On April 27, 2022 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that four abstracts with clinical trial designs and clinical data of its innate cell engagers (ICE) have been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 in Chicago, IL (Press release, Affimed, APR 27, 2022, View Source [SID1234613158]).
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The events include an oral presentation by Yago Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center with an update of the study that evaluates AFM13 pre-complexed with NK cells in patients with relapsed/refractory CD30-positive lymphomas. In addition, three "Trial in Progress" posters will be presented to provide background information and introduce the study design of the three ongoing AFM24 studies in which patients with EGFR-positive solid tumors are treated with AFM24 monotherapy or combinations with either Roche’s checkpoint inhibitor atezolizumab or NKGen Biotech’s NK cell product SNK01.
Oral presentation details:
Title: Innate cell engager (ICE) AFM13 combined with preactivated and expanded cord blood (CB)-derived NK cells for patients with refractory/relapsed CD30+ lymphoma
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, Sairah Ahmed, Swaminathan Iyer, Hun Lee, Ranjit Nair, Raphael Steiner, Karenza Alexis, Andreas Harstrick, Elizabeth J Shpall, Katayoun Rezvani
Oral session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia, Friday, June 3, 2022, 1:00 – 4.00 p.m. CDT
Poster details:
Title: A phase 1/2a open label, multicenter study to assess the safety, tolerability, pharmacokinetics, and efficacy of AFM24 in patients with advanced solid cancers: Study design and rationale.
Authors: Omar Saavedra Santa Gadea, Elena Garralda, Juanita Suzanne Lopez, Mark M. Awad, Jacob Stephen Thomas, Crescens Diane Tiu, Daniela Morales-Espinosa, Christa Raab, Bettina Rehbein, Gabriele Hintzen, Kerstin Pietzko, Paulien Ravenstijn, Michael Emig, Anthony B. El-Khoueiry
Poster details:
Title: AFM24 in combination with atezolizumab in patients with advanced EGFR-expressing solid tumors: Phase 1/2a study design and rationale.
Authors: Omar Saavedra Santa Gadea, Eric Christenson, Anthony B. El-Khoueiry, Andres Cervantes, Christa Raab, Ulrike Gaertner, Kerstin Pietzko, Gabriele Hintzen, Paulien Ravenstijn, Daniela Morales-Espinosa, Juanita Suzanne Lopez
Poster details:
Title: The combination of CD16A/EGFR innate cell engager, AFM24, with SNK01 autologous natural killer cells in patients with advanced solid tumors.
Authors: Anthony B. El-Khoueiry, Paul Y. Song, Jennifer Rubel, Dorna Y. Pourang, Christa Raab, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada
Poster session for all posters: Developmental Therapeutics – Immunotherapy, Sunday, June 5, 2022, 8:00 – 11:00 a.m. CDT
Abstract release: The full abstracts will become public at 5:00 p.m. EDT on Friday, May 26.
More details about the programs for the ASCO (Free ASCO Whitepaper) Annual Meetings are available online at www.asco.org
About AFM13
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).
About AFM24
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 is evaluating AFM24 in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies as monotherapy and in combinations with other cancer treatments. AFM24-101, a monotherapy, first-in-human phase 1/2a open-label, is a non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional details may be found at www.clinicaltrials.gov using the identifier NCT04259450. Furthermore, AFM24 is being 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).