Affimed Announces Acimtamig and AlloNK® Combination Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the U.S. Food and Drug Administration (FDA)
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).
Affimed (NASDAQ: AFMD) annuncia la designazione RMAT da parte della FDA per la sua terapia combinata di acimtamig e AlloNK® per il trattamento del linfoma di Hodgkin recidivante/rifratto (R/R HL). La designazione è stata concessa sulla base di dati di efficacia iniziali impressionanti, che mostrano un tasso di risposta globale dell'83,3% e un tasso di risposta completa del 50% in 12 pazienti, con un profilo di sicurezza ben gestito.
La designazione RMAT offre benefici di revisione accelerata simili a quelli della Designazione di Terapia Innovativa, potenzialmente accelerando il percorso della terapia verso il mercato. La terapia combinata è attualmente in fase di valutazione nel trial di fase 2 LuminICE-203, con dati completi provenienti da tutti e quattro i gruppi che verranno presentati al 66° Congresso Annuale ASH. L'azienda vede anche applicazioni potenziali nei linfomi CD30 positivi, inclusi i linfomi a cellule T periferiche (PTCL).
Affimed (NASDAQ: AFMD) anuncia la designación RMAT por parte de la FDA para su terapia combinada de acimtamig y AlloNK® para el tratamiento del linfoma de Hodgkin en recaída/refractario (R/R HL). La designación se otorgó basándose en datos de eficacia iniciales impresionantes que muestran una tasa de respuesta global del 83,3% y una tasa de respuesta completa del 50% en 12 pacientes, con un perfil de seguridad bien gestionado.
La designación RMAT proporciona beneficios de revisión acelerada similares a los de la Designación de Terapia Innovadora, lo que podría acelerar el camino de la terapia hacia el mercado. La terapia combinada se está evaluando actualmente en el ensayo de fase 2 LuminICE-203, con datos completos de todos los cuatro grupos que se presentarán en la 66ª Reunión Anual de ASH. La compañía también ve aplicaciones potenciales en linfomas positivos para CD30, incluidos los linfomas de células T periféricas (PTCL).
Affimed (NASDAQ: AFMD)는 재발/내성 호지킨 림프종(R/R HL) 치료를 위한 acimtamig와 AlloNK®의 병합요법에 대해 FDA로부터 RMAT 지정을 받았다고 발표했습니다. 이 지정은 12명의 환자에서 83.3%의 전체 반응률과 50%의 완전 반응률을 보여주는 인상적인 초기 효능 데이터를 바탕으로 부여되었습니다. 또한 안전성 프로파일도 잘 관리되고 있습니다.
RMAT 지정을 통해 혁신 치료 지정과 유사한 신속한 검토 혜택이 제공되어, 치료가 시장에 출시되는 경로를 가속화할 수 있습니다. 이 병합요법은 현재 LuminICE-203 2상 시험에서 평가되고 있으며, 네 가지 집단의 전체 데이터는 66회 ASH 연례 회의에서 발표될 예정입니다. 회사는 또한 CD30 양성 림프종, 특히 말초 T세포 림프종(PTCL)에서의 잠재적인 적용 가능성도 고찰하고 있습니다.
Affimed (NASDAQ: AFMD) annonce la désignation RMAT par la FDA pour sa thérapie combinée d'acimtamig et d'AlloNK® pour le traitement du lymphome de Hodgkin récurrent/réfractaire (R/R HL). Cette désignation a été accordée sur la base de données d'efficacité préliminaires impressionnantes, montrant un taux de réponse global de 83,3% et un taux de réponse complète de 50% chez 12 patients, avec un profil de sécurité bien géré.
La désignation RMAT offre des avantages d'examen accéléré similaires à ceux de la désignation de thérapie innovante, ce qui pourrait accélérer le chemin de la thérapie vers le marché. La thérapie combinée est actuellement évaluée dans l'essai de phase 2 LuminICE-203, avec des données complètes de tous les quatre cohortes devant être présentées lors de la 66ème Réunion Annuelle de l'ASH. L'entreprise voit également un potentiel d'application dans les lymphomes positifs pour CD30, y compris le lymphome T périphérique (PTCL).
Affimed (NASDAQ: AFMD) gibt die RMAT-Zulassung durch die FDA für die Kombinationstherapie aus Acimtamig und AlloNK® zur Behandlung des rezidivierenden/refraktären Hodgkin-Lymphoms (R/R HL) bekannt. Diese Zulassung wurde basierend auf beeindruckenden frühen Wirksamkeitsdaten erteilt, die eine gesamt Antwortquote von 83,3% und eine komplette Antwortquote von 50% bei 12 Patienten zeigen, wobei ein gut verwaltetes Sicherheitsprofil vorliegt.
Die RMAT-Zulassung bietet beschleunigte Überprüfungsbenefits, ähnlich wie die Breakthrough-Therapie-Zulassung, was möglicherweise den Weg der Therapie zum Markt beschleunigt. Die Kombinationstherapie wird derzeit in der LuminICE-203 Phase-2-Studie bewertet, wobei die vollständigen Daten aller vier Kohorten auf dem 66. ASH Jahresmeeting präsentiert werden. Das Unternehmen sieht auch Anwendungsmöglichkeiten bei CD30-positiven Lymphomen, einschließlich peripherem T-Zell-Lymphom (PTCL).
- 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
- 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?
