pp-194 Solution for infusion

Dossier type
CTD
Dossier status
Under development
Country of origin
Israel
GMP approvals
Israel
Comments
Indication: Pancreatic ductal adenocarcinoma (PDAC) — Phase 2b planned in combination with chemotherapy Clinical stage: Phase 2b — planned H2 2025 (following positive Phase 2a signal) Modality: Biological (first-in-class anti-CEACAM1 monoclonal antibody) Mechanism / Target: First-in-class antibody targeting CEACAM1 (carcinoembryonic antigen-related cell adhesion molecule 1); dual mechanism: (1) blocks CEACAM1-mediated T-cell immune checkpoint restoring cytotoxic T-cell activity; (2) disrupts CEACAM1–EGF receptor oncogenic interaction promoting tumour survival Route / form: IV infusion Differentiation: First-in-class anti-CEACAM1 immunotherapy; dual immune checkpoint and tumour survival blocking mechanism; addresses PDAC — a tumour type resistant to current immunotherapy; Phase 2b planned in pancreatic cancer where no approved immunotherapy exists;
Manufacturer #39334
Israeli clinical-stage company developing Rx first-in-class cancer therapeutics targeting the tumor microenvironment to overcome drug resistance and immune evasion. Biologic pipeline focuses on oncology with combination approaches designed to improve outcomes for solid tumor patients. Publicly listed on international and domestic exchanges with ongoing global clinical trials.
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