Biomea Fusion has dosed the first subject in the multiple myeloma (MM) cohort of Phase I COVALENT-101 clinical trial of BMF-219 in patients with relapsed/refractory (R/R) MM, acute myeloid leukaemia (AML), acute lymphocytic leukaemia (ALL), diffuse large B-cell lymphoma (DLBCL).

BMF-219 is an oral covalent menin inhibitor. It is the first menin inhibitor to be administered to subjects with R/R MM.

The multicentre, open-label, dose-escalation and dose-expansion trial will analyse the safety, tolerability and pharmacokinetics / pharmacodynamics of a once-a-day oral dose of BMF-219 in patients with R/R acute leukaemias, including AML and ALL.

Trial subjects include subpopulations for whom hindering of menin is anticipated to offer a treatment benefit, e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations.

The trial was extended to include cohorts for subjects with R/R MM and R/R DLBCL.

Subject enrolment is underway in AML and ALL cohorts while DLBCL and MM cohorts were initiated.

Furthermore, activation of the site in North America is underway.

Compelling preclinical activity of BMF-219 in MM subtypes was reported specifically ones driven by MYC, a protein vital for the growth of various kinds of tumours. 

Detecting the optimal biologic dose and recommended Phase II dose of BMF-219 monotherapy is the trial’s primary outcome measure. 

Assessing the safety of BMF-219 through treatment-emergent adverse events and serious adverse events (SAEs) are the secondary outcome measures of the trial.

Biomea CEO, board chairman and co-founder Thomas Butler said: “Today, we have taken the first step to explore the clinical potential of BMF-219, a single-agent covalent menin inhibitor, in treating relapsed / refractory multiple myeloma patients. 

“This represents the second cancer type, as well as the first cancer type outside of AML, to be studied with BMF-219.”

MM is a malignancy of plasma cells found in the bone marrow.