Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a
clinical-stage immuno-oncology company committed to giving patients
back their innate ability to fight cancer, today announced the
presentation at the American Society of Clinical Oncology (ASCO)
Annual Meeting of safety and efficacy data from the EGFR mutant
NSCLC expansion cohort of its ongoing phase 1/2 study investigating
innate cell engager (ICE®) AFM24 as monotherapy. The data included
15 evaluable patients and showed encouraging early signs of
clinical activity including confirmed partial responses and durable
stable disease. EGFR mutant NSCLC is a very aggressive and
resistant tumor type in which most classical NSCLC treatments
achieve limited to no clinical activity, especially in more
advanced patients. Affimed’s innate cell engager AFM24 aims to
reactivate the innate and consequently the adaptive immune system
to recognize and destroy EGFR mutant tumors.
“The treatment options for patients with advanced solid tumors
and EGFR alterations are limited by the development of resistance
to existing EGFR targeting therapies and by modest activity of
checkpoint inhibitors. The results we have seen with AFM24
monotherapy in an expansion cohort of advanced, refractory NSCLC
patients with EGFR mutations indicate that activating the innate
immune pathway in this patient population results in anti-tumor
activity and may offer a novel therapeutic approach. Given the
underlying molecular pathways, we believe that AFM24 could
potentially enable checkpoint inhibitors to achieve a positive
effect,” said Dr. Anthony El-Khoueiry, Associate Director of
Clinical Research at USC Norris Comprehensive Cancer Center and
principal investigator of the AFM24 studies.
The AFM24 EGFR mutant NSCLC cohort is part of the AFM24-101
open-label, non-randomized, multi-center, phase 1/2a study
(NCT04259450) investigating the safety, tolerability, and
preliminary efficacy of AFM24 monotherapy in patients with advanced
or metastatic EGFR+ solid tumors. Other cohorts being investigated
included colorectal cancer (CRC) and renal carcinoma (RCC).
At the planned interim analysis, 15 patients with EGFR mutant
NSCLC and a median of 2 prior lines of therapy had been treated
with a median of 11 doses of AFM24. As of the cut-off date, the
data showed clinical activity and signals of anti-tumor activity in
7 out of 15 heavily pre-treated patients, including two confirmed
partial responses and five patients with stable disease (SD)
resulting in an objective response rate of 13% and a disease
control rate of 47%. All patients with stable disease were
progression free for at least 3.5 months, with one patient
exhibiting ongoing SD for more than 8 months. A reduction in tumor
burden was observed in five of 13 patients (38%) with available
baseline and subsequent tumor assessments based on RECIST criteria.
All patients showed a well-managed safety profile with the majority
exhibiting mild-to-moderate treatment-related adverse events
in-line with previous findings, highlighting the well-managed
safety profile that makes AFM24 a candidate for combination
approaches. One Grade 5 (pneumonitis) adverse event was reported in
a patient with progressive disease and multiple comorbidities;
however, since relation to AFM24 could not be ruled out it is
deemed treatment related. Although the formal continuation criteria
for the cohort were not met, these data provide proof of concept
that targeting NK cells can induce remission in patients with
especially hard-to-treat solid tumors.
“We believe that AFM24 can be an important addition to the
treatment armamentarium for addressing EGFR mutant tumors as the
early anti-tumor effects support further evaluation in a
combination setting with the goal of achieving meaningful patient
benefit. That is why we are adding an EGFR mutant NSCLC cohort to
our ongoing phase 1/2 study in combination with Roche’s PD-L1
checkpoint inhibitor atezolizumab,” said Dr. Andreas Harstrick,
Chief Medical Officer at Affimed. “Our broad AFM24 program aimed at
identifying the right therapeutic settings and indications, and we
believe that the data generated to date allow us to build the right
path forward to maximize patient benefit.”
Strategic Development of AFM24
Based on the totality of the data accumulated for AFM24 to date,
Affimed will focus its near-term development efforts on advancing
AFM24 in combination with checkpoint inhibitors as part of its
ongoing AFM24-102 study to further investigate the synergies
between AFM24 and atezolizumab. Enrollment in the AFM24-101
monotherapy study will be concluded. An expansion cohort
investigating EGFR mutant NSCLC will be added to AFM24-102 based on
the encouraging signals observed in AFM24-101. Enrollment for the
AFM24-102 combination study is ongoing with early encouraging case
studies from the dose escalation supporting the hypothesis of
combining innate and adaptive immunotherapy approaches in
EGFR-positive solid tumors. An initial data update from the dose
escalation and expansion part of the study is expected in the
second half of 2023.
