Early Phase 1 Dose Escalation Signals Support Advancement into Phase 1b in Second Half of 2017
BERKELEY, CA, USA I June 01, 2017 I Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for ADU-S100 (also known as MIW815), a novel STING pathway activator, to be evaluated in combination with PDR001, Novartis’ investigational anti-PD-1 checkpoint inhibitor, for the treatment of advanced/metastatic solid tumors or lymphomas. The Phase 1b study is expected to be initiated in the second half of 2017.
“The initial insights we have gained from the ongoing trial of ADU-S100, coupled with preclinical data that suggests an anti-cancer synergy between an anti-PD-1 checkpoint inhibitor and ADU-S100, underscores the importance of evaluating these two novel approaches to treating cancer in combination with one another,” stated Natalie Sacks, M.D., chief medical officer of Aduro. “With the IND now cleared, working with Novartis, our STING program collaborator, we look forward to initiating a Phase 1b trial in the second half of the year to gain clinical insights into the STING/anti-PD-1 inhibitor combination for the treatment of multiple tumor types. At the same time, we will continue to evaluate the potential of ADU-S100 as a monotherapy in cutaneously accessible tumors as well as viscerally accessible tumors.”
The open label, global, multicenter Phase 1b study is designed to evaluate the safety and efficacy of ADU-S100 administered by intratumoral injection with PDR001 to patients with advanced/metastatic solid tumors or lymphomas.
Ongoing Phase 1 Dose Escalation Trial of ADU-S100 (MIW815) in Multiple Tumor Types
In May 2016, Aduro announced the initiation of the ongoing Phase 1, multicenter, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ADU-S100 (MIW815) in patients with cutaneously accessible metastatic solid tumors or lymphomas (see www.clinicaltrials.gov, identifier NCT02675439). The trial is ongoing and the company expects to expand into viscerally accessible lesions in the second half of 2017.
About STING Pathway Activator Platform
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. 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.
About Aduro
Aduro Biotech, Inc. is an immunotherapy company focused on the discovery, development and commercialization of therapies that transform the treatment of challenging diseases. Aduro’s technology platforms, which are designed to harness the body’s natural immune system, are being investigated in cancer indications and have the potential to expand into autoimmune and infectious diseases. Aduro’s LADD technology platform is based on proprietary attenuated strains of Listeria that have been engineered to express tumor-associated antigens to induce specific and targeted immune responses. This platform is being developed as a treatment for multiple indications, including mesothelioma, ovarian, lung and prostate cancers. Additionally, a personalized form of LADD, or pLADD, is being developed utilizing tumor neoantigens that are specific to an individual patient’s tumor. Aduro’s STING Pathway Activator platform is designed to activate the STING receptor in immune cells, resulting in a potent tumor-specific immune response. ADU-S100 is the first STING Pathway Activator compound to enter the clinic and is currently being evaluated in a Phase 1 study in patients with cutaneously accessible metastatic solid tumors or lymphomas. Aduro’s B-select monoclonal antibody platform includes a number of immune modulating assets in research and preclinical development. Aduro is collaborating with leading global pharmaceutical companies to expand its products and technology platforms. For more information, please visit www.aduro.com.
SOURCE: Aduro Biotech
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Early Phase 1 Dose Escalation Signals Support Advancement into Phase 1b in Second Half of 2017
BERKELEY, CA, USA I June 01, 2017 I Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for ADU-S100 (also known as MIW815), a novel STING pathway activator, to be evaluated in combination with PDR001, Novartis’ investigational anti-PD-1 checkpoint inhibitor, for the treatment of advanced/metastatic solid tumors or lymphomas. The Phase 1b study is expected to be initiated in the second half of 2017.
“The initial insights we have gained from the ongoing trial of ADU-S100, coupled with preclinical data that suggests an anti-cancer synergy between an anti-PD-1 checkpoint inhibitor and ADU-S100, underscores the importance of evaluating these two novel approaches to treating cancer in combination with one another,” stated Natalie Sacks, M.D., chief medical officer of Aduro. “With the IND now cleared, working with Novartis, our STING program collaborator, we look forward to initiating a Phase 1b trial in the second half of the year to gain clinical insights into the STING/anti-PD-1 inhibitor combination for the treatment of multiple tumor types. At the same time, we will continue to evaluate the potential of ADU-S100 as a monotherapy in cutaneously accessible tumors as well as viscerally accessible tumors.”
The open label, global, multicenter Phase 1b study is designed to evaluate the safety and efficacy of ADU-S100 administered by intratumoral injection with PDR001 to patients with advanced/metastatic solid tumors or lymphomas.
Ongoing Phase 1 Dose Escalation Trial of ADU-S100 (MIW815) in Multiple Tumor Types
In May 2016, Aduro announced the initiation of the ongoing Phase 1, multicenter, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ADU-S100 (MIW815) in patients with cutaneously accessible metastatic solid tumors or lymphomas (see www.clinicaltrials.gov, identifier NCT02675439). The trial is ongoing and the company expects to expand into viscerally accessible lesions in the second half of 2017.
About STING Pathway Activator Platform
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. 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.
About Aduro
Aduro Biotech, Inc. is an immunotherapy company focused on the discovery, development and commercialization of therapies that transform the treatment of challenging diseases. Aduro’s technology platforms, which are designed to harness the body’s natural immune system, are being investigated in cancer indications and have the potential to expand into autoimmune and infectious diseases. Aduro’s LADD technology platform is based on proprietary attenuated strains of Listeria that have been engineered to express tumor-associated antigens to induce specific and targeted immune responses. This platform is being developed as a treatment for multiple indications, including mesothelioma, ovarian, lung and prostate cancers. Additionally, a personalized form of LADD, or pLADD, is being developed utilizing tumor neoantigens that are specific to an individual patient’s tumor. Aduro’s STING Pathway Activator platform is designed to activate the STING receptor in immune cells, resulting in a potent tumor-specific immune response. ADU-S100 is the first STING Pathway Activator compound to enter the clinic and is currently being evaluated in a Phase 1 study in patients with cutaneously accessible metastatic solid tumors or lymphomas. Aduro’s B-select monoclonal antibody platform includes a number of immune modulating assets in research and preclinical development. Aduro is collaborating with leading global pharmaceutical companies to expand its products and technology platforms. For more information, please visit www.aduro.com.
SOURCE: Aduro Biotech
Post Views: 70
