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pp-195

Solution for infusion

Dossier type
CTD
Dossier status
Under development
Country of origin
Israel
GMP approvals
Israel
Comments
Indication: Recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) Clinical stage: Phase 2 — ongoing (combination with pembrolizumab) Modality: Small molecule (first-in-class dual signalling inhibitor) Mechanism / Target: First-in-class dual inhibitor of IRS-1/IRS-2 (insulin receptor substrate 1/2) and STAT3 signalling pathways; disrupts two key oncogenic survival cascades simultaneously; reduces resistance to checkpoint inhibitors Route / form: IV infusion Differentiation: First-in-class IRS1/2+STAT3 inhibitor; novel small molecule targeting two distinct tumour survival pathways simultaneously; Phase 2 in SCCHN with combination immunotherapy;
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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