Affimed Announces Presentations of Clinical Data from AFM13 Phase 2 REDIRECT and Pre-clinical Data Demonstrating CD16A Shedding Facilitates Repetitive Targeting of Tumor Cells by AFM13-armed NK Cells at the Annual Meeting of the American Association for Cancer Research

Rhea-AI Summary

Affimed N.V. (Nasdaq: AFMD) announced two accepted abstracts for presentation at the AACR Annual Meeting 2023, showcasing the efficacy of AFM13 in treating CD30-positive relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). The oral presentation will detail results from the phase 2 REDIRECT study, demonstrating an objective response rate (ORR) of 32.4% with a duration of response (DOR) of 2.3 months. Additionally, a poster will discuss research on CD16A shedding's role in enhancing natural killer (NK) cell functionality against tumors. Both presentations highlight AFM13's promise in the immuno-oncology field.

Positive

• AFM13 achieved an objective response rate (ORR) of 32.4% in the REDIRECT study.
• The duration of response (DOR) was noted at 2.3 months, indicating promising efficacy in R/R PTCL.

Negative

• None.

• An oral presentation on the safety and efficacy from the AFM13 phase 2 monotherapy clinical study (“REDIRECT”) in patients with CD30-positive relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL)
  
• A poster presentation from the collaboration with Prof. Björn Önfelt at the KTH Royal Institute of Technology and Karolinska Institute in Stockholm with findings from the study investigating the impact of CD16A shedding on the potential to facilitate serial killing of tumor cells by AFM13-armed NK cells

HEIDELBERG, Germany, March 14, 2023 (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 that two abstracts with clinical and preclinical data on AFM13, its anti-CD30 targeting innate cell engager (ICE^®), have been accepted for presentation at the Annual Meeting of the American Association for Cancer Research (AACR), taking place April 14-19, 2022 in Orlando, Florida.

An oral presentation will show detailed results from the AFM13 REDIRECT study evaluating the treatment of patients with CD30-positive relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL). In addition, a poster presentation will highlight results from the collaboration study with Prof. Björn Önfelt, further elucidating AFM13’s mechanism of action.

Oral presentation details:

Title: A phase 2 study of AFM13 in patients with CD30-positive relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL).
Presentation: CT003
Authors: Won Seog Kim, Jake Shortt, Pier Luigi Zinzani, Natalya Mikhaylova, Ana Marin-Niebla, Dejan Radeski, Vincent Ribrag, Eva Domingo Domenech, Ahmed Sawas, Karenza Alexis, Michael Emig, Linta Garcia, Andre Overesch, Kerstin Pietzko, Steven Horwitz.

Session Category and Title: Novel Clinical Trials for Hematological Malignancies
Session Date and Time: Sunday April 16, 2023, 3:00 PM - 5:00 PM ET
Abstract Presentation Number: CT024

The full abstract will be released at 1:00 PM ET on Friday, April 14, 2023.

Poster details:

Title: CD16A shedding facilitates repetitive targeting of tumor cells by AFM13-armed NK cells
Authors: Chiara Zambarda, Karolin Guldevall, Damien Toullec, Susanne Wingert, Christian Breunig, Sheena Pinto, Jacopo Fontana, Joachim Koch, Björn Önfelt.
Session Category and Title: Immunology; Therapeutic Antibodies 2
Session Date and Time: Monday April 17, 2023 1:30 PM - 5:00 PM
Location: Poster Section 23
Poster Board Number: 28
Published Abstract Number: 2950

Antibody-Dependent Cellular Cytotoxicity (ADCC) is a powerful mechanism of Natural Killer (NK) cells to kill antibody-opsonized target cells. However, ADCC mediated by conventional antibodies has its limitations in killing of tumor cells commonly being characterized by low tumor antigen expression.

The collaboration study with Prof. Önfelt investigated whether ICE^® molecules can induce effective ADCC while maintaining the natural function of CD16A with a particular focus on preserved CD16A shedding.

The study showed that a single cell armed with AFM13, a CD16A/CD30 targeting ICE^®, induces stronger ADCC of NK cells towards CD30-positive target cells when compared to anti-CD30 antibodies. This stronger response was reached through increasing both the overall number of cytotoxic NK cells and the fraction of NK serial killers i.e., NK cells performing three or more kills in sequence, including cells expressing low levels of CD30.

More details about the programs for the AACR Virtual Annual Meetings are available online at AACR Annual Meeting 2023 | Meetings | AACR.              

About AFM13                                                                                                                                                                                            

AFM13 is a first-in-class tetravalent bispecific innate cell engager (ICE^®) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE^® clinical program and was evaluated as monotherapy in a phase 2 trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT). Additional details can be found at www.clinicaltrials.gov (NCT04101331). The study achieved an ORR of 32.4% demonstrating anti-tumor activity with a DOR of 2.3 months and a well-managed safety profile. AFM13 acts as a bridge between the innate immune cells and the tumor creating the necessary proximity for the innate immune cells to specifically destroy the tumor cells.

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to give patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The company’s proprietary ROCK^® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK^® platform predictably generates customized innate cell engager (ICE^®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE^®. Headquartered in Heidelberg, Germany, with offices in New York, NY, 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 Contact

Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102

Media Contact

Mary Beth Sandin
Vice President, Marketing and Communications
E-Mail: m.sandin@affimed.com
Tel.: +1 (484) 888-8195

FAQ

What are the results of the AFM13 clinical study presented by Affimed at the AACR Annual Meeting 2023?

The AFM13 REDIRECT study showed an objective response rate (ORR) of 32.4% in patients with CD30-positive relapsed or refractory peripheral T-cell lymphoma, with a duration of response (DOR) of 2.3 months.

When is the oral presentation of the AFM13 clinical study at the AACR Annual Meeting?

The oral presentation is scheduled for April 16, 2023, from 3:00 PM to 5:00 PM ET.

What significant findings will be discussed in the poster presentation at the AACR Annual Meeting 2023?

The poster presentation will explore the impact of CD16A shedding on enhancing NK cell-mediated tumor cell killing.

What is the focus of Affimed's AFM13 immunotherapy?

AFM13 targets CD30-positive hematologic tumors, activating the innate immune system to destroy cancer cells.