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
publication of two abstracts with its innate cell engager (ICE®)
AFM24 in advance of the American Society of Clinical Oncology
(ASCO) Annual Meeting, taking place on June 2 - 6, 2023 in Chicago,
IL.
As of the December cut-off data for the abstract, 14 patients
were enrolled in the EGFR mutant NSCLC cohort and the best
objective response in 10 evaluable patients was a confirmed partial
response in 1 patient (change from baseline -45%); 4 patients
exhibited stable disease of which two had tumor shrinkage. AFM24
exhibited a well-managed safety profile and the most common
treatment-related adverse events (TRAE) observed were mild to
moderate infusion-related reactions (IRRs).
Updated data with a cut-off date of mid-April 2023 will be
presented by Dr. Anthony El-Khoueiry, Associate Director of
Clinical Research at USC Norris Comprehensive Cancer Center, at
ASCO on June 3, 2023 during the poster session on Developmental
Therapeutics – Immunotherapy (8:00 - 11:00 a.m. CDT). Dr.
El-Khoueiry’s presentation will include data from 15 evaluable
patients.
“The data we are generating in this study and our ongoing
combination studies will guide our decisions in identifying the
right indications and treatment regimens in which AFM24 can provide
the most value for patients. We are encouraged to see clinical
activity with AFM24 monotherapy in highly advanced NSCLC patients
who have failed prior lines of therapy,” said Dr. Andreas
Harstrick, Chief Medical Officer at Affimed. “These data show that
our mechanism of targeting NK cells is biologically relevant in the
quest to find innovative treatment strategies for patients
suffering from difficult to treat solid tumors. We look forward to
providing an update on our strategic development plan for AFM24 at
ASCO.”
As of the December cut-off date, 16 patients with Stage 4 CRC
were enrolled and treated with AFM24 with a median treatment
duration of 5.1 weeks. No objective responses were observed. Seven
patients remained on treatment as of the cut-off date, including 1
patient with confirmed stable disease ongoing for 5 months
exhibiting a tumor reduction of 17%. Treatment was adequately
tolerated with IRRs being the most common TRAEs.
Conference Call and Webcast
InformationAffimed will host a conference call and webcast
on June 3, 2023, at 6:00 p.m. CDT / 7:00 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: 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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