Affimed Presents Data Comparing T-­cell-­ and NK-­cell-­ engaging TandAbs AFM11 and AFM12 at ASH

Press Release - December 6, 2015

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Differentiated Product Profiles Provide Rationale for Indication-­Specific Approach

Heidelberg,  Germany,  Dec  6,  2015  –  Affimed  N.V.  (Nasdaq:  AFMD),  a  clinical-­stage  biopharmaceutical company developing highly targeted cancer immunotherapies, today presented  further  preclinical  data  on  the  potency  and  efficacy  of  its  anti-­CD19  compounds AFM11, the Company’s T-­cell-­engaging TandAb and AFM12, the Company’s  NK-­cell-­engaging  TandAb,  at  the  57th  Annual  American  Society  of  Hematology (ASH) conference in Orlando, Florida.

Results showed that the T-­cell engager AFM11 and the NK-­cell-­engager AFM12 were both efficacious in in vitro and in vivo studies. AFM11, with its sub-­nanomolar binding affinity to CD3 on T-­cells, demonstrated greater potency, as measured by EC50, whereas AFM12,  which  has  nanomolar  binding  affinity  to  CD16A  on  NK-­cells,  demonstrated  greater efficacy, as measured by lysis of tumor cells. In addition, in patient-­derived xenograft models, AFM12 treatment resulted in an increased number of NK-­cells and T-­cells entering the tumor microenvironment, while AFM11 and anti-­PD-­1 monotherapies caused  only  T-­cell  numbers  to  increase.  Interestingly,  combinations  of  AFM11  with  AFM12, or of either with an anti-­PD-­1 agent, all seemed to confer similar efficacies and were stronger than monotherapies. Strongest efficacy has been observed using a triple combination.

“This  side-­by-­side  comparison  of  NK-­cell  and  T-­cell  engaging  TandAbs  has  given  us  valuable insight into how to determine the best effector cell-­recruiting approach to use in different indications,” said Martin Treder, Ph.D., CSO of Affimed. “Moreover, it is exciting to see that both approaches have their merits and may in fact be compatible, opening additional  strategic  options  for  us  as  we  consider  the  further  development  of  our  pipeline.”

A Phase 1 dose-­escalation study of AFM11 in non-­Hodgkin lymphoma is ongoing and first  data  are  expected  by  the  end  of  2016.  The  Phase  1  study  of  AFM11  in  acute  lymphocytic leukemia (ALL) is expected to commence in the first half of 2016.

About AFM11

AFM11 is a bispecific T-­cell TandAb, which binds T-­cells specifically via CD3 and has a second  binding  domain  for  CD19,  a  target  on  cancer  cells.  T-­cells  are  highly  potent  cytotoxic effector cells of the adaptive immune system. They have the ability to proliferate  when  activated,  thereby  amplifying  and  accelerating  their  cytotoxic  activity.  AFM11 redirects these effector cells to CD19 expressing cancer cells and binds to both targets, CD3 and CD19, with high affinity, thereby activating and redirecting the T-­cells to kill  the  cancer  cells.  CD19  is  expressed  at  an  abnormally  high  level  in  all  B-­cell  malignancies and AFM11 is specifically designed to treat these B-­cell malignancies including Non-­Hodgkin lymphoma. AFM11 is currently in Phase 1 clinical development. Like  all  TandAbs,  AFM11  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.

About AFM12

AFM12 is a bispecific NK-­cell TandAb, which binds NK-­cells specifically via CD16A and has a second binding domain for CD19, a target on cancer cells. CD16A is expressed on NK-­cells,  highly  potent  cytotoxic  effector  cells  of  the  innate  immune  system,  enabling  AFM12 to selectively bind these effector cells. AFM12 redirects the NK-­cells to CD19-­ 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.

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.

Affimed IR Contact

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