The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Affimed and Artiva Biotherapeutics’ combination therapy for lymphoma.
Involving Artiva’s AlloNK (AB101) and Affimed’s acimtamig (AFM13), an innate cell engager, the combination therapy treats relapsed or refractory Hodgkin's lymphoma (R/R HL).
The multicentre, multi-cohort Phase II LuminICE-203 trial is currently evaluating the safety and efficacy of this combo.
Affimed announced encouraging early efficacy data from the first two cohorts of the LuminICE-203 trial, involving 12 subjects, earlier in 2024.
The findings demonstrated a well-managed safety profile, an 83.3% overall response rate and a 50% complete response rate.
Affimed CEO Dr Shawn Leland said: “This is an important regulatory milestone demonstrating that the FDA acknowledges the critical need for new therapies in R/R HL, in particular for double refractory HL patients where there are no approved therapies.
“In addition, the RMAT designation validates the strength of our growing clinical data and the promise of our innovative treatment to bring hope to patients battling this rare and difficult-to-treat cancer.”
As a first-in-class ICE, acimtamig activates the innate immune system to destroy CD30-positive hematologic tumours.
It works by engaging and activating natural killer cells and macrophages, leading to the selective killing of CD30-positive tumour cells.
The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening conditions.
It offers benefits similar to a breakthrough therapy designation but is specifically tailored for regenerative medicine products.
Affimed gains improved access to FDA resources, including the possibility of accelerated approval and priority review.
In August 2023, the FDA approved Artiva’s AlloNK (AB-101) and rituximab combination’s investigational new drug application to treat systemic lupus erythematosus in active lupus nephritis individuals.
