Faron Pharmaceuticals Oy has announced its plans and activities for the coming months under the leadership of the incoming CEO, Dr. Juho Jalkanen. The company is anticipating the initial data from the ongoing Phase 2 part of the BEXMAB trial next month, which will be crucial for ongoing partnering discussions and upcoming industry events. Faron also intends to accelerate discussions with the US Food and Drug Administration (FDA) to coordinate plans for obtaining marketing approval for MDS patients that have failed HMA.
The Phase 2 part of the BEXMAB trial is evaluating the safety and efficacy of bexmarilimab in combination with standard of care in patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS). The data readout is expected to be announced in May 2024 and will be important for the company's partnering discussions and its participation in industry events. Faron plans to approach the FDA earlier than planned this year to seek a Scientific Advice meeting regarding its registrational study plan, aiming to coordinate and finalize plans that may lead to marketing approval.
Dr. Juho Jalkanen, the incoming CEO, expressed his excitement about the pivotal year for Faron and the delivery of key milestones critical to the further development of bexmarilimab. He emphasized the company's commitment to addressing the tremendous need for an effective treatment in HMA-failed MDS patients and ensuring the timely availability of this treatment option to patients.
Faron Pharmaceuticals Oy is a global, clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies. Its lead asset, bexmarilimab, is a novel anti-Clever-1 humanized antibody being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments and as a monotherapy in last-line solid cancers.
For more information, interested parties can contact Faron Pharmaceuticals directly or visit their website.