pp-063 Solution for infusion

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
Comments
"Indication: Solid tumors and neurological conditions associated with xCT-dependent metabolic vulnerability, including newly diagnosed metastatic colorectal cancer (mCRC) in combination therapy, pediatric DIPG/DMG (diffuse glioma types) with radiation, and chemotherapy-induced peripheral neuropathy (CIPN) under monotherapy evaluation. Clinical stage: Phase 2 clinical development across oncology and neurology programs, including combination therapy for mCRC and DIPG/DMG, and monotherapy proof-of-concept studies for CIPN. Modality: Biologic therapeutic (protein/peptide-based) Mechanism / Target: Modulates the xCT (SLC7A11) cystine/glutamate antiporter, disrupting cystine uptake and glutathione production to induce oxidative stress and ferroptotic death in xCT-dependent tumor cells while supporting targeted metabolic effects in neural tissues. Route / form: Intravenous infusion Differentiation: First-in-class xCT-modulating therapeutic advancing in both high-need oncology indications and non-oncology neuropathy; demonstrates versatility in combination regimens for aggressive tumors and meaningful potential in monotherapy for CIPN, expanding its partnering and clinical value.
Manufacturer #38617

A clinical-stage biopharmaceutical company advancing a novel biologic therapy targeting solid tumors and chemotherapy-induced peripheral neuropathy through modulation of sphingolipid metabolism. It focuses on innovative cancer treatment mechanisms with global development and strategic research collaborations. The organization progresses multiple clinical programs aimed at unmet oncology needs.