Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 70

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 70
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 (CheMo4METPANC), led by Columbia University and supported equally by BioLineRx and Regeneron, initially enrolled 11 PDAC patients
in a pilot phase. In September 2023, we reported data from the pilot phase of the study. As of July 2023, of those 11 patients, seven
patients (64%) experienced a partial response (PR), of which six (55%) are now confirmed PRs, with one patient experiencing resolution
of the hepatic (liver) metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate of
91%. These findings compare favorably to historic partial response and disease control rates of 23% and 48%, respectively, reported
with the chemotherapy combination of gemcitabine and nab-paclitaxel. Additionally, analysis of paired pre- and on-treatment biopsy samples
demonstrated an increase in CD8+ T-cell density in tumors from all 11 patients treated (P = 0.007).

Based on the preliminary data from this pilot phase, the planned
single-arm study was amended to a significantly larger, randomized multi-center study, with a new planned total of 108 patients. The amended
Phase 2b study is evaluating the combination of motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine
and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone. The trial's primary endpoint is progression free survival, and a pre-specified
interim futility analysis will be conducted when 40% of progression free survival events are observed, which is expected in 2026. Secondary
objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival. In February 2024, the
first patient was dosed, with full enrollment projected for 2027.

We have also been advancing plans in collaboration with Gloria,
our Asia partner, for a Phase 2b randomized study assessing motixafortide in combination with the PD-1 inhibitor zimberelimab and standard-of-care
chemotherapy as first-line treatment in patients with metastatic pancreatic cancer. IND submission and protocol finalization was planned
for the first half of 2025, with study initiation expected during 2025. However, Gloria is not currently advancing this study according
to schedule and it is unclear when such study will