- Study will continue and combine cohorts of CD30 high and CD30
low expressing PTCL based on assessment from Independent Review
Committee
- Objective responses observed in heavily pretreated patients in
both cohorts
- Side effect profile similar to previously reported data
- Conference call scheduled for March 10th at 8:30 a.m. EST
Heidelberg, Germany, March 10,
2021 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage
immuno-oncology company committed to giving patients back their
innate ability to fight cancer, announced today its decision to
continue enrollment in the REDIRECT trial, which is evaluating
AFM13 as a monotherapy for the treatment of patients with relapsed
or refractory CD30-positive peripheral T-cell lymphoma (PTCL).
The decision to continue the trial followed a
preplanned interim futility analysis. The interim analysis was
triggered following enrollment of 20 patients in both Cohort A
(≥10% CD30) and Cohort B (>1% to <10% CD30). The futility
boundary was derived from response rates for previous therapies
that have received accelerated approval in relapsed or refractory
(R/R) PTCL. The futility analysis demonstrated that the response
rate in Cohort A achieved the predefined threshold for continuation
of the study. The response rate in Cohort B was sufficiently
comparable to allow merging of both cohorts into a single cohort
for all patients with CD30 >1%, per the study protocol. Evidence
of anti-tumor response was observed in both cohorts with complete
and partial responses. The safety analysis was consistent with
previously reported data from Affimed’s Phase 1 trials of AFM13,
with infusion related reactions (IRRs) representing the main side
effect. Following the introduction of mandatory
premedication, IRRs were markedly reduced, resulting in fewer dose
reductions and a trend towards better activity.
“We are very encouraged by the observed activity
of AFM13 in this heavily pretreated patient population, where more
than half of the patients had three or more lines of previous
therapy. These data reinforce our strategy to broadly develop AFM13
across CD30-positive lymphomas both as monotherapy and in
combination with other therapies,” said Dr. Andreas Harstrick,
Affimed’s Chief Medical Officer. “Having successfully met the
criteria for continuation, the trial will move forward by merging
the CD30 high- and low-expressing PTCL cohorts for evaluation of
the safety and efficacy of AFM13.”
“We are excited by this progress and by AFM13’s potential as
monotherapy for patients with PTCL,” said Dr. Won Seog Kim,
Principal Investigator of REDIRECT and Professor of Hematology and
Oncology at the Samsung Medical Center, Sungkyunkwan University,
Seoul, Korea. “PTCL is an aggressive and challenging cancer to
treat in patients who relapse or do not respond favorably to
current therapies, which often have high toxicity profiles, and new
therapeutic approaches are needed.”
AFM13 is also being evaluated in combination
with cord-blood derived natural killer cells in CD30-positive
lymphomas at MD Anderson Cancer Center (MDACC). Initial data from
this investigator sponsored study will be presented at the American
Association for Cancer Research (AACR) Annual Meeting in April
2021.
Investor Conference Call and Webcast Details
Affimed will host an investor conference call and webcast
today, Wednesday, March 10, at 8:30 a.m. EST, to review
the REDIRECT study interim analysis. To access the call, please
dial +1-646-741-3167 for U.S. callers, or +44 (0) 2071 928338 for
international callers, and reference conference ID 6065008
approximately 15 minutes prior to the call. To access the live
audio webcast of the conference call please visit the “Investors”
section of the company’s website at
https://www.affimed.com/investors/webcasts_cp/. A replay of the
call will be archived on Affimed’s website for 30 days after the
call.
About AFM13-202 and the REDIRECT Trial
DesignREDIRECT (also known as AFM13-202, NCT04101331) is a
registration-directed phase 2 open-label, multicenter, global study
investigating the efficacy and safety of AFM13 monotherapy in
patients with R/R CD30-positive PTCL and Transformed Mycosis
Fungoides (TMF).
The study enrolls patients who suffer from CD30 expressing PTCL
or TMF and who have relapsed after an earlier standard of care
treatment or have refractory disease. Dependent on their disease
type and the magnitude of CD30 expression on their tumor cells,
study participants are assigned to one of three study cohorts, each
cohort receiving the same treatment of weekly AFM13 infusions (a
200 mg dose per infusion). The three cohorts are comprised of
Cohort A, which includes PTCL patients with ≥10% CD30 expression on
tumor cells; Cohort B, which includes PTCL patients with >1%
to< 10% CD30 expression on tumor cells; and, Cohort C, currently
on hold, which includes TMF patients with ≥1% CD30 expression on
tumor cells.
The main goal of the study is to assess the efficacy
of AFM13 treatment as judged by the rate of objective
responses. Further goals of the study are to assess the safety
of AFM13 treatment, the immunogenicity of AFM13 (as
measured by the formation of anti-AFM13 antibodies) and the
concentration of AFM13 in the blood.
The study began recruitment in October 2019 at sites in the
United States, Australia, South Korea and seven European countries.
The TMF arm of the study (Cohort C), which is exploratory only and
not relevant to the potential consideration for accelerated
approval, will remain paused, due to COVID-19 and the high number
of assessments and site visits necessary for this group of
patients. To date, no TMF patients have been recruited into
the study.
About Affimed N.V.Affimed (Nasdaq: AFMD) is a
clinical-stage immuno-oncology company committed to give patients
back their innate ability to fight cancer by actualizing the
untapped potential of the innate immune system. The company’s
proprietary ROCK® platform enables a tumor-targeted approach to
recognize and kill a range of hematologic and solid tumors,
enabling a broad pipeline of wholly-owned and partnered single
agent and combination therapy programs. The ROCK® platform
predictably generates customized innate cell engager (ICE®)
molecules, which use patients’ immune cells to destroy tumor cells.
This innovative approach enabled Affimed to become the first
company with a clinical-stage ICE®. Headquartered in Heidelberg,
Germany, with offices in New York, NY, Affimed is led by an
experienced team of biotechnology and pharmaceutical leaders united
by a bold vision to stop cancer from ever derailing patients’
lives. For more about the company’s people, pipeline and partners,
please visit: www.affimed.com. FORWARD-LOOKING
STATEMENTSThis 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 potential of
AFM13, 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, 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,
impacts of the COVID-19 pandemic, the benefits to Affimed of orphan
drug designation 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.
Investor Relations ContactAlexander
FudukidisHead of Investor RelationsE-Mail:
a.fudukidis@affimed.comTel.: +1 (917) 436-8102
Media ContactMary Beth SandinHead of Marketing
and CommunicationsE-Mail: m.sandin@affimed.com
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