Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 189

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 4
Chunk 189
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 or other regulatory approval for their therapeutic candidates more rapidly than we may be able to do so for any existing or new product candidates of ours, which could result in their establishing a strong market position before we are able to enter the market.
 
Motixafortide
 
Stem cell mobilization
 
 Motixafortide competes directly with Mozobil® (plerixafor), which is marketed by Sanofi Genzyme as a stem cell mobilizer for autologous stem cell transplantation. During the third quarter of 2023, Mozobil’s last to expire patent expired. As a result, several companies have launched generic formulations of plerixafor at a substantially reduced price to Mozobil including Dr. Reddy’s Laboratories Ltd, Teva Pharmaceuticals USA Inc, Zydus Pharmaceuticals USA Inc, MSN Laboratories Private Ltd, Eugia Pharma Specialities Ltd, Amneal EU Ltd, Gland Pharma Ltd. and Meitheal Pharmaceuticals Inc.

The competitive development pipeline in stem cell mobilization is currently very scarce, but we are aware of GPCR Therapeutic’s burixafor +propranolol combination under clinical investigation for stem cell mobilization in multiple myeloma, which may compete with motixafortide in the future.
 
CXCR4 landscape
 
 A new CXCR4 inhibitor entered the market, X4 Pharmaceuticals' mavorixafor was approved by the FDA and EMA in 2024 and is commercialized as XOLREMDI for WHIM syndrome. Further, we are aware of other CXCR4 inhibitors in various stages of development including further development of mavorixafor for chronic neutropenia, burixafor developed by GPCR Therapeutics for stem cell mobilization in multiple myeloma, AD-214 developed by AdAlta for idiopathic pulmonary fibrosis (IPF), and Balixafortide previously developed by Spexis AG for the treatment of PDAC and TNBC. In addition, PentixaPharm is developing a radiotherapeutic targeting CXCR4-expressing cells for various cancer indications.

 Pancreatic cancer

Immuno-oncology is an area of great interest in the pharmaceutical market, specifically, immuno-oncology combination therapies. Currently 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