Policy & Regulation
First Patient Dosed in the Vitalize Phase 2B Clinical Study Evaluating IMV Lead Compound, MVP-S, in Combination with Keytruda in Patients with r/r DLBCL
13 January 2022 - - The first patient has been dosed in the Vitalize Phase 2B clinical trial, Canada-based clinical-stage company IMV Inc. (NASDAQ: IMV) (TSX: IMV) said.

Vitalize will further evaluate the clinical benefit of IMV's lead compound, maveropepimut-S (MVP-S), in combination with US-based pharmaceutical company Merck's (NYSE: MRK) anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL).

The contribution of low dose cyclophosphamide as an immune modulator will also be evaluated in this trial.

In December 2020, results of the SPiReL study were presented at the ASH annual meeting. In his presentation, Dr. Neil Berinstein, Principal Investigator of the SPiReL study and hematologist at Sunnybrook Health Sciences Center, describes that MVP-S in combination with Keytruda induced durable clinical benefit and grade 1 or 2 adverse events.

PD-L1+ patients demonstrated an objective response rate of 75%.

The Vitalize Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess MVP-S in combination with Keytruda with or without CPA.

Across the arms of this study, the combination will be evaluated in up to 150 subjects with r/r DLBCL who have received at least two prior lines of systemic therapy and who are ineligible or have failed autologous stem cell transplant or CAR-T therapy.

The primary endpoint is Objective Response Rate, centrally evaluated per Lugano and measured by the number of subjects per arm achieving a best response of Partial or Complete Response (PR+CR) during the 2-year treatment period.

All subjects will be evaluated for their baseline PD-L1 expression. Exploratory endpoints include cell mediated immune response, tumor immune cell infiltration, and biomarker analysis.

Keytruda is a registered trademark of Merck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc., Kenilworth, NJ, USA.

IMV Inc. is a clinical-stage immuno-oncology company advancing a portfolio of therapies based on the company's immune-educating platform: the DPX technology.

Through a differentiated mechanism of action, the DPX platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response.

IMV's lead candidate, maveropepimut-S (MVP-S), delivers antigenic peptides of survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers.

MVP-S treatment has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response.

MVP-S is currently being evaluated in clinical trials for hematologic and solid cancers, including Diffuse Large B Cell Lymphoma (DLBCL) as well as ovarian, bladder and breast cancers.

IMV is also developing a second immunotherapy leveraging the DPX immune delivery platform, DPX-SurMAGE.

This dual-targeted immunotherapy combines antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously.

A Phase 1 clinical trial in bladder cancer will open early 2022.