Faron Pharmaceuticals Ltd.
("Faron" or the "Company")
Inside Information: FDA Grants Fast Track Designation for Bexmarilimab in r/r MDS
Company announcement, Inside Information, 26 August 2024 at 7:00 a.m. BST / 9:00 a.m. EEST
Key highlights
- Given the strong data seen in Phase 1 and continuing in Phase 2 of Faron's BEXMAB trial, the FDA has granted Fast Track Designation (FTD) for bexmarilimab for the treatment of r/r MDS
- FTD further strengthens the bexmarilimab program by offering clinical development and commercialization benefits
Fast Track Designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a New Drug Application.
Given the previously reported promising results in both Phase 1 and 2 of Faron's BEXMAB trial when treating r/r MDS patients using a combination of bexmarilimab and azacitidine to overcome primary or developed resistance to azacitidine, bexmarilimab has been granted Fast Track Designation subsequent to the accelerated development plan proposed by the FDA in July 2024. "This news highlights the urgency for new treatment options besides HMAs for the treatment of higher-risk MDS and solidifies our case that bexmarilimab can overcome resistance to HMAs", says Dr. Juho Jalkanen CEO of Faron. Relapsed or refractory myelodysplastic syndrome is an aggressive and deadly form of blood cancer, for which there is very limited treatment option and a median survival of only 5-6 months. The standard of care for higher-risk MDS is azacitidine or another hypomethylating agent (HMA). Unfortunately, the majority of patients eventually relapse or are non-responsive to HMAs, which then leads to r/r MDS. Currently around 180,000 - 510,000 people globally live with an MDS diagnosis.
"r/r MDS is a serious life-threatening condition with limited treatment options and therefore highly significant unmet medical need. Our trial results to date in hypomethylating agent (HMA)-failed MDS have shown bexmarilimab's efficacy to induce deep, clinically meaningful responses for these patients. This FDA Fast Track Designation significantly strengthens bexmarilimab's position to become a new cornerstone treatment of r/r MDS and will facilitate the development of bexmarilimab for full market approval in r/r MDS. It also represents a significant additional recognition of the potential of myeloid cell reprogramming in overcoming resistance and activating immune system in the treatment of various hematological and solid tumors" says Dr. Bono, the CMO of Faron.
For more information please contact:
Investor Contact
Media Contact
ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner
Phone: +44 (0) 207 213 0880
Peel Hunt LLP, Broker
Christopher Golden, James Steel
Phone: +44 (0) 20 7418 8900
Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen
Phone: +358 (0)40 555 4727
Jukka Järvelä
Phone: +358 (0)50 553 8990
About BEXMAB
The BEXMAB study is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.
About Bexmarilimab
Bexmarilimab is Faron's wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.
About Faron Pharmaceuticals Ltd.
Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company's lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com.
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