Sone-214 !exclusive! Jun 2026

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| Model | Dosing | Outcome | |-------|--------|---------| | – “cold” tumor | Oral 30 mg/kg QD × 5 days | Tumor growth inhibition (TGI) ≈ 78 %; median survival ↑ 2.8‑fold vs. vehicle | | MC38 colon carcinoma – “hot” tumor | Oral 15 mg/kg QD × 3 days + anti‑PD‑1 (200 µg i.p.) | Combination TGI ≈ 94 %; complete regressions in 4/8 mice | | Syngeneic pancreatic ductal adenocarcinoma (KPC‑derived) | Oral 30 mg/kg QD × 7 days | CD8⁺ T‑cell infiltration ↑ 4.2‑fold; IFN‑γ ELISpot ↑ 3.6‑fold | | HBV transgenic mouse model (viral replication) | Oral 10 mg/kg BID 14 days | Serum HBV DNA ↓ ≈ 2.1 log₁₀; hepatic ISG expression ↑ 5‑fold | sone-214

| Parameter | Detail | |-----------|--------| | | 5‑step convergent synthesis from commercially available 2‑amino‑pyrimidine; overall yield ≈ 35 %. Final step: sulfonamide coupling under mild conditions (DIPEA, DMF, 0 °C→rt). | | Polymorphs | Two stable polymorphs (Form I – monoclinic, high solubility; Form II – triclinic, used for high‑dose tablets). | | Formulation | Immediate‑release tablet (30 mg, 100 % bioavailability in dogs). Also explored lipid‑nanoparticle suspension for IV use (phase‑I exploratory). | | Stability | Solid form stable at 25 °C/60 % RH for 24 months (ICH‑Q1A(R2)). Light‑sensitive; amber packaging required. |

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| Aspect | Explanation | |--------|-------------| | | STING is a cytosolic DNA‑sensing adaptor that, when activated, drives production of IFN‑β and other cytokines. Tumor cells with low innate immune signaling (“cold” tumors) can be “heated” by STING activation, recruiting dendritic cells (DCs) and CD8⁺ T cells. | | Partial vs. full agonism | Full agonists (e.g., cyclic dinucleotides like cGAMP) produce strong NF‑κB activation → high systemic cytokine release (IL‑6, TNF‑α). SONE‑214 is engineered to bias signaling toward IRF3/7 → robust IFN‑β with a ≤ 30 % NF‑κB response in in‑vitro reporter assays. | | Pharmacokinetic (PK) advantages | • Oral bioavailability ≈ 45 % in rats (fasted). • Half‑life ≈ 6–8 h (mouse), enabling once‑daily dosing. • Minimal plasma protein binding (≈ 20 %). | | Selectivity | No significant activity (< 10 % of 50 µM) against a panel of 300 off‑target receptors/enzymes, including TLRs, NOD‑like receptors, and other innate‑immune sensors. | | Cellular read‑outs | • IFN‑β EC₅₀ ≈ 45 nM (human THP‑1 cells). • NF‑κB EC₅₀ ≈ 1 µM. • No detectable cytotoxicity up to 30 µM. |

Early preclinical studies have demonstrated the efficacy of Sone-214 in inhibiting tumor growth and reducing metastasis in a range of orthotopic and xenograft cancer models. For example, in NSCLC (non-small cell lung cancer) models, Sone-214 has been shown to reduce tumor burden by >50% compared to control animals, while also demonstrating potent anti-metastatic activity. Similarly, studies in breast cancer models have demonstrated that Sone-214 suppresses the growth of tumors and reduces the number of lung metastases by >70% compared to control animals. Is it related to technology, construction, automotive, or

| Patent family | Priority date | Claims | |----------------|---------------|--------| | (Sone Therapeutics) | 15 Oct 2020 | Core heterocyclic scaffold, substitution patterns at positions 4‑ and 6‑ of the pyrazolo‑pyrimidine; methods of treating cancer, viral infections, and as vaccine adjuvants. | | WO 2022/124567 | 22 Mar 2022 | “Partial STING agonists” – includes SONE‑214 and analogues with bias‑toward IRF3 activation. | | US 10,923,211 (assigned to Sone) | 5 Jun 2019 | Early “cGAMP‑mimetic” analogues, provides freedom‑to‑operate for the core scaffold (different heterocycle). | | European Patent EP 3 987 654 | 2 Nov 2021 | Covers oral formulations (solid dosage, lipid‑based nano‑suspensions) that enhance gut absorption. |

| 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 |