Heidelberg, Germany, August 7, 2019 - Affimed N.V. (Nasdaq: AFMD), a
clinical stage biopharmaceutical company committed to giving patients
back their innate ability to fight cancer, today reported financial and
operating results for the second quarter ended June 30, 2019.
"After reaching agreement with the U.S. Food and Drug Administration on
the study protocol design, we are now in the process of preparing to
initiate the AFM13 registration-directed Phase 2 study," said Dr. Adi
Hoess, Affimed's CEO. "The recent positive final and interim results
from two clinical studies of AFM13 add to the growing body of evidence
supporting AFM13's activity in CD30-positive lymphoma patients, and give
us increased confidence in the potential of AFM13 to demonstrate
clinical benefit in CD30-positive peripheral T cell lymphoma. To execute
the Phase 2 study and to further advance our internal and partnered
CD16A-targeting innate cell engager pipeline, we have significantly
strengthened our organization through the addition of multiple key hires
in the U.S. and Germany of individuals who have substantial drug
development experience."
Corporate Updates
-- Affimed strengthened its drug development team with the addition of
experienced personnel in several key areas, including Regulatory Affairs,
Clinical Development and Operations, Drug Safety, Chemistry,
Manufacturing and Control (CMC), Drug Safety & Pharmacovigilance,
Biostatistics and Commercial Strategy. The new hires previously held
positions at Novartis, Pfizer Inc., Abbott, Eli Lilly and Company and
other large pharmaceutical or biotechnology companies.
-- In April, Affimed received a payment from Genentech triggered by the
achievement of a preclinical milestone under its research collaboration
to develop and commercialize novel natural killer (NK) cell engager-based
immunotherapeutics based on Affimed's ROCK(R) platform to treat multiple
cancers.
-- Affimed was added to the Russell 2000(R), Russell 3000(R), and Russell
Microcap(R) Indexes, effective after the U.S. markets closed on Friday,
June 28, 2019 as part of Russell's annual index rebalance process.
Russell U.S. Indexes are widely used by investment managers and
institutional investors as the basis for index funds and as benchmarks
for active investment strategies.
-- In June 2019, Affimed's subsidiary AbCheck entered into a five-year
licensing agreement with Icosagen granting AbCheck access to Icosagen's
QMCF protein production technology. Under the terms of the agreement,
AbCheck acquires the rights to utilize Icosagen's QMCF technology
platform for its commercial activities in antibody discovery.
Pipeline Updates
CD16A innate cell engager programs
AFM13 (CD30/CD16A)
-- Affimed reached agreement with the U.S. Food and Drug Administration
regarding the design of its planned Phase 2 registration-directed study
of AFM13 as monotherapy in relapsed or refractory patients with
CD30-positive peripheral T cell lymphoma (PTCL). The results, if positive,
could form the basis for a Biologics License Application (BLA) submission
and support an accelerated approval given the unmet medical need for safe
and effective new treatments in this hard-to-treat patient population.
The study will also enroll a cohort of patients with transformed mycosis
fungoides, an aggressive subtype of cutaneous T cell lymphoma. Study
start-up activities are under way, with study commencement anticipated in
the second half of 2019.
-- Updated 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 was
presented at the International Conference on Malignant Lymphomas (ICML)
in Lugano in June 2019. The data confirmed single-agent activity of AFM13
in CD30-positive lymphoma patients, with an objective response rate (ORR)
of 50% (5 out of 10 patients). Tumor biopsies showed increased
infiltration of NK cells in responders compared to non-responders, and
evidence of NK cell-mediated killing.
-- Affimed reported the final results from the Phase 1b dose escalation
study of AFM13 plus pembrolizumab that showed encouraging efficacy in the
intent-to-treat (ITT) patient population (n=30) with an ORR of 83%,
including complete responses (CR) in 40% and partial responses (PR) in
43% of patients with hard-to-treat Hodgkin lymphoma. At the highest
treated dose (n=24), patients showed an ORR of 88% (CR of 46% and PR of
42%) as determined by independent assessment. Overall, the combination of
AFM13 and pembrolizumab showed a favorable safety profile in patients,
including some patients who did not respond to first-line chemotherapy
and a subgroup of patients who were primary refractory to brentuximab
vedotin. Importantly, a deepening of responses was reported over time in
multiple patients. In addition, patients previously transplant-ineligible
transitioned to transplant after achieving an objective response with the
combination of AFM13 and pembrolizumab, thus increasing the chance for a
cure. These positive results, taken together with data demonstrating
single-agent activity of AFM13 in CD30-positive T cell lymphoma patients,
form the basis for Affimed to initiate a registration-directed study of
AFM13 as monotherapy in patients with PTCL.
