Faron Pharma reports improved remission rates from Bexmab Phase 1 trial to treat patients with aggressive cancers

Faron Pharmaceuticals (LSE: FARN) has reported positive data from Phase 1 of an ongoing trial investigating bexmarilimab (Bexmab) in combination with standard of care in aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Four out of five initial Phase 1 patients have now been on Bexmab with azacitidine for more than six months, with only one patient lost due to progression of their high-risk MDS into AML.

Patients were required to have previously had no success with hypomethylating agents alone, such as azacitidine.

Three additional patients have since been enrolled in Phase 1.

One dropped out of the study early in the cycle due to an unrelated serious adverse event, leading to an overall response rate of 87.5%.

Durability of remission

The latest results showed more patients were responding positively to Bexmab and there had been a good durability of remission.

While the data does not allow for a precise estimation of median overall survival, Faron said the survival benefit seen with the patients had been “very encouraging”.

“Normally, patients with relapsed or refractory high-risk MDS have a median overall survival of less than six months,” the company said.

“The median overall survival of patients treated in this trial is not yet available but based on the current data, it is estimated to be significantly higher than traditionally seen with current standard of care or with current approved treatments.”

Under-served population

The company said the results were “remarkable” and confirmed the belief that Faron may finally have a treatment for the under-served high-risk MDS population.

“The data strongly supports [the idea that] a registrational trial would be positive against any contemporary comparator when the final endpoint is survival,” it said.

“We eagerly await completion of the Phase 2 part of the Bexmab study so we can present the data to the US Food and Drug Administration as soon as possible.”

Investigational immunotherapy

Bexmarilimab is Faron’s wholly-owned investigational immunotherapy designed to overcome resistance to existing treatments and optimise clinical outcomes by targeting myeloid cell function and “igniting” the immune system.

The drug binds to Clever‐1, which is an immuno-suppressive receptor found on macrophages leading to tumour growth and metastases.

By targeting this receptor, bexmarilimab is believed to be able to alter the tumor micro-environment, “re-programming” the macrophages from an immuno-suppressive state to an immuno-stimulatory one and priming the immune system to attack tumours.