AFM24 (EGFR) + atezolizumab in NSCLC - In EGFRwt NSCLC, the Disease Control Rate (DCR) was 76% (25/33 patients), with 48% (16/33) showing tumor shrinkage and an Objective Response Rate (ORR) of 21% (1 CR, 6 PRs)[16] - In EGFRmut NSCLC, the DCR was 71%, with 41% (7/17) showing tumor shrinkage and an ORR of 24% (1 CR, 3 PRs)[16] - Preliminary median Progression-Free Survival (PFS) in EGFRwt NSCLC was 5.6 months, with 36% of patients ongoing[33, 49] - Patients without prior taxane exposure in EGFRwt NSCLC showed a 25% ORR and a preliminary median PFS of 74 months[47, 53] - Post-hoc analysis showed increasing AFM24 exposure resulted in higher ORR, with the highest exposure group (Q4) achieving a 5455% ORR and a 9091% DCR[68] Acimtamig (AFM13) + AlloNK® in r/r HL - In relapsed/refractory Hodgkin Lymphoma (r/r HL), the ORR was 864% (19/22 patients), including a 545% Complete Response (CR) rate[16, 91] - All patients in the LuminICE-203 study were refractory to brentuximab vedotin (BV) and checkpoint inhibitors (CPIs)[80] AFM28 in r/r AML - In the highest dose level (300 mg), a composite complete remission rate (CRcR) of 40% (4/10 patients) was achieved in relapsed/refractory Acute Myeloid Leukemia (r/r AML)[16, 107]

Core Points - Affimed N.V. has received a notice from Nasdaq indicating that its common shares will be suspended from trading on May 20, 2025, due to insolvency filing and compliance concerns [1][2] - The company filed for insolvency in the local court of Mannheim, Germany, on May 13, 2025 [3] Company Overview - Affimed N.V. is a clinical-stage immuno-oncology company focused on harnessing the innate immune system to combat cancer through its proprietary innate cell engagers (ICE) [4] - The company is headquartered in Mannheim, Germany, and aims to develop therapies for various hematologic and solid tumors [4]

Core Viewpoint - Affimed N.V. has filed for insolvency proceedings due to insufficient funds to continue operations and has determined that it is overindebted [1][2][3][4]. Group 1: Company Situation - Affimed N.V. is a clinical-stage immuno-oncology company focused on harnessing the innate immune system to combat cancer [5]. - The company has been unable to raise sufficient capital despite ongoing fundraising efforts, leading to substantial doubt about its ability to continue as a going concern [2][3]. - The management board has concluded that both Affimed N.V. and its subsidiary Affimed GmbH are overindebted and must file for insolvency under German law [3][4]. Group 2: Insolvency Proceedings - On May 13, 2025, the management board filed for ordinary insolvency proceedings for both Affimed N.V. and Affimed GmbH with the local court in Mannheim, Germany [4]. - The outcome of the insolvency proceedings remains uncertain, including whether the companies will emerge as going concerns [4]. - The filing for insolvency will lead to the suspension and subsequent delisting of the company's common shares from The Nasdaq Global Market [4].

Core Insights - Affimed N.V. presented findings on its innate cell engager (ICE®) AFM24 for advanced non-small cell lung cancer (NSCLC) at the 2025 AACR Annual Meeting, highlighting the potential of AFM24 as a novel immunotherapy treatment [1][5] Exposure-Response Analysis - The analysis involved 72 NSCLC patients treated with either 480 mg of AFM24 monotherapy or in combination with atezolizumab, categorizing patients into high and low exposure groups based on median trough levels [2][4] - A quartile analysis showed a significant increase in objective response rate (ORR) from 0% in the lowest quartile to 50% in the highest quartile, with a notable ORR of 37.04% in the high-exposure group versus 7.14% in the low-exposure group [4][10] - Higher drug exposure was associated with improved outcomes, including a median progression-free survival (mPFS) of 7.3 months in the high-exposure group compared to 2.9 months in the low-exposure group [9][10] Future Development Plans - Pharmacokinetic modeling suggests that a 720 mg weekly dose of AFM24 will achieve target exposure levels by the second week of treatment, which corresponds to the high exposure group in the analysis [6][7] - The company plans to incorporate the 720 mg dose in future studies to optimize clinical benefits and reduce the risk of early disease progression [6][7] Mechanism of Action - AFM24 is a tetravalent, bispecific ICE® that activates the innate immune system by binding to CD16A on immune cells and epidermal growth factor receptors (EGFR) on tumors, facilitating tumor cell killing through antibody-dependent mechanisms [11] Company Overview - Affimed N.V. is a clinical-stage immuno-oncology company focused on harnessing the innate immune system to combat cancer, with several ICE® molecules in clinical development for various hematologic and solid tumors [12]

Core Insights - Affimed N.V. announced that 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 oral presentation at the ASCO Annual Meeting scheduled for May 30 – June 3, 2025 [1] - Two abstracts on AFM24 in combination with atezolizumab for non-small cell lung cancer (NSCLC) have also been accepted for poster presentations at the same event [1] Presentation Details - The oral presentation will cover the completed dose-finding part of the phase 2 study of acimtamig in combination with AlloNK for relapsed or refractory classical Hodgkin lymphoma, scheduled for May 30, 2025 [2] - The poster presentations will include initial results from a phase 2a study of AFM24 in combination with atezolizumab for advanced/metastatic EGFR-expressing NSCLC without driver mutations and for NSCLC with EGFR kinase domain mutations, both scheduled for June 2, 2025 [2] Company Overview - Affimed N.V. is a clinical-stage immuno-oncology company focused on harnessing the innate immune system to combat cancer through its proprietary innate cell engagers (ICE) [4] - The company is headquartered in Mannheim, Germany, and aims to provide innovative therapies that enable tumor-targeted approaches to treat various hematologic and solid tumors [4]

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 min ...

