--AFM13/anti-PD-1 combination induces cross-talk between innate and adaptive immunity--
--TandAbs targeting EGFRvIII and EGFRwt are highly potent drug candidates to treat EGFR-related cancers--
HEIDELBERG, Germany, March 17, 2016 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, announced today that preclinical data from a combination study of Affimed's lead candidate AFM13 and checkpoint modulators, including checkpoint inhibitor PD-1, as well as data on Affimed's preclinical programs AFM21/22 and AFM24 will be presented at the American Association for Cancer Research (AACR) 2016 Annual Meeting being held April 16 - 20, 2016 in New Orleans, LA.
On Monday, April 18, "Immune checkpoint inhibition by anti-PD-1 or CD137 co-stimulation enhances cytotoxicity towards CD30+ tumors mediated by the bispecific tetravalent CD30/CD16A TandAb AFM13" (Abstract #2323) will be available in a poster session. The results of this preclinical study, conducted in collaboration with Stanford University, confirm earlier evidence of the synergy of our lead candidate, the CD30/CD16A-specific NK-cell engager AFM13, in combination with PD-1 inhibitors in in vivo PDX models with human CD30+ Hodgkin lymphoma (HL) tumors. Our data demonstrate that this synergy is mediated by tumor-infiltrating lymphocytes, macrophages and dendritic cells, and provide strong evidence for cross-talk between innate and adaptive immunity induced by AFM13-recruited human NK-cells. Together with AFM13's adequate safety profile in patients, these results further justify the Phase 1b combination study investigating AFM13 in combination with pembrolizumab in relapsed/refractory HL patients which we expect to be initiated in the first half of this year.
On Sunday, April 17, "Anti-EGFRvIII TandAbs recruiting either T or NK cells are highly specific and potent therapeutic antibody candidates for the treatment of EGFRvIII+ tumors" (Abstract #580) will be available in a poster session. In this preclinical study we report development of tetravalent, bi-specific TandAbs (tandem antibodies) that recognize EGFRvIII, the most prevalent tumor-specific variant of the epidermal growth factor receptor, EGFR. Our TandAbs recruit either T-cells or NK-cells, both of which are highly potent and efficacious immune effector cells, by binding to their activating receptors CD3 (AFM21) and CD16A (AFM22), respectively. This allows for the selective destruction of EGFRvIII-positive tumor cells, while sparing healthy, EGFRvIII-negative cells. The AFM21/22 program further validates the robustness of our proprietary TandAb technology platform, allowing for rapid identification of candidate molecules which are stable, highly expressed, and display significant in vitro and in vivo cytotoxicity to cancer cells.
On Sunday, April 17, "Highly cytotoxic EGFR/CD16A TandAbs specifically recruit NK cells to potently kill various types of solid tumors" (Abstract #593) will be available in a poster session. In this preclinical study we describe the development of our novel bispecific, tetravalent EGFR/CD16A-specific NK-cell TandAbs and provide evidence for their therapeutic potential. When constitutively activated through amplification or dysregulation, the EGFR wild type (EGFRwt) plays an important role in the pathophysiology of numerous solid cancers. Specifically utilizing the cytotoxic potential of NK-cells for the elimination of EGFR-overexpressing cancer cells, we engineered a set of EGFR/CD16A TandAbs and selected ideal candidates based on their binding, thermostability and cytotoxic properties. Our data suggest that EGFR/CD16A TandAbs are novel, highly potent drug candidates suitable for the treatment of EGFR-overexpressing malignancies and suited to overcome the intrinsic or acquired resistance to other EGFR-targeting treatments such as tyrosine kinase inhibitors or monoclonal antibodies, which has been observed in a large number of patients.
Full abstracts of the presentations can be accessed on the AACR website at www.aacr.org.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. Affimed's product candidates are being developed in the field of immuno-oncology, which represents an innovative approach to cancer treatment that seeks to harness the body's own immune defenses to fight tumor cells. The most potent cells of the human defense arsenal are types of white blood cells called natural killer cells, or NK-cells, and T-cells. Affimed's proprietary, next-generation bispecific antibodies, called TandAbs for their tandem antibody structure, are designed to direct and establish a bridge between either NK-cells or T-cells and cancer cells, triggering a signal cascade that leads to the destruction of cancer cells. Affimed has focused its research and development efforts on three proprietary TandAb programs for which it retains global commercial rights. For more information, please visit www.affimed.com.
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 are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements regarding the risk of cessation or delay of any of the ongoing or planned clinical studies and/or development of our product candidates. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our clinical development activities, regulatory oversight, product commercialization, intellectual property claims, and the risks, uncertainties and other factors described under the heading "Risk Factors" in Affimed's filings with the Securities and Exchange Commission. 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.
Anca Alexandru, Head of Communications
Phone: +49 6221 64793341