 2X-121 was well tolerated with no myelotoxicity observed. The planned Phase 2 study using a DRP™ is expected to significantly improve response rates seen in this initial study.
Filed Under: Drug Discovery