Affimed Receives FDA Fast Track Designation for AFM13 in Combination with AlloNK® for the Treatment of Patients with Relapsed or Refractory Hodgkin Lymphoma
Wednesday, September 13, 2023
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 FDA has granted fast track designation to the combination of its innate cell engager (ICE®) AFM13 with AlloNK® for the potential treatment of relapsed/refractory (r/r) Hodgkin lymphoma (HL). The combination treatment is entering Phase 2 development and will be investigated in Affimed’s LuminICE-203 study (NCT05883449), which received IND-clearance earlier this year; the study also includes an exploratory cohort of CD30-positive peripheral T-cell lymphoma patients.
“Our clinical data of AFM13 in combination with allogeneic NK cells has shown outstanding efficacy and a well-managed safety profile in late-stage, muti-refractory, patients with r/r Hodgkin and Non-Hodgkin lymphoma,” said Dr. Wolfgang Fischer, Chief Operating Officer at Affimed. “The FDA fast track designation is a testament to the powerful potential our combination approach may deliver for these patients in high need, and we remain committed to working closely with the FDA to expedite development of this important therapy.”
Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. The FDA’s decision is based on available data showing the potential of the AFM13 and AlloNK® combination therapy to overcome current limitations in the treatment of r/r HL. With the Fast Track Designation, the therapeutic development of the combination can benefit from more frequent engagement with the FDA, which will support the collection of appropriate data needed to accelerate its development.
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
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 AlloNK® 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.
Affimed Investor Relations Contact
Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102
Affimed Media Contact
Mary Beth Sandin
Vice President, Marketing and Communications
E-Mail: m.sandin@affimed.com
