• Stable disease was observed in three out of seven heavily pretreated patients
• No dose-limiting toxicities or unexpected toxicities were observed

HEIDELBERG, Germany, July 31, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that an abstract with clinical trial results of its innate cell engager (ICE®) AFM24 in combination with NKGen Biotech’s SNK01 (autologous non-genetically modified NK cells), has been accepted for a poster presentation at the ASCO Breakthrough conference from 3-5 August 2023 in Yokohama, Japan. The presentation includes dose escalation phase data on safety and efficacy of the phase 1 study in patients with advanced or metastatic EGFR-expressing solid tumors (NCT05099549).

As of June 2023, seven patients with a mean number of five prior therapies received the combination of AFM24 and SNK01. No unexpected or dose-limiting toxicities were observed, and the PK properties were similar to AFM24 monotherapy. The best objective response was stable disease in three out of the seven patients, including patients with heavily pretreated microsatellite stable colorectal cancer (MSS CRC).

“The poster at ASCO Breakthrough is the first clinical presentation of a bispecific NK cell engager in combination with autologous NK cells,” said Dr. Anthony El-Khoueiry, Associate Director of Clinical Research and Phase I Program Director at the USC Norris Comprehensive Cancer Center and principal investigator of the AFM24 studies. “Our data establish the feasibility of this novel combinatorial approach; the stabilization of disease in heavily pre-treated patients with microsatellite stable colorectal cancer was clinically meaningful.”

“The data presented provide proof-of-concept for the combination of AFM24 with NK cells with good tolerability,” said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. “Despite this, Affimed and NKGen Biotech mutually decided to discontinue the presented study. In line with Affimed’s NK cell combination experience for AFM13, Affimed is currently evaluating the best option to advance AFM24 with an allogeneic off-the-shelf NK cell product.”

Details of the poster presentation are as follows:

Title: AFM24 in combination with autologous NK cells (SNK01) in patients with advanced/metastatic epidermal growth factor receptor (EGFR) expressing solid tumors: Initial results from the Phase 1 dose‑escalation study

Presenting Author: Anthony B. El-Khoueiry

Poster Session: Poster Session A, August 3, 2023, 11:45 – 13:15 JST (GMT+9)

Poster Number: 26

More details about the ASCO Breakthrough conference are available online at Breakthrough: ASCO in Asia | ASCO Breakthrough

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.

Affimed is evaluating AFM24 as monotherapy and in combinations with other cancer treatments in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

AFM24-101, a monotherapy, first-in-human phase 1/2a open-label, is a non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional details may be found at www.clinicaltrials.gov using the identifier NCT04259450.

AFM24 is also being evaluated in a phase 1/2a study in combination with Roche’s PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442).

Furthermore, Affimed and NKGen Biotech are investigating AFM24 in combination with NKGen Biotech’s NK cell SNK01 in a phase 1/2a study (AFM24-SNK01-103, NCT05099549).

Based on the totality of the data accumulated for AFM24, the Company has decided to focus AFM24’s near-term development on advancing AFM24 in combination with checkpoint inhibitors. Affimed is also evaluating options for a combination of AFM24 with an allogeneic off-the-shelf NK cell product which the Company expects to be well suited for heavily pretreated patient populations.

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.

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 the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AB-101 and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

Investor Relations 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