Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 67

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 67
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 American Society of Hematology (ASH) Annual Meeting. Five
patients completed mobilization and apheresis with motixafortide alone, and four of five with motixafortide in combination with natalizumab. Motixafortide
alone, and in combination with natalizumab, were found to be safe and well-tolerated in the trial. Common adverse events were transient
and included Grade 1-2 injection site (pruritis, tingling/pain) and systemic reactions (pruritis, hives). No grade 4 adverse events or
vaso-occlusive events occurred. Motixafortide alone, and in combination with natalizumab, resulted in robust CD34+ HSC mobilization
to peripheral blood. Motixafortide alone mobilized a median of 198 CD34+ cells/μl (range 77-690) to PB with median 3.49x106CD34+ cells/kg as part of a single blood volume collection, projecting the collection of 13.9x106HSCs in a normal, single-day four-blood-volume apheresis collection session. Motixafortide in combination with natalizumab mobilized a
median of 231 CD34+ cells/μl (range 117-408), with median 4.64x106CD34+ cells/kg collected as part of a single blood volume collection, projecting the collection of 18.6x106CD34+ HSCs in a single day four blood volume apheresis collection session. Following the out-licensing of motixafortide to Ayrmid, the
study is being continued under the Ayrmid License Agreement.

In May 2024, we announced that we entered into a multi-center Phase
1 clinical trial sponsored by St. Jude Children’s Research Hospital, Inc. to evaluate motixafortide for the mobilization of CD34+
hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with SCD. Investigators in the trial from
St. Jude Children’s Research Hospital, Inc. and two other clinical sites have extensive SCD gene therapy clinical development experience
and are recognized leaders in the field. Following the out-licensing of motixafortide to Ayrmid, the study is being continued under the
Ayrmid License Agreement. The first patient in the study was dosed in February 2025.

Pancreatic