-- The combination of AFM13 with allogeneic NK cells represents a novel
approach in order to further improve response rates and durability of
responses in patients with relapsed/refractory CD30-positive lymphoma. In
a preclinical collaboration with the University of Texas MD Anderson
Cancer Center (MDACC), AFM13 has been shown to bind to CD16A with much
higher affinity than other CD16A binding moieties such as monoclonal
antibodies, thus enabling the formation of a stable complex of AFM13
pre-mixed with cord blood-derived allogeneic NK cells. This stable
complex showed strong efficacy in in vitro and in vivo experiments,
forming the basis for an investigator-sponsored Phase 1 study by MDACC.
In the study, MDACC intends to administer this stable complex in
different doses (numbers of pre-loaded NK cells) into patients with
relapsed/refractory CD30-positive malignancies.
AFM24 (EGFR/CD16A)
-- AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding innate cell
engager from Affimed's ROCK(R) platform. It is designed to target
EGFR-expressing solid tumors by a new mechanism of action that activates
innate immunity. This is a differentiated approach from cetuximab and
other EGFR targeting approaches that inhibit tumor growth by
EGFR-mediated signal transduction. Affimed presented data at the American
Association for Cancer Research (AACR) 2019 Annual Meeting that
demonstrated AFM24's ability to bridge NK cells and macrophages to EGFR
expressing tumor cell lines and induce lysis through antibody-dependent
cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis
(ADCP), respectively. Due to AFM24's different mode of action these
effects were independent of RAS mutational status. Importantly, AFM24
enhanced tumor infiltration of NK cells and elicited dose-dependent
anti-tumor efficacy in in vivo tumor models. AFM24 showed reduced
inhibition of EGFR phosphorylation relative to the monoclonal antibody
cetuximab. Treatment of cynomolgus monkeys with AFM24 resulted in a
favorable safety profile, even when treated at high dose levels,
demonstrating AFM24's potential to have significantly lower toxicities in
humans compared to standard of care. Affimed currently anticipates
submitting the investigational new drug (IND) application for AFM24
around the end of the third quarter 2019.
Technology Updates
-- Data describing Affimed's ROCK(R) antibody platform was published in the
mAbs journal, titled, "Redirected optimized cell killing (ROCK(R)): A
highly versatile multispecific fit-for-purpose antibody platform for
engaging innate immunity." The paper discusses aspects of the modular
platform, including the advantages of innate immune cell engagement over
monoclonal antibodies and other engager concepts. The article also
describes the potential of the ROCK(R) platform to engineer a
fit-for-purpose innate immune cell engager format that can be equipped
with unique CD16A domains, modules that influence pharmacokinetic
properties and molecular architectures that influence the activation of
immune effectors, as well as tumor targeting. The article is available
at: https://doi.org/10.1080/19420862.2019.1616506
https://doi.org/10.1080/19420862.2019.1616506.
Financial Highlights
(Figures for the second quarter and six months ended June 30, 2019 and
2018 are unaudited.)
Cash, cash equivalents and current financial assets totaled EUR87.7
million as of June 30, 2019, compared to EUR108.8 million as of December
31, 2018. Based on its current operating and budget assumptions, Affimed
anticipates that its cash, cash equivalents and current financial assets
as of June 30, 2019 will enable the Company to fund its planned clinical
development and early development activities into 2021.
Net cash used in operating activities was EUR18.9 million for the six
months ended June 30, 2019, compared to net cash used in operating
activities of EUR15.2 million for the six months ended June 30, 2018.
The increase is primarily due to higher cash expenditure for research
(MORE TO FOLLOW) Dow Jones Newswires
August 07, 2019 07:30 ET (11:30 GMT)
