On September 30, 2022 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported an update on the open-label VITALIZE study evaluating its lead product maveropepimut-S (MVP-S) in combination with pembrolizumab and intermittent low-dose cyclophosphamide (CPA) in patients with relapses, refractory diffuse large B cell lymphoma (r/r DLBCL) (Press release, IMV, SEP 30, 2022, View Source [SID1234621587]).
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"There is growing enthusiasm for the VITALIZE trial and for the active and well-tolerated treatment option MVP-S represents for patients with relapsed or refractory DLBCL," said Dr. Matthew J. Matasar, Section Head for aggressive B cell lymphoma at the Memorial Sloan Kettering Cancer Center, and primary investigator for the VITALIZE trial. Dr. Matasar added: "Both site activation and enrollment have increased substantially in the last few months, despite there being a number of competitive trials in this space. This reflects the therapeutic potential of MVP-S in combination with pembrolizumab and cyclophosphamide in relapsed or refractory DLBCL. We look forward to sharing maturing clinical response data at a scientific conference early next year."
"As previously committed, the company is providing an update on our VITALIZE Phase 2b trial. The results of this trial will be an important validation for both MVP-S and, more broadly, the DPX platform," said Andrew Hall, CEO IMV. "To be able to confirm that a survivin-targeted vaccine provides meaningful efficacy in a refractory DLBCL population through a company sponsored, multi-national study would be significant for the whole class of therapeutic vaccines."
In the investigator-initiated SPiReL trial (NCT03349450), the combination of MVP-S, pembrolizumab and low-dose, intermittent cyclophosphamide provided clinical benefit (complete and partial responses by Cheson criteria) in r/r DLBCL patients. Moreover, translational analyses showed that clinical benefit was most notable in patients showing survivin-specific T cell responses (data presented by Berinstein et al., ASH (Free ASH Whitepaper) 2020). The VITALIZE study is an open label, multi-centric, international phase 2b trial designed to explore further the clinical benefit of MVP-S combined with pembrolizumab with and without low-dose, intermittent cyclophosphamide in patients with r/r DLBCL.