Main highlights
- The latest results from the BEXMAB study show more responders and better durability of remission among MDS patients in whom HR HMA has failed.
- 4/5 of the initial phase 1 HR HMA failure MDS patients were still alive after 8 months of follow-up.
- Although data are not yet available to accurately estimate median overall survival, the survival benefits already seen in the current follow-up of these first five patients are very encouraging. This compares favorably with that observed with modern comparators.
- Three HR MDS patients who failed HMA were further enrolled in the phase 1 part, and a total of 7 of 8 responded, resulting in an overall response rate of 87.5%.
- Fallon will host a virtual webinar to discuss additional data tomorrow, Tuesday, March 19th at 11:00 EET/9am GMT.
TURKU, Finland and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) — Fallon Pharmaceuticals, Inc. (AIM: FARN, First North: FARON) is developing a smart technology to reprogram bone marrow cells to activate antitumor activity. We are a clinical-stage biopharmaceutical company pursuing innovative approaches. Ongoing study of immunity in the blood and solid tumor microenvironment today entered Phase 2 in high-risk (HR) myelodysplastic syndrome (MDS) patients who have failed previous hypomethylating agents provided further data from patients treated in phase 1 of the BEXMAB trial (HMA).
Previous BEXMAB study results showed a high overall response rate (ORR) of 5/5 in HR HMA-deficient MDS patients with no approved therapy. The majority of initial phase 1 patients are currently receiving: Bexmarilimab After more than 6 months of combination therapy with azacitidine, only one patient lost his life due to transition from HR MDS to acute myeloid leukemia (AML). Of her first five patients, four are still alive after her eight months. Usually, the median overall survival (mOS) of patients with relapsed or refractory HR MDS is less than 6 months. Her mOS for patients treated in the BEXMAB trial is not yet available, but based on current data, it is likely to be significantly higher than traditionally seen with current standard of care (or currently approved therapies). Estimated.
Following the previously reported five HMA-failed HR MDS patients, three new HMA-failed HR MDS patients were enrolled, filling the remaining Phase 1 slots. Although it is too early to assess survival or durability in these patients, the previously observed high ORR is supported in 2/3 responders. A third patient dropped out of the study early in cycle 2 due to an unrelated serious adverse event (SAE), and her current ORR is 8 patients in her HR MDS population who had failed HMA. There were 7 middle school students (87.5%). The best responses for these 8 patients were: 1 complete response (CR), 3 bone marrow complete responses (mCR), 1 partial response (PR), and 2 hematologic improvement. , and 1 with stable disease (SD) with early withdrawal. Unrelated SAE.
Mika Kontro, MD, associate professor at Helsinki University Hospital Comprehensive Cancer Center and principal investigator of the BEXMAB trial, said: Bexmarilimab and azacytidine. Although the median overall survival rate is not yet known, some patients are alive and, importantly, enjoy a good quality of life more than 12 months after starting treatment. is reassuring.I'm still very excited about the possibilities. Bexmarilimab It can significantly improve outcomes for patients suffering from these aggressive symptoms. ”
Dr. Marc Jarkanen, CEO of Fallon, said: “These data are truly remarkable and support our belief that treatments may finally be available for this underserved patient population. When the endpoint is survival, there is strong support for the registration trial to be positive against modern comparators. Completion of the Phase 2 portion of the BEXMAB trial will allow these data to be submitted to the FDA as soon as possible. I’m looking forward to it.”
mOS has not yet been achieved for the five frontline HR MDS patients with 100% ORR previously reported at last year's American Society of Hematology (ASH) Annual Meeting. The r/r AML patient cohort reported at ASH is larger (n= 18) and has a more mature follow-up (median follow-up of 6 months), with mOS currently >8 months. Estimates (subject to change as some patients are still being treated). Her historical mOS in this population is approximately 6 months. This means that the current data support performing a registration trial using mOS as an endpoint in this population as well.
Fallon will be hosting a virtual webinar to discuss these data tomorrow, Tuesday, March 19th at 11:00 EET/9am GMT.
You will have the opportunity to ask questions during the webcast. To register for the event, please visit https://faron.videosync.fi/bexmab-study-update/ or contact our IR team at investor.relations@faron.com for more information.
For more information, please contact us below.
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About Bexumab
The BEXMAB study is an open-label, phase 1/2 clinical trial. Bexmarilimab In combination with standard of care (SoC) in advanced hematological malignancies such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The primary objective is to determine safety and tolerability. Bexmarilimab Used in conjunction with SoC (azacytidine) treatment. Directly targeting Clever-1 could limit the replicative capacity of cancer cells, increase antigen presentation, and induce an immune response, potentially making current treatments more effective. Clever-1 is highly expressed in both AML and MDS and is associated with treatment resistance, limited T cell activation, and poor outcome.
About bexmarilimab
Bexmarilimab An investigational immunotherapy, wholly owned by Fallon, designed to target the function of bone marrow cells and activate the immune system to overcome resistance to existing treatments and optimize clinical outcomes. I am. Bexmarilimab It binds to Clever-1, an immunosuppressive receptor found on macrophages, causing tumor growth and metastasis (i.e., helping cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, Bexmarilimab Altering the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) state, upregulates interferon production, primes the immune system to attack the tumor, and adapts to standard therapy. sensitize cancer cells to
About Fallon Pharmaceuticals Co., Ltd.
Faron (AIM: FARN, First North: FARON) is a global clinical-stage biopharmaceutical company focused on tackling cancer with novel immunotherapies. Its mission is to bring the potential of immunotherapy to more people by discovering new ways to control and harness the power of the immune system.Our main assets are Bexmarilimaba novel anti-Clever-1 humanized antibody, has the potential to remove cancer immunosuppression through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential treatment for patients with blood cancers in combination with other standard treatments. For more information, please visit www.faron.com.
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