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- || TOS-358 / Totus Medicines
Trial completion date, Trial primary completion date: TOS-358-001: A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors (clinicaltrials.gov) - Dec 31, 2023
P1, N=241, Recruiting, Sponsor: Totus Medicines
- TOS-358 / Totus Medicines
TOS-358, a first-in-class covalent PI3K? inhibitor, demonstrates superior efficacy and does not induce significant hyperglycemia at efficacious doses in multiple animal models (Section 15; Poster Board #24) - Mar 14, 2023 - Abstract #AACR2023AACR_7347;
This data reveals that highly specific and potent covalent inhibition of PI3K? leads to dramatically superior efficacy and an improved safety profile.
- TOS-358 / Totus Medicines
Inhibition of wild-type PI3K? signaling is required for durable efficacy in PI3K? mutant cancer cells due to robust re-activation of wild-type PI3K? signaling (Section 15; Poster Board #23) - Mar 14, 2023 - Abstract #AACR2023AACR_7346;
mutant and wild type signaling to achieve durable efficacy in PI3K? mutant tumors.
- TOS-358 / Totus Medicines
A study to evaluate the safety and tolerability of the covalent phosphoinositide-3-kinase (PI3K)-alpha Inhibitor, TOS-358, in adult subjects with select solid tumors (Section 46; Poster Board #12) - Mar 14, 2023 - Abstract #AACR2023AACR_7138;
P1
Enrolment to the study commences in US with European sites planned to open later in 2023. Clinical trial information: NCT05683418.
- TOS-358 / Totus Medicines
Development and validation of a pharmacodynamic (PD) assay for TOS-358, the first covalent inhibitor of PI3K? in clinical development (Section 42; Poster Board #26) - Mar 14, 2023 - Abstract #AACR2023AACR_3649;
across multiple diverse tumor types, mutations, and tissues. This approach enables highly sensitive target engagement analysis of TOS-358 across multiple formats.
- ||| TOS-358 / Totus Medicines
Enrollment open: TOS-358-001: A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors (clinicaltrials.gov) - Mar 14, 2023
P1, N=241, Recruiting, Sponsor: Totus Medicines
This approach enables highly sensitive target engagement analysis of TOS-358 across multiple formats. Not yet recruiting --> Recruiting
- | TOS-358 / Totus Medicines
New P1 trial: TOS-358-001: A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors (clinicaltrials.gov) - Jan 13, 2023
P1, N=241, Not yet recruiting, Sponsor: Totus Medicines
- TOS-358 / Totus Medicines
Preclinical characterization of TOS-358, a potent and selective covalent inhibitor of wild-type and mutant PI3Kα with superior anticancer activity (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_235;
Finally, TOS-358 generated little or no glucose impact in mice and dogs at exposures that produced superior efficacy in these cancer models. Taken together, our in vitro and in vivo data reveal TOS-358 to be a potent, selective covalent inhibitor of PI3Kα with superior anticancer activity to comparator molecules.