Faron Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company driven to combatting cancer through innovative immunotherapies, has announced exciting clinical data from its Phase I/II BEXMAB study. The promising results demonstrate the potential of the futuristic treatments designed to help treat the devastating disease.
Faron Pharmaceuticals’ groundbreaking immunotherapy asset, Bexmarilimab, is being assessed in the BEXMAB study (NCT05428969) to treat relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
Excitingly, initial data reported on June 9th, 2023 at the EHA 2023 Hybrid Congress demonstrates the significant potential of this therapy in combination with standard of care. Let’s see if the next clinical trial stage translates this promise into reality.
We have new and exciting updates on our BEXMAB Phase I Study – get up-to-date information on the progress of this groundbreaking research now! Learn how we’re making progress in the quest to improve treatments in this highly anticipated trial.
Three out of five patients in a trial of a 6 mg/kg bexmarilimab + azacitidine doublet dosing had an amazing outcome: complete remission of marrow blasts. This is an incredible result, offering hope to many for future treatments.
Impressively, in the 6 mg/kg + azacitidine doublet cohort, three out of five patients achieved a remarkable complete recovery of their blood counts (CR).
Eight out of 15 observed ORs span across all three doublet dosing cohorts, displaying the efficacy of the dosing across a wide range of patients.
Out of the eight patients who were treated with one of three varied dosages of HMAs, four experienced treatment failure from the SoC hypomethylating agents.
All three patients with MDS and prior HMA failure experienced excellent outcomes, ranging from partial responses (PR) to complete responses (CR) across dosing cohorts.
Excitingly, four out of six patients in the triplet dosing cohort treated with azacitidine, venetoclax and bexmarilimab have achieved an objective response.
We are thrilled to see the promising efficacy signals of bexmarilimab and the lasting effects it has already demonstrated in patients with no other treatment options for advanced AML and MDS. The BEXMAB trial, led by Dr. Mika Kontro, Associate Professor, Helsinki University Hospital Comprehensive Cancer Center, provides a unique hope for these individuals and is a breakthrough development in cancer care.
Faron is preparing to take the next step in the development of BEXMAB, with plans to seek advice from the FDA in Q3 2023 and advance to Phase II in H2 2023, targeting patients who have been refractory to the current standard of care in Acute Myeloid Leukemia (AML) and have failed Hematopoietic Stem Cell Transplants (HSCTs) in Myelodysplastic Syndromes (MDS).
Excitement is building for bexmarilimab as new data indicates its potential to help tackle the unmet medical need in relapsed/refractory AML and MDS. Chief Medical Officer Dr. Marie-Louise Fjällskog is thrilled to advance bexmarilimab in the fight against cancer, and looks to generate further supporting data in preparation for a likely BLA filing in the first half of 2025.
Faron’s investigational immunotherapy, Bexmarilimab, is designed to tackle tumor growth and spread through a novel approach, by targeting myeloid cell function and priming the immune system. This immunotherapy binds to Clever-1, an immunosuppressive receptor found on tumor-associated macrophages, thereby altering the tumor microenvironment and re-programming macrophages from a state of immunosuppression to one of immunostimulation.
The resulting immune response can then be used to attack cancer cells directly, as well as sensitizing them to standard care treatments. In this way, Bexmarilimab has the potential to not only overcome resistance to existing treatments, but also to optimize overall clinical outcomes.
The BEXMAB study is an innovative clinical trial aiming to determine the effectiveness and safety of the novel therapy, bexmarilimab, in combination with the standard of care (SoC) for aggressive hematological malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
By directly targeting Clever-1, this unique therapy seeks to diminish the replication capacity of cancer cells, increase antigen presentation, evoke an immune response, and enhance the potency of current treatments.
It has been noted that Clever-1 is highly irregular among patients with AML and MDS, which can lead to therapy resistance, reduced T cell activation, and disappointing results. Thus, the primary goal is to determine the recommended Phase II dose for optimal results.
About Faron Pharmaceuticals Ltd.
Faron, a clinical-stage biopharmaceutical company (AIM: FARN, First North: FARON), is bringing the power of immunotherapy to a larger population of cancer patients. Its lead asset, bexmarilimab, is a novel anti-Clever-1 humanized antibody that has the potential to remove immunosuppression of cancers by targeting myeloid cell function.
Currently, bexmarilimab is being tested in Phase I/II clinical trials as a potential adjuvant therapy, potentially helping to combine the efficacy and safety of traditional treatments with the power of modern immunotherapy.