A poster presentation featuring preclinical data on AFM28, a novel Innate Cell Engager developed for treatment of Acute Myeloid Leukemia and other CD123+ myeloid malignanciesA poster presentation on AFM13 precomplexed NK cells that maintained biological activity and potency after one cycle of freezing, resulting in a cryopreserved, off-the-shelf CAR-like NK cell therapyA company sponsored investor event in mid-December to provide a clinical development update on AFM13
HEIDELBERG, Germany, Nov. 04, 2021 (GLOBE NEWSWIRE) -- 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 it will present two posters on its innate cell engagers (ICE) at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH).
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: Gtz J-J., Pahl J., Schmitt N., Mller 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 Affimeds 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., Mller 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. 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 Virtual Annual Meeting please visit: https://www.hematology.org/meetings/annual-meeting.
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 Affimeds 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 Affimeds 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 http://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).
About Affimed N.V.
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 companys 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 companys people, pipeline and partners, please visit: http://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 our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and our other product candidates, the value of our ROCK platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading Risk Factors in Affimeds filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
Investor Relations Contact
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 Tel.: +1 (484) 888-8195
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