Affimed N.V. (AFMD)

MANNHEIM, Germany, May 14, 2025 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it has received a written notice from the staff of the Nasdaq Listing Qualifications Department (the “Staff”) notifying the Company that, in accordance with Nasdaq Listing Rule 5101, 5110(b) and IM-5101-1, the trading of the Company's common shares will be suspended at the opening of business on May 20, 2025, and a Form 25 Notification of Delisting will be filed with the U.S. Securities Exchange Commission to delist the Company's securities from The Nasdaq Stock Market (“Nasdaq”).

MANNHEIM, Germany, May 13, 2025 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced its decision to file an application for opening of insolvency proceedings with the local court of Mannheim in Germany.

An exposure-outcome analysis in 72 patients with refractory non-small cell lung cancer (NSCLC) who received AFM24 at 480 mg weekly demonstrates that higher drug exposure (above median) leads to improved objective response rate (33.3% vs 5.6%) and longer progression free survival (PFS) (7.3 mo. vs 2.9 mo.) without a negative impact on safetyThese findings will be incorporated in future AFM24 trials to further improve efficacy outcomes of patients treated with AFM24 MANNHEIM, Germany, April 29, 2025 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today presented findings on an exposure-outcome analysis of its innate cell engager (ICE®) AFM24, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) in a poster session at the 2025 Annual Meeting of the American Association for Cancer Research (AACR). The analysis is based on post-hoc exposure-response data from 72 NSCLC patients treated with 480 mg of AFM24 monotherapy or a combination of AFM24 with atezolizumab. For all patients, trough levels over time were used to calculate the patient’s mean exposure to AFM24. Patients were then split into high and low AFM24 exposure groups for the analysis using the respective median as a cut-off. aAdsList.push('Article'); aAdsListSize.push([300, 250]); aAdsListCA.push(null); Key Findings from the Exposure-Response AnalysisObjective Response Rate (ORR): 33.3% in the high-exposure group vs. 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 monthsOverall Survival (OS): Not yet mature in the high-exposure group vs. 13 months in the low-exposure group A quartile analysis further confirmed the exposure-efficacy relationship, showing a stepwise increase in ORR from 0% in the lowest quartile to 50% in the highest. Subgroup analysis of 55 patients treated with AFM24 plus atezolizumab showed consistent results: 37.04% ORR in the high-exposure group vs. 7.14% in the low group. Importantly, higher exposure was not associated with an increased rate of more serious or severe adverse events. “Advanced NSCLC is a devastating disease and remains an area of high unmet need,” said Andreas Harstrick, MD, Chief Medical Officer of Affimed. “These findings strengthen our clinical rationale for dose optimization and highlight the potential of AFM24 – particularly in combination with atezolizumab – as a novel, chemotherapy-free, immunotherapy-based treatment approach. Importantly, the data suggest that achieving higher drug exposure early in treatment may prevent rapid disease progression.”Further Development Pharmacokinetic (PK) modeling indicates that a 720 mg weekly dose of AFM24—previously established as safe—achieves target exposure levels by the second week of treatment that correspond to the high exposure group in the post-hoc analysis. Based on these findings, Affimed will include the 720 mg dose moving forward to optimize clinical benefit and reduce early progression risk. “These data provide compelling evidence that higher exposure may translate to better outcomes in patients with advanced NSCLC,” Dr. Harstrick added. “With dose optimization in hand, we are positioned to advance AFM24 in its potential to deliver durable benefit in a difficult-to-treat patient population.”Conclusions The data show a strong correlation between exposure and clinical outcome with a significantly increased risk for early tumor progression in the low exposure group. PK modeling suggests that a dose of 720 mg AFM24 weekly will result in exposure levels exceeding the cutoff for the high exposure group as early as week two. The 720 mg dose, which has already been established as safe in the phase 1 trial, will be used in future AFM24 studies. More details about the programs for the AACR Annual Meeting 2025 are available online at AACR Annual Meeting 2025 | Meetings | AACR.About AFM24 AFM24 is a tetravalent, bispecific ICE® that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. About Affimed N.V. Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the 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. Investor Relations Contact Alexander FudukidisDirector, Investor RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102Media ContactMary Beth Sandin Vice President, Marketing and CommunicationsE-Mail: m.sandin@affimed.com Source: Affimed N.V.2025 GlobeNewswire, Inc., source Press Releases

MANNHEIM, Germany, April 29, 2025 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today presented findings on an exposure-outcome analysis of its innate cell engager (ICE®) AFM24, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) in a poster session at the 2025 Annual Meeting of the American Association for Cancer Research (AACR).

