Affimed N.V. (Nasdaq:AFMD), a clinical stage biopharmaceutical
company focused on discovering and developing highly targeted
cancer immunotherapies, today announced the presentation of
preclinical data from three studies at the 58th American Society of
Hematology (ASH) Annual Meeting and Exposition 2016 in San Diego,
California.
“We continue to generate data that further
elucidate the mechanism of action of our drugs as well as the
activation of NK-cells by our CD16A-engaging bispecific antibodies.
Studies with our lead drug AFM13 showed that the combination with
IL-2 or IL-15 had a synergistic effect on AFM13-mediated expansion,
which is induced by an upregulation of the respective interleukin
receptors on NK-cells,” said Dr. Adi Hoess, CEO of Affimed. “In
addition, we are working to overcome the hurdle represented by the
limited number of tumor-specific targets for T- or NK-cell
engagement by developing trispecific tetravalent antibodies, which
show increased tumor cell selectivity.
AFM13
On Saturday, December 3, the Company and its
collaboration partner, the German Cancer Research Center (DKFZ),
Heidelberg, presented a poster (Abstract #1764) sharing additional
insights into the mechanism of action of lead product candidate
AFM13, a CD30/CD16A-specific NK-cell engager. Expanding on previous
studies demonstrating synergistic efficacy of AFM13 when combined
with checkpoint modulation (e.g. anti-PD-1), the poster identifies
other potential future candidates for AFM13 combination therapies,
as well as biomarkers that may be predictive of NK-cell responses
to AFM13 treatment.
In vitro, NK-cell cytotoxicity towards CD30+
tumor cells and IFN-γ production were substantially increased in
the presence of AFM13, and AFM13 was significantly more potent than
a native anti-CD30 IgG1 antibody. A detailed analysis showed that
interaction of NK-cells with AFM13-coated tumor cells up-regulated
the expression of NK-cell surface receptors such as CD25, CD69 and
CD137/4-1BB, as well as additional markers that may serve as
NK-cell checkpoints. Importantly, AFM13-mediated CD16A engagement
enhanced the potential of NK-cells for proliferation and expansion
when subsequently incubated with the cytokines IL-15 or IL-2. This
effect was observed even in target cells resistant to naïve
NK-cells and to NK-cells activated only with IL-2/IL-15.
In summary, the data presented at ASH
demonstrates that AFM13 specifically enhances the cytotoxic,
proliferative and cytokine-producing potential of NK-cells. In
addition, the results indicate that the distinctive modulation of
NK-cell receptors can be utilized to monitor NK-cell responses
during AFM13 therapy and to select candidates for therapeutic
combination strategies.
AFM11
In a poster presented on Monday, December 5,
Affimed along with its collaboration partners from University
Hospital Wuerzburg, determined the effects of treatment history on
T-cell engagement (Abstract #4130). Specifically, the researchers
analyzed the activity of the CD19/CD3-specific TandAb AFM11 on
T-cells derived from NHL patients after different chemotherapeutic
regimens (R-Bendamustine, R-CHOP and HD-BEAM), compared to T-cells
from healthy donors. Even though patient T-cells were significantly
reduced in number after chemotherapy and displayed functional
defects, AFM11 was able to activate them for potent target cell
lysis with comparable efficacy to T-cells from healthy donors.
Lower efficacy was only observed at limiting effector cell
counts.
The study also reported that the type of prior
chemotherapeutic regimen had an effect on AFM11-mediated T-cell
engagement. While T-cells from patients treated with R-CHOP
displayed responsiveness similar to T-cells from healthy donors,
lower cytotoxic activity was measured for T-cells from
R-Bendamustine and HD-BEAM pretreated patients.
In summary, T-cell-engaging immunotherapies such
as bispecific T-cell-recruiting antibodies or chimeric antigen
receptor T-cells (CAR-T) have emerged as highly active therapeutics
in hematological malignancies and these results highlight the
importance of taking the specifics of chemotherapeutic pretreatment
into account in the planning of immuno-oncology trials.
Trispecific Antibodies
In another poster on Monday, December 5, Affimed
presented details on its trispecific antibody format being
investigated in a multiple myeloma (MM) model system (Abstract
#4513). TandAbs are tetravalent antibodies and thereby show
bivalent binding to both cancer and immune cells. The Company has
engineered trispecific tetravalent antibodies that redirect
NK-cells to tumor cells co-expressing two surface antigens
(‘dual-targeting’), thereby leading to increased tumor cell
selectivity. Due to its largely tumor cell-specific expression
profile, B-cell maturation antigen (BCMA/CD269) has emerged as a
promising target antigen for antibody-based therapies of MM. CD200
was selected as the second MM-expressed surface antigen found in
the majority of patients. In vitro, the trispecific antibodies
selectively engaged NK-cells through bivalent binding to CD16A and
monovalent binding to both BCMA and to CD200. Binding to
BCMA+/CD200+ cells and the resulting increase in avidity led to
preferential lysis of antigen double-positive cells compared with
antigen single-positive cells. These data suggest that
dual-targeting may increase the therapeutic window compared to
approaches targeting only one antigen.
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 IRPhone: +1 347394 6793E-Mail:
IR@affimed.com or c.stewart@affimed.com
Media Contact:
Anca Alexandru, Head of Communications, EU IRPhone: +49 6221
64793341E-Mail: a.alexandru@affimed.com
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