On September 23, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, reported that preliminary results from its ongoing Phase 2 basket trial, evaluating DPX-Survivac in combination with Merck’s Keytruda (pembrolizumab) and intermittent low dose cyclophosphamide (CPA) in patients with advanced and metastatic solid tumors, will be presented during the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress, being held September 27 – October 1, 2019, in Barcelona, Spain (Press release, IMV, SEP 23, 2019, View Source [SID1234539701]).

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Presentation Details

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, William Osler Cancer Centre Date and Time: Sept. 30, 2019, 12:00-13:00 CEST – poster will be displayed all day

Abstract Number: 1208P
Session Title: Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Poster Display: Session 3, Poster Area – Hall 4

ESMO has published the official abstracts on its meeting website in advance of the ESMO (Free ESMO Whitepaper) Annual Meeting at 00:05 CEST on Sept. 23rd, 2019. The cut-off date for inclusion of data in the abstract was August 21st, 2019.

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 Canada.

About DPX-Survivac

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 National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.