Core Insights - Affimed N.V. announced that an abstract on AFM24 dose optimization has been accepted for presentation at the AACR Annual Meeting 2025 [1][2] Group 1: Presentation Details - The title of the poster presentation is "Dose-Optimization Using Exposure Response Analysis in AFM24 (in Monotherapy and with Atezolizumab) in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer" [2] - The presentation will take place on April 29, 2025, from 9:00 AM to 12:00 PM CDT [2] - The published abstract number is CT161, and it will be available online on April 25, 2025 [3] Group 2: 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) [4] - The mechanism of action for AFM24 involves engaging innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis [4] Group 3: About Affimed N.V. - Affimed is a clinical-stage immuno-oncology company focused on harnessing the innate immune system to fight cancer [5] - The company's innate cell engagers (ICE®) are designed to target and kill a variety of hematologic and solid tumors [5] - Affimed is headquartered in Mannheim, Germany, and is led by a team of biotechnology and pharmaceutical leaders [5]

Core Viewpoint - Affimed N.V. is actively participating in the Leerink Partners Global Healthcare Conference 2025, highlighting its commitment to advancing immuno-oncology and engaging with investors [1][2]. Company Overview - Affimed N.V. is a clinical-stage immuno-oncology company focused on empowering patients to combat cancer by harnessing the innate immune system [3]. - The company develops innate cell engagers (ICE) that target and eliminate various hematologic and solid tumors, utilizing its proprietary ROCK platform to create customized molecules [3]. - Affimed is headquartered in Mannheim, Germany, and is led by a team of experienced biotechnology and pharmaceutical professionals dedicated to innovative cancer treatments [3]. Event Details - The CEO, Dr. Shawn Leland, will participate in a fireside chat at the conference on March 11, 2025, at 2:20 p.m. Eastern Daylight Time [1]. - A live webcast of the presentation will be available on Affimed's website, with a replay accessible for 30 days post-event [2].

Core Insights - The combination of AFM24 and atezolizumab shows promising clinical activity in heavily pretreated NSCLC patients, with an overall response rate (ORR) of 21% in EGFR wild-type patients and 24% in EGFR mutant patients, alongside a disease control rate (DCR) of 76% and 71% respectively [1][7][10] - A post-hoc analysis indicates that higher exposure to AFM24 correlates with significantly improved response rates and progression-free survival (PFS), leading to a planned increase in dosage to 720 mg weekly for future development [1][9][10] NSCLC EGFR Wild-type Cohort Update - The patient population included 43 patients in the full analysis set, with 33 in the per protocol set, having a median of 2 prior lines of therapy [3] - The combination therapy resulted in an ORR of 21%, with tumor shrinkage observed in 48% of patients and a preliminary median PFS of 5.6 months [5] NSCLC EGFR Mutant Cohort Update - The cohort consisted of 28 patients in the full analysis set, with 17 patients in the per protocol set, all having received prior EGFR-specific TKI therapy [6] - The combination therapy achieved an ORR of 24%, with tumor shrinkage in 41% of patients and a median PFS of 5.6 months [7] Safety Profile - The combination therapy was well tolerated, with infusion-related reactions being the most common adverse event reported in 54% of patients, and no unexpected safety findings were identified [4][10] Post-Hoc Exposure-Response Analysis - The analysis included 44 patients treated with 480 mg AFM24, revealing that the high exposure group had an ORR of 46% and a median PFS of 7.4 months, indicating a clear relationship between exposure and efficacy [8][9] Company Overview - Affimed N.V. is a clinical-stage immuno-oncology company focused on harnessing the innate immune system to combat cancer, with its proprietary ROCK® platform generating innovative innate cell engagers (ICE®) for targeted tumor therapy [11][12]

Core Insights - The U.S. FDA has granted RMAT designation to Affimed's combination therapy of acimtamig and Artiva's AlloNK for treating relapsed or refractory Hodgkin Lymphoma, based on early efficacy data showing an 83.3% overall response rate and a 50% complete response rate [1][3][2] Group 1: Regulatory Milestone - RMAT designation aims to expedite the development and review of regenerative medicine therapies, providing benefits similar to Breakthrough Therapy Designation, specifically for regenerative medicine products [2] - This designation allows Affimed enhanced access to FDA resources, potentially leading to accelerated approval and priority review, which could significantly reduce the time to market for the combination therapy [2] Group 2: Clinical Data and Efficacy - Early efficacy data from the LuminICE-203 trial indicated an overall response rate of 83.3% (10 out of 12 patients) and a complete response rate of 50% (6 out of 12 patients), with a well-managed safety profile [1][3] - Data from all cohorts of the LuminICE-203 trial will be presented at the 66th ASH Annual Meeting on December 8, 2024 [3] Group 3: Broader Applications - The combination therapy has potential applicability in other CD30 positive lymphomas, such as peripheral T-cell lymphoma, which is resistant to conventional therapies and has a high risk of relapse [4] - Establishing clinical proof-of-concept in peripheral T-cell lymphoma could enhance the commercial potential of the combination therapy significantly [4] Group 4: Product Information - Acimtamig (AFM13) is a first-in-class innate cell engager designed to activate the innate immune system to target and destroy CD30-positive hematologic tumors [5] - The LuminICE-203 trial is a Phase 2 open-label, multicenter, multi-cohort study evaluating the safety and efficacy of acimtamig in combination with Artiva's AlloNK in patients with relapsed/refractory classical Hodgkin lymphoma and CD30-positive peripheral T-cell lymphoma [6]