Affimed Announces Acimtamig and AlloNK® Combination Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the U.S. Food and Drug Administration (FDA)
Rhea-AI Summary
Affimed (NASDAQ: AFMD) announces FDA's RMAT designation for its combination therapy of acimtamig and AlloNK® for treating relapsed/refractory Hodgkin Lymphoma (R/R HL). The designation was granted based on impressive early efficacy data showing an 83.3% overall response rate and 50% complete response rate in 12 patients, with a well-managed safety profile.
The RMAT designation provides expedited review benefits similar to Breakthrough Therapy Designation, potentially accelerating the therapy's path to market. The combination therapy is currently being evaluated in the LuminICE-203 phase 2 trial, with complete data from all four cohorts to be presented at the 66th ASH Annual Meeting. The company also sees potential application in CD30 positive lymphomas, including peripheral T-cell lymphoma (PTCL).
Positive
- Achieved 83.3% overall response rate and 50% complete response rate in early trials
- Received RMAT designation, enabling expedited FDA review and potential accelerated approval
- Potential expansion into PTCL market could increase commercial opportunity 2-3x
- Well-managed safety profile in clinical trials
Negative
- Still in phase 2 trials, requiring further clinical validation
- patient data (only 12 patients) in current efficacy results
Insights
The FDA's RMAT designation for acimtamig + AlloNK® combination represents a significant regulatory milestone for Affimed. The impressive efficacy data showing an
The RMAT designation provides substantial benefits including expedited review and potential accelerated approval pathways, which could significantly reduce time-to-market. The expansion potential into CD30-positive peripheral T-cell lymphoma could increase the addressable market by 2-3x, representing a major commercial opportunity beyond the initial Hodgkin Lymphoma indication.
This regulatory milestone is particularly significant for Affimed given its current market cap of just
The strong early efficacy data in a difficult-to-treat patient population with no approved therapies positions Affimed well for potential partnerships or licensing deals. The expedited regulatory pathway could also reduce development costs and time to market, improving the company's cash runway and strategic options.
Designation was based on early efficacy data demonstrating an
MANNHEIM, Germany, Dec. 05, 2024 (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 U.S. FDA has granted RMAT designation to the combination therapy of Affimed’s innate cell engager (ICE®) acimtamig and Artiva Biotherapeutic’s AlloNK® (AB101) for the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL). The combination is being evaluated in the on-going LuminICE-203 multicenter, multi-cohort phase 2 trial.
RMAT designation is intended to expedite the development and review of regenerative medicine therapies, including cell therapies, that aim to address serious or life-threatening conditions. RMAT designation provides the same expedited review benefits as a Breakthrough Therapy Designation, but is exclusively focused on regenerative medicine products. This designation provides Affimed enhanced access to FDA resources including the potential for accelerated approval and priority review. These benefits could significantly reduce the time required to deliver the acimtamig and AlloNK® combination to R/R HL patients in need.
“This is an important regulatory milestone demonstrating that the FDA acknowledges the critical need for new therapies in R/R HL, in particular for double refractory HL patients where there are no approved therapies,” said Dr. Shawn M. Leland, PharmD, RPh, Chief Executive Officer of Affimed. “In addition, the RMAT designation validates the strength of our growing clinical data and the promise of our innovative treatment to bring hope to patients battling this rare and difficult-to-treat cancer.”
Earlier this year, Affimed reported promising early efficacy data from cohorts 1 and 2 (12 patients) of the LuminICE-203 trial. The data showed an overall response rate (ORR) of
This promising combination has applicability not only in HL, but also in other CD30 positive lymphomas such as peripheral T-cell lymphoma (PTCL), which can also be resistant to conventional therapies, has a high risk of relapse, and where few products are approved. Generating clinical proof-of-concept in PTCL would also highlight a potential path to increasing the commercial potential of the combination by two to three-fold in comparison to the number of patients with double-refractory HL.
About Acimtamig
Acimtamig (AFM13) 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 destroy the tumor cells.
About LuminICE-203 (AFM13-203)
LuminICE-203 (AFM13-203) is a Phase 2 open-label, multicenter, multi-cohort study. The trial is evaluating the safety and efficacy of the combination of acimtamig (AFM13) with Artiva Biotherapeutics’ allogeneic NK cell AlloNK® (AB-101) in patients with relapsed/refractory classical Hodgkin lymphoma and CD30-positive peripheral T cell lymphoma (NCT05883449).
The study builds on the unprecedented efficacy results from an investigator sponsored study, AFM13-104, which investigated acimtamig in combination with cord blood-derived NK cells in patients with refractory/recurrent CD30-positive Hodgkin or non-Hodgkin lymphoma (NCT04074746).
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 innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the 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 acimtamig (AFM13), AFM24, AFM28 and the Company’s other product candidates; the value of its ROCK® platform; its ongoing and planned clinical trials; its corporate restructuring, the associated headcount reduction and the impact this may have on Company’s anticipated savings and total costs and expenses; 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 acimtamig in combination with NK cell therapy is based on acimtamig 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.
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
FAQ
What are the response rates for Affimed's acimtamig and AlloNK combination therapy in R/R HL patients?
What is the significance of RMAT designation for AFMD's combination therapy?
What additional indications is Affimed (AFMD) targeting with the acimtamig and AlloNK combination?
