Update on EGFR-wildtype NSCLC Trial: Affimed's AFM24-102 Clinical Response

Affimed N.V., a clinical-stage immuno-oncology company, has released an update on its ongoing AFM24-102 phase 1/2a study concerning EGFR-wildtype non-small cell lung cancer (NSCLC). The study has observed positive responses in heavily pre-treated patients, prompting an expansion of the patient cohort to 40 individuals. As of January 4, 2024, the data from 15 patients showed one complete response and two partial responses, with another partial response pending confirmation. These patients had received a median of two prior treatments and had not responded to PD-[L]1 targeted therapy.

The company's decision to increase the number of participants in the EGFR-wildtype NSCLC cohort is based on the promising results seen in the initial group. Affimed's focus is on addressing the significant need for new treatment options for patients who have exhausted all previous lines of therapy, including those that did not respond to PD-1/PD-L1 treatments. The company is also continuing to enroll patients in the EGFR-mutant NSCLC cohort, with data from both cohorts expected to be released in the first half of 2024.

Dr. Andreas Harstrick, CMO and interim CEO of Affimed, expressed optimism regarding the treatment's effectiveness in patients who had not responded to previous therapies. He emphasized the importance of expanding the study to provide more insights into the potential of the treatment for heavily pre-treated patients.

Affimed's proprietary ROCK® platform is central to the development of its innate cell engager (ICE®) molecules, which leverage the body's immune system to target and destroy a variety of tumors. The platform's predictability allows for the creation of customized ICE® molecules, exemplified by AFM24, a tetravalent, bispecific ICE® that activates the innate immune system by binding to CD16A on immune cells and EGFR on solid tumors.

The AFM24-102 study is an open-label, non-randomized, multicenter trial that evaluates the combination of AFM24 with atezolizumab in patients with EGFR-expressing advanced solid malignancies. The study is designed to assess the safety, tolerability, and preliminary efficacy of the combination therapy in patients who have not responded to previous treatments.

In addition to the ongoing trial with atezolizumab, Affimed is exploring the potential of combining AFM24 with an allogeneic off-the-shelf NK cell product, which could be beneficial for heavily pre-treated patient populations.

The company, headquartered in Mannheim, Germany, is dedicated to harnessing the innate immune system's potential to combat cancer and has a bold vision to prevent the disease from disrupting patients' lives. Affimed's leadership team consists of experienced professionals from the biotechnology and pharmaceutical industries, united by their commitment to advancing cancer treatments.