Press Release - April 16, 2018
Heidelberg, Germany, April 16, 2018 – Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, today presented a poster entitled “Pharmacokinetics and in vitro/in vivo characterization of high-affinity bispecific EGFR/CD16A NK cell engagers for the treatment of EGFR-expressing tumors” in the “Therapeutic Antibodies, Including Engineered Antibodies 2” session at the American Association for Cancer Research (AACR) 2018 Annual Meeting in Chicago.
Despite several marketed agents such as cetuximab and tyrosine kinase inhibitors, there is a significant medical need for a novel approach to treat EGFR+ tumors by widening the therapeutic window and addressing current treatment resistance. To meet the need ofreducing or avoiding side effects stemming from inhibition of EGFR signal transduction of healthy cells, such as skin toxicity, Affimed selected a novel EGFR-binding domain with differentiating features from cetuximab and applied its unique, NK cell engager platform to generate product candidates with high potency and efficacy. Two development candidates, AFM24_I and AFM24_T, were selected, both targeting CD16A on NK cells and EGFR on tumor cells. Through this binding modality and the resulting immune effector cell activation, both molecules are differentiated from cetuximab by their immunotherapeutic mechanism of action. While AFM24_T reflects the traditional TandAb profile, AFM24_I is designed to emulate an IgG-like halflife allowing for more convenient dosing.
“Our NK cell platform enables us to generate molecules against validated oncology targets, while addressing limitations of existing standard treatments,” said Dr. Martin Treder, Affimed’s Chief Scientific Officer. “We look forward to advancing our AFM24 program into the clinic, especially given the demonstrated synergies of our NK cell engagers with other immune activating agents, which could be truly beneficial in the treatment of solid tumors.” AFM24 (_I and _T) possesses high affinity, binding to both EGFR-expressing tumor cells and human NK cells even in the presence of physiological levels of immunoglobulins (IgGs), which compete for NK cell activation with standard monoclonal antibodies (mAbs). Notably, while showing less inhibition of EGFR signaling compared to cetuximab, both molecules demonstrated superior cytotoxicity of target cells irrespective of their Ras mutational status. Mutated Ras is a negative predictive biomarker for marketed EGFR-targeting mAbs, and patients bearing this mutation are not eligible for treatment with these antibodies. When investigated in a cynomolgus pilot toxicology study, AFM24_T showed a favorable safety profile without skin toxicity.
AFM24_I, based on Affimed’s novel modular NK cell platform, demonstrated its unique pharmacokinetic profile similar to that of mAbs and also elicited dose-dependent tumor growth inhibition in a humanized animal model. IND-enabling studies are ongoing and both candidates are being explored in combination with immune activating agents, based on encouraging data for Affimed’s lead NK cell engager AFM13 indicating clinical synergy with the anti-PD-1 antibody pembrolizumab.
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.
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, 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, expectations regarding 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 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, EU IR
Phone: +49 6221 64793341 E-Mail: email@example.com, IR@affimed.com