Affimed Announces AFM24 Clinical Abstracts Accepted for the Annual Meeting of the American Society of Clinical Oncology (ASCO)

Rhea-AI Summary

Affimed N.V. (Nasdaq: AFMD) announced that interim results from its phase 1/2 study of AFM24 have been accepted for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2023. The study includes a non-small cell lung cancer (NSCLC) cohort with a poster session on June 3, and results from a colorectal cancer (CRC) cohort accepted for online publication. AFM24 is a bispecific innate cell engager designed to activate the innate immune system against tumors, leveraging its unique mechanism to bind CD16A on immune cells and EGFR on cancer cells. The full abstracts will be available on May 26, 2023. This innovative treatment is being evaluated both as a monotherapy and in combination with other therapies.

Positive

• Interim results from AFM24-101 phase 1/2 study accepted for ASCO presentation, indicating recognition in the oncology field.
• AFM24 shows a novel mechanism by targeting CD16A and EGFR, potentially enhancing treatment efficacy.

Negative

• No specific clinical results or data provided to demonstrate treatment efficacy or safety, creating uncertainty for investors.

• AFM24-101 phase 1/2 interim results from the non-small cell lung cancer cohort accepted for poster presentation
  
  
• AFM24-101 phase1/2 interim results from the colorectal cancer cohort accepted for online publication
  

HEIDELBERG, Germany, April 26, 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 its innate cell engager (ICE®) AFM24 have been accepted for the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2 - 6, 2023 in Chicago, IL.

NSCLC Abstract and Presentation Details:

Title: Leveraging innate immunity with AFM24, a novel CD16A and epidermal growth factor receptor (EGFR) bispecific innate cell engager: Interim results for the non-small cell lung cancer (NSCLC) cohort

Authors: Anthony B. El-Khoueiry, Delcia Rivas, Se Hoon Lee, Jacob Stephen Thomas, Yu Jung Kim, Andrés Cervantes, Omar Saavedra Santa Gadea, Byoung Yong Shim, Laura Kohlhas, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada

Poster presentation session: Developmental Therapeutics—Immunotherapy, June 3, 2023, 8:00 AM-11:00 AM CDT

Abstract Number for Publication: 2533

CRC Abstract Details:

Title: Investigating the novel CD16A and epidermal growth factor receptor (EGFR) bispecific innate cell engager, AFM24, to leverage the innate immune system: Interim results from the colorectal cancer (CRC) cohort

Authors: Andrés Cervantes, Delcia Rivas, Se Hoon Lee, Jacob Stephen Thomas, Yu Jung Kim, Omar Saavedra Santa Gadea, Byoung-Yong Shim, Laura Kohlhas, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada, Anthony B. El-Khoueiry

Abstract Number for Publication: e14508

The full abstracts will become public at 5:00 p.m. EDT on Friday, May 26. More details about the programs for the ASCO Annual Meetings are available online at www.asco.org.

About AFM24

AFM24 is a tetravalent, bispecific innate cell engager (ICE®) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

Affimed is evaluating AFM24 as monotherapy and in combinations with other cancer treatments in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

AFM24-101, a monotherapy, first-in-human phase 1/2a open-label, is a non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional details may be found at www.clinicaltrials.gov using the identifier NCT04259450.

AFM24 is also being evaluated in a phase 1/2a study in combination with Roche’s PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442).

Furthermore, Affimed and NKGen Biotech initiated a phase 1/2a study (AFM24-103), investigating AFM24 in combination with NKGen Biotech’s NK cell SNK01 (NCT05099549).

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 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.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AB-101 and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

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

FAQ

What are the interim results of AFM24-101 presented by Affimed at ASCO 2023?

The interim results from the AFM24-101 phase 1/2 study for non-small cell lung cancer were accepted for a poster presentation at ASCO 2023.

When will the AFM24 colorectal cancer results be available?

The results from the colorectal cancer cohort will be published online on May 26, 2023.

What is AFM24's mechanism of action?

AFM24 is a bispecific innate cell engager that binds to CD16A on innate immune cells and EGFR on tumor cells, activating the immune response.

What is the significance of the ASCO Annual Meeting for Affimed and AFM24?

The acceptance of AFM24's results for presentation at ASCO signifies validation of the clinical research and potential interest from the oncology community.

Is Affimed evaluating AFM24 in combination with other therapies?

Yes, Affimed is assessing AFM24 both as a monotherapy and in combination with other cancer treatments.