Aduro Biotech Announces First Patient Dosed in Phase 2 Study of ADU-S100 (MIW815) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
September 04, 2019 at 08:30 AM EDT
BERKELEY, Calif., Sept. 04, 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 that the first patient has been dosed in a Phase 2 clinical trial of ADU-S100 (MIW815), a novel STING pathway activator, in combination with KEYTRUDA® (pembrolizumab), an approved anti-PD-1 antibody, as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
“The dosing of the first patient in the Phase 2 clinical study of ADU-S100 in combination with pembrolizumab marks an important advancement for Aduro as we shift from heavily pre-treated, heterogenous patient populations to earlier lines of treatment for patients with specific tumor types,” said Dimitry S.A. Nuyten, M.D., Ph.D., chief medical officer of Aduro. “There is increasing evidence that the potential benefit from immunotherapies is greater in patients with fewer prior therapies. With the recent FDA approval of pembrolizumab as first-line treatment for patients with metastatic or unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1], we look forward to continuing the progress of our clinical program by investigating the potential synergistic benefit ADU-S100 may provide as a combination treatment option.”
The Phase 2, open-label, multicenter trial, which is part of an ongoing research and development collaboration with Novartis, is designed to evaluate the efficacy and safety of ADU-S100 (MIW815) administered intratumorally in combination with pembrolizumab in the first-line setting. The planned population will consist of 33 adults with PD-L1 positive recurrent or metastatic head and neck cancer (see www.clinicaltrials.gov, identifier NCT03937141).
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, ADU-S100 (MIW815) has been tested in a Phase 1 clinical trial as a single agent and is currently being investigated in a Phase 1 clinical trial in combination with ipilimumab as well as in a Phase 1b combination trial with spartalizumab (PDR001), an investigational anti-PD-1 monoclonal antibody. These studies are enrolling patients with cutaneously accessible, advanced/metastatic solid tumors or lymphomas. ADU-S100 (MIW815) is also being investigated in a Phase 2 clinical trial in combination with pembrolizumab, an approved anti-PD-1 antibody. 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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