Purple Biotech Reports Potential Biomarker Data Support CM24’s Mechanism of Action
2023年10月6日 - 8:50PM
Purple Biotech Ltd. ("Purple Biotech" or "the Company")
(NASDAQ/TASE: PPBT), a clinical-stage company developing
first-in-class therapies that harness the power of the tumor
microenvironment to overcome tumor immune evasion and drug
resistance, today reported new biomarker data for its lead oncology
drug, CM24, a first-in-class anti-CEACAM1 monoclonal antibody. Data
were presented at the American Association for Cancer Research
(AACR) Special Conference: Pancreatic Cancer in Boston in a
scientific poster titled: “Phase 1 Study of CM24 in Combination
with Nivolumab in Patients with Advanced Pancreatic Cancer –
Survival, Exploratory Biomarkers and Effect on Neutrophil
Extracellular Traps (NETs)”.
The poster shows that higher pre-treatment
levels of tumor infiltrating lymphocytes that express CEACAM1may
associated with longer survival in patients treated with CM24 and
nivolumab.
In addition, the poster shows high expression of
CEACAM1 on neutrophils and NETs , and enhanced levels of serum NETs
in PDAC patients, and demonstrates for the first time that CM24
treatment significantly reduced the level of NET marker in
patients’ serum.
“These encouraging data, demonstrating increased
survival of PDAC patients whose biopsies show higher
CEACAM1-positive lymphocytes, are consistent with the CM24
Mechanism of Action (MoA) in suppressing the immune evasion and
suggest CEACAM1 expressing lymphocytes as a potential biomarker for
CM24 therapy” said Purple Biotech VP R&D, Dr. Hadas Reuveni.
“In addition, the significant reduction in the levels of NETs in
patients’ serum following treatment with CM24 suggests a novel MoA
that may reduce NET-related complications, especially relevant in
PDAC patients, and may be used as a potential pharmacodynamic
marker for CM24.”
The CM24 and nivolumab combination has shown in
phase 1 encouraging initial activity and safety profile in PDAC
patients who have progressed after second-line therapy. CM24’s
novel target is CEACAM1, which is overexpressed on tumor cells and
infiltrating immune cells.
CM24 is now being evaluated in a randomized
Phase 2 study (NCT04731467) in combination with Bristol Myers
Squib’s nivolumab plus standard of care (SoC) chemotherapy, as a
second line treatment for pancreatic ductal adenocarcinoma (PDAC).
The primary endpoint is overall survival of patients treated with
CM24 in combination with nivolumab and SoC chemotherapy vs. SoC
chemotherapy alone.
“NETs and CEACAM1 will continue to be monitored
and investigated in our ongoing randomized Phase 2 study of CM24 in
pancreatic cancer patients,” stated Purple Biotech CEO, Gil Efron.
“We look forward to reporting data from this study in the near
term.”
The full poster can be viewed on the Purple
Biotech website
at https://purple-biotech.com/pipeline/#1Publications.
About Purple Biotech
Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a
clinical-stage company developing first-in-class therapies that
seek to overcome tumor immune evasion and drug resistance. The
Company's oncology pipeline includes NT219, CM24 and IM1240. NT219
is a dual inhibitor, novel small molecule that simultaneously
targets IRS1/2 and STAT3. In a Phase 1/2 study of NT219, the
Company is currently advancing it in a dose escalation as a
monotherapy treatment of solid tumors, and in a dose escalation in
combination with cetuximab for the treatment of recurrent and
metastatic squamous cell carcinoma of the head and neck (SCCHN) or
colorectal adenocarcinoma (CRC). These studies will be followed by
an expansion phase of NT219 at its recommended Phase 2 level in
combination with cetuximab in patients with recurrent and
metastatic SCCHN. CM24 is a humanized monoclonal antibody that
blocks CEACAM1, an immune checkpoint protein that supports tumor
immune evasion and survival through multiple pathways. The Company
is advancing CM24 as a combination therapy with anti-PD-1
checkpoint inhibitors in a Phase 2 study for the treatment of
pancreatic ductal adenocarcinoma (PDAC). The Company has entered
into a clinical collaboration agreement with Bristol Myers Squibb
for the Phase 2 clinical trials to evaluate the combination of CM24
with the PD-1 inhibitor nivolumab in addition to chemotherapy.
IM1240 is a preclinical, conditionally-activated tri-specific
antibody that engages both T cells and NK cells to mount a strong,
localized immune response within the tumor microenvironment. The
third arm specifically targets the Tumor Associated Antigen (TAA)
5T4 that is expressed in a variety of solid tumors and is
correlated with advanced disease, increased invasiveness and poor
clinical outcomes. IM1240 has a cleavable capping technology that
confines the compound's therapeutic activity to the local tumor
microenvironment, and thereby potentially increases the anticipated
therapeutic window in patients. The Company's corporate
headquarters are located in Rehovot, Israel. For more information,
please visit https://purple-biotech.com/.
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and are subject to a number of assumptions, involve known and
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future results, performance or achievements expressed or implied by
the forward-looking statements. Important factors that could cause
or contribute to such differences include, among others, risks
relating to: the plans, strategies and objectives of management for
future operations; product development for NT219, CM24 and IM1240;
the process by which such early stage therapeutic candidates could
potentially lead to an approved drug product is long and subject to
highly significant risks, particularly with respect to a joint
development collaboration; the fact that drug development and
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CONTACTS:
Company Contact: Lior Fhima Chief Financial
Officer IR@purple-biotech.com
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