Full Press Release Details
Purple Biotech Reports Final Data from
Phase 2 Study of CM24 in Pancreatic Cancer Patients at AACR 2025 Annual Meeting: Improved Outcomes and Significant Efficacy in Biomarker-Enriched
REHOVOT, Israel, April 30, 2025 (GLOBE NEWSWIRE)
-- Purple Biotech Ltd. ("Purple Biotech" or "the Company")
(NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug
resistance, announced today that a poster presentation titled "Final analysis of the randomized Phase 2 cohort of CM24 with nivolumab
and chemotherapy in pancreatic cancer & potential serum biomarkers" is being presented during the session "Liquid Biopsy:
Circulating Nucleic Acids 4 / Predictive Biomarkers 1" at the Annual Meeting of the American Association of Cancer Research (AACR
2025) on Wednesday, April 30, 2025.
"These statistically significant biomarker
results, with up to a 90% reduction in risk of death over the control group, are highly encouraging and we believe warrant a biomarker-driven
Phase 2b study," stated Purple Biotech CEO Gil Efron. "The new, previously unpublished data presented at AACR demonstrate
significant overall survival (OS) and progression-free survival (PFS) benefit for patients meeting the criteria of either serum CEACAM1
or tumor CEACAM1 biomarkers. With these final data reported, we believe CM24 could potentially be positioned as a therapy targeting CEACAM1
in cancers with large unmet needs."
At AACR 2025, Purple Biotech presented final data
from its randomized, controlled, open-label, multicenter Phase 2 study (NCT04731467),
which established proof of concept in a biomarker-enriched subgroup of 31 patients with advanced/metastatic pancreatic ductal adenocarcinoma
(PDAC) who were post-first line therapy, and compared treatment with CM24 + nivolumab + Nal-IRI/5FU/LV against treatment with Nal-IRI/5FU/LV
The following is a summary of the findings.
The combination of CM24, nivolumab and Nal-IRI/5FU/LV
chemotherapy was well tolerated and demonstrated quantitative improvement in all efficacy parameters, including OS, PFS, objective response
rate (ORR), disease control rate (DCR) and CA19-9, in previously treated PDAC patients.
Without consideration of biomarkers, a consistent
improvement in the treatment arm compared to the control arm was observed, as follows:
Biomarker results included the following:
A statistically significant benefit to patients
with defined pre-treatment ranges of serum CEACAM1 or tumor CEACAM1 expression (H score) compared to the control arm (representing a subgroup
of 52% of patients):
Statistically significant results in patients
with defined pre-treatment serum CEACAM1 or myeloperoxidase (MPO) levels (representing a subgroup of 80% of patients):
A statistically significant benefit for CM24-nivolumab
treatment in patients with high CEACAM1+Tumor cell H score and low PD-L1 CPS (representing a subgroup of 38% of patients):
"The identification of CEACAM1 as a potential
biomarker, both in serum and at the tumor, corresponds with the multi-faceted function of CEACAM1, as part of the neutrophil extracellular
trap (NET) structure affecting NET-related tumor immune evasion, metastasis and other cancer-associated complications, such as thrombosis,
at the level of the whole body, as well as modulation of the tumor microenvironment (TME)," stated Purple Biotech VP of Research
and Development, Dr. Hadas Reuveni. "Targeting CEACAM1 by CM24 suggests a potential new approach that may address tumor-associated
mechanisms affecting the patient at the levels of the tumor, the TME and the whole body. The biomarker data accumulated in this clinical
study may help us to direct the treatment of patients who might have a higher chance to benefit from the treatment and could expand our
understanding of CEACAM1 and NETs in cancer biology."
Final conclusions from the study:
demonstrated quantitative improvement in all efficacy
parameters, including OS, PFS, ORR and CA19-9, in previously treated PDAC patients.
"The design of the randomized trial enabled
us to evaluate the benefit of CM24 and nivolumab in combination with standard of care chemotherapy and to analyze potential biomarker
data to better prepare for the next study." stated Purple Biotech Head of Clinical and Regulatory Affairs, Dr. Michael Schickler.
"We currently expect the design of the next Phase 2b study to include an additional group testing CM24 alone in combination with
standard of care with patients selected based on the identified biomarkers, potentially in indications such as gastric and/or biliary
tract cancer, in addition to PDAC."
The poster will be available at the Publication
section on Purple Biotech's website following its presentation at the conference.
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 CM24, NT219, and CAPTN-3. CM24 is a humanized monoclonal antibody that blocks CEACAM1, which supports tumor immune evasion and
survival through multiple pathways. CEACAM1 on tumor cells, immune cells and neutrophil extracellular traps is a novel target for the
treatment of multiple cancer indications. As proof of concept of these novel pathways, the Company completed a Phase 2 study for the treatment
of pancreatic ductal adenocarcinoma (PDAC) with CM24 as a combination therapy with the anti-PD-1 checkpoint inhibitor nivolumab and chemotherapy,
demonstrating clear and consistent improvement across all efficacy endpoints and the identification of two potential serum biomarkers.
NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose escalation study was concluded
as a monotherapy and in combination with cetuximab, in which NT219 demonstrated anti-tumor activity in combination with cetuximab in second-line
patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). The Company is advancing NT219 into
a Phase 2 study in collaboration with the University of Colorado, to treat R/M SCCHN patients in combination with cetuximab or pembrolizumab.
The Company is advancing CAPTN-3, a preclinical platform of conditionally activated tri-specific antibodies, which engage both T cells
and NK cells to induce a strong, localized immune response within the tumor microenvironment. The cleavable capping technology confines
the compound's therapeutic activity to the local tumor microenvironment, thereby potentially increasing the anticipated therapeutic window
in patients. The third arm specifically targets the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action
by unleashing both innate and adaptive immune systems to mount an optimal anti-tumoral immune response. IM1240 is the first tri-specific
antibody in development that targets the 5T4 antigen, which is expressed in a variety of solid tumors and is associated with advanced
disease, increased invasiveness, and poor clinical outcomes. The Company's corporate headquarters are located in Rehovot, Israel. For
more information, please visit https://purple-biotech.com/.
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reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current
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unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance
or achievements to be significantly different from any 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 commercialization involves a lengthy
and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the
expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect
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including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form 20-F for the
year ended December 31,2024 and in our other filings with the U.S. Securities and Exchange Commission ("SEC"), including our
cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These