Purple Biotech's Chief Executive Officer Gil Efron Issued A Letter To Shareholders Highlighting The Company's Scientific Progress, Operational Execution, And Strategic Milestones During 1H 2025

Author: Benzinga Newsdesk | July 24, 2025 07:29am

2025 First Half Highlights

CM24 (α-CEACAM1 monoclonal antibody)

• Our Phase 2 dataset demonstrated strong objective response rates (ORR) in biomarker-enriched subgroups of second line PDAC patients, as outlined below. These results suggest compelling efficacy signals. Importantly, these findings reinforce the potentially significant role of our identified biomarkers in guiding future patient selection and clinical trial design. 
  • ORR for the intent-to-treat (ITT) group: 25% versus 7% in control group
  • ORR in biomarker-enriched subgroups: 37.5% (with serum or tumor CEACAM1 levels) and 31% (with serum CEACAM1 or myeloperoxidase (MPO) levels) versus 0% in control group.
• Completed final analysis of our Phase 2 study in second-line PDAC and presented results at AACR 2025:
  • Progression-free survival (PFS): hazard ratio (HR)=0.75 in the ITT group; biomarker-enriched subgroups HR=0.22 and 0.39
  • Overall survival (OS): HR=0.81 in the ITT group; biomarker-enriched subgroups HR=0.05 and 0.28

We believe that these results support the advancement of a future biomarker-driven Phase 2b study, with the potential for improved outcomes.

CAPTN-3 Tri-Specific Antibody Platform

• Presented comprehensive in vivo and ex vivo data at EACR 2025, highlighting the synergistic activity of the platform's masked CD3, NKG2A, and tumor-associated antigen arms.
• Novel capping technology demonstrated potential to enhance safety and potency.

Platform was spotlighted by Dr. Amir Horowitz at ASGCT 2025 for its approach to targeting the HLA-E/NKG2A axis to selectively activate NK and CD8+ T cells, potentially addressing treatment resistance.

NT219 (IRS1/2 degrader & STAT3 blocker)

• Initiated a Phase 2 combination study with PD-1 or EGFR inhibitors, in collaboration with the University of Colorado
• Biomarker insights (pIGF1R, pSTAT3) from the Phase 1 trial were presented at AACR 2025.

Upcoming Catalysts

• Plan to advance CM24 into a biomarker-driven Phase 2b study in second-line PDAC targeting approximately 165 patients
• Targeting investigational new drug (IND) application submission to the U.S. Food and Drug Administration for the first development candidate from our novel CAPTN-3 platform in 2026, with plans to initiate first-in-human trials following IND approval.
• Expect to generate interim NT219 Phase 2 data in 2026, alongside new preclinical data for next-generation assets.

We maintained disciplined cash management in the first half of 2025, and currently expect our financial runway to extend into mid-2026. Additional funding will be required to support the execution of future clinical studies.

Posted In: PPBT