Sone-214 !new! Jun 2026

Sone-214 represents an exciting new development in cancer treatment, with its novel mechanism of action targeting the c-MET signaling pathway offering a promising approach to the treatment of various types of cancer. As clinical trials continue to evaluate the efficacy and safety of Sone-214, this small molecule inhibitor may emerge as a valuable addition to the oncology armamentarium, providing new hope for patients seeking effective and targeted cancer therapies.

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| Phase | Status | Key Milestones | |-------|--------|----------------| | | Completed 2022 (GLP tox, CMC) | IND submission to FDA (March 2023) | | Phase I (first‑in‑human, healthy volunteers) | Completed (Oct 2023) | • Single‑ascending dose (SAD) up to 150 mg – tolerable. • PK: Cmax at 2 h; half‑life ≈ 7 h; linear exposure 10‑150 mg. • PD: IFN‑β ↑ 3‑5‑fold at 50 mg; IL‑6 unchanged. • No serious adverse events (SAEs). | | Phase I/IIa (oncology – solid tumors) | Ongoing (as of Apr 2024) | • Open‑label, dose‑escalation (25‑100 mg PO daily) in patients with advanced melanoma, NSCLC, and pancreatic cancer. • Primary endpoint: safety/tolerability; secondary: ORR, PFS, immune‑gene signatures. | | Phase IIb (combination with anti‑PD‑1) | Planned for H2 2025 | • Multi‑center, randomized (SO‑214 + pembrolizumab vs. pembrolizumab alone) in refractory melanoma and head‑and‑neck SCC. | | Regulatory | IND active; fast‑track designation granted (FDA, Dec 2023) for “immunogenic tumor conversion”. | | Is it related to technology, construction, automotive, or

| Species | NOAEL (No‑Observed‑Adverse‑Effect Level) | Key observations | |---------|------------------------------------------|-------------------| | Rat (28‑day repeat dose) | 30 mg/kg/day PO | No clinical chemistry changes; mild lymphoid hyperplasia reversible after wash‑out | | Cynomolgus monkey (14‑day repeat dose) | 10 mg/kg/day PO | No cytokine storm; transient ↑ in IFN‑β (peak 12 h post‑dose) without fever; no cardiac or hepatic toxicity | | Safety pharmacology (hERG, CNS) | No effect up to 100 µM | No QT prolongation; no sedation or motor impairment in rotarod assay |

No weight loss > 5 % at the highest tested dose (60 mg/kg). Serum ALT/AST ≤ 1.2× baseline. Histopathology showed only mild, transient splenic hyperplasia (consistent with IFN response).

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