Affimed GmbH

MANNHEIM, Germany I December 09, 2024 I 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. The study included 29 heavily pretreated R/R AML patients across six AFM28 dose levels. The median number of prior treatment lines was two and 86% of patients had an adverse risk profile according to the 2022 guidelines from the European LeukemiaNet (ELN2022). AFM28 was administered intravenously once a week across six dose levels, ranging from 25 mg to 300 mg. AFM28 was well tolerated, and the most common treatment-emergent adverse events were IRRs, observed in 45% of patients. All IRRs were mild to moderate (Grade 1 or 2). One patient demonstrated grade 1 cytokine release syndrome (CRS). No neurotoxicity or signs for immune-effector related side effects were seen. One of six patients treated at 250 mg showed a CR and stayed on treatment for 6.5 months. At the 300 mg dose level, 1 CR and 3 CRi were seen in 10 evaluable patients for a CRcR of 40%. Four of 10 patients are still on treatment with the option to deepen responses. “Achieving a 40% composite complete remission rate with AFM28 in R/R AML is a significant milestone, especially in this difficult-to-treat patient population. Importantly, we see activity independent of mutational status, including patients with negative prognostic molecular profiles. Safety has been manageable which provides the basis for further development of AFM28 either as single agent or in combination regimens,” said Dr. Andreas Harstrick, MD, Chief Medical Officer at Affimed. The AFM28 Phase 1 study is on-going. About AFM28 AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE ® , is designed to bring our immunotherapeutic approach to patients with acute myeloid leukemia (AML). It engages NK cells to initiate leukemic cell killing via antibody-dependent cellular cytotoxicity, even at low CD123 expression levels. AFM28 is currently in clinical development as monotherapy in patients with R/R AML (NCT05817058). 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 . SOURCE: Affimed

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. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/. To access the call by phone, please use link https://register.vevent.com/register/BI9c2d6fa7af764cb7b550c5ce464ce5cf, and you will be provided with dial-in details and a pin number. Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call. 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 ContactAlexander FudukidisDirector, Head of Investor RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102

The multi-cohort Phase II LuminICE-203 trial is currently evaluating the efficacy and safety of the combo. Credit: PaeGAG/Shutterstock. The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Affimed and Artiva Biotherapeutics’ combination therapy for lymphoma. Involving Artiva’s AlloNK (AB101) and Affimed’s acimtamig (AFM13), an innate cell engager, the combination therapy treats relapsed or refractory Hodgkin’s lymphoma (R/R HL). The multicentre, multi-cohort Phase II LuminICE-203 trial is currently evaluating the safety and efficacy of this combo. Affimed announced encouraging early efficacy data from the first two cohorts of the LuminICE-203 trial, involving 12 subjects, earlier in 2024. The findings demonstrated a well-managed safety profile, an 83.3% overall response rate and a 50% complete response rate. Affimed CEO Dr Shawn Leland said: “This is an important regulatory milestone demonstrating that the FDA acknowledges the critical need for new therapies in R/R HL, in particular for double refractory HL patients where there are no approved therapies. “In addition, the RMAT designation validates the strength of our growing clinical data and the promise of our innovative treatment to bring hope to patients battling this rare and difficult-to-treat cancer.” As a first-in-class ICE, acimtamig activates the innate immune system to destroy CD30-positive hematologic tumours. It works by engaging and activating natural killer cells and macrophages, leading to the selective killing of CD30-positive tumour cells. The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening conditions. It offers benefits similar to a breakthrough therapy designation but is specifically tailored for regenerative medicine products. Affimed gains improved access to FDA resources, including the possibility of accelerated approval and priority review. In August 2023, the FDA approved Artiva’s AlloNK (AB-101) and rituximab combination’s investigational new drug application to treat systemic lupus erythematosus in active lupus nephritis individuals.