A number of clinical and preclinical programs are in development featuring our tetravalent bispecific ICE® (innate cell engager) molecules based on the ROCK® (Redirected Optimized Cell Killing) platform, and have already shown a favorable safety profile and promising signs of therapeutic efficacy.

AFM13 is a first-in-class ICE® molecule that has the potential to deliver clinically meaningful benefits to patients with CD30+ lymphomas.1

AFM24 is an EGFR-binding ICE® molecule that kills EGFR-expressing tumors, and through ADCC and ADCP, holds promise to treat all patient subtypes with a more acceptable safety profile compared with current advanced treatments, while remaining immune to the challenge of resistance.2

AFM28 is an ICE® that binds to CD123 on leukemic cells and is being developed for patients with relapsed and refractory acute myeloid leukemia (AML).

Expanding our pipeline is the Affivant-partnered AFVT-2101 (formally AFM32), a Genentech-partnered ICE® molecule, and several ICE® + NK-cell combinations.

Innate Cell Engagers

Pre-Clinical
Phase 1
Phase 2
Additional Information
Disease Target CD30

AFM13-202 MONOTHERAPY

Peripheral T cell lymphoma
Phase 2b
Completed

AFM13-203 + ADOPTIVE NK CELLS

CD30-positive lymphoma
Pre-Clinical
Collaboration with

AFM13-104 + ADOPTIVE NK CELLS

CD30-positive lymphoma
Phase 1/2a
Ongoing

AFM13-103 + ANTI-PD-1

Hodgkin lymphoma (post BV)
Phase 1b
Completed
Disease Target EGFR

AFM24-101 MONOTHERAPY

Multiple EGFR+ solid tumors
Phase 1/2a
Active, Not Recruiting

AFM24-102 + ANTI-PD-L1

Multiple EGFR+ solid tumors
Phase 1/2a
Ongoing

AFM24-103 + ADOPTIVE NK CELLS

Multiple EGFR+ solid tumors
Phase 1/2a
Active, Not Recruiting
Disease Target CD123

AFM28-101 MONOTHERAPY

Acute Myeloid Leukemia (AML)
Phase 1
Ongoing

AFM28 + ADOPTIVE NK CELLS

Acute Myeloid Leukemia (AML)
Pre-Clinical
Pre-IND
Disease Target FRα

AFVT-2101 (AFM32) - AFFIVANT

Solid tumors
Pre-Clinical
Pre-IND, Partnered with
Disease Target Undisclosed

Novel ICE® - GENENTECH

Multiple indications (not disclosed)
Pre-Clinical
Pre-IND, Partnered with
Disease Target Undisclosed

Novel ICE®

Multiple indications (not disclosed)
Pre-Clinical
Pre-IND
BV = brentuximab vedotin
CD = cluster of differentation
EGFR = epidermal growth factor receptor
FRα = Folate receptor alpha
ICE® = innate cell engager
IND = investigational new drug
NK = natural killer
PD-1 = programmed death protein1
PD-L1 = programmed death ligand 1
Affimed programs
Partnered programs
List is not exhaustive

Expanded Access Policy

Affimed does not currently have an expanded access program for our investigational products. Expanded access, also known as compassionate use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease to gain access to an investigational drug for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
We are focused on enrolling and conducting the clinical trials necessary to bring innovative, safe, and effective products to patients as quickly as possible. Participation in one of our clinical trials is the only way to access Affimed’s investigational products at this time. We encourage patients and healthcare providers interested in our investigational products to learn more about our ongoing studies by visiting Affimed Clinical Studies on our website. For more information, please contact us at info@affimed.com

Our clinical trials

Selected posters and publications


Hematological Malignancies

  • Bartlett et al., ASH 2018: A Phase 1 Study Investigating the Combination of AFM13 and the Monoclonal Anti-PD-1 Antibody Pembrolizumab in Patients with Relapsed/Refractory Hodgkin Lymphoma after Brentuximab Vedotin Failure: Updated Safety and Efficacy Data. View poster
  • Bartlett et al., Blood. A phase 1b study of AFM13 in combination with pembrolizumab in patients with relapsed or refractory Hodgkin lymphoma. Please see: Blood. 2020;136:2401-2409.
  • Kerbauy et al., Clin Cancer Res. Combining AFM13, a Bispecific CD30/CD16 Antibody, with Cytokine-Activated Blood and Cord Blood-Derived NK Cells Facilitates CAR-like Responses Against CD30+ Malignancies. Please see: Clin Cancer Res. 2021;27:3744-3756.
  • Sawas et al., 15-ICML 2019: Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma with Cutaneous Presentation: A Biomarker Phase Ib/IIa Study (NCT03192202). View poster
  • Oral Presentation: Ansell et al., ICML 2019: Final Results from a Phase 1b Dose Escalation Study to Assess the Safety of AFM13 in Combination with Pembrolizumab in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (AFM13-103). View poster
  • Marin et al., ASH 2018: The CD30/CD16A bispecific innate immune cell engager AFM13 elicits heterogeneous single-cell NK cell responses and effectively triggers memory like (ML) NK cells. View poster


Solid Tumors

  • Wingert et al., MAbs. Preclinical evaluation of AFM24, a novel CD16A-specific innate immune cell engager targeting EGFR-positive tumors. Please see: MAbs. 2021;13:1950264.
  • Pahl et al., AACR 2021: AFM24 is a novel, highly potent, tetravalent bispecific EGFR/CD16A-targeting Innate Cell Engager (ICE®) designed for the treatment of EGFR-positive malignancies. View poster
  • Reusch et al., AACR 2020: AFM24, a bispecific EGFR/CD16A Innate Cell Engager with the potential to overcome resistance to current targeted treatments for EGFR-positive malignancies. View poster
  • Kluge et al., AACR 2018: Preclinical Characterization of the Bispecific EGFR/CD16A Innate Immune Cell Engager AFM24 for the Treatment of EGFR-Expressing Solid Tumors. View poster


ICE® Molecules: Mechanism of Action

  • Wingert et al., ASH 2018: CD16A-Specific Tetravalent Bispecific Immuno-Engagers Potently Induce Antibody-Dependent Cellular Phagocytosis (ADCP) by Macrophages. View poster


ROCK® Platform

  • Ellwanger et al., MAbs. Redirected optimized cell killing (ROCK®): A highly versatile multispecific fit-for-purpose antibody platform for engaging innate immunity. Please see: MAbs. 2019;11:899-918.


See all Publications and Posters

ADCC=antibody-dependent cellular cytotoxicity; ADCP=antibody-dependent cellular phagocytosis; EGFR=epidermal growth factor receptor; IND=investigational new drug; NK=natural killer.

References: 1. Rothe A, Sasse S, Topp MS, et al. A phase 1 study of the bispecific anti-CD30/CD16A antibody construct AFM13 in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2015;125(26):4024-4031. 2. Reusch U, Damrat M, Wingert S, et al. AFM24, a bispecific EGFR/CD16A innate cell engager with the potential to overcome resistance to current targeted treatments for EGFR-positive malignancies. Poster presented at: American Association for Cancer Research (AACR) Annual Meeting; June 22-24, 2020; Virtual. Poster 5659.