On November 5, 2020 Artiva Biotherapeutics, Inc., and Affimed N.V. (NASDAQ: AFMD), both immuno-oncology companies focused on developing and commercializing therapies utilizing the innate immune system, reported that that they have entered into an exclusive collaboration agreement to assess combining elements of their respective platforms in the generation of targeted, off-the-shelf allogeneic NK cell therapies (Press release, Affimed, NOV 5, 2020, View Source [SID1234615396]).
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The R&D collaboration will assess the feasibility and preclinical activity of combinations of Artiva’s allogeneic NK cell product AB-101 and Affimed’s ICE molecules, building on earlier preclinical studies demonstrating synergistic cytotoxic activity. Under the agreement, Affimed’s ICE molecules targeting EGFR and other undisclosed targets will be combined with Artiva’s GMP-grade allogeneic NK cells during the cell manufacturing process. The pre-manufacturing process will include the loading of AB-101 with Affimed ICE molecules prior to cryopreservation, creating specifically targeted allogeneic cells without the requirement for viral transduction. The resulting cryopreserved, off-the-shelf, targeted allogeneic NK cell products will be assessed for anti-tumor activity and development potential. The costs of manufacturing and preclinical assessments will be shared by both companies. The agreement provides for potential further development of selected combination products.
"The combination of Artiva’s highly scaled, optimized NK-cell manufacturing platform with Affimed’s tumor-targeting ICE molecules has the potential for an efficient and flexible therapeutic combination product platform, and preclinical assessments have already demonstrated the potential of this approach," said Tom Farrell, President and CEO of Artiva. "Our NK cells are activated during the manufacturing process resulting in high and consistent expression of innate tumor engagement receptors, including CD16A, making them the ideal platform to combine with tumor-specific targeting ICE from Affimed’s platform."
"The collaboration with Artiva represents a visionary approach which can lead to a new class of drugs providing a potent and targeted innate immune system-cytotoxic response," said Dr. Adi Hoess, Affimed’s Chief Executive Officer. "Our ROCK platform has been proven to rapidly and predictably generate a set of diverse innate cell engagers, with consistent profiles in tumor lysis and safety making our ICE molecules optimally suited for combination therapy with NK cells."
Using its ROCK (Redirected Optimized Cell Killing) platform, Affimed has developed a novel pipeline of ICE products; tetravalent, bispecific therapeutics specific for tumor targets such as epidermal growth factor receptor (EGFR) and CD30 and maintaining high affinity CD16A-binding for enhanced activation of innate immunity, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
Artiva’s AB-101 is a universal NK cell therapy for use in combination with monoclonal antibodies or novel modalities such as NK cell engagers. In preclinical studies, AB-101 has demonstrated enhanced antibody-dependent cellular cytotoxicity with a variety of therapeutic antibodies. The company plans to enter the clinic this year with AB-101, assessing monotherapy safety and efficacy and subsequent therapeutic potential in combination with an anti-CD20 monoclonal antibody for the treatment of relapsed refractory B-cell lymphoma. The first batches of AB-101 drug product, manufactured at very large scale and cryopreserved in infusion-ready media, have already been produced for clinical use.