READ THE FULL BLRX RESEARCH REPORT
We are initiating on BioLineRx Ltd. (NASDAQ:BLRX) with our valuation based on the company's progress advancing Motixafortide for the mobilization of hematopoietic stem cells (HSCs) for autologous transplantation in subjects with multiple myeloma (MM). Pivotal trials for this indication have been completed, a pre-new drug application (NDA) meeting has been conducted and an NDA submission is planned for 1H:22. The company's main area of research and innovation targets various solid and hematopoietic malignancies. The late clinical-stage biopharmaceutical company has in-licensed two compounds that are in various stages of development. The most advanced candidate is Motixafortide for stem cell mobilization. It has completed Phase III and pharmacoeconomic studies and trial data is being compiled to go before the FDA for approval. Other programs are in Phase II or earlier development for specific cancer indications.
BioLineRx is developing two candidates. The first, Motixafortide, or BL-8040, has successfully completed a Phase III study in stem cell mobilization for multiple myeloma patients and is targeting NDA submission in 1H:22. The drug is also in development for metastatic pancreatic cancer and other solid tumors, and acute myeloid leukemia (AML). The second candidate in the portfolio is AGI-134, a synthetic α-Gal glycolipid that is being investigated for the treatment of solid tumors.
BioLineRx aims to provide a new standard of care treatment option for autologous bone marrow transplantation in patients with various hematological malignancies using Motixafortide. Top-line results from the GENESIS trial demonstrated a 3.5-fold increase in achieving target stem cell mobilization in two apheresis sessions for Motixafortide and granulocyte-colony stimulating factor (G-CSF) vs. G-CSF alone. The combination investigational treatment yielded more CD34+ stem cells to be mobilized in less time, with equal engraftment efficacy, safety, and tolerability, and in fewer leukapheresis sessions compared with standard of care (SoC) alone. The candidate molecule has demonstrated measurable clinical, pharmacological and cost reduction benefits.
We anticipate a near term submission of a new drug application (NDA) to the FDA and marketing authorization application (MAA) to the EMA. Following what we anticipate to be a normal review period, commercialization of Motixafortide is expected in 2023 in the United States, with Europe to follow twelve to eighteen months thereafter, if approved. There are over 70,000 stem cell transplants in the US and Europe each year for blood cancers of which approximately 45,000 are autologous. The strong evidence for high mobilization yield of Motixafortide as monotherapy and in combination with G-CSF supports high penetration into stem cell transplant procedures.
Motixafortide is also being evaluated in pancreatic cancer. The drug attracts immune cells into the tumor microenvironment and induces T cell infiltration turning a tumor hot, thereby giving checkpoint inhibitors room to work. Motixafortide has completed a Phase IIa program with pembrolizumab and chemotherapy targeting metastatic pancreatic cancer.
BioLineRx' second candidate is AGI-134, a glycolipid-like small molecule that coats tumor cells with xenoantigen Galα1-3Galβ1-4GIcNAc (α-Gal) in situ. Drug administration leads to opsonization, essentially tagging a pathogen for immune destruction by antibodies, utilizing pre-existing, natural anti-α-Gal antibodies which trigger T-cell mediated anti-tumoral immunity. This asset is in a Phase I/IIa study for solid tumors and is expected to provide a read out in the first half of 2022.
In our initiation, we provide a scientific background on cytokines and their various receptors, including CXCR4, which is implicated in the mobilization of hematopoietic stem cells. Background on chemokine agonists available in the market and in advanced studies is offered. We discuss stem cell transplantation and its relevant statistics. The report then moves into a review of BioLineRx' clinical candidates: Motixafortide and AGI-134. Mechanism of action is detailed and clinical trials both completed and active are examined for each indication. Epidemiology and standard of care treatment are presented for MM, AML along with additional details for pancreatic cancer. A review of the company's intellectual property is followed by an exposition on the competitive environment and management profiles. We conclude with a summary of recent financial and operational events, risks and our valuation assumptions.
Key reasons to own BLRX shares:
➢ Motixafortide is an advanced candidate in multiple indications
◦ Completed Phase III clinical trial for stem cell mobilization
◦ Active pancreatic cancer program has completed Phase IIa
➢ Motixafortide provides material improvement over primary therapy in HSCT
◦ 3.5x more effective vs. SoC for mobilization in primary endpoint
◦ 9.3x more effective vs. SoC for mobilizing >6 million cells in one apheresis session
◦ Almost 90% of patients advanced to transplantation after one apheresis session
◦ Greater cell collection after apheresis allowing for second HSCT if needed
➢ Compelling economic and safety rationale for Motixafortide
◦ Superior efficacy
◦ Fewer apheresis sessions reduce infection risk & hospital bed demand
➢ NDA submission for Motixafortide in stem cell mobilization expected in 1H:22
➢ Motixafortide & anti-PD-1 combination seeking partner for Phase IIb in pancreatic cancer
◦ Combination study may initiate in next 12 months
➢ Phase I/IIa AGI-134 in development for solid tumors
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