Faron’s anticipated opening in solid tumors

Translation: Original published in Finnish on 1/28/2026 at 7:00 am EET.

Faron announced on Tuesday that it is expanding the clinical development program for bexmarilimab to solid tumors. The company is supporting a new investigator-initiated phase I/II BEXAR study, which will investigate the tolerability, safety, and preliminary efficacy of the drug candidate in soft tissue sarcoma in combination with standard treatment. The news marks Faron's first concrete opening in solid tumors since the MATINS study. The company announced its plans for BEXAR at the CMD in fall 2024, so the start of the study was expected.

Bexmarilimab is now being studied in soft tissue sarcoma

Faron announced in a press release that it is expanding bexmarilimab's clinical program by supporting the investigator-initiated BEXAR study. Investigator-initiated trials are based on academic interest and are not usually designed in cooperation with the regulatory authority from the perspective of meeting the requirements for a marketing authorization application. However, they provide useful information that can advance commercialization opportunities and are cost-effective to implement from Faron's perspective. The randomized design of the trial is also a qualitative advantage.

This is a randomized Phase I/II trial evaluating the combination of bexmarilimab and the standard-of-care chemotherapy doxorubicin in patients with metastatic soft tissue sarcoma. The trial is funded (i.e. "sponsored") by MEDSIR, which specializes in oncology research, and is conducted in collaboration with University Hospital Vall d’Hebron in Barcelona. Due to the early research phase, potential commercialization in soft tissue sarcoma is not expected until around the mid-2030s.

The expansion into soft tissue sarcoma is biologically justified, as these tumors often show expression of bexmarilimab's target protein, Clever-1. Soft tissue sarcomas are often immunologically inactive, or "cold." Therefore, common cancer drugs, immune checkpoint inhibitors, work poorly in them. There is a significant medical need in these cancers. Sarcomas are characterized by an immunosuppressive microenvironment where macrophage cells inhibit the function of the immune system. The aim of the trial is to clarify whether bexmarilimab can reprogram tumor macrophages, turn the tumor into an immunologically "hot" tumor, and thus improve treatment efficacy.

The investigator-initiated trial (IIT) approach supports the strategy

Faron's development focus has recently shifted strongly towards blood cancers, and the company aims to initiate a pivotal Phase II/III BEXMAB-02 registration trial in high-risk MDS patients this year. Regarding solid tumors, Faron published an updated development plan at the CMD in fall 2024. The updated strategy introduced BEXAR and other solid tumor projects. Thus, the news of BEXAR's initiation did not come as a surprise. The investigator-initiated trial (IIT) approach is strategically sound for the company, as it allows for the collection of clinical evidence in new indications at a low cost from Faron's perspective. Faron's next key task is to secure funding for the BEXMAB-02 trial. Based on current information, the company would not have the resources to finance solid tumor trials itself, so the investigator-initiated model is logical for the company.