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, announced today that
three abstracts of clinical trial designs of its AFM24 innate cell
engager (ICE®) have been published and will be presented at the
American Society of Clinical Oncology (ASCO) Annual Meeting, taking
place on June 3-7, 2022 in Chicago, IL.
"We recognize the challenges in treating EGFR-expressing solid
tumors and believe our broad approach in developing AFM24 is an
important step in finding alternative treatments for the many
patients suffering from severe cancers that have progressed after
treatment with current therapies,” said Dr. Andreas Harstrick,
Chief Medical Officer at Affimed. “We are very excited to have
these trial designs showcased at ASCO illustrating why we believe
AFM24 can provide a promising alternative to current
treatments.”
The Trial in Progress posters provide background information and
introduce the study designs of the three ongoing AFM24 studies in
which patients with a variety of EGFR-positive solid tumors are
treated with AFM24 monotherapy or in combinations with either
Roche’s checkpoint inhibitor, atezolizumab, or NKGen Biotech’s
autologous NK cell product, SNK01.
Affimed’s ICE® molecules are tetravalent, bispecific and
therefore can bind to tumor cell-surface antigens and CD16A
expressed on natural killer (NK) cells and macrophages, inducing
antibody-dependent cellular cytotoxicity (ADCC) and antibody
dependent cellular phagocytosis (ADCP), respectively.
AFM24 activates the innate immune system to kill cancer cells by
binding to CD16A on innate immune cells and EGFR, a protein widely
expressed on solid tumors.
Details about the Abstracts
The AFM24 monotherapy study
(NCT04259450) abstract
includes information about the dose-escalation phase of the
study.
AFM24 utilizes the patient’s innate immunity to redirect and
activate immune cells, overcoming resistance to current therapies.
The primary mode of action of AFM24 is to redirect NK cells and
macrophages to EGFR+ tumor cells inducing antibody-dependent
cellular cytotoxicity and antibody-dependent cellular phagocytosis,
respectively. Preclinical studies showed AFM24 induced killing of
EGFR+ tumor cell lines independent of EGFR expression level and
independent of mutations in the EGFR signaling pathway. In vivo
studies in cynomolgus monkeys demonstrated a favourable safety
profile.
An ongoing phase 1/2a, first-in-human study is evaluating AFM24
in patients with locally advanced or metastatic, treatment
refractory solid tumors that are known to express EGFR. The phase 1
dose escalation study was designed to establish the maximum
tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of
AFM24 and evaluate the safety, efficacy, immunogenicity,
pharmacokinetic (PK) and pharmacodynamic (PD) responses.
AFM24 was administered intravenously once weekly until disease
progression, intolerable toxicity, patient withdrawal, or
termination of treatment at investigator’s discretion. AFM24 had a
well-managed safety profile and the RP2D was established at 480
mg.
In parallel to the continuing dose escalation phase (cohort 7 at
720 mg), a phase 2a dose expansion study was initiated, and the
first patient was enrolled in January 2022. This Simon two-stage
study will assess AFM24 at the RP2D in patients with different
EGFR-expressing tumors. The trial will progress to the second stage
unless the null hypothesis, that the true tumor response rate is
below a specific value, is confirmed at the end of stage one.
Eligible patients must have positive histological or cytological
staining of EGFR in >1% of tumor cells. The primary endpoint of
the study is to establish the overall response rate in three
disease-specific cohorts. These include patients with clear cell
renal cell carcinoma (ccRCC), KRAS wild-type colorectal cancer
(KRASwt CRC) and EGFR-mutant non-small cell lung cancer (EGFRmut
NSCLC). Secondary endpoints include treatment-emergent adverse
events, serious adverse events, PK, PD, and immunogenicity.
Authors: Omar Saavedra Hadea, Elena Garralda,
Juanita Suzanne Lopez, Mark M. Awad, Jacob Stephen Thomas, Crescens
Diane Tiu, Daniela Morales-Espinosa, Christa Raab, Bettina Rehbein,
Gabriele Hintzen, Kerstin Pietzko, Paulien Ravenstijn, Michael
Emig, Anthony B. El-Khoueiry
The AFM24 combination with atezolizumab
study
(NCT05109442)
abstract details the trial design and rationale
for the combination study of AFM24 and atezolizumab in patients
with advanced EGFR-expressing solid tumors.
Anti-programmed death-ligand 1 (PD-L1) immune checkpoint
inhibitors which enhance anti-tumor activity of a patient’s
adaptive immunity, have already demonstrated efficacy as
monotherapy and are playing an increasingly prominent role in
cancer treatment. The combination of AFM24 and PD-L1 inhibitor,
atezolizumab, may represent a promising new treatment modality,
enhancing both the innate and adaptive immune responses to target
EGFR+ tumor cells.
