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.

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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.