Preliminary Results From IMV’s Phase 2 Basket Trial Evaluating DPX-Survivac as a Combination Therapy in Patients with Advanced and Metastatic Solid Tumors to Be Presented at ESMO Congress 2019
Poster Title: “Safety and efficacy results of the combination of DPX-Survivac, pembrolizumab and intermittent low dose cyclophosphamide (CPA) in subjects with advanced and metastatic solid tumours (preliminary results)”
Presenter: Henry J Conter, M.D., Medical Oncology Director,
Date and Time:
Abstract Number: 1208P
Session Title: Immunotherapy of Cancer
Poster Display: Session 3, Poster Area – Hall 4
About the Phase 2 Basket Trial
IMV’s Phase 2 basket trial is an open label, multi-center study, evaluating DPX-Survivac across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer, non-small cell lung cancer (NSCLC) and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.
Subjects will receive DPX-Survivac (SC: 2 x 0.25 mL every three weeks, followed by up to 11 x 0.1 mL every nine weeks), in combination with pembrolizumab (IV: 200 mg every 3 weeks cycle) and CPA (oral: 50 mg BID on alternating weeks) across the five cohorts. The study is designed to assess primary endpoints of safety and objective response rate (ORR), with multiple secondary and exploratory measures.
The study included a safety lead-in, which included 20 patients from all five cohorts. The five cohorts are now expanded to recruit additional subjects following a Simon two stage design. Enrollment in the ovarian cancer cohort will be randomized 1:1 into two arms with and without CPA. All other cohorts will utilize a single-arm design and administer treatment with the triple combination. IMV expects to enroll 184 patients across clinical sites in the U.S. and
DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that programs targeted T cells in vivo. It has demonstrated the potential for industry-leading targeted, persistent, and durable T cell activation. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a cytotoxic T cell immune response against cancer cells presenting survivin peptides on their surface.
Survivin, recognized by the
DPX-Survivac has received Fast Track designation from the
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