TEL AVIV - BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical company, has initiated the Phase 2 CheMo4METPANC clinical trial, dosing the first patient in a study to assess the effectiveness of its drug candidate motixafortide in combination with other cancer therapies for treating pancreatic cancer.
The trial, conducted in collaboration with Columbia University, is evaluating motixafortide alongside a PD-1 inhibitor, cemiplimab, and standard chemotherapies gemcitabine and nab-paclitaxel, compared to the chemotherapy drugs alone. The study marks the first large, multi-center, randomized evaluation of this combination for first-line pancreatic ductal adenocarcinoma (PDAC) treatment.
Philip Serlin, CEO of BioLineRx, expressed optimism based on preliminary data, highlighting the urgent need for new treatments given the limited success of traditional immunotherapies in addressing PDAC, which often leads to poor patient outcomes.
The CheMo4METPANC trial aims to enroll 108 patients, focusing on progression-free survival as the primary endpoint. Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit, and overall survival.
Motixafortide, already approved by the FDA for stem cell mobilization in multiple myeloma patients, is also being tested as a monotherapy and in combination with other drugs for different indications.
Pancreatic cancer is known for its low early diagnosis rate and dismal prognosis. In the United States alone, an estimated 66,000 adults will be diagnosed with the disease in 2024. The 5-year relative survival rate is exceptionally low, particularly for patients with metastatic cancer.
The drug's mechanism, inhibiting the CXCR4 receptor, is designed to enhance the immune system's response to the tumor. The pilot phase of the trial showed promising results, with a high disease control rate among participants.
BioLineRx, headquartered in Israel with operations in the U.S., is focused on developing therapies for oncology and rare diseases. The company's pipeline includes treatments for sickle cell disease and solid tumors.
This news is based on a press release statement.
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