On February 20, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage biopharmaceutical company pioneering a novel class of immunotherapies, reported that company management will host a conference call & webcast to report topline results from DeCidE1, an ongoing Phase 2 study evaluating its lead compound, DPX-Survivac, in patients with advanced recurrent ovarian cancer, on Tuesday, February 25, 2020 at 8:00 am EST (Press release, IMV, FEB 20, 2020, View Source [SID1234554573]).
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IMV aims to make immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer. Patients with advanced, recurrent ovarian cancer have limited treatment options. The five-year survival rate for women with advanced disease is less than 30%1.
In 2020, the standard of care for recurrent cancer is single-agent chemotherapy, which elicits a response rate of ~12% with limited duration of benefit and severe adverse effects. There is a significant need for more effective and better-tolerated therapies in recurrent ovarian cancer.
Conference Call & Webcast Information
Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (International).
All interested parties are able to register and access the live audio webcast by clicking the link available under the Investors section of the company’s website: "Events, Webcasts & Presentations".
The webcast will be recorded and available on the IMV website for 30 days following the call.
About the DeCidE1 Study
"DeCidE1" is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac with intermittent low dose cyclophosphamide. This phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and –resistant ovarian cancer. Patients received two subcutaneous injections of DPX-Survivac three weeks apart and every eight weeks thereafter, and intermittent low dose CPA, one week on, and one week off for up to one year. Paired tumor biopsies were performed prior to treatment and on treatment.
Primary endpoints of this study are overall response rate, disease control rate and safety. Secondary endpoints include cell mediated immunity, immune cell infiltration in paired biopsy samples, duration of response, time to progression, overall survival and biomarker analyses.
About DPX-Survivac
DPX-Survivac is the lead candidate in IMV’s new class of targeted immunotherapies designed to elicit antigen-specific functional, robust and sustained de novo T cell response. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of five unique HLA-restricted survivin peptides formulated in IMV’s proprietary DPX drug delivery platform and known to induce a cytotoxic CD8+ T cell response against survivin expressing cancer cells.
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.
Company has recently published data with DPX-Survivac (as single regimen or in combination with Merck’s Keytruda) at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2019 (see poster) and at the ASCO (Free ASCO Whitepaper)-SITC symposium in February 2020 (see poster).
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.