On June 1, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported 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 (Press release, Aduro Biotech, JUN 1, 2017, View Source [SID1234519336]). The Phase 1b study is expected to be initiated in the second half of 2017. Schedule your 30 min Free 1stOncology Demo! "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."
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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.
Month: June 2017
Announcement on submission of the Clinical Trial Plan Notification for phase I clinical trial of Oncolytic virus HF10 against pancreatic cancer in Japan
On June 1, 2017 Takara Bio Inc. (Takara Bio) reported that the Clinical Trial Notification was submitted to PMDA (Pharmaceuticals and Medical Devices Agency; Japanese regulatory agency) to conduct phase I clinical trial of oncolytic virus HF10 (Development code: TBI-1401) as regenerative medicine product in Japan on May 31 (Press release, Takara Bio, JUN 1, 2017, View Source [SID1234519334]). Schedule your 30 min Free 1stOncology Demo! This clinical trial will be conducted in patients with unresectable advanced pancreatic cancer to evaluate safety of HF10 in combination with existing chemotherapeutic drug.
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After the clearance, the protocol will be reviewed by each IRB (Institutional Review Board) and the study will be initiated. In this clinical trial, the HF10 manufactured at Center for Gene and Cell Therapy, Takara Bio’s facility, will be used.
Takara Bio is currently conducting clinical trials in patient with unresctable and metastatic melanoma in Japan and US. Based on the results which were obtained so far, the intratumoral injections of HF10 are safe and well-tolerated, and encouraging tumor response was demonstrated. And also, the investigator-initiated clinical research for pancreatic cancer was completed, and the good results were reported*.
Inovio Announces Clinical Trial Collaboration to Evaluate a Novel T-cell Immunotherapy in Combination with a PD-L1 Checkpoint Inhibitor
On June 1, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported a clinical collaboration with Genentech, a member of the Roche Group, for advanced bladder cancer (Press release, Inovio, JUN 1, 2017, View Source [SID1234519333]). The phase 1b/2 immuno-oncology trial will evaluate Genentech’s atezolizumab (TECENTRIQ) in combination with Inovio’s INO-5401, a T cell activating immunotherapy encoding multiple antigens, and INO-9012, an immune activator encoding IL-12. Schedule your 30 min Free 1stOncology Demo! The multi-center open-label trial will be managed by Inovio, and Genentech will supply atezolizumab. It is anticipated to start in 2017 and designed to evaluate the safety, immune response and clinical efficacy of the combination therapy in approximately 80 patients with advanced bladder cancer, specifically advanced unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. The majority of the patients to be enrolled in the trial will have previously received and failed to demonstrate meaningful response to a checkpoint inhibitor alone. Thus the study will evaluate potential benefit of a checkpoint inhibitor combined with a DNA-based immunotherapeutic and T-cell activator within a bladder cancer patient population with very limited treatment options and poor outcomes. The immunologic analyses accompanying the study will provide further insight into mechanisms of checkpoint inhibition and T-cell activation in bladder cancer.
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Nearly 430,000 new cases of urinary bladder cancer are diagnosed each year worldwide; it accounts for about 165,000 deaths worldwide annually. Advanced unresectable or metastatic UC remains a high unmet medical need as survival remains poor for most patients who experience disease progression or intolerance to treatment during or after platinum-containing chemotherapy. The approval of several checkpoint inhibitors for advanced unresectable or metastatic UC has improved response and survival rates for some patients, however, the majority of patients do not experience meaningful clinical responses to checkpoint inhibitor monotherapy.
Inovio’s INO-5401, an immunotherapy encoding multiple cancer antigens, is designed to generate and activate T-cells to many cancer types including bladder cancer. INO-9012, an immune activator encoding IL-12, is designed to amplify and accelerate T cell immune responses to INO-5401. Combining INO-5401/INO-9012 with atezolizumab may provide a synergistic therapeutic effect as a result of generating higher levels of activated T cells and simultaneously inhibiting PD-L1. Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells.
Dr. Joaquim Bellmunt, MD, PhD, Dana-Farber/Brigham and Women’s Cancer Center Associate Professor, Harvard Medical School, said, "Urothelial carcinoma represents an area of high unmet need. Checkpoint inhibitors offer significant potential, however, only a proportion of patients respond to these therapies alone. Increasing evidence suggests that combinatorial approaches are needed and a combination of a checkpoint inhibitor with an immunotherapy that generates antigen-specific T cells may offer the potential for significantly increased benefit."
Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, "We are excited to collaborate with Genentech, a leader in the development of transformative products to treat cancer. I am a strong believer in combination immuno-oncology regimens employing an immunotherapy to generate significant antigen-specific killer T cells then blocking T cell suppression via checkpoint inhibition. We believe INO-5401 has significant potential as a cancer immunotherapeutic in combination with a checkpoint inhibitor to address the high unmet medical need for advanced bladder cancer patients and to provide meaningful benefit for checkpoint inhibitor refractory patients."
About Metastatic Urothelial Carcinoma (UC)
The prognosis for patients with advanced unresectable or metastatic UC is poor, with limited treatment options. It is a disease that has seen no major advances for more than 30 years until the approvals of checkpoint inhibitors. Expected survival is generally less than 12 months; in the U.S., five-year survival of patients with distant metastasis is 5%. In the US, an estimated 79,000 new cases of urinary bladder cancer are expected in 2017.
About INO-5401
INO-5401 includes Inovio’s SynCon antigens for WT1, hTERT and PSMA and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted WT1, hTERT and PSMA among a list of attractive cancer antigens, designating them as high priorities for cancer immunotherapy development and placing WT1 at the top of the antigen list. The hTERT antigen is expressed in 85% of cancers; the WT1 and PSMA antigens are also widely prevalent in many cancers. In addition, INO-5401 is being evaluated for the treatment of GBM in combination with a checkpoint inhibitor.
Immunocore Highlights IMCgp100 clinical data in Uveal Melanoma at ASCO 2017 Annual Meeting
On June 1, 2017 Immunocore Limited, the world’s leading TCR company developing biological drugs to treat cancer, infectious diseases and autoimmune diseases, reported that new clinical data from a second Phase I study of its lead programme, IMCgp100, will be presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on 3 June 2017 (Press release, Immunocore, JUN 1, 2017, View Source [SID1234519332]). Schedule your 30 min Free 1stOncology Demo! The abstract will be presented by Dr Takami Sato, MD, PhD, Department of Medical Oncology, Kimmel Cancer Center, Thomas Jefferson University, in the poster session Melanoma/Skin Cancers on Saturday 3 June, 13:15-16:45. The title of the abstract (number 9531, found at Poster Board number 139) is: Intra-patient escalation dosing strategy with IMCgp100 results in mitigation of T-cell based toxicity and preliminary efficacy in advanced uveal melanoma.
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Chris Coughlin, Chief Medical Officer of Immunocore commented: "We continue to be excited by the compelling clinical data we are observing with IMCgp100 in patients uveal melanoma and are advancing our lead programme into a pivotal study. There are no treatments that have shown any survival benefit in this disease so the unmet need is high."