Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 84

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 84
---
 there are thousands of immuno-oncology combination treatments being
tested in clinical trials that aim to transform scientific innovation into practice-changing cancer drugs.

In the field of pancreatic cancer, motixafortide competes indirectly
with the few currently approved treatments for PDAC. Motixafortide is believed to modulate the effector/suppressor cell ratio toward a
proinflammatory profile, which may act synergistically with checkpoint inhibitor agents to enhance the anti-tumor activity of infiltrated
T cells. In the first line setting, Gemcitabine in combination with Abraxane® or FOLFIRINOX regimen are the current standard of care.
In February 2024, Ipsen’s Onivyde® obtained approval in first line PDAC in the NALIRIFOX regimen based on phase III NAPOLI
-3.

Oncologists have limited options of existing therapies for second-line
metastatic patients. The only FDA-approved second-line treatment is Onivyde® in combination with 5FU and LV for gemcitabine-treated
patients.

In addition to chemotherapy, Merck’s KEYTRUDA® was approved
for MSI-H cancers (approximately 1% of all cases) and Lynparza® is approved for maintenance of BRCA mutated metastatic pancreatic
cancer (approximately 7% of all cases), while in April 2024, ENHERTU® received accelerated approval for HER2+ solid tumors (approximately
2-6% of PDAC) following prior systemic treatment.

We are aware of late clinical stage development in metastatic PDAC by other companies,
including daraxonrasib by Revolution Medicines for RAS-mutant PDAC, quemliclustat from Arcus Biosciences, nadunolimab from Cantargia.

In the last several years we have seen a number of late-stage clinical
failures of compounds for advanced PDAC, most notably Fibrogen’s pamrevlumab, in the last year. Most of these failed trials have
been based on a single promising endpoint. Despite a busy early-stage clinical pipeline, there are only a few phase III and approved assets,
demonstrating a high attrition rate in PDAC.

46

BL-5010

BL-5010 competes with a variety of approved destructive and non-destructive
treatments for skin lesions. Both Endwarts®(Meda
Health) and Eskata®(Aclaris therapeutics) are medical
device-based