Affimed and NKMax America Announce FDA Clearance of IND Application to Study the Combination of AFM24, an EGFR Targeted Innate Cell Engager, with SNK-01 Natural Killer Cell Therapy in Solid Tumors

Rhea-AI Summary

Affimed N.V. (NASDAQ: AFMD) and NKMax America Inc. announced the FDA's clearance of an IND for a Phase 1/2a study. This trial will explore the combination of AFM24, an EGFR/CD16A innate cell engager, with SNK-01, an autologous NK-cell product, targeting solid tumors expressing EGFR. The aim is to improve treatment outcomes for patients who have failed conventional therapies. The study will assess safety, pharmacokinetics, and preliminary efficacy, marking a significant step for both companies in advancing innate immunity-based therapies.

Positive

• FDA clearance of IND for AFM24/SNK-01 study is a significant milestone.
• The study focuses on patients with high medical needs who have not succeeded with conventional therapies.
• Exploration of a novel therapeutic approach could enhance treatment outcomes for solid tumors.

Negative

• None.

Heidelberg, Germany and Santa Ana, Calif., March 31, 2021 - Affimed N.V. (NASDAQ: AFMD), a clinical-stage immuno-oncology company, and NKMax America Inc., a clinical stage biotech company, announced today that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug application (IND) for an Affimed and NKMax America co-sponsored Phase 1/2a  dose escalation and expansion study in which the two companies will investigate the combination of AFM24, an EGFR/CD16A innate cell engager (ICE®), and SNK-01, an autologous NK-cell product, in patients suffering from tumors known to express EGFR. The combination represents a novel approach to exploring innate immunity-based therapeutics to treat patients with solid tumors who failed conventional therapy with the aim to improve outcomes for high-medical need patient populations.

“This combination is part of our overall development strategy for AFM24, the first and only innate cell engager in clinical development for solid tumors. In addition to NK cell-based combinations, we are also developing AFM24 as single agent and in combination with atezolizumab in several tumor indications,” said Dr. Andreas Harstrick, Affimed’s Chief Medical Officer. “The mechanism of action of the two compounds could be highly synergistic as AFM24 has strong binding affinity to NK cells, directing them to kill tumor cells. Moreover, this combination approach represents an opportunity to supplement patients with dysregulated innate immune systems with targeted cellular therapy.”  

“The FDA clearance of our IND application for SNK-01 in combination with AFM24 is an important milestone for our Natural Killer cell therapy development program,” said Stephen Chen, Chief Operating Officer and Chief Technical Officer of NKMax America.  “We look forward to investigating this combination as part of our comprehensive strategy aimed at producing a cell therapy for patients with advanced/metastatic EGFR-expressing cancers.”

Further Information About the AFM24/SNK-01 Phase 1/2a study

The Phase 1/2a study is based on preclinical in vitro testing, combining Affimed’s ICE® AFM24 with NKMax America autologous NK-cell product SNK-01, which showed enhanced activity of NK cell induced target cell killing. The Phase 1/2a study will be an open-label, non-randomized, multi-center, US only, dose escalation trial to evaluate the combination in adult patients with EGFR-expressing tumors. The primary objective of the phase 1 study part will be to establish the safety and the recommended phase 2 dose of AFM24/SNK-01 combination, as well as to evaluate pharmacokinetics, pharmacodynamics, and preliminary activity in patients with advanced cancers expressing EGFR. The phase 2a portion of the study will evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes.

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to give 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 NKMax America

NKMax America Inc. is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across its autologous and allogeneic products which are all derived from peripheral blood. Our first in class autologous product, SNK-01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase 1/2a combination trial with Keytruda in Stage IV non-small cell lung cancer. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. www.nkmaxamerica.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, NKMax America’s NK cell technology and SNK-01, 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

Alex Fudukidis
Head of Investor Relations
Email: a.fudukidis@affimed.com   
Tel.: +1 (917) 436-8102

NK Max America Contact

Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing
Email: dchua@nkmaxamerica.com   
Tel.: +1 (949) 396-6830

FAQ

What is the FDA approval related to Affimed and NKMax America?

The FDA cleared an IND for a Phase 1/2a study of AFM24 and SNK-01, exploring their combination for treating EGFR-expressing tumors.

What is the purpose of the Phase 1/2a study for AFM24 and SNK-01?

The study aims to establish safety, determine recommended doses, and evaluate preliminary efficacy in treating advanced cancers.

How does the combination of AFM24 and SNK-01 work?

AFM24 directs NK cells to target and kill tumor cells, potentially enhancing treatment effectiveness for patients with weakened immune responses.

What types of tumors are targeted in the FDA-cleared study?

The study focuses on patients with tumors known to express EGFR.

When was the FDA clearance for the new drug application announced?

The FDA clearance was announced on March 31, 2021.