SNX281 / Stingthera - LARVOL DELTA

A novel approach for first-in-human dose selection using population dose-response modelling to find a minimum anticipated biological effect level. (PubMed, Br J Clin Pharmacol) - "Our novel population modelling-based MABEL strategy for first-in-human dose selection resulted in successful clinical translation of a small molecule STING agonist."

Journal • P1 data • Oncology • IFNB1 • STING

Study of SNX281 in Subjects With Advanced Solid Tumors and Lymphoma (clinicaltrials.gov) - P1 | N=27 | Terminated | Sponsor: Stingthera, Inc. | Trial completion date: Jul 2026 ➔ Jan 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2026 ➔ Jan 2024; Sponsor decision (not due to safety concerns)

Checkpoint inhibition • Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Study of SNX281 in Subjects With Advanced Solid Tumors and Lymphoma (clinicaltrials.gov) - P1 | N=27 | Active, not recruiting | Sponsor: Stingthera, Inc. | Recruiting ➔ Active, not recruiting | N=134 ➔ 27

Checkpoint inhibition • Combination therapy • Enrollment change • Enrollment closed • Metastases • Monotherapy • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Study of SNX281 in Subjects With Advanced Solid Tumors and Lymphoma (clinicaltrials.gov) - P1 | N=134 | Recruiting | Sponsor: Stingthera, Inc. | Trial completion date: Mar 2024 ➔ Jul 2026

Trial completion date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Trial of SNX281, a systemically delivered small molecule STING agonist, in solid tumors and lymphomas. (SITC 2021) - P1 | "The single-agent treatment arm of SNX281 is planned to evaluate at least 2 expansion cohorts in ovarian cancer and colorectal carcinoma while the combination treatment arm of SNX281 and pembrolizumab is planned to enroll subjects with advanced cancer who have relapsed on or have become refractory to prior immune checkpoint therapy given in an indicated setting. Clinical Trial Information: NCT04609579 Trial Registration NCT04609579"

Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • CD8 • IL6 • STING • TNFA

Chip to clinic: The design of a small molecule clinical STING agonist using physics-based simulations (ACS-Fall 2022) - "The immune mediated mode of action also induces a memory response that prevents tumor recurrence and growth upon rechallenge. SNX281 is example of a novel therapeutic that leverages control of an important innate immune pathway to treat cancer."

Clinical • Oncology • STING

Stingthera, Inc. Announces Clinical Collaboration with Merck to Evaluate SNX281 in Combination With KEYTRUDA (pembrolizumab) in Certain Patients with Advanced Solid Tumors and Lymphoma (GlobeNewswire) - "Stingthera, Inc. today announced it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada) to evaluate the combination of SNX281, Stingthera’s investigational small molecule activator of the Stimulator of Interferon Genes (STING) protein, and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors and lymphoma who have relapsed on or have become refractory to prior immune checkpoint therapy. Under the terms of the agreement, Stingthera is responsible for conducting the clinical trial, which was initiated with the SNX281 monotherapy arm in late November 2020."

Licensing / partnership • Lymphoma • Oncology • Solid Tumor

Study of SNX281 in Subjects With Advanced Solid Tumors and Lymphoma (clinicaltrials.gov) - P1; N=128; Recruiting; Sponsor: Silicon Therapeutics; Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Clinical • Combination therapy • Enrollment open • Monotherapy • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Silicon Therapeutics Announces Dosing of First Patient in Phase 1 Open-Label Clinical Trial of SNX281 for Advanced Solid Tumors or Lymphoma (Businesswire) - “Silicon Therapeutics…announced treatment of the first patient with its therapeutic candidate SNX281 in a Phase 1 clinical trial in patients with advanced solid tumors or lymphoma….This Phase 1 open-label, multicenter, multidose, first-in-human clinical trial of SNX281 will evaluate the safety and tolerability of SNX281 alone and in combination with the PD-1 inhibitor pembrolizumab in subjects with relapsed or refractory solid tumors or lymphomas. The trial is designed to enroll up to 128 patients.”

Trial status • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Study of SNX281 in Subjects With Advanced Solid Tumors and Lymphoma (clinicaltrials.gov) - P1; N=128; Not yet recruiting; Sponsor: Silicon Therapeutics

Checkpoint inhibition • Clinical • Combination therapy • Monotherapy • New P1 trial • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor