On November 4, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will present two posters on its innate cell engagers (ICE) at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper) (Press release, Affimed, NOV 4, 2021, View Source [SID1234594504]).

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Details of presentations:
Poster presentation 1:
Title: AFM28, a Novel Bispecific Innate Cell Engager (ICE), Designed to Selectively Re-Direct NK Cell Lysis to CD123+ Leukemic Cells in Acute Myeloid Leukemia and Myelodysplastic Syndrome
Abstract: 3344
Authors: Götz J-J., Pahl J., Schmitt N., Müller T., Haneke T., Kozlowska I., Sarlang S., Knackmuss S., Peters E., Reusch U., Ross T., Nowak D., Hofmann W-K. and Merz C.
Presentation time: Monday December 13, 2021, 6:00 PM – 8:00 PM EST

AFM28 is a novel ICE, developed on Affimed’s ROCK platform, specifically designed to address patient needs in Acute Myeloid Leukemia (AML) and other CD123+ myeloid malignancies, including high-risk Myelodysplastic Syndrome (MDS).

The bispecific, tetravalent antibody AFM28 binds selectively and with high affinity the surface antigen CD123, which is almost universally expressed on leukemic blast and leukemic stem cells in AML, and CD16A on NK cells. It is thereby initiating antibody-dependent cell-mediated cytotoxicity (ADCC) against CD123+ tumor cells and is well suited to be investigated as monotherapy and in combination with allogeneic NK cell transfer. AFM28 is currently in preclinical development and a first-in-human clinical study is expected to start in the second half of 2022.

Poster presentation 2:
Title: Cryopreserved CAR-like NK Cells Pre-Complexed with the CD30/CD16A Bispecific Innate Cell Engager (ICE) AFM13 for the Treatment of CD30+ Malignancies
Abstract: 3992
Authors: Reusch U., Ellwanger K., Fucek I., Müller T., Schniegler-Mattox U., Pahl J., Tesar M., and Koch J.
Presentation time: Monday, December 13, 2021, 6:00 PM – 8:00 PM EST

AFM13 precomplexed NK cells maintained biological activity and potency after one cycle of freezing, demonstrating a promising approach to develop a cryopreserved off-the-shelf CAR-like NK cell immunotherapeutic. The high ADCC potency and efficacy of NK cells were maintained and a long cell surface retention, independent of CD16A polymorphism, has been demonstrated. The data to be presented support the development of a cryopreserved, off-the shelf ICE / NK cell product, adding to the clinical utility of the treatment.

Full abstracts of the presentations are published in the November supplemental issue of Blood, a publication of the American Society of Hematology (ASH) (Free ASH Whitepaper). Classical posters, as well as short poster presentations, including a slide deck and graphic poster will be available for in-person and virtual attendees.

For more details about the ASH (Free ASH Whitepaper) Virtual Annual Meeting please visit: View Source

Company sponsored event on AFM13 in mid-December
Affimed intends to host an investor event to provide a clinical development update on AFM13. AFM13 is currently investigated in two clinical studies: (i) in AFM13-202, as monotherapy in peripheral T cell lymphoma (PTCL); and (ii) in AFM13-104, in combination with adoptive NK cell transfer in CD30-positive lymphomas. Affimed will provide further guidance about the event in early December. The clinical study AFM13-104, currently underway at The University of Texas MD Anderson Cancer Center, is evaluating AFM13 precomplexed with cord blood-derived NK cells in patients with CD30-positive lymphoma. In April 2021, initial data from the dose escalation portion of the study showed an objective response rate of 100% (2 complete responses and 2 partial responses) in four patients with relapsed/refractory Hodgkin Lymphoma. The dose-escalation part (3 dose levels, each 3 patients) was completed in July 2021 and additional patients have since been enrolled at the highest dose level.

About AFM28
AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE developed on Affimed’s ROCK platform, is designed to bring a new immunotherapeutic approach to patients with CD123+ myeloid malignancies, including acute myeloid leukemia and myelodysplastic syndrome (MDS). It engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels. Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123+ myeloid disease.

About AFM13
AFM13 is a first-in-class 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 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 or transformed mycosis fungoides (REDIRECT). The study is actively recruiting, and additional details can be found at www.clinicaltrials.gov (NCT04101331). In addition, The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored phase 1 trial in combination with cord blood-derived allogeneic NK cells in patients with relapsed/refractory CD30-positive lymphomas (NCT04074746).