Faron Pharmaceuticals Oy announced objective responses in 3 out of 5 patients dosed in the first doublet cohort of the Company's Phase I/II BEXMAB study. BEXMAB is investigating bexmarilimab, Faron's wholly-owned precision immunotherapy asset, in combination with standard of care in multiple hematological malignancies. The responses from these patients are further defined as: Complete remission with incomplete blood count recovery (CRi) in a patient with relapsed/refractory acute myeloid leukemia observed after 4 treatment cycles CR in a patient with previously untreated myelodysplastic syndrome observed after 6 cycles of treatment Partial remission in a patient with MDS with prior failure to azacitidine observed after 2 treatment cycles.

The primary objective of the BEXMAB study is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine and venetoclax) treatment and to identify the recommended Phase II dose. Secondary objectives include characterizing preliminary efficacy as well as bexmarilimab's pharmacokinetic profile in combination with SoC treatment and assessing its immunogenicity. The first cohort dosed at 1mg/kg of bexmarilimab has been completed for the doublet, and currently enrollment is ongoing into the 3mg/kg cohort.

The Company has opened the first triplet cohort with bexmarilimab, azacitidine and venetoclax in newly diagnosed AML patients who are not able to tolerate chemotherapy. In December 2022, the Company announced for the first cohort that the azacitidine-refractory AML patient achieved a CR, with incomplete blood cell count recovery after four treatment cycles. This was followed by full blood count recovery after five treatment cycles.

It was also announced that another patient demonstrated a PR, and this patient now has become a CR. The safety profile remains strong. In December, the Company announced that bexmarilimab continues to be well-tolerated with no dose-limiting toxicities or safety concerns observed in the five patients receiving 1mg/kg weekly dosing together with azacitidine.

The 5-patient doublet arm at 3mg/kg is fully enrolled, with the triplet arm at three patients recruited. All sites are in Finland, but the Company anticipates sites in the U.S. to be opened during First Quarter 2023 to speed up recruitment even further. Marie-Louise Fjällskog will discuss the most recent BEXMAB findings at the LLS TAP virtual panel on January 18.

The panel, titled "European Partners: Dream Big, Make Bold Progress", will highlight companies that have worked in close collaboration with the LLS TAP program, including Faron, to advance their therapeutic portfolios.