Affimed Announces Approval of Clinical Trial Application in France for a Phase 1 Study of AFM28 in Relapsed/Refractory Acute Myeloid Leukemia

Rhea-AI Summary

Affimed N.V. (Nasdaq: AFMD) has received authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM) for a clinical trial application (CTA) for its AFM28 in a phase 1 study targeting relapsed/refractory acute myeloid leukemia (AML). The trial, set to initiate in the first half of 2023, aims to investigate the safety and tolerability of AFM28, a bispecific Innate Cell Engager. This marks a significant milestone in Affimed's strategy to provide viable treatment options for AML patients, addressing a critical need in oncology.

Positive

• Authorization of AFM28 monotherapy for phase 1 study by ANSM.
• Initiation of clinical development on track for the first half of 2023.
• Focus on a critical area of unmet medical need in relapsed/refractory AML.

Negative

• None.

• AFM28 monotherapy receives authorization of a Clinical Trial Application (CTA) for the phase 1 study by the French National Agency for the Safety of Medicines and Health Products (ANSM)
• Initiation of AFM28 clinical development in the first half of 2023 on track

HEIDELBERG, Germany, Dec. 22, 2022 (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 the ANSM has authorized a CTA for the phase 1 study of AFM28 (AFM28-101) in relapsed/refractory acute myeloid leukemia (AML).

“The CTA approval in France is an important milestone in our strategy to develop AFM28 as quickly as possible,” said Dr. Wolfgang Fischer, Chief Operating Officer at Affimed. “AML is one of the worst blood cancers with poor patient prognosis, especially in the relapsed or refractory setting, with no standard-of-care salvage regimen currently available. Given the aggressive nature of the disease, and the desperate need for viable treatment options, it is a high priority for Affimed to advance the clinical development of AFM28 for relapsed/refractory AML patients.”

CTA applications for AFM28-101 in other European jurisdictions are ongoing, and additional applications are planned for submission early in 2023. Additionally, Affimed plans to investigate AFM28 in combination with allogenic natural killer (NK) cell therapy.

About AFM28-101

AFM28-101 is a phase 1 multicenter, open label, first-in-human dose escalation study of AFM28, a bispecific Innate Cell Engager (ICE®) that targets CD123 and CD16A in patients with CD123–positive relapsed/refractory (r/r) acute myeloid leukemia (AML). The study is planned to investigate the safety, tolerability, PK and PD of AFM28 IV monotherapy in patients with CD123-positive r/r AML. The goal of dose escalation is to establish the maximum tolerated dose and/or one or more recommended phase 2 doses to guide clinical development of AFM28 as a monotherapy and/or in combination with other therapeutic approaches, e.g., allogeneic natural killer (NK) cell therapy.

About AFM28

AFM28, a tetravalent bispecific CD123- and CD16A-binding Innate Cell Engager (ICE®) developed on Affimed’s Redirected Optimized Cell Killing (ROCK®) platform, is designed to bring a new immunotherapeutic approach to patients with CD123-positive myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) by engaging natural killer (NK) cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels. Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123-positive leukemias.

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 Redirected Optimized Cell Killing (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 AFM28 and the Company’s other product candidates, the value of its Redirected Optimized Cell Killing (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 trends that may affect the industry or the Company, 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 and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the United States Securities and Exchange Commission. 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
Tel: +1 (484) 888-8195

 

FAQ

What is the purpose of the AFM28 clinical trial?

The AFM28 clinical trial aims to test the safety, tolerability, and pharmacokinetics of AFM28 in patients with relapsed/refractory acute myeloid leukemia (AML).

When will the AFM28 clinical trial start?

The AFM28 clinical trial is scheduled to start in the first half of 2023.

What does AFM28 target in cancer treatment?

AFM28 targets CD123 and CD16A, focusing on treating CD123-positive relapsed/refractory acute myeloid leukemia (AML).

How does AFM28 work in cancer therapy?

AFM28 works by engaging natural killer (NK) cells to initiate tumor cell killing through antibody-dependent cellular cytotoxicity (ADCC).

What are the next steps for Affimed after the CTA approval?

Affimed plans to submit additional CTA applications for AFM28-101 in other European jurisdictions and investigate combinations with allogeneic NK cell therapy.