According to FDA, bexmarilimab is safe, but dosage requires additional evidence

Translation: Original comment published in Finnish on 3/23/2023 at 6:56 am.

On Wednesday, Faron reported news on the end-of-Phase I/II meeting of the MATINS study with the FDA. According to FDA feedback, the cancer drug candidate bexmarilimab (BEX) is safe and the study can move to the final Phase II/III. However, further data to find the optimal dosage is required for the continuation of MATINS. The release contained no major surprises and does not affect our view of the share.

BEX’s safety data was estimated to be sufficient, but optimal dosage requires additional evidence

In the MATINS study, BEX has been administered to more than 200 end-stage cancer patients with little or no other treatment options available. Our assessment in the initiation of coverage report states that the safety profile of the drug seems good. The FDA now estimates, with its own strict criteria, that the toxicological data provided by Faron is sufficient to allow MATINS to continue to the final Phase II/III. In terms of dosage, Faron presented a 1 mg/kg dose every 3 weeks to the FDA. According to the release, further evidence is needed to find the optimal dosage before moving forward. We expect that these studies will take a few months to complete.

The FDA also provided feedback on using a biomarker in patient selection

The use of biomarkers is proven to increase the probability of successful drug development (see initiation of coverage report). Here, biomarkers refer to markers such as those measured in blood or stained from tissue samples, which would enable selecting patients who are more likely to benefit from treatment. According to the release, the FDA provided feedback and guidance on further development of a biomarker staining assay (Clever-1). Clever-1 is the target for BEX, so patients who have a high number of cells showing Clever-1 in their tumor could also respond best to BEX treatment. Setting up Clever-1 determination still requires more work but we find the news positive for both the MATINS and BEXCOMBO studies.

The press release did not offer any big surprises

The positive safety profile being confirmed was in line with our expectations. The requested additional evidence concerning the dosage was not particularly dramatic in our opinion either, although we expect that it will take some time to carry out new studies. On the other hand, the strengthened outlook for the possible use of biomarkers was positive news. We do not believe the provided information has any material effect on our estimates, so we maintain our view of the share unchanged for now. In the short term, we look forward to further information on the BEXMAB blood cancer study, which is currently in a very active phase. Moving all three BEX studies forward will require additional funding, so we are also interested in future news flow on this front. Faron's financing portfolio includes at least share issues, debt financing (IPF Partners) and possible licensing agreements.