• AFM24-101 phase 1/2 results in 10 patients from the non-small cell lung cancer (NSCLC) cohort demonstrated clinical activity and a well-managed safety profile in heavily pretreated patients with EGFR mutant NSCLC; updated interim analysis data of 15 patients from the NSCLC cohort will be presented at ASCO on June 3, 2023
  
• AFM24-101 phase 1/2 interim results from the colorectal cancer (CRC) cohort show AFM24 was well tolerated in heavily pretreated patients with EGFR positive CRC
• Company to host a conference call / webcast on June 3, 2023 to discuss updated results with a later cutoff date and provide a strategic update on AFM24
  

HEIDELBERG, Germany, May 25, 2023 (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, today announced the publication of two abstracts with its innate cell engager (ICE^®) AFM24 in advance of the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place on June 2 - 6, 2023 in Chicago, IL.

As of the December cut-off data for the abstract, 14 patients were enrolled in the EGFR mutant NSCLC cohort and the best objective response in 10 evaluable patients was a confirmed partial response in 1 patient (change from baseline -45%); 4 patients exhibited stable disease of which two had tumor shrinkage. AFM24 exhibited a well-managed safety profile and the most common treatment-related adverse events (TRAE) observed were mild to moderate infusion-related reactions (IRRs).

Updated data with a cut-off date of mid-April 2023 will be presented by Dr. Anthony El-Khoueiry, Associate Director of Clinical Research at USC Norris Comprehensive Cancer Center, at ASCO on June 3, 2023 during the poster session on Developmental Therapeutics – Immunotherapy (8:00 - 11:00 a.m. CDT). Dr. El-Khoueiry’s presentation will include data from 15 evaluable patients.

“The data we are generating in this study and our ongoing combination studies will guide our decisions in identifying the right indications and treatment regimens in which AFM24 can provide the most value for patients. We are encouraged to see clinical activity with AFM24 monotherapy in highly advanced NSCLC patients who have failed prior lines of therapy,” said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. “These data show that our mechanism of targeting NK cells is biologically relevant in the quest to find innovative treatment strategies for patients suffering from difficult to treat solid tumors. We look forward to providing an update on our strategic development plan for AFM24 at ASCO.”

As of the December cut-off date, 16 patients with Stage 4 CRC were enrolled and treated with AFM24 with a median treatment duration of 5.1 weeks. No objective responses were observed. Seven patients remained on treatment as of the cut-off date, including 1 patient with confirmed stable disease ongoing for 5 months exhibiting a tumor reduction of 17%. Treatment was adequately tolerated with IRRs being the most common TRAEs.

Conference Call and Webcast Information
Affimed will host a conference call and webcast on June 3, 2023, at 6:00 p.m. CDT / 7:00 EDT to review the monotherapy data and provide a strategic update on the AFM24 program going forward.

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/BIca5147f060da49d5963a0b00a7bc8a66, 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.

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 are investigating AFM24 in combination with NKGen Biotech’s NK cell SNK01 in a phase 1/2a study (AFM24-103, 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: 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