Affimed Presents Additional Data on Combination of AFM13 with Checkpoint Inhibitors at ASH

Press Release - December 6, 2015

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Data Indicate AFM13 / anti-­PD-­1 Combination Stimulates Innate and Adaptive Immune System Crosstalk

Heidelberg,  Germany,  Dec  6,  2015  –  Affimed  N.V.  (Nasdaq:  AFMD),  a  clinical-­stage  biopharmaceutical company developing highly targeted cancer immunotherapies, today presented  preclinical  data  on  the  potency  and  efficacy  of  the  combination  of  the  Company’s NK-­cell-­engaging TandAb, AFM13, with various checkpoint inhibitors, including  further  data  with  a  marketed  anti-­PD-­1  agent,  at  the  57th  annual  American  Society of Hematology (ASH) conference in Orlando, Florida.

Results showed that AFM13, the Company’s CD30/CD16A TandAb, in combination with anti-­PD-­1 therapy demonstrated the most impressive synergy of the checkpoint inhibitors tested in the study. Specifically, the data showed that AFM13 rapidly enriches the tumor microenvironment with NK-­cells and this enrichment is subsequently followed by tumor infiltration  of  cytotoxic  T  lymphocytes  (CTLs).  In  contrast,  single-­agent  anti-­PD-­1  treatment had only a minor effect on CTL infiltration and, unsurprisingly, the number of NK-­cells  was  not  increased.  Importantly,  when  AFM13  and  anti-­PD-­1  were  co-­administered, both the NK-­cell and CTL infiltration were further enhanced. In addition, further  corroborating  the  observed  efficacy,  the  combination  of  AFM13  and  anti-­PD-­1  showed a substantial increase in cytokines, such as interferon gamma, within the tumor.
“These  findings  are  remarkable  because  they  demonstrate  that  our  NK-­cell-­engaging  TandAbs may have the unique ability to trigger the body’s natural immune cascade,” said Adi Hoess, CEO of Affimed. “We look forward to seeing more mature data from ongoing studies as well as generating new data for AFM13 in 2016 to confirm these initial exciting results.”

Interim  data  from  the  ongoing  Phase  2  monotherapy  study  of  AFM13  in  relapsed/refractory Hodgkin lymphoma are expected in the second quarter of 2016, with full  data  on  the  primary  endpoint  by  year-­end  2016.  In  addition,  the  first  combination  study of AFM13 plus anti-­PD-­1 is on track to start in the first half of 2016. A translational study of AFM13 in CD30+ lymphoma patients with cutaneous manifestation is expected to begin in the near-­term.

About AFM13

AFM13 is a first-­in-­class bispecific NK-­cell TandAb®, which binds NK-­cells (Natural Killer cells)  specifically  via  CD16A  and  has  a  second  binding  domain  for  CD30,  a  cancer-­specific target. CD16A is expressed on NK-­cells, highly potent cytotoxic effector cells of the  innate  immune  system,  enabling  AFM13  to  selectively  bind  these  effector  cells.  AFM13 redirects the NK-­cells to CD30-­expressing cancer cells and binds both targets with high affinity, establishing a bridge whereby the NK-­cells are activated and redirected to kill the cancer cells. AFM13 is designed to treat CD30-­positive malignancies including Hodgkin lymphoma (HL) and T-­cell lymphoma (TCL) and is currently in Phase 2 studies in  HL  patients.  Like  all  TandAbs®,  AFM13  is  a  stable,  off-­the-­shelf,  targeted  immunotherapeutic which does not require continuous infusion due to a favorable half-­life in a patient’s bloodstream, yet is tunable by dosing adjustment when required. This highly specific NK-­cell antibody and the related bispecific platform are unique to Affimed.

About NK-­Cell TandAbs, T-­Cell TandAbs and Trispecific Abs

Affimed  develops  TandAbs  and  Trispecific  Abs  to  substantially  increase  the  efficacy,  specificity and/or extend the therapeutic window of current therapeutics. TandAbs and Trispecific Abs are a new generation of proprietary, tumor-­cell engaging antibodies with a  tetravalent  architecture  characterized  by  four  binding  domains.  These  tetravalent  molecules bind to tumor and immune cells with high affinity. Although generation of such complex  antibodies  is  very  challenging,  Affimed  has  succeeded  in  producing  them  economically and at high quality. Leveraging this expertise, Affimed has implemented three platform technologies:

  • Bispecific TandAbs engaging NK-­cells (via CD16A)
  • Bispecific TandAbs engaging T-­cells (via CD3)
  • Trispecific Abs engaging either NK-­ or T-­ cells

Affimed’s TandAbs have already demonstrated promising signs of therapeutic activity in patients and robust and efficient production processes for these highly stable molecules have  been  established  in  mammalian  cell  systems.  Affimed’s  Trispecific  Abs,  which  target two distinct tumor epitopes and engage T-­ or NK-­cells to lyse the tumor cells that express both targets, are validated preclinically.

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.

Affimed 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, 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.

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Caroline Stewart, Head IR & Communication Phone: +1 347 394 6793
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