Affimed Announces Acceptance of Three Abstracts at the 2024 ASH Annual Meeting Including an Oral Presentation Underscoring Advancing Clinical Pipeline in Leukemia and Lymphoma
Affimed announced the acceptance of three abstracts for presentation at the 66th ASH Annual Meeting in December 2024. The presentations include clinical results from the AFM28 phase 1 dose escalation study in relapsed/refractory acute myeloid leukemia (AML), featuring promising efficacy and safety data. Additionally, preclinical data will showcase AFM28's in vitro efficacy combined with NK cells against leukemic blasts. The company will also present updated clinical results from the LuminICE-203 study evaluating acimtamig (AFM13) in combination with AlloNK® for relapsed/refractory Hodgkin Lymphoma.
Affimed ha annunciato l'accettazione di tre abstract per la presentazione al 66° Congresso Annuale ASH, che si svolgerà a dicembre 2024. Le presentazioni includeranno risultati clinici dello studio di escalation della dose fase 1 di AFM28 nella leucemia mieloide acuta (AML) relapsata/refrattaria, mettendo in evidenza dati promettenti di efficacia e sicurezza. Inoltre, verranno presentati dati preclinici che mostreranno l'efficacia in vitro di AFM28 in combinazione con cellule NK contro i blastici leucemici. La società presenterà anche risultati clinici aggiornati dello studio LuminICE-203 che valuta acimtamig (AFM13) in combinazione con AlloNK® per il linfoma di Hodgkin relapsato/refrattario.
Affimed anunció la aceptación de tres resúmenes para su presentación en la 66ª Reunión Anual de ASH que se celebrará en diciembre de 2024. Las presentaciones incluirán resultados clínicos del estudio de escalado de dosis de fase 1 de AFM28 en leucemia mieloide aguda (AML) en recaída/refractaria, destacando datos prometedores de eficacia y seguridad. Además, se presentarán d datos preclínicos que mostrarán la eficacia in vitro de AFM28 combinada con células NK contra los blastos leucémicos. La compañía también presentará resultados clínicos actualizados del estudio LuminICE-203 que evalúa acimtamig (AFM13) en combinación con AlloNK® para linfoma de Hodgkin en recaída/refractario.
Affimed는 2024년 12월에 열리는 제66회 ASH 연례 회의에서 발표할 세 가지 초록이 수락되었다고 발표했습니다. 발표 내용에는 재발/불응성 급성 골수성 백혈병(AML)에서 AFM28 1상 용량 중증 연구의 임상 결과가 포함되어 있으며, 유망한 효과와 안전성 데이터를 특징으로 합니다. 또한, 전임상 데이터는 백혈병 세포에 대한 NK 세포와 결합된 AFM28의 시험관 내 효능을 보여줄 것입니다. 이 회사는 또한 re발/불응성 호지킨 림프종에서 AlloNK®와 함께 acimtamig(AFМ13)를 평가하는 LuminICE-203 연구의 업데이트된 임상 결과를 발표할 것입니다.
Affimed a annoncé l'acceptation de trois résumés pour présentation lors du 66ème Congrès Annuel de l'ASH, qui se tiendra en décembre 2024. Les présentations incluront des résultats cliniques de l'étude de montée de dose de phase 1 d'AFM28 dans la leucémie myéloïde aiguë (LMA) en rechute/réfractaire, mettant en avant des données prometteuses sur l'efficacité et la sécurité. De plus, des données précliniques montreront l'efficacité in vitro d'AFM28 combinée avec des cellules NK contre les blasts leucémiques. L'entreprise présentera également des résultats cliniques mis à jour de l'étude LuminICE-203 évaluant l'acimtamig (AFM13) en combinaison avec AlloNK® pour le lymphome de Hodgkin en rechute/réfractaire.
Affimed gab die Annahme von drei Abstracts zur Präsentation auf dem 66. ASH-Jahrestreffen im Dezember 2024 bekannt. Die Präsentationen umfassen klinische Ergebnisse der AFM28-Phase 1-Dosissteigerungsstudie bei rezidivierter/refraktärer akuter myeloischer Leukämie (AML), die vielversprechende Wirkungs- und Sicherheitsdaten aufweist. Darüber hinaus werden präk klinische Daten die in-vitro-Wirkung von AFM28 in Kombination mit NK-Zellen gegen leukämische Blastzellen präsentieren. Das Unternehmen wird auch aktualisierte klinische Ergebnisse der LuminICE-203-Studie vorstellen, die acimtamig (AFM13) in Kombination mit AlloNK® zur Behandlung von rezidiviertem/refraktärem Hodgkin-Lymphom evaluiert.
