BioLineRx Announces Initiation of Randomized Phase 2 Clinical Trial in First Line Metastatic Pancreatic Cancer Based on Preliminary Data from Single-Arm Pilot Phase; Combination Trial Includes Investigational Candidate Motixafortide
A poster of the amended clinical trial design was presented at the 2023
"Metastatic pancreatic cancer is a uniformly fatal disease for which current treatments result in limited benefits," said Tami Rachmilewitz, MD, Chief Medical Officer at BioLineRx. "Unfortunately, newer immunotherapy approaches, while beneficial against other solid tumor types, have had limited efficacy in pancreatic cancer due to immunosuppressive pathways. Combining checkpoint inhibitors, chemotherapy, and a CXCR4 inhibitor has shown promise in earlier preclinical and clinical studies, including an earlier single arm study using motixafortide as the CXCR4 inhibitor (COMBAT/KEYNOTE-202) in patients receiving second line treatment for pancreatic cancer, and we are very encouraged by the results seen in the initial pilot phase of the study in patients receiving first line treatment. We look forward to continuing the clinical research of this treatment regimen in this randomized trial."
"Working with our collaborators, we are excited to be advancing the clinical development of motixafortide in pancreatic cancer and look forward to the presentation of data from the pilot phase of the randomized trial later this year," said
Data from the pilot stage of the Phase 2 study is planned for submission to a congress later this year. The primary endpoint of the randomized trial is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.
About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In
About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.
Forward Looking Statement
Various statements in this release concerning
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