On June 1, 2024 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 and immune system to overcome tumor immune evasion and drug resistance, reported positive interim data from its randomized, controlled, open label, multicenter Phase 2 study of CM24 in second-line metastatic pancreatic ductal adenocarcinoma (PDAC) presented at a late-breaking abstract poster presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Purple Biotech, JUN 1, 2024, View Source;id=308199&p=2326565&I=1206939-c7Z3G6f3m8 [SID1234643938]).

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"These exciting interim data demonstrate the potential of CM24 in combination with nivolumab plus the standard-of-care chemotherapy regimen Nal-IRI/5FU/LV to improve clinical outcomes for advanced metastatic PDAC patients. We are highly encouraged by the meaningful results of our primary endpoint, Overall Survival, as well as by the concordant and consistent improvement in all secondary endpoints including PFS, ORR, DCR and CA19-9" stated Gil Efron, Chief Executive Officer of Purple Biotech.

Michael Cecchini, MD Assistant Professor of Medicine at the Yale Cancer Center, a principal investigator in this study, commented, "As a clinician, it is encouraging to see these interim data in the Nal-IRI arm suggesting the potential for improved clinical outcomes for patients with late-stage metastatic PDAC who are in dire need of new effective therapies. These patients face very limited time with their families, and the prospect of potentially lengthening their lives while delaying their disease progression by approximately two months overall is clinically meaningful. These data justify further investigation of CM24 in combination with nivolumab together with standard-of-care chemotherapy to potentially improve outcomes for patients facing a very poor prognosis from this type of tumor".

The Phase 2 study is evaluating CM24, a novel first-in-class multi-functional anti-CEACAM1 antibody, in combination with Bristol Myers Squibb’s immune checkpoint inhibitor nivolumab plus SoC chemotherapy in second-line PDAC patients versus SoC chemotherapy alone. CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein responsible for tumor immune evasion and poor tumor response and/or resistance to immune checkpoint inhibitors. The primary endpoint of the study is OS and the secondary endpoints include PFS, ORR and DCR. A Bayesian methodology was used to estimate the magnitude of effect of the experimental arm versus the SoC arm and the study is not powered for hypothesis testing. A total of 63 patients have been enrolled, across 18 centers in the U.S., Spain, and Israel in 2 parallel independent randomized study cohorts (total of 2 arms per cohort). The experimental arms administered patients with CM24 plus nivolumab and a choice of one of two SoC chemotherapies for second-line PDAC, dependent on prior first line therapy regimen; either gemcitabine/nab-paclitaxel or liposomal irinotecan (Nal-IRI)/5-fluorouracil (5-FU) and leucovorin (LV) (Nal-IRI/5FU/LV), while the control arms administered either respective chemotherapy alone. CA19-9 as well as additional exploratory biomarkers are also being evaluated. Of the 63 patients enrolled, 32 were in the gemcitabine/nab-paclitaxel study (experimental and control) and 31 were in the Nal-IRI/5FU/LV study (experimental and control). An analysis of the gemcitabine/nab-paclitaxel study will be performed when the data are sufficiently mature. Topline final data are expected by the end of 2024.

The study interim efficacy results as of the cutoff date of May 8, 2024, are summarized in the following table:

Metric CM24 + Nivolumab + Nal/IRI/5FU/LV Arm
(n = 16) Nal/IRI/5FU/LV Arm
(n = 15)
Hazard ratio for OS 0.74 (95% CI: 0.31-1.77)
Median OS 7.72 months 5.62 months
6 months OS rate 53% 39%
Hazard Ratio for PFS 0.72 (95% CI: 0.33-1.60)
Median PFS 3.8 months 1.9 months
3 months PFS rate 60% 47%
6 months PFS rate 19% 10%
ORR 25% 7%
DCR 63% 40%
A consistent and continuous decrease of CA19-9, a validated and clinically predictive PDAC biomarker, was observed in the experimental arm (61% on average) vs. an increase in the control arm (34% on average).

The CM24+nivolumab+Nal/IRI/5FU/LV regimen was well tolerated, with the most frequent treatment emergent Grade 3 or higher adverse events being diarrhea (19%), fatigue (19%) and anemia (6%).