- AFM28 phase 1 study shows promising efficacy and safety data in AML treatment
- Multiple presentations at major industry conference (ASH) demonstrating pipeline progress
- None.
Insights
The acceptance of three abstracts at ASH, particularly the oral presentation of AFM28 Phase 1 data in AML, represents incremental progress but lacks immediate market impact. While promising efficacy and safety data for AFM28 in relapsed/refractory AML could be significant, the abstracts' acceptance alone doesn't provide actionable clinical results.
The LuminICE-203 study update for acimtamig (AFM13) with AlloNK in Hodgkin Lymphoma and preclinical data for AFM28 with NK cells are scientifically interesting but preliminary. For a company with a
MANNHEIM, Germany, Nov. 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 three abstracts on two of its innate cell engagers (ICE®) are accepted for presentation at the 66th ASH Annual Meeting and Exposition taking place December 7-10, 2024, in San Diego, California. An oral presentation will feature clinical results including promising efficacy and safety data from the AFM28 phase 1 dose escalation study in relapsed/refractory acute myeloid leukemia (AML). A poster with preclinical data will highlight the in vitro efficacy of AFM28 in combination with both patient-derived autologous NK cells and healthy volunteer-derived allogeneic NK cells against leukemic blasts.
Updated clinical results from all 4 cohorts of the run-in phase from the LuminICE-203 study evaluating acimtamig (AFM13) in combination with AlloNK® (AB-101) for relapsed/ refractory Hodgkin Lymphoma will be shared in a poster session.
Details for the oral presentation and poster sessions are as follows:
| Abstract Title | Date / Time / Presenter | Session Name / Location |
| “Investigating the Novel Combination of the Innate Cell Engager (ICE®) Acimtamig with Off-the-Shelf Allogeneic Natural Killer Cells AlloNK® in Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL): Initial Results of the Phase 2 Luminice-203 Study” | December 8, 2024 6:00 PM - 8:00 PM PT Joseph Maakaron, MD Division of Hematology, Oncology and Transplantation, Department of Medicine, Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA |
|
| “Engaging Innate Immunity by AFM28, an Innate Cell Engager (ICE®) Targeting CD123-Positive Leukemic Cells in Patients with Relapsed/Refractory Acute Myeloid Leukemia: Safety and Efficacy Results of a First-in-Human Phase 1 Study” | December 9, 2024 10:30 AM - 12:00 PM PT Oral Presentation Time: 11:45 AM PT Pau Montesinos, MD, PhD Hospital Universitari i Politècnic La Fe, Valencia, Spain |
|
| “The Bispecific Innate Cell Engager AFM28 Can Leverage AML Patient’s NK Cells in Addition to Allogeneic NK Cells, Enabling Elimination of CD123+ Leukemic Stem and Progenitor Cells in AML and MDS” | December 9, 2024 6:00 PM - 8:00 PM PT Nanni Schmitt, Dr. sc. hum. Department of Hematology and Oncology, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany |
|
The abstracts are available online at the 66th ASH Annual Meeting and Exposition – Hematology.
The final oral presentation and clinical poster will be available after the congress on Affimed’s website at Publications & Posters.
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 AFM28
AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE®, is designed to bring our immunotherapeutic approach to patients with acute myeloid leukemia (AML). It engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity, even at low CD123 expression levels. AFM28 is currently in clinical development as monotherapy in patients with AML (NCT05817058).
About AFM28-101
AFM28-101 is a first-in-human Phase 1 open-label, nonrandomized, multicenter, multiple ascending dose escalation study evaluating AFM28 monotherapy in patients with relapsed/refractory CD123-positive AML (NCT05817058).
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.
Investor Relations
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 are the key presentations for Affimed (AFMD) at ASH 2024?
When will Affimed (AFMD) present at the 2024 ASH Annual Meeting?
What are the latest clinical results for Affimed's (AFMD) AFM28 drug?
