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Affimed and NKGen Biotech Announce Initiation of Patient Recruitment in a First-in-human Phase 1/2a Trial of Innate Cell Engager AFM24 in Combination with Autologous NK Cell Product SNK01

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  • Patient recruitment is open for the first-in-human proof of concept trial of the combination of AFM24 and SNK01 NK cells in three advanced or metastatic EGFR-expressing cancers, namely non-small cell lung cancer, squamous cell carcinoma of the head and neck and colorectal cancer

  • The study is supported by pre-clinical data recently presented at the AACR-NCI-EORTC conference on Molecular Targets and Cancer Therapeutics

HEIDELBERG, Germany and SANTA ANA, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) and NKGen Biotech, both clinical stage biotech companies focused on harnessing the power of the body’s innate immune system, announced today the initiation of patient recruitment in the open-label, multi-center phase 1/2a study (NCT05099549) evaluating the safety, tolerability, and anti-tumor activity of the innate cell engager (ICE®) AFM24 (Affimed’s tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding ICE®) in combination with SNK01 (ex vivo expanded and activated autologous NK cell therapy from NKGen Biotech).

The objective of the phase 1 dose escalation is to evaluate safety and tolerability data for escalating AFM24 doses in combination with a fixed dose of SNK01 and to determine the maximum tolerated and recommended phase 2 dose for the expansion phase. Phase 2a will investigate additional tolerability, safety and anti-tumor activity. The trial will include patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck (SCCHN), as well as patients with microsatellite instability (MSI) low/DNA mismatch repair proficient colorectal cancer (CRC) regardless of KRAS mutational status.

“Existing therapeutics that target EGFR rely on inhibiting EGFR signaling, an approach that has been hampered by intrinsic and acquired resistance mechanisms,” said Dr. Anthony El-Khoueiry, Phase I Program Director at the USC Norris Comprehensive Cancer Center, part of Keck Medicine of USC. El-Khoueiry is also associate professor of clinical medicine, Keck School of Medicine of USC and principal investigator for the study. “The combination of AFM24 with SNK01 represents a novel approach to leverage EGFR expression in multiple solid tumor types and optimally engage the innate immune system; this may be especially beneficial for patients with an impaired immune system or low NK cell numbers.”

The clinical study is supported by preclinical data generated through the collaboration of Affimed and NKGen Biotech, including data that were recently presented at the AACR-NCI-EORTC conference on Molecular Targets and Cancer Therapeutics. In the preclinical studies, AFM24 demonstrated robust binding to SNK01 cells and enhancement of the cytotoxic activity of SNK01 cells towards EGFR-positive A-431 cells, compared to untargeted SNK01 cells. In addition, markers for NK cell degranulation and intracellular IFNγ were increased in the combined therapy, indicating increased anti-tumor activity.

The AACR-NCI-EORTC conference presentation may be found at: https://www.affimed.com/rock-platform/publications-posters/ and https://nkgenbiotech.com/scientific-publications/

About AFM24

AFM24 is a tetravalent, bispecific innate cell engager (ICE®) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

In addition to the AFM24-103 study presented here, Affimed is evaluating AFM24 as a monotherapy (AFM24-101) for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. The first-in-human phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov using the identifier NCT04259450.

About SNK01

SNK01 is a cell-based, patient-specific, ex vivo expanded and activated autologous NK cell therapy agent, manufactured from the patient’s leukapheresis or whole blood. NK cells are a subset of cytotoxic lymphocytes with the ability to directly attack virally infected cells or cancer cells and carry out immunoregulatory functions by the secretion of cytokines and chemokines.

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 by actualizing the untapped potential of the innate immune system. The company’s proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a 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.

About NKGen Biotech

NKGen Biotech, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK Natural Killer (NK) Cell therapeutics. Leveraging our proprietary cell expansion and activation technology and cutting-edge cell manufacturing expertise, we have the ability to infinitely expand natural killer cells while significantly enhancing cytotoxicity across our peripheral blood-derived products. NKGen Biotech’s lead product candidate, SNK01, is currently in Phase 1 and Phase 1/2a clinical trials for the treatment of advanced refractory solid tumors both as a monotherapy and in combination with other agents including checkpoint inhibitors and cell engagers. NKGen Biotech is committed to the vision of executing on our clinical strategies with the goal of commercializing our NK cell therapies to help save and sustain patients’ lives worldwide. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com.

FORWARD-LOOKING STATEMENTS

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, NKGen Biotech’s NK cell technology and SNK01, 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.

Affimed Investor Contact
Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102

Media Contact
Mary Beth Sandin
Vice President, Marketing and Communications
E-Mail: m.sandin@affimed.com
Tel: +1 (484) 888-8195

NKGen Biotech Contact
Denise Chua, MBA, CLS, MT(ASCP)
Vice President, Investor Relations and Corporate Communications
E-mail: dchua@nkgenbiotech.com
Tel: +1 (949) 396-6830


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