MANNHEIM, Germany, April 23, 2025 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced an abstract on the phase 2 LuminICE-203 study of its innate cell engager (ICE®) acimtamig in combination with AlloNK® (AB-101) has been accepted for an oral presentation at the Annual Meeting of the American Society for Clinical Oncology (ASCO) taking place May 30 – June 3, 2025 in Chicago, Illinois. In addition, two abstracts on AFM24 in combination with atezolizumab in non-small cell lung cancer (NSCLC) have been accepted as poster presentations.

MANNHEIM, Germany, April 21, 2025 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it has received a written notice (the “Notice”), dated April 15, 2025, from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty (30) consecutive business days, the bid price for the Company's common shares had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq under Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Rule”).

MANNHEIM, Germany, March 25, 2025 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced an abstract on AFM24 dose optimization using exposure response analysis has been accepted for presentation as a poster at the Annual Meeting of the American Association for Cancer Research (AACR) taking place April 25-30, 2025 in Chicago, Illinois.

MANNHEIM, Germany, March 03, 2025 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that its Chief Executive Officer, Dr. Shawn Leland, PharmD, RPh, will participate in a fireside chat at the Leerink Partners Global Healthcare Conference 2025 on Tuesday, March 11, 2025 at 2:20 p.m. Eastern Daylight Time.

MANNHEIM, Germany, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the oral presentation of data on AFM28 at the 66th ASH Annual Meeting and Exposition. The data, derived from the first-in-human Phase 1 study of AFM28, showed promising results in R/R AML, with signs of clinical efficacy and a well-managed safety profile at doses up to 300 mg weekly.

MANNHEIM, Germany, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it will host a conference call on Tuesday, December 17, at 8:30 a.m. EST / 14:30 CET to review clinical data from AFM24-102, the combination trial of its AFM24 innate cell engager ICE® with atezolizumab in non-small cell lung cancer.

MANNHEIM, Germany, Dec. 08, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the presentation of data in a poster session at the 66th ASH Annual Meeting and Exposition. The dataset includes 22 patients from the run-in phase of the LuminICE-203 (AFM13-203) phase 2 open-label, multicenter, multi-cohort study. The trial evaluates the safety and efficacy of the combination of acimtamig (AFM13) with Artiva Biotherapeutics' allogeneic NK cell AlloNK® in patients with R/R cHL.

The FDA bestows a Regenerative Medicine Advanced Therapy tag to Affimed's acimtamig in combination with AlloNK for treating Hodgkin lymphoma. Shares fall.

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients

Affimed N.V. (NASDAQ:AFMD ) Q3 2024 Earnings Call Transcript November 14, 2024 8:30 AM ET Company Participants Alex Fudukidis - Head of Investor Relations & Director of Investor Relations Shawn Leland - Chief Executive Officer Andreas Harstrick - Chief Medical Officer Michael Wolf - Head of Finance & Administration Conference Call Participants Li Watsek - Cantor Daina Graybosch - Leerink Partners Yanan Zhu - Wells Fargo Li Chen - HC Wainright Yale Jen - Laidlaw & Company Dara Azar - Stifel Operator Good day, everyone.

MANNHEIM, Germany, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the quarter ended September 30, 2024.

MANNHEIM, Germany, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it will release third quarter 2024 results and corporate update on Thursday, November 14, 2024. The Company will host a conference call at 8:30 a.m. EST / 14:30 CET.