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BioLineRx Ltd’s (NASDAQ:BLRX) poster, which includes new data from the single-arm pilot phase of the investigator-initiated, randomized CheMo4METPANC Phase 2 combination trial, will be presented at the 2025 American Society of Clinical Oncology Annual Meeting.
The CheMo4METPANC trial is evaluating motixafortide, cemiplimab, and standard-of-care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).
Updated results from the pilot phase indicate that four of eleven patients remained progression-free after more than one year.
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Two patients underwent definitive treatment for mPDAC: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response.
An analysis of pre-and-on-treatment biopsies and peripheral blood mononuclear cells (PBMCs) also revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination.
In addition, patients achieving a partial response were found to have higher pre-treatment proportions of CXCL12-producing cancer-associated fibroblasts, a potential marker of response.
The pilot clinical trial of motixafortide, cemiplimab, gemcitabine and nab-paclitaxel (N=11) demonstrated an overall response rate (ORR) of 64% (7/11) and a disease control rate (DCR) of 91% (10/11), compared to historical ORR and DCR of 23% and 48%, respectively, with gemcitabine and nab-paclitaxel.
Based on these results, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 108 patients.
The trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies. The trial will be fully enrolled in 2027, and a prespecified interim analysis is planned for when 40% of PFS events are observed.
Earlier this week, BioLineRx said it reduced operating expense run rate by over 70% beginning January 1, 2025, through the APHEXDA program transfer to Ayrmid and the resulting shutdown of the company’s U.S. commercial operations in Q4 2024, as well as additional headcount and other operating expense reductions.
The company completed financing in January 2025, raising gross proceeds of $10 million and reaffirmed cash runway through the second half of 2026.