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Affimed Secures the US FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Acimtamig and AlloNK Combination

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Affimed

Affimed Secures the US FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Acimtamig and AlloNK Combination

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  • The US FDA has granted RMAT designation to acimtamig (innate cell engager) plus AB101 (Artiva Biotherapeutic’s AlloNK) for treating r/r Hodgkin Lymphoma (R/R HL)
  • The regimen of acimtamig (AFM13) & AB-101 is being assessed under the P-II (LuminICE-203) trial for its safety and efficacy in treating r/r classical Hodgkin lymphoma and CD30+ peripheral T cell lymphoma
  • Affimed's LuminICE-203 trial showed promising early results in cohort 1 & 2 (n=12), with an ORR of 83.3% & CRR of 50% along with a manageable safety profile. Full data from all four cohorts will be highlighted at ASH 2024

Ref: Affimed | Image: Affimed

Related News:- Affimed’s AFM13 + AlloNK Receives the US FDA’s Fast Track Designation for Relapsed or Refractory Hodgkin Lymphoma

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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