Full Press Release Details
Purple Biotech Reports Potential Biomarker Data
Support CM24's Mechanism of Action
Israel, Oct. 06, 2023 (GLOBE NEWSWIRE) -- 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
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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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 commercialization involves a lengthy
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Chief Financial Officer