New Pancreatic Cancer Therapy to Be Tested in Phase 2 Study

New Pancreatic Cancer Therapy to Be Tested in Phase 2 Study

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.

Inês holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.
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Inês holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.
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