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 data
updates from two phase 1/2a trials with AFM24, the company’s
tetravalent, bispecific innate cell engager (ICE®), in patients
with solid tumors. AFM24 binds both EGFR on tumor cells and CD16A
on natural killer (NK) cells and macrophages, thereby facilitating
the killing of EGFR-positive tumor cells. Abstracts for the
upcoming data presentations at the 37th Annual Meeting of the
Society for Immunotherapy of Cancer (SITC) were published today.
The full updated clinical data sets will be presented in two poster
presentations on November 10 and November 11, 2022 and will be made
available through the following link on Affimed’s website:
Publications and Posters - Affimed
“The new data presented at this conference demonstrate that
AFM24 is capable to activate the innate but also the adaptive
immune response in cancer patients while showing a very good safety
profile. We are also very encouraged by the early efficacy data
that we observe with the combination of AFM24 and atezolizumab,”
said Andreas Harstrick, M.D., Affimed’s Chief Medical Officer. “We
look forward to the ongoing investigation of AFM24 in both trials
as a new treatment option for a patient population that is in
desperate need of effective therapies.”
Poster Number 729: Targeting Epidermal Growth Factor
Receptor (EGFR)-Expressing Solid Tumors With AFM24, A Novel
CD16A Bispecific Innate Cell Engager: Comprehensive
Correlative Science Findings From A Phase 1 Study
The first poster presentation includes correlative science
findings from the phase 1 part of the ongoing monotherapy phase
1/2a study (NCT04259450) evaluating the safety and efficacy of
AFM24 in patients with metastatic, treatment-refractory
EGFR-positive solid tumors. In total, 35 patients with a range of
tumor types were treated to date including patients with colorectal
cancer (19/35), non-small cell lung cancer (8/35) and other solid
tumors (8/35) were treated.
NK cells in peripheral blood showed upregulation of activation
markers which coincided with transient loss of NK cells from
peripheral blood. This indicates migration of NK cells to the
tumor. In addition, cytotoxic CD8-positive T-cell levels increased
in the tumor, pointing to a crosstalk with the adaptive immune
system.
In all patients, AFM24 monotherapy demonstrated a well-managed
safety profile.
Poster Number 745: AFM24 and atezolizumab combination in
patients with advanced epidermal growth
factor receptor-expressing (EGFR-positive) solid tumors:
Initial results from the Phase 1 dose-escalation
study
The second poster to be presented at SITC will include a data
update from the phase 1/2a combination study (NCT05109442)
evaluating AFM24 together with Roche’s PD-L1 checkpoint inhibitor
atezolizumab (Tecentriq®) in patients with advanced,
treatment-refractory EGFR+ solid tumors. The aim of the two-part
study is to establish the recommended phase 2 dose (RP2D) of AFM24
in combination with atezolizumab as well as to assess initial data
on the efficacy and safety of AFM24 in combination with
atezolizumab.
So far, four patients with gastric (1/4) or pancreatic (3/4)
adenocarcinomas have been enrolled in the first dose cohort, with
three completing the safety lead-in phase and receiving 160 mg
AFM24 and atezolizumab. The preliminary data indicate that the
combination of AFM24 and atezolizumab is a promising approach, with
no dose-limiting toxicities observed.
Among three patients evaluated in cohort 1, clinical activity
was observed in two patients, while one patient awaited tumor
assessment at cut-off date. One ongoing partial response was
observed in a patient with gastric cancer and skin metastases who
had rapidly progressed following four prior lines of therapy,
including a PD-1 inhibitor, and an ongoing stable disease at 4+
months with symptomatic improvement was observed in a patient with
pancreatic adenocarcinoma. Dose escalation is proceeding with an
AFM24 dose of 480 mg.
Combining AFM24 with atezolizumab may synergistically enhance
the innate and adaptive immune responses, respectively, to target
EGFR-positive tumors.
For more information as well as to access the full abstracts,
please visit
https://www.sitcancer.org/2022/abstracts/abstracts2022.
Both posters will be made available on Affimed’s website as of
November 10, 2022, in line with SITC’s embargo policy.
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 combination
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 initiated a phase 1/2a
study (AFM24-103), investigating AFM24 in combination with NKGen
Biotech’s NK cell SNK01 (NCT05099549).
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.
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 Tel.: +1 (484)
888-8195
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