Aduro Biotech and Novartis Present Results from Ongoing Phase 1b Study of STING Agonist ADU-S100 (MIW815) in Combination with Anti-PD-1 Monoclonal Antibody Spartalizumab (PDR001) in Patients with Advanced Solid Tumors or Lymphomas
June 02, 2019 at 11:45 AM EDT
BERKELEY, Calif., June 02, 2019 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, today announced the presentation of data from an ongoing Phase 1b clinical trial in collaboration with Novartis. Aduro’s ADU-S100 (MIW815), a novel STING pathway activator, is being evaluated in combination with Novartis’ spartalizumab (PDR001), an investigational anti-PD-1 monoclonal antibody, in patients with advanced solid tumors or lymphomas. The findings were presented as an oral abstract today by Dr. Funda Meric-Bernstam at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL (Abstract #2507).
“We are pleased with the clinical progress to date of ADU-S100 in combination with spartalizumab,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “The safety profile and preliminary anti-tumor activity demonstrated in patients with triple-negative breast cancer and other tumor types are encouraging. We look forward to completing dose escalation and evaluating with our partner Novartis the clinical and pharmacodynamic biomarker activity that may provide a basis for advancing this combination therapy toward dose expansion in tumor types where the potential to benefit patients is greatest.”
Isaacs continued, “Our goal remains for ADU-S100 to be broadly explored as a combination agent, given our belief in the synergistic effects of STING agonism with checkpoint inhibitor therapy. Enrollment in our study of ADU-S100 and ipilimumab in relapsed/refractory melanoma is ongoing and we anticipate initiation of our study of ADU-S100 and pembrolizumab in first line head and neck cancer in the second half of 2019.”
Study Design and Findings from Ongoing Phase 1b Trial of ADU-S100 (MIW815) + Spartalizumab (Data cut-off: April 5, 2019)
The Phase 1b multi-center, open-label, dose-escalation clinical trial (see www.clinicaltrials.gov, identifier NCT03172936) enrolled patients with advanced, metastatic treatment-relapsed/refractory solid tumors or lymphomas and evaluated two treatment schedules. All patients received a fixed dose of 400 mg of intravenous (IV) spartalizumab on day 1 and either an intratumoral (IT) injection of ADU-S100 (MIW815) on days 1, 8 and 15 in a 28-day cycle or an IT injection of ADU-S100 (MIW815) on day 1 of every 28-day cycle. Data presented were based on findings from 83 enrolled patients, with 53 patients in the weekly group and 30 patients in the monthly group.
No dose-limiting toxicities were reported during the first cycle in any of the 50 – 1,600 µg dose cohorts. The adverse events of the combination of ADU-S100 (MIW815) and spartalizumab reported were no more frequent or severe than those reported in either single agent trial. The most common (≥5 percent of patients) treatment-related adverse events (TRAEs) of any grade were injection site pain (13.3 percent), pyrexia (12.0 percent), diarrhea (9.6 percent) and rash (6.0 percent). Grade 3/4 TRAEs (in ≥2 pts) were increased lipase (3.6 percent), diarrhea, increased ALT and increased AST (all 2.4 percent). Treatment was discontinued in two patients due to adverse events (2.4 percent).
About STING Pathway Activator Technology
Aduro’s lead molecule, ADU-S100 (MIW815), is the first therapeutic in development specifically targeting STING. In collaboration with Novartis, it is being tested in a Phase 1 clinical trial as a single agent and in combination with ipilimumab, and in a Phase 1b combination trial with spartalizumab (PDR001), Novartis’ investigational anti-PD-1 monoclonal antibody. These studies are enrolling patients with cutaneously accessible, advanced/metastatic solid tumors or lymphomas. The trials are evaluating the ability of ADU-S100 (MIW815) to activate the immune system and recruit specialized immune cells to attack the injected tumor, leading to a broad immune response that seeks out and kills distant metastases.
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