IMV Inc. Announces Early Positive Results from Phase 2 Clinical Trial of Lead Candidate DPX-Survivac in Combination with Merck’s Keytruda® in Patients with DLBCL
The preliminary data included assessment of safety and clinical activity (based on modified Cheson criteriai) for the first four evaluable patients who have completed their first CT scan after the start of treatment. The data showed that:
- Two of the first four evaluable participants showed tumor regressions at the first on-treatment CT scan.
- The first enrolled participant demonstrated a tumor regression of 48% at first on-treatment scan;
- The second participant demonstrated a partial response (PR) via a tumor regression of 66% at first on-treatment scan.
- Preliminary data from the third participant demonstrated stable disease.
- The other participant had early disease progression less than two months following treatment initiation and was discontinued from the study.
- The combination therapy appears to demonstrate an acceptable safety profile, with no serious adverse events reported to date.
“These data have provided IMV’s first clinical data for DPX-Survivac in combination with Merck’s Keytruda, and we are encouraged by these early signs of clinical activity in DLBCL,” said
The study’s primary endpoint is to document the objective response rate. Secondary objectives include measuring tumor regression, and documenting the toxicity profile and durations of response. In addition, researchers will perform analyses to assess circulating antigen specific immune responses and changes in tumor-infiltrating T cell immune responses within the tumor microenvironment. Investigators also plan to assess potential biomarkers of immune and clinical response.
IMV announced initiation of patient dosing for this trial earlier this year. This trial is supported in part by a research grant from the Investigator-Initiated Studies Program of
This trial is one of the two Phase 2 studies evaluating the anti-cancer activity of IMV’s lead candidate, DPX Survivac, in combination with Merck’s pembrolizumab and low dose cyclophosphamide. The other ongoing trial is evaluating the triple combination immunotherapy in patients with advanced ovarian cancer.
DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that programs targeted T cells in vivo. It has demonstrated the potential for industry-leading targeted, persistent, and durable T cell activation. IMV believes this MOA is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptide antigens formulated in IMV’s proprietary DPX drug development platform. DPX-Survivac is believed to work by eliciting a cytotoxic T cell immune response against cells presenting survivin peptides.
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 anti-cancer therapies. IMV has identified over 15 cancer indications in which the over-expression of survivin can be targeted by DPX-Survivac.
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. It is currently being evaluated in multiple Phase 1b/2 clinical trials.
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i Cheson, B.D.,, Pfistner, B., Juweid, M.E., Gascoyne, R.D., Specht, L., Horning, S.J., . . . and Diehl, V. (2007). Revised Response Criteria for Malignant Lymphoma.
Source: IMV Inc.