Press Release - March 8, 2022
In a Clinical Trials Plenary Session an update of the phase 1/2 study evaluating cord blood-derived NK cells that are pre-complexed with the innate cell engager AFM13 in patients with CD30-positive lymphomas will be presented
Heidelberg, Germany, March 8, 2022 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that two abstracts with clinical data of its innate cell engagers (ICE®) have been accepted for presentation at the annual meeting of the American Association for Cancer Research (AACR), taking place April 8-13, 2022 in New Orleans, Louisiana.
The two events include an oral presentation with an update of the study that evaluates AFM13 pre-complexed with NK cells in patients with CD30-positive lymphomas and a poster presentation with data of the dose-escalation phase of the AFM24 monotherapy study for solid tumor treatment.
Title: Innate cell engager (ICE®) AFM13 combined with preactivated and expanded cord blood (CB)-derived NK cells for patients with refractory/relapsed CD30+ lymphoma
Presentation: CT003
Authors: Yago Nieto, Pinaki Banerjee, Indreshpal Kaur, Roland Bassett, Lucila Kerbauy, Rafet Basar, Mecit Kaplan, Lori Griffin, Daniel Esqueda, Christina Ganesh, Melissa Barnett, Amin Alousi, Chitra Hosing, Jeremy Ramdial, Neeraj Saini, Samer Srour, Karenza Alexis, Andreas Harstrick, Elizabeth J Shpall, Katayoun Rezvani
Session: Clinical Trials of Cellular Immunotherapies, Sunday, April 10, 1:00 – 3:00 p.m. CST
Title: A phase 1/2a first-in-human study of AFM24, a CD16A/epidermal growth factor (EGFR) bispecific Innate Cell Engager (ICE®), in patients with locally advanced or metastatic EGFR-expressing solid tumors: Preliminary findings from the dose-escalation phase
Abstract number: CT149
Authors: Anthony El-Khoueiry, Juanita Lopez, Omar Saavedra, Mark Awad, Jacob Thomas, Crescens Tiu, Elena Garralda, Bettina Rehbein, Gabriele Hintzen, Kerstin Pietzko, Christa Raab, Erich Rajkovic, Paulien Ravenstijn, Michael Emig
Session: Phase I Clinical Trials 1, Monday, April 11, 1:30 p.m. – 5:00 p.m. CST
Abstract release: The full abstract will become public at 1:00 p.m. ET on Friday, April 8
More details about the programs for the AACR Virtual Annual Meetings are available online at www.aacr.org.
AFM13 is a first-in-class innate cell engager (ICE®) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 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. AFM13 is Affimed’s most advanced ICE® clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT, NCT04101331).
In addition, The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored phase 1/2 trial in combination with cord blood-derived allogeneic NK cells in patients with relapsed/refractory CD30-positive lymphomas (NCT04074746).
AFM24 is a tetravalent, bispecific innate cell engager (ICE®) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
Affimed evaluates AFM24 as a monotherapy (AFM24-101) for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. The first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov using the identifier NCT04259450. Furthermore, AFM24 is evaluated in a phase 1/2a study in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442). Affimed and NKGen Biotech have initiated a Phase 1/2a study (AFM24-103), investigating AFM24 in combination with SNK01, NKGen Biotech’s NK cell product (NCT05099549).
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to give 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 Heidelberg, 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.
Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102
Mary Beth Sandin
Vice President, Marketing and Communications
E-Mail: m.sandin@affimed.com
Tel.: +1 (484) 888-8195