Affimed Announces Acimtamig as International Nonproprietary Name for AFM13

Rhea-AI Summary

Affimed N.V. (Nasdaq: AFMD) announced that the World Health Organization has selected 'acimtamig' as the nonproprietary name for the Company’s investigational drug for CD30-positive Lymphomas, previously known as AFM13. Acimtamig (AFM13) is currently being evaluated in combination with AlloNK® in patients with relapsed or refractory Hodgkin Lymphoma in LuminICE-203, a phase 2 study. The therapy was granted fast track designation by the FDA, aiming to treat serious conditions and fill an unmet medical need.

MANNHEIM, Germany, Nov. 09, 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 that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) has selected "acimtamig" for the nonproprietary name of the Company’s investigational drug for CD30-positive Lymphomas, previously known as AFM13. Following the WHO nomenclature scheme, the name recognizes the drug as a tumor targeting bispecific antibody.

Acimtamig (AFM13) is currently being evaluated in combination with AlloNK^® (formerly AB-101) natural killer (NK) cells in patients with relapsed or refractory (r/r) Hodgkin Lymphoma in LuminICE-203, a phase 2, open-label, multi-center study (NCT05883449); the study also includes an exploratory cohort of CD30-positive peripheral T-cell lymphoma patients (PTCL). Acimtamig and AlloNK^® therapy was recently granted fast track designation by the FDA, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

“Selection of the INN acimtamig by the WHO is an important milestone in the clinical development of AFM13 with initiation of the LuminICE-203 study underway,” said Dr. Adi Hoess, Chief Executive Officer at Affimed. “It adds to the momentum of the fast track designation awarded by the FDA earlier this year to the acimtamig and AlloNK^® combination. We look forward to reporting the first data from the LuminICE-203 study in the first half of 2024 and to bringing this important therapy to patients with high unmet needs.”

About Acimtamig (AFM13)
Acimtamig is a first-in-class ICE^® that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. Acimtamig 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. Acimtamig is a tetravalent bispecific innate cell engager designed to act 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 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 Mannheim, 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 Statement
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 is the new nonproprietary name for Affimed N.V.'s investigational drug for CD30-positive Lymphomas?

The new nonproprietary name for the drug is 'acimtamig', previously known as AFM13.

What study is acimtamig (AFM13) currently being evaluated in?

Acimtamig (AFM13) is currently being evaluated in LuminICE-203, a phase 2 study in patients with relapsed or refractory Hodgkin Lymphoma.

What designation was recently granted to the acimtamig and AlloNK® therapy by the FDA?

The therapy was granted fast track designation by the FDA, aiming to treat serious conditions and fill an unmet medical need.

When is the first data from the LuminICE-203 study expected to be reported?

The first data from the LuminICE-203 study is expected to be reported in the first half of 2024.