A Phase 2, Open-Label, Multi-Center Study of Innate Cell Engager AFM13 in Combination with Allogeneic Natural Killer Cells (AB-101) in Subjects with Recurrent or Refractory Hodgkin Lymphoma and CD-30 Positive Peripheral T-Cell Lymphoma

AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL.

Start Date10 Oct 2023

Sponsor / Collaborator

Affimed GmbH

[+1]

NCT05817058

/ RecruitingPhase 1

A Phase 1 Multicenter, Open Label, First-in-Human Dose Escalation Study of AFM28, a Bispecific ICE® That Targets CD123 and CD16A, in Patients With CD123-Positive Relapsed/Refractory Acute Myeloid Leukemia

This study is a First In Human, phase 1, open-label, non-randomized, multi-center, multiple ascending dose escalation study evaluating AFM28 as a monotherapy in subjects with Relapsed/Refractory CD123-positive Acute Myeloid Leukemia (AML). AFM28 is a tetravalent monoclonal antibody targeting the interleukin-3 receptor subunit alpha (IL3RA, CD123) and the low affinity immunoglobulin gamma Fc region receptor III-A (FCGR3A, CD16A). It is developed as an antineoplastic agent for hematologic malignancies known to express CD123. The primary pharmacological Mode of Action of AFM28 is induction of cell death of CD123-expressing cells by stimulating Antibody-Dependent Cell-mediated Cytotoxicity mediated by CD16A-expressing immune cells, primarily Natural Killer cells. The aim of the dose escalation is to determine the Maximum Tolerated Dose (MTD) and/or establish one or more Recommended Phase 2 Doses, based on safety, preliminary anti-leukemic activity and Pharmacokinetics / Pharmacodynamics data.

Start Date21 Mar 2023

Sponsor / Collaborator

Affimed GmbH

EUCTR2019-003296-19-DE

/ Unknown statusPhase 1/2

A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients with Advanced Solid Cancers

Start Date03 May 2022

Sponsor / Collaborator

Affimed GmbH

100 Clinical Results associated with Affimed GmbH

0 Patents (Medical) associated with Affimed GmbH

Literatures (Medical) associated with Affimed GmbH

06 Jan 2025·CLINICAL CANCER RESEARCH

A Phase II Study of Acimtamig (AFM13) in Patients with CD30-Positive, Relapsed, or Refractory Peripheral T-cell Lymphomas

Article

Author: Alexis, Karenza ; Mikhailova, Natalia ; Shortt, Jake ; Zinzani, Pier Luigi ; Horwitz, Steven ; Garcia, Linta ; Ravenstijn, Paulien ; Radeski, Dejan ; Hajela, Pallavi ; Elbadri, Riham ; Emig, Michael ; Pietzko, Kerstin ; Ribrag, Vincent ; Domingo Domenech, Eva ; Sawas, Ahmed ; Pinto, Sheena ; Kim, Won Seog ; Overesch, Andre

Abstract:

Purpose::

Patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) generally have poor prognoses and limited treatment options. This study evaluated the efficacy of a novel CD30/CD16A bispecific innate cell engager, acimtamig (AFM13), in patients with R/R PTCL.

Patients and Methods::

Patients included those with CD30 expression in ≥1% of tumor cells and who were R/R following ≥1 prior line of systemic therapy. Acimtamig (200 mg) was administered once weekly in 8-week cycles. The primary endpoint was the overall response rate by fluorodeoxyglucose-PET per independent review committee; secondary and exploratory endpoints included duration of response, safety, progression-free survival, and overall survival.

Results::

The overall response rate in 108 patients was 32.4% [95% confidence interval (CI), 23.7, 42.1] with a complete response rate of 10.2% (95% CI, 5.2, 17.5); the median duration of response was 2.3 months (95% CI, 1.9, 6.5). Patients with R/R angioimmunoblastic T-cell lymphoma exhibited the greatest number of responses [53.3% (95% CI, 34.3, 71.7)]. Responses were independent of CD30 expression level, prior brentuximab vedotin treatment, or steroid premedication. Acimtamig exhibited a tolerable safety profile; the most common treatment-related adverse events were infusion-related reactions in 27 patients (25.0%) and neutropenia in 11 patients (10.2%). No cases of cytokine release syndrome or acimtamig-related deaths were reported. Despite exhibiting promising clinical activity and tolerable safety in a heavily pretreated PTCL population, the study did not meet the criteria for the primary endpoint.

Conclusions::

The promising clinical efficacy observed warrants further investigation, and development of acimtamig for patients with R/R CD30+ lymphomas continues in combination with allogeneic NK cells.

