Heidelberg, Germany, April 5, 2017 - Affimed
N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company
focused on discovering and developing highly targeted cancer
immunotherapies, announced today the presentation of preclinical
data for the Company's lead candidate AFM13, its preclinical
programs AFM24 and AFM26, as well as its MHC-peptide-targeting
discovery program at the American Association for Cancer Research
(AACR) 2017 Annual Meeting being held April 1 - 5, 2017 in
Washington, D.C.
"We continue to evolve and advance our
leadership position in the NK-cell engager field and our unique
portfolio of tetravalent, bispecific immune cell engagers," said
Dr. Martin Treder, CSO of Affimed. "At AACR, we presented
differentiating data on our two novel NK-cell engagers targeting
EGFR and BCMA and we introduced a platform for the specific
targeting of MHC-peptide complexes, which opens up the therapeutic
target space of tumor-specific antigens for T-cell engagement."
AFM13 (#2997)
In a presentation on Monday, April 3, 2017,
Affimed provided insights into the molecular characteristics and
function of its NK-cell engagers and their potential to
therapeutically reactivate NK-cells that are dysregulated in
cancer. The Company's CD16A-specific tetravalent, bispecific
antibodies are well-differentiated from native and Fc-engineered
monoclonal antibodies by their high affinity and ability to
overcome interference from serum IgG, leading to highly potent
NK-cell activation. Furthermore, Affimed's lead product candidate
AFM13, targeting CD30/CD16A, induced upregulation of specific
interleukin receptors on NK-cells in a target-dependent manner. The
Company presented further evidence of AFM13 modulating NK-cells by
sensitizing them to IL-2 and IL-15 stimulation. After exposure to
AFM13, the NK-cells showed improved IL-2- and IL-15-mediated
proliferation and cytotoxicity. In summary, these data support the
strategy of combining Affimed's NK-cell engagers with cytokines to
potentially achieve deeper clinical responses.
AFM24 (#3641/14)
In a poster session on Tuesday, April 4, 2017,
Affimed presented data for its first-in-class tetravalent,
bispecific EGFR/CD16A-targeting NK-cell engager AFM24.
Designed to address the critical unmet need in recurrent or
metastatic EGFR-positive tumors, AFM24 possesses a novel mechanism
of action offering higher efficacy and an improved safety profile
as compared to current EGFR-targeting marketed agents. In vitro and
in vivo, AFM24 shows high potency and its NK-cell killing is
virtually unaffected by polyclonal serum IgG interference.
Importantly, AFM24 showed an excellent safety profile in toxicity
studies in cynomolgus monkeys, with single intravenous
administration being well-tolerated up to the highest dose level of
93.75 mg/kg. In summary, AFM24 lead candidates have the potential
to exhibit a favorable side effect profile and reduced toxicity and
to address the resistance to other targeted anti-EGFR therapeutic
agents.
AFM26 (#5671/25)
In a poster session on Wednesday, April 5, 2017,
Affimed presented data for AFM26, a first-in-class
BCMA/CD16A-targeted tetravalent bispecific antibody designed to
redirect NK-cell cytotoxicity to multiple myeloma (MM). In vitro,
AFM26 potently induced NK-cell-mediated lysis of BCMA-positive
myeloma cell lines and exhibited both greater efficacy and potency
than anti-CS1 IgG1 (elotuzumab). Notably, AFM26 had a much higher
affinity to primary human NK-cells than native or Fc-enhanced mAbs
in both the presence and absence of competing serum IgG, suggesting
that AFM26 can activate NK-cells despite the high M-protein levels
characteristic for MM. Furthermore, AFM26 showed significantly
longer NK-cell surface retention than native and Fc-enhanced IgG
formats. In summary, AFM26 alone or in combination with ex
vivo-expanded NK-cells appears to be a highly promising approach to
eliminate minimal residual disease (MRD) in the
post-transplantation period. These data suggest that AFM26 is
uniquely suited to engage NK-cells in MM. Furthermore, the
long-lasting NK-cell surface retention and inability to induce
NK-cell depletion may allow premixing of NK-cells ex vivo prior to
infusion.
MHC-peptide targeting (#3753/9)
In a poster session on Tuesday, April 4, 2017,
Affimed presented data on its MHC-peptide-targeting discovery
program. Addressing the need to open up the therapeutic target
space of tumor-specific antigens for effective and safe T-cell
engagement, the Company, together with its collaboration partner
Immatics, identified a novel tumor-associated MHC/peptide complex,
the HLA-A*02-binding peptide MMP1-003. MMP1-003 originates from
matrix metalloproteinase 1 (MMP1), a protein overexpressed in
several solid tumors and associated with advanced stage, metastasis
and poor prognosis. The Company's subsidiary AbCheck identified
highly specific antibody domains (scFvs) directed against the MMP1
peptide in an MHC-complex. Using these scFvs, Affimed generated and
characterized specific and potent T-cell-engaging tetravalent
bispecific antibodies. The lead antibody demonstrated excellent
specificity and potent cytotoxicity of endogenously
target-expressing cancer cell lines and no lysis of control cell
lines. In summary, Affimed has developed novel tumor-targeting
antibodies with the potential to open up the therapeutic space to
T-cell-engagement by providing access to intracellular proteins
that are presented as disease-specific MHC/peptide complexes.
Affimed's presentation and posters can be
downloaded on Affimed's corporate website at
http://www.affimed.com/events-aacr-2017.php.
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 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.
IR Contact: Caroline Stewart, Head IR Phone: +1 347394
6793 E-Mail: IR@affimed.com or c.stewart@affimed.com
Media Contact: Anca Alexandru, Head of Communications, EU
IR Phone: +49 6221 64793341 E-Mail: a.alexandru@affimed.com
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