Heidelberg, Germany, June 24, 2019 – Affimed
N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company
committed to giving patients back their innate ability to fight
cancer, today announced the presentation of data updates on two
clinical studies at the 15th International Conference on Malignant
Lymphoma (ICML) in Lugano, Switzerland.
The data from an oral and a poster presentation
featured Affimed’s lead innate cell engager AFM13, a first-in-class
tetravalent, bispecific antibody derived from the ROCK® platform
that is being developed to treat CD30-positive lymphomas. AFM13
specifically binds to CD30 on tumor cells and to CD16A on innate
immune cells, such as NK cells and macrophages.
“The results of the completed Phase 1b study of
AFM13 in combination with pembrolizumab in Hodgkin lymphoma and of
Columbia University’s study of AFM13 in patients with relapsed or
refractory CD30-positive lymphoma with cutaneous presentation
substantiate the potential of AFM13 to make a difference in the
lives of patients with limited to no treatment options,” said Dr.
Leila Alland, Affimed’s Chief Medical Officer. “We look forward to
advancing our innate cell engagers in future clinical studies,
including our registration-directed study of AFM13 in relapsed and
refractory peripheral T cell lymphoma and transformed mycosis
fungoides.”
Final clinical results from a Phase 1b
combination study of AFM13 and pembrolizumab in patients with
relapsed or refractory Hodgkin lymphoma
(Abstract #128, oral presentation)
Final results from a completed Phase 1b dose
escalation study of AFM13 in combination with pembrolizumab
(Keytruda®) in patients with relapsed or refractory Hodgkin
lymphoma (HL; NCT02665650) were presented during an oral session by
Dr. Stephen M. Ansell, Professor of Medicine at Mayo Clinic
Rochester, MN and Chair of Faculty Development and Recruitment,
Division of Hematology, Department of Internal Medicine, and
International Coordinating Principal Investigator of the study.
Overall, the combination of AFM13 and
pembrolizumab was well tolerated, with no new or worsening safety
signals compared to known safety profiles of each agent alone. At
the highest treated dose, the objective response rate (ORR) of 88%
(by both independent and investigator assessments) and the complete
response (CR) rates of 42% and 46% by investigator and independent
assessments, respectively, compared favorably to the historical
data of monotherapy pembrolizumab in a similar patient population,
with the CR rates approximately double that of pembrolizumab. The
estimated progression-free survival (PFS) was 78% and 45% at 6 and
12 months, respectively. Response rates were high amongst the
subgroup of patients who were primary refractory to brentuximab
vedotin (BV), with 11 of the 13 patients achieving an objective
response (ORR 85%, 46% CR rate). A deepening of responses was
reported over time in multiple patients, and patients previously
transplant-ineligible transitioned to transplant after achieving an
objective response with the combination of AFM13 and
pembrolizumab.
"Despite advances in the treatment of patients
with Hodgkin lymphoma, there remains a need for new treatment
options for patients who have failed multiple lines of treatment,”
commented Dr. Ansell. “I am encouraged by the results achieved in
this study, which showed that the combination of AFM13 and
pembrolizumab is well-tolerated and achieved high and deep response
rates even in patients who were refractory to brentuximab
vedotin.”
Updated clinical and immunological data
from a Phase 1b/2a study of AFM13 in patients with relapsed or
refractory CD30-positive lymphoma with cutaneous presentation
(Abstract #259, poster presentation)
New data from an AFM13 Phase 1b/2a study in
patients with relapsed or refractory CD30-positive lymphoma with
cutaneous presentation (NCT03192202) were presented by Dr. Ahmed
Sawas, Assistant Professor of Medicine at the Columbia University
College of Physicians and Surgeons and the New York-Presbyterian
Hospital, and Principal Investigator of the study. In this study,
AFM13 was well tolerated and resulted in a high ORR of 50% (1 CR
and 4 PRs) including therapeutic activity post-BV failure. This
included 2 of 5 responses in the subset of patients with
transformed mycosis fungoides (T-MF), a particularly hard-to-treat
disease.
Analysis of tumor biopsies showed increased
numbers of NK cells both before and during treatment with AFM13
amongst the patients responding to therapy. This was also
associated with markers of NK cell-mediated tumor cell killing. In
the peripheral blood, NK cell activation markers were observed
amongst the responders, and there were associated decreases in
total numbers of circulating NK cells and regulatory T cells.
Overall, the data support the potential of AFM13
as a novel immuno-therapeutic to treat CD30-expressing lymphomas. A
registration-directed Phase 2 international multicenter study of
AFM13 in refractory peripheral T cell lymphoma (PTCL) and T-MF is
planned.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical stage
biopharmaceutical company committed to giving patients back their
innate ability to fight cancer. Affimed’s fit-for-purpose ROCK®
platform allows innate cell engagers to be designed for specific
patient populations. The Company is developing single and
combination therapies to treat cancers. 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, the value of our ROCK®
platform, 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 Investor
Contact:Gregory Gin, Head of Investor RelationsE-Mail:
IR@affimed.com
Affimed Media Contact:Anca
Alexandru, Head of Communications, EU IRE-Mail:
media@affimed.com
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Aug 2024 to Sep 2024
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Sep 2023 to Sep 2024