• Two of the first four evaluable participants showed tumor regressions at the first on-treatment CT scan
• DPX-Survivac has received fast-track status from FDA
• It also has orphan drug status from the FDA and the EMA

IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, today announced details of the initial data from an ongoing investigator-sponsored Phase 2 clinical trial. In the study, investigators are evaluating IMV’s lead candidate, DPX-Survivac, in combination with low dose cyclophosphamide and Merck’s checkpoint inhibitor Keytruda (pembrolizumab), in patients with persistent or recurrent/refractory diffuse large B-cell lymphoma (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 Frederic Ors, IMV’s Chief Executive Officer. “Our clinical results in ovarian cancer have consistently showed that our proprietary T cell technology has the capacity to generate regressions in solid tumors. One of IMV’s key objectives is to provide patients with more effective treatment options by expanding our clinical program to include other hard-to-treat cancer indications. While these data are preliminary, we are pleased to see the promising initial activity in a blood cancer, where checkpoints inhibitors alone have thus far shown modest anti-cancer activity.” ii

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.

IMV currently has three therapies in development. Two are cancer immunotherapies and one is a vaccine for RSV