BioLineRx and Merck will work together in a Phase 2 clinical trial to investigate BioLineRx’s cancer therapy platform, BL-8040, combined with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with metastatic pancreatic cancer.
“We are extremely happy to collaborate with MSD, a pioneer and world leader in cancer immunotherapy. This marks the entrance of BL-8040 into this exciting field, which is already transforming the lives of many cancer patients,” Dr. Kinneret Savitsky, BioLineRx’s CEO, said in a press release. “Because certain tumors exhibit only a modest response to existing immunotherapies, we are increasingly seeing clinical studies involving combinations of immuno-oncology agents with other classes of drugs.
“We are initiating this study with the hope that it will show that the combination of BL-8040 with KEYTRUDA has the potential to expand the benefit of immunotherapy to cancer types currently resistant to immuno-oncology treatments, such as pancreatic cancer, which represents a significant unmet medical need,” Dr. Savitsky added. “If this potential can be realized, it will be an extremely important advance in the fight against cancer, as well as a seminal milestone for BioLineRx.”
The single-arm, multicenter, open-label Phase 2 trial will evaluate the tolerability, safety and clinical response of a Keytruda and BL-8040 combination in patients with metastatic pancreatic adenocarcinoma. It will also evaluate various pharmacodynamic parameters, like the combination therapy’s ability to enhance T-cell infiltration into a tumor and their reactivity.
Keytruda is a humanized monoclonal antibody intended to increase the ability of the patient’s immune system to help detect and fight tumor cells. It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, so as to trigger T-lymphocytes.
BL-8040 is BioLineRx’s lead oncology platform. A CXCR4 antagonist, BL-8040 is a mobilizer of immune cells and was seen in previous clinical studies to induce direct tumor cell death. Studies also suggest that CXCR4 antagonists may effectively induce the migration of anti-tumor T-cells into the tumor’s micro-environment.
“Today, there is a great opportunity and need to bring forward new scientific breakthroughs for the treatment of pancreatic cancer,” said Dr. Eric Rubin, a vice president at Merck Research Laboratories. “Evaluating the potential of combination therapies through strategic collaborations in difficult-to-treat tumor types continues to be an important part of our immuno-oncology clinical development program for KEYTRUDA.”
The trial will be performed and sponsored by BioLineRx, and is expected to begin by mid-2016. Upon the trial’s conclusion, or before, both partners have the option of expanding the collaboration to include a pivotal registration study. Other details of the partnership agreement were not released.