Faron Pharmaceuticals has announced updated positive clinical data from the ongoing Phase I/II BEXMAB study for patients with haematological malignancies.

The BEXMAB study (NCT05428969) investigates bexmarilimab and standard of care (SoC) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML).

New data

In updated data released on 19 July, Faron said that three out of five patients in the 6mg/kg bexmarilimab and azacitidine doublet cohort showed an objective response (OR) of complete remission of bone marrow blasts (mCR). Of these three patients, one also achieved a complete recovery of blood counts (CR).

Eight of the 15 ORs were observed across all three doublet-dosing cohorts. Four of the eight patients in the three doublet dosing cohorts (1mg/kg, 3mg/kg and 6mg/kg) failed SoC hypomethylating agents (HMAs). All three patients with MDS and prior HMA failure demonstrated partial response (PR), mCR and CR. In addition, four out of six patients in the triplet dosing cohort treated with azacitidine, venetoclax and bexmarilimab have shown an objective response.

This data builds on earlier positive results presented on 9 June 2023 at the European Haematology Association (EHA) 2023 Hybrid Congress.

“Strong potential”

Associate professor at Helsinki University Hospital Comprehensive Cancer Centre and principal investigator of the BEXMAB trial, Dr Mika Kontro said: “We are extremely encouraged by the continued efficacy signals of bexmarilimab and the long duration of the responses seen so far. Our goal is to offer a unique hope for patients with no other treatment options in this late stage of AML and MDS.”

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Chief medical officer Dr Marie-Louise Fjällskog added: “The data indicates bexmarilimab has the strong potential to tackle an unmet medical need in relapsed/refractory AML and MDS. We’re excited to advance bexmarilimab as a leading agent in the fight against cancer and look forward to generating further supporting data ahead of an anticipated BLA filing in H1 2025.”

Faron is now planning on seeking advice from the US Food and Drug Administration (FDA) during Q3 2023 with hopes to advance to Phase II in H2 2023 in patients who are refractory to SoC in AML and have failed HMAs in MDS.