An ongoing phase 1/2a open-label, non-randomized, multicenter,
dose escalation (phase 1) and dose expansion (phase 2) study was
initiated in November 2021 to evaluate the safety, tolerability and
efficacy of AFM24 in combination with atezolizumab. The primary aim
of the phase 1 study is to determine the maximum tolerated dose and
the RP2D of AFM24. Eligible patients must have advanced,
histologically confirmed EGFR+ disease and confirmed disease
progression after treatment with ≥1 prior therapy.
A standard 3+3 design will be used to determine the RP2D.
Escalating doses of AFM24 will be given to each cohort as weekly
intravenous (IV) infusions. The starting dose and at least two
planned dose escalations are based on results from the ongoing
AFM24 monotherapy trial. Atezolizumab is given at a fixed dose of
840 mg biweekly IV infusion. Patients will receive AFM24 and
atezolizumab treatment until disease progression, intolerable
toxicity, patient withdrawal, or termination of treatment at
investigator’s discretion.
The phase 2a study will establish the overall response rate and
safety of the combination therapy in patients with
advanced/metastatic, or treatment refractory gastric,
esophagogastric, hepatocellular, hepatobiliary, pancreatic, or
non-small cell lung cancer.
For both phases, secondary endpoints include treatment-emergent
adverse events, serious adverse events, pharmacokinetics (PK),
pharmacodynamics (PD), and immunogenicity.
Authors: Omar Saavedra Hadea, Eric Christenson,
Anthony B. El-Khoueiry, Andreas Cervantes, Christa Raab, Ulrike
Gartner, Kerstin Pietzko, Gabriele Hintzen, Paulien Ravenstijn,
Daniela Morales-Espinosa, Juanita Suzanne Lopez
The AFM24 combination study with SNK01 autologous
natural killer cells
(NCT05099549) includes
information about the dose-escalation and dose-expansion phase of
AFM24 in combination with SNK01 autologous NK cells in patients
with advanced EGFR+ solid tumors.
Autologous NK cell transfer represents a promising treatment
strategy, with ex vivo expansion and activation enhancing the
specificity and anti-tumor activity of NK cells. The efficacy of
this approach may be enhanced through the addition of
tumor-targeting antibodies, augmenting NK-cell mediated ADCC.
An ongoing phase 1/2a open-label, non-randomized, multicenter,
dose escalation (phase 1) and dose expansion (phase 2) study were
initiated in November 2021 to evaluate the safety, tolerability and
efficacy of AFM24 in combination with SNK01 autologous NK cells in
patients with advanced EGFR+ solid tumors.
The primary aim of the phase 1 study is to determine the maximum
tolerated dose and RP2D of AFM24 in combination with SNK01 at a
fixed dose of NK cells using a standard 3+3 design.
Eligible patients must have advanced or metastatic disease with
positive immunohistochemical staining for EGFR in > 1% of tumor
cells and be refractory to standard-of-care treatment.
AFM24 is administered at an escalating dose as weekly
intravenous (IV) infusions; the starting dose (160 mg) and the dose
escalations for each cohort are based on the results from the
ongoing monotherapy trial. SNK01 NK cells are given at a fixed dose
as a weekly IV infusion, concomitantly with AFM24.
Patients will receive the combination therapy until disease
progression, intolerable toxicity, patient withdrawal, or
termination of treatment at investigator’s discretion.
Phase 2 will establish the overall response rate of combination
therapy in patients with treatment refractory, advanced or
metastatic squamous cell carcinoma of the head and neck, non-small
cell lung cancer, or colorectal cancer as the primary endpoint.
Efficacy will also be measured by assessing progression-free and
overall survival. Secondary endpoints for both phases include
treatment-emergent adverse events, serious adverse events,
pharmacokinetics and immunogenicity.
Authors: Anthony B. El-Khoueiry, Paul Y. Song,
Jennifer Rubel, Dorna Y. Pourang, Christa Raab, Gabriele Hintzen,
Michael Emig, Pilar Nava-Parada
More details about the program for the ASCO Annual Meeting 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 in patients with advanced
EGFR-expressing solid malignancies whose disease has progressed
after treatment with previous anticancer therapies as monotherapy
and in combinations with other cancer treatments. 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.
Furthermore, AFM24 is being evaluated in a phase 1/2a study in
combination with Roche’s anti-PD-L1 checkpoint inhibitor
atezolizumab (AFM24-102, NCT05109442). Affimed and NKGen Biotech
have initiated a phase 1/2a study (AFM24-103), investigating AFM24
in combination with SNK01, NKGen Biotech’s autologous NK cell
product (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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