· Exclusive collaboration to assess feasibility and activity of pre-manufactured, co-vialed, cryopreserved, off-the-shelf NK cell combination therapeutics targeting EGFR and additional targets
· Proof of concept, preclinical assessment to establish activity and feasibility of the combination of Artiva’s allogeneic natural killer (NK) cells and Affimed’s innate cell engagers (ICE®)
San Diego and Heidelberg, Germany, 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, announced today 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.
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.
About Artiva Biotherapeutics: Scaling NK Cell Therapy for Cancer
Artiva’s mission is to deliver to cancer patients highly effective cellular immunotherapies that are also safe and immediately accessible. Artiva’s pipeline of universal and targeted NK cell therapies leverages the innate anti-tumor biology and safety features of NK cells. The therapies are optimized for enhanced efficacy through chimeric antigen receptors (CARs) or therapeutic antibody combination therapy. Artiva’s pipeline leverages a manufacturing platform that supports large-scale production and cryopreservation of off-the-shelf allogeneic NK cell therapies and proprietary CAR-NK technologies to augment therapeutic activity. Artiva’s platform incorporates cell expansion, activation, and engineering technology developed by the company’s corporate partner, GC LabCell, a member of the GC family of companies, one of the Republic of Korea’s leading biopharmaceutical groups. Artiva is headquartered in San Diego.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer. Affimed’s fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, please visit www.affimed.com.
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of Affimed’s ROCK® platform, ICE® product candidates and AFM24, the potential of Artiva’s NK cell, CAR-NK cell, and AB-101 products, the potential benefits of combining Affimed’s ICE product candidates with Artiva’s NK cell technology, and preclinical development and clinical trials, and other factors described under the heading “Risk Factors” in Affimed’s filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and neither company assumes any obligation to update these forward-looking statements, even if new information becomes available in the future.