- AFM13: Encouraging data supports initiation of monotherapy
registration-directed study in first half of 2019; Combination study
with cord blood-derived natural killer cells planned to initiate at MD
Anderson; Clinical data updates from monotherapy study and combination
study with Keytruda(R) (pembrolizumab) expected in 2019 -
- AFM24: IND submission planned for mid-2019; Plans to initiate
first-in-human study in second half of 2019 -
- AFM11: Submitted all documents as requested by FDA in an effort to
resume the AFM11 clinical program in ALL -
Heidelberg, Germany, March 27, 2019 - Affimed N.V. (Nasdaq: AFMD), a
clinical stage biopharmaceutical company committed to giving patients
back their innate ability to fight cancer, today provided an update on
recent operational progress and reported financial results for the year
ended December 31, 2018.
"2018 was a year in which Affimed made substantial progress. We achieved
tremendous clinical and corporate milestones that further demonstrated
our innate immunity expertise and the potential for therapeutics based
on our novel CD16A-targeting innate cell engager approach to treat
cancer," said Dr. Adi Hoess, Affimed's CEO. "With our current financial
resources, including funds received from Genentech under our
collaboration, we believe we are well-positioned to achieve additional
milestones in 2019 and beyond, including advancing our lead development
candidate, AFM13, into a market registration-directed study and entering
the clinic with AFM24, our second innate cell engager and a potential
treatment for multiple solid tumor malignancies."
Anticipated 2019 Milestones
-- Affimed plans to initiate in the first half of 2019 a Phase 2
registration-directed study of AFM13 as monotherapy in relapsed or
refractory patients with peripheral T cell lymphoma (PTCL) and
transformed mycosis fungoides (TMF), a subset of cutaneous T cell
lymphoma (CTCL).
-- Affimed plans to report updated data from the combination study of AFM13
with Merck's Keytruda(R) (pembrolizumab) in patients with relapsed or
refractory Hodgkin lymphoma (HL), and expects additional data from
Columbia University's study investigating AFM13 monotherapy in patients
with relapsed or refractory CD30-positive lymphoma with cutaneous lesions
in the first half of 2019.
-- A study of cord blood-derived allogeneic natural killer (NK) cells in
combination with AFM13 is planned to be initiated by Affimed's
collaboration partner The University of Texas MD Anderson Cancer Center
(MDACC) in the first half of 2019.
-- Affimed plans to report updated data of AFM24 at the American Association
for Cancer Research (AACR) Annual Meeting 2019, March 29 - April 3, 2019,
and anticipates completing investigational new drug (IND)-enabling
studies of AFM24 by mid-year 2019 to support the initiation of the
first-in-human study of AFM24 in the second half of 2019.
Key Pipeline Updates
CD16A innate cell engager programs
AFM13 (CD30/CD16A)
-- Data from an investigator-sponsored translational Phase 1b/2a study of
AFM13 in patients with relapsed or refractory CD30-positive lymphoma with
cutaneous manifestation led by Columbia University were presented at the
60th American Society of Hematology (ASH) Annual Meeting and Exposition
in December 2018. The data confirmed single-agent activity of AFM13 in
CD30-positive lymphoma patients. In addition, an analysis of biomarker
correlatives showed a temporary decrease in circulating NK cells during
therapy, with post therapy recovery. Tumor biopsies showed increased
infiltration of CD56+ NK cells in responders compared to non-responders.
-- Affimed provided an update on its Phase 1b trial of AFM13 in combination
with pembrolizumab in patients with HL. Data from 24 patients showed that
the combination of AFM13 and pembrolizumab could be safely administered
and achieved objective response and complete response (CR) rates that
compare favorably to the historical data of pembrolizumab in a similar
patient population, with the CR rate approximately double that of
pembrolizumab. The data was presented at the ASH Annual Meeting 2018.
-- An oral presentation by MDACC at the ASH Annual Meeting 2018 described
the successful development of a novel premixed product of expanded
allogeneic cord-blood derived NK cells preloaded with AFM13 to redirect
the specificity of NK cells against CD30-positive malignancies in
preclinical models, as well as in vivo data confirming the antitumor
activity of these AFM13-NK cells.
