pp-084 Solution for infusion

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Advanced solid tumors and hematologic malignancies dependent on anti-apoptotic BCL-2 family signaling, including small cell lung cancer (SCLC), non–small cell lung cancer (NSCLC), and other apoptosis-resistant tumors. Clinical stage: Phase I/II clinical development in multiple tumor settings, evaluating both monotherapy and combination regimens. Modality: Small-molecule targeted therapy Mechanism / Target: Dual inhibitor selectively targeting BCL-2 and BCL-XL to restore apoptotic activity in cancer cells by disrupting survival signaling pathways. Route / form: Intravenous formulation Differentiation: Engineered to balance potent BCL-2/BCL-XL inhibition while potentially reducing dose-limiting thrombocytopenia commonly associated with BCL-XL blockade; early clinical data support antitumor activity in apoptosis-driven cancers with a tolerability profile favorable for combination strategies.
Manufacturer #38620

A global, clinical-stage biopharmaceutical company discovering, developing and commercializing small-molecule therapies addressing unmet needs in hematological cancers and other serious diseases. It advances programs through international registrational trials with strategic development and partnership goals. The organization integrates R&D and global expansion efforts.