Pharma Focus Asia

BioLineRx Initiates First Patient Dosing in Randomized Phase 2 Combination Clinical Trial for Motixafortide in First-Line Pancreatic Cancer (PDAC)

Thursday, February 29, 2024

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) has initiated the randomized CheMo4METPANC Phase 2 combination clinical trial, representing a crucial advancement in its efforts to develop groundbreaking therapies for oncology and rare diseases. This trial is investigating the effectiveness of the CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard chemotherapies gemcitabine and nab-paclitaxel in first-line pancreatic cancer (PDAC), with the first patient having received treatment. In collaboration with Columbia University, this investigator-initiated trial is the first large-scale, multi-center, randomized exploration of motixafortide alongside a PD-1 inhibitor and first-line PDAC chemotherapies.

BioLineRx, emphasized the urgent need for innovative approaches in treating pancreatic ductal adenocarcinoma (PDAC), citing its historical resistance to traditional immunotherapy and poor prognosis. Encouraged by early pilot data, Serlin expressed optimism for the expanded Phase 2 CheMo4METPANC trial, aiming to enhance treatment options for PDAC patients.

The single-arm pilot phase of the CheMo4METPANC trial, led by Dr. Manji, yielded promising results, which will be presented at the 10th Annual Immuno-Oncology (IO) 360° Summit in Brooklyn, New York. Notably, as of July 2023, a substantial portion of patients in the pilot phase exhibited positive responses, with a disease control rate of 91%.

Motixafortide, BioLineRx's flagship therapeutic candidate, achieved FDA approval in September 2023 for mobilizing hematopoietic stem cells in patients with multiple myeloma, under the brand name APHEXDA®. Additionally, motixafortide is undergoing evaluation in a Phase 1 clinical trial for its potential application in sickle cell disease (SCD).

The CheMo4METPANC Phase 2 trial, registered under Identifier: NCT04543071, aims to enroll 108 patients and is jointly supported by Columbia University, BioLineRx, and Regeneron. Its primary endpoint is progression-free survival (PFS), with secondary objectives including safety, response rate, and overall survival.

Pancreatic cancer, characterized by its poor prognosis and low early detection rates, remains a significant challenge in oncology. With an estimated 66,000 new cases in the United States in 2024, effective treatment strategies are urgently needed, especially for metastatic PDAC, where prognosis is particularly grim.

Motixafortide's mechanism of action involves inhibiting CXCR4, a receptor overexpressed in various cancers, including PDAC. By modulating the immune response against tumors, motixafortide has shown promise in preclinical and clinical studies, offering a potential avenue for enhancing anti-tumoral activity and improving patient outcomes in PDAC.

In conclusion, the commencement of the CheMo4METPANC Phase 2 trial marks a significant step forward in BioLineRx's mission to address the unmet needs of patients with PDAC, leveraging innovative therapeutic combinations to improve treatment efficacy and patient survival rates.



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