-- Based on preliminary feedback from the U.S. Food and Drug Administration
(FDA) and on data presented at the ASH Annual Meeting 2018, Affimed
announced plans at the Company's Research & Development Day in December
to pursue a registrational pathway for AFM13 monotherapy in relapsed or
refractory patients with PTCL and TMF with potential for accelerated
approval. The broader clinical development strategy for AFM13 includes
potentially expanding into other CD30-positive lymphoma indications and
additional treatment lines with significant unmet need. In collaboration
with strategic partners, Affimed plans to investigate AFM13 in
combination with other immunotherapy agents, such as an anti-PD-1/PD-L1
antibody agent and with adoptive NK cell transfer.
-- Together with its collaboration partners from Washington University
School of Medicine, Saint Louis, MO, Affimed will present data at the
AACR Annual Meeting 2019, aimed at describing NK cell functional
responses to tumor cells triggered by AFM13.
AFM24 (EGFR/CD16A)
-- Innate cell engagers developed from Affimed's ROCK(R) (Redirected
Optimized Cell Killing) platform enable targeting of clinically validated
tumor antigens, such as EGFR, for which current therapies have shown
limited efficacy due to resistance and/or dose-limiting toxicities.
AFM24, designed to treat patients with a variety of EGFR-expressing solid
tumors, has the potential for broader efficacy through higher potency at
both high and low EGFR expression levels and in KRAS mutant tumors, as
well as a more favorable safety profile as compared to current
therapeutic anti-EGFR monoclonal antibodies. Affimed will present data at
the AACR Annual Meeting 2019 that highlights the differentiating features
of AFM24 versus standard of care anti-EGFR therapies, such as cetuximab,
including tumor cell killing independent of RAS mutational status,
induced tumor lysis through antibody-dependent cellular cytotoxicity
(ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as
toxicology studies demonstrating a favorable safety profile.
T cell engager programs
AFM11 (CD19/CD3)
-- Preliminary data on the clinical activity and safety of AFM11 from a
Phase 1 study of AFM11 in relapsed/refractory acute lymphoblastic
leukemia (ALL), including several patients with complete remissions, were
presented at the ASH Annual Meeting 2018.
-- Affimed recently submitted a complete response document to the FDA that
summarizes the clinical data from the two AFM11 Phase 1 studies with a
request that the clinical hold be lifted so that clinical development of
AFM11 may proceed in patients with ALL.
2018 Corporate Updates
-- In February, Affimed raised approximately $24.5 million (EUR19.7 million)
in net proceeds from an underwritten public offering.
-- In March, Leila Alland, M.D. joined Affimed as Chief Medical Officer. Dr.
Alland brings more than 20 years of oncology experience, having held
leadership roles in drug development at Tarveda Therapeutics, AstraZeneca,
Bristol-Myers Squibb and Novartis.
-- In May, Affimed introduced its ROCK(R) (Redirected Optimized Cell
Killing) platform. The Company's proprietary, unique and fit-for-purpose
ROCK(R) platform enables the generation of first-in-class, tetravalent,
multi-specific immune cell engagers. Based on its modularity, ROCK(R)
allows for antibody engineering of highly customizable innate and T cell
engagers to generate clinical candidates tailored to multiple disease
indications and settings, including generation of molecules against
validated oncology targets, to address the limitations of existing
treatments.
-- In August, Affimed entered into a research collaboration and license
agreement with Genentech, a member of the Roche Group, to develop and
commercialize novel NK cell engager-based immunotherapeutics based on
Affimed's ROCK(R) platform to treat multiple cancers. Affimed received
$96 million in upfront and committed funding, and may be eligible to
receive up to an additional $5 billion including payments on achievement
of certain development, regulatory and commercial milestones, plus
royalties on sales. In March 2019, Affimed announced that it will receive
a payment in an undisclosed amount triggered by the achievement of a
preclinical milestone under its collaboration with Genentech.
2018 Financial Highlights
Cash, cash equivalents and current financial assets totaled EUR108.8
million as of December 31, 2018 compared to EUR39.8 million as of
December 31, 2017. Affimed anticipates that its cash, cash equivalents
and current financial assets as of December 31, 2018 will enable the
Company to fund its operations, including clinical development and early
development activities, into 2021 assuming all of the Company's programs
advance as currently contemplated.
(MORE TO FOLLOW) Dow Jones Newswires
March 27, 2019 07:30 ET (11:30 GMT)
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