First Patient Receives Motixafortide in Phase 2 Pancreatic Cancer Trial

BioLineRx, a biopharmaceutical firm, has initiated a Phase 2 clinical trial in partnership with Columbia University, focusing on the drug motixafortide for first-line pancreatic cancer treatment. The trial, known as CheMo4METPANC, is a significant multi-center study that compares the efficacy of motixafortide combined with the PD-1 inhibitor cemiplimab and standard chemotherapy drugs gemcitabine and nab-paclitaxel against chemotherapy alone.

The CEO of BioLineRx, Philip Serlin, highlighted the need for innovative treatments for pancreatic ductal adenocarcinoma (PDAC), which has shown minimal response to traditional immunotherapy, leading to unfavorable outcomes for patients. Encouraging early pilot data has prompted the progression to a larger, randomized Phase 2 trial.

Dr. Gulam Manji from Columbia University is scheduled to present the pilot phase results at the IO 360° Summit, showcasing the drug's potential. As of July 2023, the pilot phase demonstrated a 64% partial response rate in 11 patients, with a disease control rate of 91%.

Motixafortide, the flagship candidate of BioLineRx, received FDA approval in September 2023 for use in combination with filgrastim to mobilize stem cells in multiple myeloma patients under the brand APHEXDA®. It is also under evaluation in a Phase 1 trial for sickle cell disease treatment.

The CheMo4METPANC trial, registered with ClinicalTrials.gov, involves 108 patients and aims to assess the combination therapy's impact on progression-free survival, safety, response rate, and overall survival.

Pancreatic cancer is notorious for its low early diagnosis rate and grim prognosis. In the U.S. for 2024, around 66,000 new diagnoses are expected, with the disease accounting for 3% of all cancers and 7% of cancer-related deaths. The 5-year survival rate varies significantly based on the stage at which the cancer is detected.

Motixafortide operates by inhibiting the CXCR4 receptor, which is overexpressed in many cancers, including PDAC. It modulates the immune system to enhance anti-tumoral activity and reduce pro-tumoral effects.

BioLineRx, headquartered in Israel with U.S. operations, is dedicated to developing transformative therapies for oncology and rare diseases. The company's mission is to translate scientific breakthroughs into practical treatments for patients in need.