IMV Inc. Presents New Positive Data from Phase 2 Monotherapy Arm of Its Decide1 Trial in Advanced Ovarian Cancer and Continued Duration of Clinical Benefits to Patients with Progression Free Survival
Tumor regressions demonstrate potential for DPX-Survivac immunotherapy in hard-to-treat solid tumors
Data correlations of survivin specific T cell levels and durable clinical benefit continue to link novel mechanism of action of DPX-Survivac with anti-cancer activity
These new data are from the ongoing Phase 1b/2 trial evaluating the safety and efficacy of IMV’s lead candidate DPX-Survivac and intermittent low-dose cyclophosphamide (CPA), with and without Incyte’s IDO1 enzyme inhibitor epacadostat, in patients with advanced recurrent ovarian cancer. New data from evaluable patients from the phase 2 monotherapy arm of the trial indicated the potential for DPX-Survivac to impact solid tumor growth in hard to treat ovarian cancer patients. Longer-term follow-up from the phase 1b portion of the trial continued to demonstrate that the levels of survivin-specific T cells in the blood of patients – a measure of DPX-Survivac’s novel mechanism of action (MOA) – correlated with durable clinical benefits.
Updated Clinical Data for DeCidE1
In a poster
- Of seven patients evaluable at data cut-off in the monotherapy arm, five showed signs of treatment benefits, including reduction of target lesions in two patients, while two patients progressed.
- Within the group of four patients with low tumor burden – a potential predictor of response – three showed stable diseases including two reductions in tumor burden continuing the positive trend seen in earlier results.
- All subjects evaluable for T cell responses (five of five) showed survivin specific T cell activation in the blood, four of five showed a robust response. IHC analysis for tumor infiltration is ongoing
- Treatments have been well tolerated.
“We believe that immunotherapy can and should be an integral part of
treatment options for hard-to-treat cancers, including solid tumor
indications like ovarian cancer in which patients continue to maintain
an urgent need for better outcomes,” said Frederic Ors, Chief Executive
The data also highlighted long-lasting responders from the phase 1b portion of the study with key takeaways as follows:
- Prolonged duration of clinical benefits reaching up to more than two years, surpassing the progression-free survival to previous treatments, including platinum-based chemotherapy.
Long-lasting clinical benefits and high levels of survivin specific T
cells are associated with long-term treatment;
- One subject has received DPX-Survivac for more than 21 months so far. This finding is the longest duration of treatment for DPX-Survivac on record to date.
- It is supportive of DPX Survivac’s ability to maintain high levels of survivin-specific T cells in the blood over a prolonged period of time.
About the DeCidE1 Phase 1b/2 Trial
The DeCidE1 study is an open label, uncontrolled phase 1b/2 trial to
assess the safety and efficacy of DPX-Survivac and cyclophosphamide with
and without epacadostat in individuals with advanced, platinum-sensitive
and resistant ovarian cancer. IMV completed enrollment of 53 subjects in
the phase 1b cohort in
The amended phase 2 cohort of the DECIDE1 trial is targeting enrollment
of at least 16 subjects in the population with a lower baseline tumor
burden. Enrollment is ongoing at multiple sites in the U.S. and
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 mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a cytotoxic T cell immune response against cancer cells presenting survivin peptides on their surface.
Survivin, recognized by the
DPX-Survivac has received Fast Track designation from the
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 are based on the estimates and
opinions of management on the date the statements are made. However,
they should not be regarded as a representation that any of the plans
will be achieved. Actual results may differ materially from those set
forth in this press release due to risks affecting the Corporation,
including access to capital, the successful completion of clinical
trials and receipt of all regulatory approvals.
Andrea Cohen, Sam Brown Inc.
O: (917) 209-7163
Marc Jasmin, IMV Senior Director, Investor Relations and Communications
O: (902) 492-1819 ext :1042
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