Affimed Highlights the Potential of its Innate Cell Engager AFM24 as EGFR-targeting Therapy for Solid Tumors as Monotherapy and in Combination with Adoptive NK Cell Transfer at AACR Virtual Annual Meeting I

Rhea-AI Summary

Affimed N.V. (Nasdaq: AFMD) has announced promising pre-clinical data for its Innate Cell Engager (ICE®) AFM24, demonstrating significant tumor cell killing capabilities independent of KRAS mutations. Presented at the AACR Virtual Annual Meeting, AFM24 shows potential in combination with adoptively transferred NK cells, leading to dose-dependent tumor regression. This innovative mechanism may change the treatment landscape for EGFR-expressing solid tumors. The company continues to evaluate AFM24 for patients with advanced malignancies, supported by regulatory approvals for ongoing clinical trials.

Positive

• AFM24 demonstrates strong tumor cell killing independent of KRAS mutations.
• Combination with NK cells results in dose-dependent tumor regression.
• Potential to change treatment paradigms for EGFR-expressing tumors.

Negative

• None.

• AFM24 induces strong tumor cell killing independent of KRAS mutations
• AFM24, in combination with adoptive NK cells, leads to dose-dependent tumor regression

Heidelberg, Germany, April 12, 2021 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announces pre-clinical data on its Innate Cell Engager (ICE^®) AFM24 as monotherapy and in combination with adoptively transferred NK cells at the American Association for Cancer Research (AACR) Virtual Annual Meeting I.

AFM24, an EGFR/CD16A-binding ICE^®, mediates antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) and has the potential to overcome toxicity and resistance hurdles associated with current EGFR signaling inhibitors through its differentiated mechanism of action. AFM24 induces NK cell-mediated ADCC against EGFR-expressing tumor cells even in the presence of competing IgG and can induce potent cell killing in tumors independent of KRAS mutations.

In addition, data from a xenograft mouse model demonstrate that AFM24 in combination with adoptively transferred NK cells results in dose-dependent tumor regression.

“AFM24’s novel mechanism of action is independent of EGFR signaling and has the potential to change the treatment paradigm for EGFR-expressing solid tumors,” said Dr. Arndt Schottelius, Affimed’s Chief Scientific Officer. “Demonstrating that AFM24, in combination with NK cells, shows tumor regression in vivo is an important pre-clinical proof of concept. Combination therapies with NK cells could broaden the potential AFM24 opportunities to treat a range of EGFR-expressing malignancies.”

Affimed is currently evaluating AFM24 as monotherapy for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24-101 is a first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional information about the trial may be found at www.clinicaltrials.gov, using the identifier NCT04259450.

In March 2020, the U.S. Food and Drug Administration (FDA) cleared an investigational new drug application (IND) for a Phase 1/2a study investigating the combination of AFM24 with SNK-01, an autologous NK cell product of NKGen Biotech (formerly known as NKMax America), in cancer patients with EGFR-expressing tumors.

In February 2020, Affimed announced a clinical collaboration with Roche to explore the combination of AFM24 with Roche’s PD-L1 checkpoint inhibitor atezolizumab (Tecentriq^®).

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.

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 our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, and our other product candidates, the value of our ROCK® platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other 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 we assume 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

FAQ

What is AFM24 from Affimed?

AFM24 is an Innate Cell Engager (ICE®) targeting EGFR/CD16A, promoting tumor cell killing.

What were the findings presented at the AACR Annual Meeting?

AFM24 induced strong tumor cell killing and showed dose-dependent tumor regression when combined with NK cells.

What are the implications of AFM24's mechanism of action?

Its mechanism is independent of EGFR signaling, potentially addressing resistance in cancer treatments.

What clinical trials is Affimed conducting for AFM24?

Affimed is evaluating AFM24 in a Phase 1/2a study for patients with advanced EGFR-expressing solid tumors.

How can I find more information about Affimed's clinical trials?

Additional information can be found on clinicaltrials.gov under identifier NCT04259450.