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MANNHEIM, Germany - Affimed N.V. (NASDAQ: AFMD), a clinical-stage immuno-oncology company whose stock has surged over 31% in the past week according to InvestingPro data, has reported significant findings from an analysis of its drug AFM24 for treating non-small cell lung cancer (NSCLC). The study showed that patients with higher exposure to AFM24 had better response rates and longer progression-free survival, without additional safety concerns.
The post-hoc exposure-response analysis included 72 patients with refractory NSCLC who received 480 mg of AFM24 weekly. The results indicated that the objective response rate (ORR) was 33.3% in the high-exposure group compared to 5.6% in the low-exposure group. Additionally, the median progression-free survival (mPFS) was 7.3 months for the high-exposure group versus 2.9 months for the low group.
The data, presented at the 2025 Annual Meeting of the American Association for Cancer Research (AACR), also revealed a stepwise increase in ORR from 0% in the lowest quartile to 50% in the highest. Subgroup analysis of patients treated with a combination of AFM24 and atezolizumab showed consistent results, with a 37.04% ORR in the high-exposure group versus 7.14% in the low-exposure group.
Dr. Andreas Harstrick, Chief Medical Officer of Affimed, stated that these findings support the clinical rationale for dose optimization of AFM24, especially in combination with atezolizumab, as a novel, chemotherapy-free treatment approach.
Pharmacokinetic modeling suggests that a 720 mg weekly dose of AFM24, previously established as safe, achieves target exposure levels by the second week of treatment. This dosage is expected to be used in future studies to optimize clinical benefit and reduce early progression risk.
AFM24 is a tetravalent, bispecific innate cell engager (ICE®) that activates the innate immune system by binding to CD16A on immune cells and epidermal growth factor receptors (EGFR) on cancer cells, leading to tumor cell killing through antibody-dependent cellular cytotoxicity and phagocytosis.
The findings from this analysis highlight the potential of AFM24 in improving outcomes for patients with advanced NSCLC. While Affimed plans to incorporate the 720 mg dose in future trials, InvestingPro data shows the company maintains a strong financial position with more cash than debt on its balance sheet, though it’s currently experiencing rapid cash burn. According to InvestingPro analysis, the stock appears undervalued at current levels, with 3 analysts recently revising their earnings estimates upward for the upcoming period. Discover more insights about AFMD and access comprehensive analysis of 1,400+ stocks with an InvestingPro subscription.
This news is based on a press release statement from Affimed N.V. With the company’s next earnings report due on May 21, 2025, investors can access detailed financial analysis and 12 additional ProTips through InvestingPro’s comprehensive research platform.
In other recent news, Affimed N.V. has received a notification from Nasdaq regarding its non-compliance with the minimum bid price rule. The company’s stock price has closed below the required $1.00 per share for 30 consecutive business days, violating Nasdaq Listing Rule 5450(a)(1). Affimed has until October 13, 2025, to regain compliance with this rule. If the company fails to meet the requirement by the deadline, it may consider transferring its securities to The Nasdaq Capital Market, which could grant an additional 180 days to comply, subject to certain conditions. This notice currently does not affect the listing or trading of Affimed’s common shares on the Nasdaq. The company is evaluating its options to address the issue. Affimed continues its work on developing therapies that utilize the innate immune system to combat cancer.
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