31 Dec 2023·mAbs

Selection of bispecific antibodies with optimal developability using FcRn‑pH‑HPLC as an optimized FcRn affinity chromatography method

Article

Author: Tasser, Carolin ; Ellwanger, Kristina ; Koch, Joachim ; Müller, Thomas ; Tesar, Michael ; Schniegler-Mattox, Ute ; Fucek, Ivica

A challenge when developing therapeutic antibodies is the identification of candidates with favorable pharmacokinetics (PK) early in development. A key determinant of immunoglobulin (IgG) serum half‑life in vivo is the efficiency of pH-dependent binding to the neonatal Fc receptor (FcRn). Numerous studies have proposed techniques to assess FcRn binding of IgG-based therapeutics in vitro, enabling prediction of serum half-life prior to clinical assessment. FcRn high-performance liquid chromatography (HPLC) assays FcRn binding of therapeutic IgGs across a pH gradient, allowing the correlation of IgG column retention time to the half‑life of a therapeutic IgG in vivo. However, as FcRn retention time cannot be directly compared to an in vivo parameter, modifications to FcRn-HPLC are required to enable interpretation of the data within a physiological context, to provide more accurate estimations of serum half-life. This study presents an important modification to this method, FcRn-pH-HPLC, which reproducibly measures FcRn dissociation pH, allowing correlation with previously established half-lives of therapeutic antibodies. Furthermore, the influence of incorporating various antibody modifications, binding modules, and their orientations within IgGs and bispecifics on FcRn dissociation pH was evaluated using antibodies from the redirected optimized cell killing (ROCK®) platform. Target and effector antigen-binding domain sequences, their presentation format and orientation within a bispecific antibody alter FcRn retention; tested Fc domain modifications and incorporating stabilizing disulfide bonds had minimal effect. This study may inform the generation of mono-, bi- and multi-specific antibodies with tailored half-lives based on FcRn binding properties in vitro, to differentiate antibody-based therapeutic candidates with optimal developability.

01 Nov 2022·Trends in immunology

Reimagining antibody-dependent cellular cytotoxicity in cancer: the potential of natural killer cell engagers

Review

Author: Carter, Paul J ; Schottelius, Arndt ; Pinto, Sheena ; Koch, Joachim ; Pahl, Jens

Bi-, tri- and multispecific antibodies have enabled the development of targeted cancer immunotherapies redirecting immune effector cells to eliminate malignantly transformed cells. These antibodies allow for simultaneous binding of surface antigens on malignant cells and activating receptors on innate immune cells, such as natural killer (NK) cells, macrophages, and neutrophils. Significant progress with such antibodies has been achieved, particularly in hematological malignancies. Nevertheless, several major challenges remain, including increasing their immunotherapeutic efficacy in a greater proportion of patients, particularly in those harboring solid tumors, and overcoming dose-limiting toxicities and immunogenicity. Here, we discuss novel antibody-engineering developments designed to maximize the potential of NK cells by NK cell engagers mediating antibody-dependent cellular cytotoxicity (ADCC), thereby expanding the armamentarium for cancer immunotherapy.

News (Medical) associated with Affimed GmbH

06 Nov 2024

·www.globenewswire.com

Affimed to Report Third Quarter 2024 Financial Results & Corporate Update on November 14, 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. 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/BIb9251d6bc6504a4da37a53cdb1b0ac94, 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 a 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 RelationsAlexander FudukidisDirector, Head of Investor RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102

Financial StatementImmunotherapy

10 Sep 2024

·www.globenewswire.com

Affimed to Present at the Cantor Global Healthcare Conference 2024

MANNHEIM, Germany, Sept. 10, 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 its Chief Executive Officer, Shawn M. Leland, PharmD, RPh, will participate in a fireside chat at the Cantor Global Healthcare Conference 2024 on Tuesday, September 17, 2024 at 8:00 a.m. Eastern Daylight Time / 14:00 Central European Time. A live webcast of the presentation will be accessible on Affimed’s website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/. A replay of the call will be archived on Affimed’s website for 30 days after the call. For more information on the conference or to schedule a one-on-one meeting with Affimed’s management, please contact your Cantor Fitzgerald representative or Alex Fudukidis via email at a.fudukidis@affimed.com or phone at +1 (917) 436-8102. 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 a 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

29 Aug 2024

·www.globenewswire.com

Affimed to Report Second Quarter 2024 Financial Results & Corporate Update on September 5, 2024

MANNHEIM, Germany, Aug. 29, 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 second quarter 2024 results and corporate update on Thursday, September 5, 2024. The Company will host a conference call at 8:30 a.m. EDT / 14:30 CET. 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 linkhttps://register.vevent.com/register/BI53034c7725d043b0854377307e1cd8a3, 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 a 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

Financial StatementImmunotherapy

100 Deals associated with Affimed GmbH

100 Translational Medicine associated with Affimed GmbH

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Pipeline

Pipeline Snapshot as of 25 Apr 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Acimtamig ( CD16a x CD30 )	CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma More	Phase 2
AFM-24 ( CD16a x EGFR )	Advanced Malignant Solid Neoplasm More	Phase 1/2
Atezolizumab ( PDL1 )	Advanced Malignant Solid Neoplasm More	Phase 1/2
Ubilical cord blood derived NK cell therapy (Affimed)	Hodgkin's Lymphoma More	Phase 1/2
AFM-28 ( CD123 x CD16a )	Relapsing acute myeloid leukemia More	Phase 1

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