On September 19, 2023 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that pilot phase data from an investigator-initiated, open-label, multicenter Phase 2 clinical trial with motixafortide in first-line pancreatic ductal adenocarcinoma (PDAC) will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer taking place in Boston, Massachusetts, September 27-30, 2023 (Press release, BioLineRx, SEP 19, 2023, View Source [SID1234635241]). The Phase 2 clinical trial is designed to evaluate the company’s CXCR4 inhibitor motixafortide in combination with PD-1 inhibitor cemiplimab and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).

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Sponsored by Columbia University, the single-arm pilot phase of the Phase 2 trial focused on the safety of the drug combination. Additionally, based on the original protocol, if ≥3 of the planned 10 patients within the pilot phase experienced a partial response (PR) by RECIST criteria within 16 weeks, the combination would be considered promising and an expansion cohort of an additional 30 patients would be initiated for enrollment. Earlier this year, following a review of the pilot phase data, the trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients. A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract).

Presentation at AACR (Free AACR Whitepaper) Special Conference in Cancer Research: Pancreatic Cancer

Westin Copley Place, Boston Massachusetts

Plenary Session Details

Title: CheMo4METPANC: Combination Chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) Motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in METastatic treatment-naïve PANCreatic adenocarcinoma

Presenter: Gulam A. Manji, MD, PhD, Columbia University Irving Medical Center/New York Presbyterian, New York, N.Y.

Session: Plenary Session 3: Clinical Updates

Date: Thursday, September 28, 2023

Time: 2:30-4:40 pm EDT

About Pancreatic Cancer

Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2023, an estimated 64,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths. Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of people who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%.[i] These data highlight the need for the development of new therapeutic options.

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.