Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 62

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 62
---
.

35

ASCT is part of the standard treatment paradigm for a number of
blood cancers, including multiple myeloma. In the U. S., as many as 8,000 ASCTs are performed each year in patients with multiple myeloma.
The success of ASCT depends on adequate mobilization of stem cells during the treatment process. The American Society for Transplantation
and Cellular Therapy (ASTCT) guidelines recommend a collection target of 3-5 x 106CD34+ cells/kg and a higher target of double the recommended target if multiple transplants are planned. The International Myeloma Working
Group (IMWG) guidelines recommend a collection of 4-6 x 106CD34+ cells/kg with a higher target of 8-10 x 106CD34+
cells/kg to allow for two transplants if needed. Historically, depending on induction regimens and mobilization strategies, up to 47%
of patients have had challenges collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session. Increased
age, as well as exposure to lenalidomide-containing induction regimens, including 3-4 drug combination regimens, have been associated
with impaired stem cell mobilization.

To begin the stem cell mobilization process, a patient will receive
a daily dose of G-CSF for four days. Daily doses of G-CSF will continue until the target collection goal is met with the addition of up
to four daily doses of plerixafor as needed. For patients unable to mobilize sufficient numbers of cells for harvesting during this primary
mobilization phase, rescue therapy may be carried out followed by an additional number of apheresis sessions as necessary.

In March 2015, we reported successful top-line results from a Phase
1 safety and efficacy trial for the use of motixafortide as a novel stem cell mobilization treatment for allogeneic bone marrow transplantation
at Hadassah Medical Center in Jerusalem.

In March 2016, we initiated a Phase 2 trial for motixafortide in
allogeneic stem cell transplantation, conducted in collaboration with the Washington University School of Medicine, Division of Oncology
and Hematology. In May 2018, we announced positive top-line results of this study showing, among other things, that a single injection
of motixafortide mobilized sufficient amounts of CD34+ cells required for transplantation at a level of efficacy similar to that achieved