HEIDELBERG, Germany, April 21, 2016 -- Affimed N.V. (Nasdaq:AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, announced that the Company presented data on its EGFR-targeting TandAb immune cell engagers on Sunday, April 17, in two poster presentation at the American Association for Cancer Research (AACR) 2016 Annual Meeting in New Orleans, LA.
A number of EGFR-targeting drugs have been approved to treat solid tumors including tyrosine kinase inhibitors and monoclonal antibodies such as cetuximab. Despite demonstrated clinical efficacy of such anti-EGFR therapeutics, intrinsic or acquired resistance has been observed in a substantial number of patients and, to date, no meaningful immunotherapeutic effect has been shown. Displaying significant advances over IgG-based antibodies in recruiting NK-cells, Affimed's TandAbs bind NK-cells with higher affinity compared to IgGs and they do not bind to neutrophils, thereby avoiding a diluting effect on NK-cell efficacy. Additionally, TandAbs do not compete with the IgGs circulating in the bloodstream, making the TandAbs more effective. Based on these features, NK-cell TandAbs represent potentially effective immunotherapeutics, overcoming the intrinsic deficits of IgG-based antibodies.
Affimed has developed novel tetravalent, bi-specific TandAbs that recognize EGFRvIII, the most prevalent tumor-specific variant of the epidermal growth factor receptor, and TandAbs that target the wild-type EGFR (EGFRwt), which, when constitutively activated through binding by growth factors or mutations, plays an important role in the pathophysiology of numerous solid cancers such as colorectal, lung or head and neck cancer. The data presented at AACR demonstrate that Affimed's EGFR-targeting preclinical candidates AFM21 (EGFRvIII/CD3), AFM22 (EGFRvIII/CD16A) and AFM24 (EGFR/CD16A) are highly specific and potent drug candidates suitable for the treatment of solid tumors with potentially broader and superior therapeutic properties compared to competitors' products.
"Targeting EGFRwt as well as EGFRvIII provides the opportunity to move beyond hematological malignancies and broaden our TandAb approach into treating solid tumors," said Dr. Martin Treder, CSO of Affimed. "Having the unique opportunity to select either NK- or T-cell engagement for the clinical development of EGFRvIII-targeting TandAbs allows for developing the appropriate effector function in each of the selected clinical indications."
Specifically utilizing the cytotoxic potential of NK-cells for the elimination of EGFR-overexpressing cancer cells, Affimed engineered a set of EGFRwt/CD16A TandAbs and selected ideal candidates based on their binding, thermostability and cytotoxic properties. The selected lead candidate, AFM24, was shown to bind to human and cynomolgus EGFRwt and CD16A, respectively, and was highly stable in buffer and serum. In addition, AFM24 demonstrated high affinity binding and specificity to several EGFR-positive cell lines from different tumor types, with no binding observed to target-negative cells. Directly compared to cetuximab, AFM24 showed superior anti-tumor efficacy in vitro.
The AFM21/22 and AFM24 programs further validate the robustness of Affimed's 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.
About Affimed N.V.
Affimed (Nasdaq:AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK- and T-cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases. For more information, please visit 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 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, collaborations, 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.
CONTACT: IR Contact:
Caroline Stewart, Head IR
Phone: +1 347394 6793
E-Mail: [email protected] or [email protected]
Media Contact:
Anca Alexandru, Head of Communications
Phone: +49 6221 64793341
E-Mail: [email protected]


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