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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)

995 Days ago

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
The Aduro-proprietary STING pathway activator product candidates, including ADU-S100 (MIW815), are synthetic small molecule immune modulators that are designed to target and activate human STING. STING is generally expressed at high levels in immune cells, including dendritic cells. Natural activation of STING is not always sufficient to prevent the growth and spread of cancer cells. In preclinical models, ADU-S100 (MIW815) directly activates STING to further amplify the natural anti-tumor response. Once activated, the STING receptor initiates a profound innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of a systemic tumor antigen-specific T cell adaptive immune response.

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.

About Aduro
Aduro Biotech, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies that are designed to harness the body’s natural immune system for the treatment of patients with challenging diseases. Aduro’s product candidates in the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways are being investigated in cancer, autoimmune and inflammatory diseases. ADU-S100 (MIW815), which potentially activates the intracellular STING receptor for a potent tumor-specific immune response, is being evaluated in patients with cutaneously accessible metastatic solid tumors or lymphomas. BION-1301, a first-in-class humanized IgG4 monoclonal antibody that fully blocks APRIL binding to both the BCMA and TACI receptors, is being evaluated in IgA nephropathy. Aduro is collaborating with a number of leading global pharmaceutical companies to help expand and drive its product pipeline. For more information, please visit www.aduro.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for our therapies, the progress of our clinical programs, including the patient population for our Phase 2 trial, our ability to investigate the potential synergistic benefit ADU-S100 as a combination treatment option and our ability to expand and drive our product pipeline alone or with collaborators. In some cases, you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “expect” or the negative or plural of these words or similar expressions.  Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, early or preliminary clinical trial results may not be predictive of future results, our history of net operating losses and uncertainty regarding our ability to achieve profitability, our ability to develop and commercialize our product candidates, our ability to use and expand our technologies to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, our reliance on third parties, and our ability to obtain and adequately protect intellectual property rights for our product candidates.  We discuss many of these risks in greater detail under the heading “Risk Factors” contained in our quarterly report on Form 10-Q for the quarter ended June 30, 2019, which is on file with the Securities and Exchange Commission. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Investor Relations Contact: Media Contact:
Noopur Liffick Aljanae Reynolds
510-809-2465 510-809-2452
investors@aduro.com press@aduro.com

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