IMV Inc. Presents Optimistic Preliminary Outcomes From The MVP-S Section 2B VITALIZE Trial

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IMV Inc. Presents Optimistic Preliminary Outcomes From The MVP-S Section 2B VITALIZE Trial

NewsNero

February 13, 2023

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Early evaluation reveals clinically significant exercise in refractory DLBCL sufferers

A number of confirmed full responses noticed in closely pre-treated sufferers

No antagonistic security and tolerability sign reported, per earlier medical trials

DARTMOUTH, Nova Scotia, & CAMBRIDGE, Mass. — IMV Inc. (Nasdaq: IMV; TSX: IMV) (“IMV” or the “Firm”), a clinical-stage biopharmaceutical firm growing a portfolio of immune-educating therapies primarily based on its novel DPX^® platform to deal with stable and hematologic cancers, as we speak introduced constructive preliminary information from the VITALIZE Section 2B trial evaluating its lead DPX product, maveropepimut-S (“MVP-S”), together with pembrolizumab in sufferers with relapsed, refractory Diffuse Massive B Cell Lymphoma (“r/r DLBCL”).

Key preliminary findings from the continuing VITALIZE trial:

8 Sufferers with an ECOG¹ rating of 0-1 have been enrolled in arm 1 of the examine. Of those, 6 have to date been evaluable for efficacy;
Of those 6 evaluable sufferers, 3 sufferers confirmed confirmed full responses, 1 affected person was assessed with steady illness as greatest response and a pair of sufferers have been assessed with progressive illness as greatest response; and
2 sufferers with poor stage of baseline performance (ECOG ≥ 2) failed to remain on examine by way of to the primary scan and due to this fact couldn’t be evaluated.

Total Response Price (“ORR”) will likely be communicated when the totality of stage one information can be found for definitive evaluation.

“VITALIZE is our most superior and rigorous trial so far, and we’re inspired by the best way the info for MVP-S are trending. That is probably the most refractory inhabitants of sufferers we’ve handled to date, and to point out full, confirmed medical responses is notable. These constructive preliminary outcomes, mixed with the accelerating recruitment of the AVALON examine in platinum resistant ovarian most cancers add, we consider, to the rising business enthusiasm concerning the potential for MVP-S in a number of tumor settings,” mentioned Andrew Corridor, CEO of IMV.

In regards to the VITALIZE Examine

The VITALIZE Section 2B trial is a randomized, parallel group, Simon two-stage examine designed to evaluate IMV’s lead candidate, MVP-S, together with pembrolizumab with (arm 1) or with out (arm 2) cyclophosphamide. Throughout the arms of this examine, the mix will likely be evaluated in as much as 30 sufferers in stage one (two arms of 15) with the choice to develop to as much as a complete of 102 topics in stage two with r/r DLBCL who’ve acquired at the least two prior traces of systemic remedy and who’re ineligible or have failed autologous stem cell transplant (ASCT) or CAR-T remedy.

In regards to the AVALON examine

The AVALON examine is an open label, company-sponsored section 2b, single arm trial evaluating the efficacy and security of MVP-S and intermittent low-dose cyclophosphamide (CPA) in sufferers with platinum-resistant ovarian most cancers. The examine is a Simon two-stage design the place as much as 41 topics will likely be evaluated in stage one, with the choice to develop to as much as a complete of 73 sufferers in stage two. Sufferers collaborating within the trial will obtain two doses of subcutaneous MVP-S as soon as each three weeks, adopted by an MVP-S dose as soon as each eight weeks, plus low-dose oral CPA on a repeating cycle of 1 week on/one week off.

About IMV

IMV Inc. is a clinical-stage immuno-oncology firm advancing a portfolio of therapies primarily based on the Firm’s immune-educating platform, DPX^®. By means of a differentiated mechanism of motion, the DPX platform delivers instruction to the immune system to generate a particular, sturdy, and chronic immune response. IMV’s lead candidate, maveropepimut-S (MVP-S), delivers antigenic peptides from survivin, a well-recognized most cancers antigen generally overexpressed in superior cancers. MVP-S additionally delivers an innate immune activator and a common CD4 T cell helper peptide. These parts foster maturation of antigen presenting cells in addition to sturdy activation of CD8 T cell effector and reminiscence operate. MVP-S remedy has been properly tolerated and has demonstrated outlined medical profit in a number of most cancers indications in addition to the activation of a focused and sustained, survivin-specific anti-tumor immune response. MVP-S is at the moment being evaluated in medical trials for hematologic and stable cancers, together with Diffuse Massive B Cell Lymphoma (DLBCL) in addition to ovarian, bladder and breast cancers. IMV can be growing a second immunotherapy leveraging the DPX immune supply platform, DPX-SurMAGE. This dual-targeted immunotherapy combines antigenic peptides for each the survivin and MAGE-A9 most cancers proteins to elicit immune responses to those two distinct most cancers antigens concurrently. A Section 1 medical trial in bladder most cancers, utilizing MVP-S or DPX-SurMAGE, was initiated in early 2022. For extra data, go to www.imv-inc.com and join with us on Twitter and LinkedIn.

IMV Ahead-Wanting Statements

This press launch incorporates forward-looking data beneath relevant securities regulation. All data that addresses actions or developments that we anticipate to happen sooner or later is forward-looking data. Ahead-looking statements use such phrase as “will”, “could”, “potential”, “consider”, “anticipate”, “proceed”, “anticipate” and different comparable terminology. Ahead-looking statements are primarily based on the estimates and opinions of administration on the date the statements are made. On this press launch, such forward-looking statements embrace, however should not restricted to, statements relating to the potential and efficacy of MVP-S, the potential influence of the VITALIZE examine and timing of availability of the ORR from the remaining stage one sufferers from its Section 2B trial, the Firm’s skill to advance its growth technique, and the prospects for its lead immunotherapy and its different pipeline of immunotherapy candidates. IMV Inc. assumes no accountability to replace forward-looking statements on this press launch besides as required by regulation. These forward-looking statements contain recognized and unknown dangers and uncertainties, and people dangers and uncertainties embrace, however should not restricted to, these associated to the detailed outcomes when introduced being at the least per the preliminary outcomes from the VITALIZE Section 2B trial, the Firm’s priorities with MVP-S and its DPX supply platform, the potential for its supply platform and the anticipated timing of enrollment and outcomes for its medical trial applications and research as different dangers detailed infrequently in our ongoing quarterly filings and annual data type. Buyers are cautioned to not depend on these forward-looking statements and are inspired to learn IMV’s steady disclosure paperwork, together with its present annual data type, in addition to its audited annual consolidated monetary statements which can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

¹ ECOG is a measure of affected person performance and is measured in line with a standardized measure starting from 0-5. Oken et al., Toxicity and response standards of the Japanese Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-655. PMID: 7165009