Faron Pharmaceuticals has pointed to the latest snapshot of early-stage data as proof that its tumor-associated macrophage candidate bexmarilimab is ready to enter phase 2 trials this year.
The Finnish biotech shared a new update from the first part of its phase 1/2 study Wednesday, July 19, pulling out blood cancer data points that it claimed showed the antibody has “strong potential” in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
Bexmarilimab hits Clever-1, a scavenger receptor linked to the spread of cancer. Inhibiting Clever-1, also known as Stabilin-1 and FEEL-1, may change macrophages and monocytes from immunosuppressive to pro-inflammatory and thereby activate T-cell responses, which has led Faron to test its candidate as a single agent and in combination with approved checkpoint inhibitors in solid tumor patients.
The phase 1/2 BEXMAB study launched back in June last year with the aim of enrolling a total of 181 patients with relapsed/refractory AML, MDS or chronic myelomonocytic leukemia to assess the safety of increasing dose levels of bexmarilimab when combined with standard of care, according to ClinicalTrials.gov.
In this morning’s update, Faron chose to shine a spotlight on the five patients who received the 6-mg/kg combination of bexmarilimab and the chemotherapy azacitidine. Of these five patients, three showed an objective response of complete remission of blasts—a term for abnormal immature white blood cells—in their bone marrow. One of these patients also achieved a complete recovery of their blood count, the biotech noted.
In total, eight overall responses were recorded across the three dosing cohorts—1 mg/kg, 3 mg/kg and 6 mg/kg—of patients taking bexmarilimab and azacitidine.
Meanwhile, of the six trial participants who received a triple treatment of bexmarilimab, azacitidine and the leukemia drug Venclexta, four showed an objective response, the biotech noted.
“The data indicates bexmarilimab has the strong potential to tackle an unmet medical need in relapsed/refractory AML and MDS,” said Faron’s chief medical officer Marie-Louise Fjällskog, M.D., Ph.D., in the release. “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.”
The company’s next steps are to seek FDA advice in the third quarter of 2023 as well as launching the phase 2 portion of the BEXMAB study in the second half of the year. This midstage part of the study will focus on patients whose AML has been refractory to standard of care and for whom hypomethylating agents have failed against MDS.
It’s some welcome good news for Faron’s bexmarilimab ambitions, which had been muted by data last year suggesting the antibody struggled to drive responses when given as a monotherapy.
Investors sent Faron’s share price up 14.8% to 3.28 euros on the Helsinki stock exchange by Wednesday afternoon from a Tuesday close of 2.86 euros.