IMV Provides an Update on The VITALIZE Trial

Enrollment has accelerated in the last quarter, reflecting enthusiasm for this novel treatment option

Data to be presented at a scientific conference in early 2023

DARTMOUTH, Nova Scotia, & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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, today provided 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).

“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 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.

About IMV

IMV Inc. is a clinical-stage immuno-oncology company advancing a portfolio of therapies based on the Company’s immune-educating platform, DPX^®. 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 from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers. MVP-S also delivers an innate immune activator and a universal CD4 T cell helper peptide. These elements foster maturation of antigen presenting cells as well as robust activation of CD8 T cell effector and memory function. 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, using MVP-S or DPX-SurMAGE, was initiated in early 2022. For more information, visit www.imv-inc.com and connect with us on Twitter and LinkedIn.

IMV Forward-Looking Statements

This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements use such word as “will”, “may”, “potential”, “believe”, “expect”, “continue”, “anticipate” and other similar terminology. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In this press release, such forward-looking statements include, but are not limited to, statements regarding the potential impact of the VITALIZE and AVALON studies and the anticipated date data from such studies will be available; the anticipated rate of enrollment in IMV’s studies and clinical trial programs, the anticipated upcoming milestones and clinical trial outcomes with respect to IMV’s product candidates, in particular MVP-S and DPX-SurMAGE, the date to which IMV’s current cash position is expected to sufficiently fund operations; the Company’s ability to advance its development strategy, the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates, as well as, IMV’s ability to maintain its Nasdaq listing beyond the Compliance Period. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties, and those risks and uncertainties include, but are not limited to, those related to the Company’s expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as other risks detailed from time to time in our ongoing quarterly filings and annual information form. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.