Affimed N.V. (NASDAQ: AFMD) and Artiva Biotherapeutics Inc., both immuno-oncology companies focused on developing and commercializing therapies utilizing the innate immune system, announced a new strategic partnership to jointly develop, manufacture, and commercialize a combination therapy comprised of Affimed’s Innate Cell Engager (ICE®) AFM13 and Artiva’s cord blood-derived, cryopreserved off-the-shelf allogeneic NK cell product candidate, AB-101.
Affimed submitted a pre-IND meeting request for the AFM13 and AB-101 co-administered combination therapy to the FDA requesting feedback on the clinical trial design in relapsed/refractory (r/r) Hodgkin lymphoma (HL) with an exploratory arm evaluating the combination in r/r CD30-positive peripheral T-cell lymphoma (PTCL) and potential path to registration. FDA responded to this request and guided to providing feedback by Q1 2023.
This clinical agreement follows the parties’ existing two-year preclinical collaboration to assess combining elements of the companies’ respective platforms in the generation of targeted, off-the-shelf allogeneic NK cell therapies.
As part of the collaboration, the companies evaluated the combination of AFM13 and AB-101 in various preclinical models and generated data that supports development of a co-administered combination therapy.
Meantime, AFMD shares began Thursday up 28 cents, or 16.6%, to $1.97.
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