• Analysis of 72 refractory non-small cell lung cancer (NSCLC) patients treated with 480 mg weekly of AFM24 shows that higher drug levels (above the median) correlate with better objective response rates (33.3% vs 5.6%) and longer progression-free survival (PFS) (7.3 months vs 2.9 months), without compromising safety.
• These results will inform future AFM24 trials to enhance the efficacy of AFM24 in treated patients.

MANNHEIM, Germany, April 29, 2025 — Affimed N.V. (Nasdaq: AFMD), an immuno-oncology company focused on harnessing the innate immune system to fight cancer, presented data on the exposure-outcome relationship of its innate cell engager (ICE®) AFM24 in advanced or metastatic non-small cell lung cancer (NSCLC) patients at a poster session during the 2025 American Association for Cancer Research (AACR) Annual Meeting.

The analysis uses retrospective exposure-response data from 72 NSCLC patients who received either 480 mg of AFM24 alone or AFM24 combined with atezolizumab. Average AFM24 exposure was calculated for each patient using trough levels measured over time. Patients were then divided into high and low exposure groups based on the median exposure level.

Key Findings from the Exposure-Response Analysis

• Objective Response Rate (ORR): 33.3% in the high-exposure group compared to 5.6% in the low-exposure group (p=0.0059)
• Disease Control Rate (DCR): 83.3% vs. 58.3% (p=0.0367)
• Median Progression-Free Survival (mPFS): 7.33 vs. 2.86 months
• Overall Survival (OS): Not yet mature in the high-exposure group vs. 13 months in the low-exposure group

A quartile analysis further supported the exposure-efficacy link, demonstrating a gradual increase in ORR from 0% in the lowest quartile to 50% in the highest. A subgroup analysis of 55 patients treated with AFM24 plus atezolizumab yielded similar results: a 37.04% ORR in the high-exposure group versus 7.14% in the low-exposure group. Importantly, higher exposure did not lead to a greater incidence of serious adverse events.

“Advanced NSCLC is a serious disease with significant unmet needs,” said Andreas Harstrick, MD, Chief Medical Officer of Affimed. “These results reinforce the rationale for optimizing the AFM24 dose and highlight its potential, especially when combined with atezolizumab, as a new, chemotherapy-free, immunotherapy option. The data also suggest that achieving higher drug exposure early in treatment may prevent rapid disease progression.”

Further Development

Pharmacokinetic (PK) modeling suggests that a weekly dose of 720 mg of AFM24—previously shown to be safe—can achieve target exposure levels matching those of the high-exposure group in the analysis by the second week of treatment. Based on these findings, Affimed will use the 720 mg dose in future trials to maximize clinical benefits and reduce the risk of early progression.

“These data provide compelling evidence that increased exposure may lead to improved outcomes for advanced NSCLC patients,” Dr. Harstrick added. “With dose optimization underway, we are well-positioned to advance AFM24’s potential to provide lasting benefits for this challenging patient population.”

Conclusions

The data demonstrate a strong relationship between drug exposure and clinical outcome, with a significantly increased risk of early tumor progression in the low-exposure group. PK modeling indicates that a weekly dose of 720 mg AFM24 will achieve exposure levels above the cutoff for the high-exposure group as early as week two. The 720 mg dose, which has already been shown to be safe in a phase 1 trial, will be utilized in future AFM24 studies.

Additional information about the programs for the AACR Annual Meeting 2025 can be found online at .

About AFM24
AFM24 is a tetravalent, bispecific ICE® that activates the innate immune system. It binds to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein commonly found on solid tumors, to kill cancer cells. AFM24, created using Affimed’s ROCK® platform, employs a unique mechanism of action that uses EGFR to recruit innate immune cells for tumor cell destruction via antibody-dependent cellular cytotoxicity and phagocytosis.

About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company focused on restoring the body’s natural ability to fight cancer by utilizing the innate immune system. The Company’s innate cell engagers (ICE®) offer a tumor-targeted approach to identify and eliminate a variety of hematologic and solid tumors. ICE® molecules are developed using the Company’s proprietary ROCK® platform, which allows for the creation of customized molecules that harness the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are currently in clinical development, being investigated as both monotherapy and combination therapy. Affimed, headquartered in Mannheim, Germany, is led by an experienced team of biotechnology and pharmaceutical executives with a shared vision of preventing cancer from disrupting patients’ lives. For more information about the Company’s team, pipeline, and partners, please visit: www.affimed.com.

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