(RTTNews) - BioLineRx Ltd. (BLRX), a clinical-stage biopharmaceutical company, announced on Friday that updated results from the pilot phase of its Phase 2 CheMo4METPANC trial demonstrated promising clinical activity for its lead candidate motixafortide in first-line metastatic pancreatic ductal adenocarcinoma or PDAC.
These data will be featured in a poster presentation at the ASCO 2025 Annual Meeting on May 31 in Chicago.
The trial is evaluating motixafortide, a CXCR4 inhibitor, in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy or gemcitabine and nab-paclitaxel, versus chemotherapy alone.
In the pilot phase or n=11, 4 of 11 patients remained progression-free for over one year, while 2 patients underwent definitive treatments, including radiation and surgery, after significant tumor responses.
The combination therapy showed a 64 percent overall response rate or ORR and 91 percent disease control rate or DCR, significantly higher than historical response rates of 23 percent ORR and 48 percent DCR seen with chemotherapy alone.
Biomarker analysis revealed enhanced CD8+ T-cell infiltration in tumors following treatment, supporting the immunomodulatory effect of the regimen.
In particular, patients with partial responses had higher pre-treatment levels of CXCL12-producing cancer-associated fibroblasts, suggesting a potential biomarker of response.
In response to these results, the study has been expanded to a randomized design, increasing enrollment from 30 to 108 patients, with full enrollment expected by 2027.
An interim analysis is planned once 40 percent of progression-free survival or PFS events are observed.
"These data are highly encouraging in one of the most difficult cancers to treat," said Philip Serlin, CEO of BioLineRx.
He further added that, "They support the idea that motixafortide, when used with cemiplimab and chemotherapy, can reshape the tumor microenvironment and improve outcomes."
The poster presentation will take place on May 31 at McCormick Place, under the gastrointestinal cancer track.
Motixafortide is also approved in the U.S. as APHEXDA for stem cell mobilization in multiple myeloma, and BioLineRx is advancing its broader oncology pipeline with support from development partners including Regeneron.
Currently, BLRX is trading at $6.97, up by 81.96 percent on the Nasdaq.
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