New Phase 2 Clinical Trial Results Continue to Demonstrate Potential Clinical Benefit of IMV’s DPX-Survivac in Combination with Merck’s Keytruda in Patients with DLBCL
Complete radiologic responses linked to T cell activity observed in two of first six evaluable patients
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At the first “on treatment” assessment, five of the first six patients demonstrated clinical benefit, including four patients with tumor regressions. Two patients reached a complete radiological response, one a partial response, and two had stable disease while on study. In addition, the combination continued to demonstrate an acceptable safety profile.
“We are highly encouraged by the level of activity that we are observing with the combination of DPX-Survivac and Keytruda in these patients with DLBCL,” said Frederic Ors, IMV’s Chief Executive Officer. “We believe that the clinical benefits the SPiReL trial has yielded thus far, and the data linking this antitumor activity with the T cell responses, support DPX-Survivac’s novel mechanism of action and our combination immunotherapy approach. We will continue working with our partners to advance this clinical study towards improving the lives of patients with difficult-to-treat cancers who need better treatment options.”
Updated SPiReL Data Highlights:
At the time of data cut-off for this analysis, 11 patients were enrolled in the trial. Efficacy data from the first six evaluable patients are based on modified Cheson criteriai:
Two patients achieved a complete radiological response
- These patients have shown the best survivin specific T cell responses to DPX-Survivac among the analyzed samples
- One patient with a Complete Response (CR) has completed the one-year study period
- One patient achieved a Partial Response (PR) at first “on treatment” scan
Two patients have reached stable disease
- Each of these patients has remained progression free for six and eight months while on treatment
- One patient with bulky disease progressed at first scan
- Two subjects are not evaluable, coming off trial at day 7 and day 28
- The treatment combination appears to be well-tolerated with only 2 serious adverse events related to treatment (low white blood count and low neutrophil count)
- Radiological results from three additional patients are pending
The ICML abstract was published on
IMV will host a conference call and webcast to discuss the SPIREL
Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of
malignant lymphoma worldwide and accounts for approximately one third of
all non-Hodgkin lymphomas. In
About the SPiReL Study
SPiReL (DPX-Survivac with Low Dose
Cyclophosphamide administered with Pembrolizumab
in Patients with persistent or Recurrent/refractory
Diffuse Large B-Cell Lymphoma) is a Phase 2
non-randomized, multi-centre, open-label study. Primary Investigator Dr.
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 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.
The U.S. Food and Drug Administration (
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Marc Jasmin, IMV Senior Director, Investor Relations and Communications
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