AFM24 is also currently being investigated in combination with
an autologous NK cell product together with NKGen Biotech. The dose
escalation part of this study is ongoing and initial data are
expected to be available in H2 2023. Affimed and NKGen have
mutually decided to discontinue the study. In line with Affimed’s
NK cell combination experience for AFM13, the Company will evaluate
the best options to advance this project with an allogeneic
off-the-shelf NK cell product which the Company expects to be
better suited for combination with AFM24 in a highly advanced
patient population.
The Company will provide further details, including data from
all three AFM24 monotherapy cohorts, and guidance on the clinical
development plan for AFM24 in a conference call and webcast
scheduled today.
Conference Call and Webcast
InformationAffimed will host a conference call and webcast
on June 3, 2023, at 6:00 p.m. CDT / 7:00 p.m. EDT to review the
monotherapy data and provide a strategic update on the AFM24
program going forward.
The conference call will be available via phone
and webcast. The live audio webcast of the call will be available
in the “Webcasts” section on the “Investors” page of the Affimed
website
at https://www.affimed.com/investors/webcasts-and-corporate-presentation/.
To access the call by phone, please use
link:https://register.vevent.com/register/BIca5147f060da49d5963a0b00a7bc8a66 and
you will be provided with dial-in details and a pin number.
Note: To avoid delays, we
encourage participants to dial into the conference call 15 minutes
ahead of the scheduled start time. A replay of the webcast will be
accessible at the same link for 30 days following the call.
More details about the programs for the ASCO Annual Meetings are
available online at www.asco.org
About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE®)
that activates the innate immune system by binding to CD16A on
innate immune cells and EGFR, a protein widely expressed on solid
tumors, to kill cancer cells. Generated by Affimed’s
fit-for-purpose ROCK® platform, AFM24 represents a distinctive
mechanism of action that uses EGFR as a docking site to engage
innate immune cells for tumor cell killing through
antibody-dependent cellular cytotoxicity and antibody-dependent
cellular phagocytosis.
Affimed is evaluating AFM24 as monotherapy and in combinations
with other cancer treatments in patients with advanced
EGFR-expressing solid malignancies whose disease has progressed
after treatment with previous anticancer therapies.
AFM24-101, a monotherapy, first-in-human phase 1/2a open-label,
is a non-randomized, multi-center, multiple ascending dose
escalation and expansion study. Additional details may be found at
www.clinicaltrials.gov using the identifier NCT04259450.
AFM24 is also being evaluated in a phase 1/2a study in
combination with Roche’s PD-L1 checkpoint inhibitor atezolizumab
(AFM24-102, NCT05109442).
Furthermore, Affimed and NKGen Biotech are investigating AFM24
in combination with NKGen Biotech’s NK cell SNK01 in a phase 1/2a
study (AFM24-103, NCT05099549).
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology
company committed to giving 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 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 the Company’s
intentions, beliefs, projections, outlook, analyses and current
expectations concerning, among other things, the potential of
AFM13, AFM24, AFM28 and the Company’s other product candidates, the
value of its ROCK® platform, its ongoing and planned preclinical
development and clinical trials, its collaborations and development
of its products in combination with other therapies, the timing of
and its ability to make regulatory filings and obtain and maintain
regulatory approvals for its product candidates, its intellectual
property position, its collaboration activities, its ability to
develop commercial functions, clinical trial data, its results of
operations, cash needs, financial condition, liquidity, prospects,
future transactions, growth and strategies, the industry in which
it operates, the macroeconomic trends that may affect the industry
or the Company, such as the instability in the banking sector
experienced in the first quarter of 2023, impacts of the COVID-19
pandemic, the benefits to Affimed of orphan drug designation, the
impact on its business by political events, war, terrorism,
business interruptions and other geopolitical events and
uncertainties, such as the Russia-Ukraine conflict, the fact that
the current clinical data of AFM13 in combination with NK cell
therapy is based on AFM13 precomplexed with fresh allogeneic cord
blood-derived NK cells from The University of Texas MD Anderson
Cancer Center, as opposed to Artiva’s AB-101 and other
uncertainties and factors described under the heading “Risk
Factors” in Affimed’s filings with the SEC. Given these risks,
uncertainties, and other factors, you should not place undue
reliance on these forward-looking statements, and the Company
assumes no obligation to update these forward-looking statements,
even if new information becomes available in the future.
Investor Relations Contact
Alexander FudukidisDirector, Investor
RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102
Media Contact
Mary Beth Sandin Vice President, Marketing and
CommunicationsE-Mail: m.sandin@affimed.com
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