Acimtamig

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients Dec. 05, 2024 -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the U.S. FDA has granted RMAT designation to the combination therapy of Affimed’s innate cell engager (ICE®) acimtamig and Artiva Biotherapeutic’s AlloNK® (AB101) for the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL). The combination is being evaluated in the on-going LuminICE-203 multicenter, multi-cohort phase 2 trial. RMAT designation is intended to expedite the development and review of regenerative medicine therapies, including cell therapies, that aim to address serious or life-threatening conditions. RMAT designation provides the same expedited review benefits as a Breakthrough Therapy Designation, but is exclusively focused on regenerative medicine products. This designation provides Affimed enhanced access to FDA resources including the potential for accelerated approval and priority review. These benefits could significantly reduce the time required to deliver the acimtamig and AlloNK® combination to R/R HL patients in need. “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,” said Dr. Shawn M. Leland, PharmD, RPh, Chief Executive Officer of Affimed. “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.” Earlier this year, Affimed reported promising early efficacy data from cohorts 1 and 2 (12 patients) of the LuminICE-203 trial. The data showed an overall response rate (ORR) of 83.3% (10/12) and a complete response rate (CRR) of 50% (6/12), with a well-managed safety profile. Data from all four cohorts of the run-in phase of the LuminICE-203 trial will be featured in a poster session at the 66th ASH Annual Meeting and Exposition on December 8, 2024. This promising combination has applicability not only in HL, but also in other CD30 positive lymphomas such as peripheral T-cell lymphoma (PTCL), which can also be resistant to conventional therapies, has a high risk of relapse, and where few products are approved. Generating clinical proof-of-concept in PTCL would also highlight a potential path to increasing the commercial potential of the combination by two to three-fold in comparison to the number of patients with double-refractory HL. Acimtamig (AFM13) is a first-in-class ICE® that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. Acimtamig induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. Acimtamig is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor, creating the necessary proximity for the innate immune cells to destroy the tumor cells. LuminICE-203 (AFM13-203) is a Phase 2 open-label, multicenter, multi-cohort study. The trial is evaluating the safety and efficacy of the combination of acimtamig (AFM13) with Artiva Biotherapeutics’ allogeneic NK cell AlloNK® (AB-101) in patients with relapsed/refractory classical Hodgkin lymphoma and CD30-positive peripheral T cell lymphoma (NCT05883449). The study builds on the unprecedented efficacy results from an investigator sponsored study, AFM13-104, which investigated acimtamig in combination with cord blood-derived NK cells in patients with refractory/recurrent CD30-positive Hodgkin or non-Hodgkin lymphoma (NCT04074746). Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com. The content above comes from the network. if any infringement, please contact us to modify.

The multi-cohort Phase II LuminICE-203 trial is currently evaluating the efficacy and safety of the combo. Credit: PaeGAG/Shutterstock. 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.