Best response data from 18 patients confirms favorable safety
profile and overall response rate of 89%
Management to host conference call today at 8:30 a.m. ET /
2:30 p.m. CET to discuss future development plans for AFM13
Heidelberg, Germany, June 15, 2018 - Affimed
N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company
focused on discovering and developing highly targeted cancer
immunotherapies, today presented new interim data from the Phase 1b
dose escalation study evaluating AFM13, its lead NK cell engager
candidate, at the European Hematology Association (EHA) 23rd
Congress in Stockholm. Dr. Eva Domingo of the Instituto Catalán de
Oncología L'Hospitalet, Barcelona, Spain, presented the poster,
titled A Phase 1 Study Investigating the Combination of AFM13 and
the Monoclonal Anti-PD-1 Antibody Pembrolizumab in Patients with
Relapsed/Refractory Hodgkin Lymphoma after Brentuximab Vedotin
Failure: Updated Safety and Efficacy Data. The poster is available
on the Affimed website at:
http://www.affimed.com/publications.php#posters.
Assessment of 18 patients treated at the highest
AFM13 dose showed best overall response rate (ORR) of 89% (16/18
patients) and complete metabolic response rate (CmR) of 28% (5/18
patients). The ORR and CmR for these 18 patients compare favorably
to those of anti-PD-1 monotherapy in similar patient
populations.
Responders included three patients who were
either primary refractory to or had relapsed during front-line
therapy and were refractory to all subsequent lines of therapy. The
combination of AFM13 and pembrolizumab was well tolerated, with
most adverse events mild to moderate in nature and manageable with
standard of care measures.
"The high response rates in this study, in terms
of both partial and complete responses, continue to compare
favorably to the historical data of anti-PD-1 monotherapy, and
would be expected to translate into meaningful progression free and
overall survival over time," said Dr. Stephen Ansell, Principal
Investigator of the study. "Importantly, these data have shown that
AFM13 can be safely administered in combination with Keytruda® and
has the potential to improve patient outcomes."
A total of 30 patients were recruited into the
Phase 1b study with enrollment completed in February 2018. The
interim analysis included 24 of the 30 patients (6 from cohorts 1
and 2, and 18 from cohort 3 and the extension cohort) who had
undergone at least one post-baseline disease assessment as of the
data cut-off date.
"We are very excited about the potential
opportunities for AFM13 to benefit patients with CD30-positive
malignancies," said Dr. Leila Alland, Affimed's Chief Medical
Officer. "We are planning additional studies of AFM13 in
patients with CD30-positive malignancies and are actively seeking
guidance from experts on our development plans including potential
accelerated approval paths."
Conference Call and Webcast
InformationAffimed's management will host a conference call
today, June 15, 2018, at 8:30 a.m. ET. For both "listen-only"
participants and those participants who wish to take part in the
question-and-answer session, the call can be accessed by dialing +1
929-477-0448 (international numbers are available
on Affimed's homepage) five minutes prior to the start of
the call and providing the Conference ID 6246081. A webcast of the
conference call can be accessed in the "Events" section on the
"Investors & Media" page of the Affimed website at
http://affimed.com/events-june-2018.php. A replay of the webcast
will be available on Affimed's website shortly after the conclusion
of the call and will be archived on the Affimed website for 30 days
following the call.
About AFM13AFM13 is a first-in-class tetravalent,
bispecific NK cell engager that specifically binds to CD30 on tumor
cells and to CD16A on NK cells. AFM13 is being developed in
Hodgkin lymphoma (HL) and in other CD30-positive lymphomas.
AFM13 has shown a favorable safety profile and signs of therapeutic
efficacy in a monotherapy setting in studies in Hodgkin Lymphoma
and CD30+ lymphoma with cutaneous manifestation. In addition, data
from a combination study of AFM13 with Merck's anti-PD1 antibody
Keytruda® (pembrolizumab) supports proof of principle for the
combination of NK cell engagement with checkpoint inhibition. AFM13
has been granted orphan drug designation by the U.S. Food and Drug
Administration.
About Affimed's Phase 1b study of AFM13 in combination with
Keytruda® (pembrolizumab)
(NCT02665650)Ongoing Phase 1b study to evaluate the
safety and tolerability of the combination of the Affimed's lead
product candidate AFM13 with pembrolizumab (Keytruda®) as salvage
therapy after failure of standard therapies including brentuximab
vedotin (BV) in relapsed or refractory (R/R) Hodgkin lymphoma (HL).
Patients received escalating doses of AFM13 in combination with
pembrolizumab at a flat dose of 200 mg administered every 3 weeks
following the classical 3+3 design. Response assessment is
performed every 12 weeks by PET/CT according to the Lugano
Classification Revised Staging System for malignant lymphoma.
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,
the value of our ROCKTM 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 IR Contact: Greg Gin, Head US IRE-Mail:
g.gin@affimed.com
Affimed Media Contact: Anca Alexandru, Head of
Communications, EU IRE-Mail: a.alexandru@affimed.com
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