Broker comments20 Sep 2022 11:56
Faron Pharmaceuticals: Top-line Dose Variation Data From MATINS
2022-09-20
11:00
Faron has announced top-line data on dose variation from the phase I/II MATINS study with lead candidate Bexmarilimab. Redeye is encouraged by the results and looks forward to the further clinical development of the candidate.
Kevin Sule
Earlier this morning, Faron announced top-line data on bexmarilimab dose variation in MATINS patients. The MATINS trial is a phase I/LL study investigating the safety and efficacy of Bexmarilimab monotherapy in ten different hard-to-treat metastatic or inoperable solid tumor cohorts. In the initial part I (safety/dose-finding) and part II (dose confirmation), Bexmarilimab showcased a good safety profile and clinically relevant effect on overall survival (updated analysis show 14.9 months for patients who benefited from treatment compared to 4.4 months for those who did not). The latest segment of the trial, part III (dose exploration), focused on exploring higher dose levels and frequencies to determine the finalized dose for further studies with Bexmarilimab.
Data from the study showed that higher doses, up to 30mg/kg (previously 0.1-10 mg/kg), were well tolerated as was more frequent dosing of 1-3 mg/kg administered every week to every other week. This data suggests that bexmarilimab dosing can be effective across several dosing regimens, not being constrained by dose-limiting toxicity. We believe that this further indicates that combination therapy with anti-PD-1 treatment would also be well tolerated, boding well for the BEXMAB, BEXLUNG, and BEXCOMBO studies. following a detailed evaluation of this latest data, Faron expects to submit a full data package to the FDA to obtain regulatory advice for further clinical development of Bexmarilimab as a monotherapy last-line treatment and as an early-line combination therapy.
As also suggested in previous results, treatment with Bexmarilimab induced significant systemic interferon-gamma (IFN-?) increase – where the lower the pre-existing IFN-gamma response is, the higher the IFN-gamma levels will increase with Bexmarilimab treatment. This finding is truly essential in identifying and determining patients likely to benefit from treatment, which can be possible through a validated staining antibody. We argue that Faron is now well-positioned to drive a biomarker strategy to guide patient selection ahead successfully.
Overall, we are encouraged by the results from the dose exploration part of MATINS as it bolsters our view of Bexmarilimab’s safety profile and clinical relevance. While we view these data as positive, they align with our previous valuation assumptions. Accordingly, we do not make any adjustments to our valuation as of now.
We reiterate our fair value Base Case valuation of EUR 4 per share (Bull 10, Bear 2).