On April 16, 2019 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, reported the following statement regarding recent market activity (Press release, IMV, APR 16, 2019, View Source [SID1234535155]).
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In recent weeks, shares of IMV Inc. have come under unwarranted market pressure and the management team believes it is prudent to provide a mid-quarter update on the health of the business and the Company’s upcoming Q2 clinical milestones.
"From a financial and clinical results standpoint, IMV has recently achieved noteworthy milestones and, based on clinical results observed thus far, our long term outlook remains unchanged and very promising," said Frederic Ors, Chief Executive Officer. "We have strengthened our balance sheet and expanded our shareholder base through a recent equity offering completed with Wells Fargo as lead underwriter. In addition, IMV has also reported promising clinical results from the phase 2 cohort of the DECIDE clinical study, which we believe confirm the potential activity of DPX-Survivac as monotherapy."
Phase 2 Cohort of the DECIDE Clinical Study in Ovarian Cancer
As reported earlier this year, IMV’s latest clinical results update indicated that six patients receiving DPX-Survivac monotherapy with intermittent low-dose cyclophosphamide (mCPA) reached the first CT scan assessment and key related findings were as follows:
83% of the subjects (5 of 6) showed stable disease (SD), including two tumor regressions;
80% (4 of 5) of those with stable disease were in subjects with a lower baseline tumor burden (BTB) of less than 5 centimeters, which also included the two tumor regressions.
In earlier stages of this trial, durable clinical responses occurred after 140 days. As of March 25, 2019, these responses had endured for 20 months or more. Additional data at the 140-day mark of this cohort will be available by the end of the first half of 2019. The amended phase 2 cohort of the DECIDE trial focuses on patients with low tumor burden (less than 5 centimeters targeting the enrollment of at least 16 additional patients at numerous sites in the U.S. and Canada.
Phase 2 Study in Combination with KEYTRUDA in Relapsed/Refractory DLBCL (SPIREL)
As of April 5, 2019, ten patients have been enrolled and treated across four different clinical sites in Canada. Additional patients are being screened and IMV expects to report updated clinical data at about the same time than the bi-annual International Conference on Malignant Lymphoma, which will be held in Lugano Switzerland starting June 18, 2019.
Phase 2 Basket Trial in Combination with KEYTRUDA in Multiple Solid Tumors
Screening and enrollment of patients is ongoing at multiple clinical sites across the U.S. and Canada for five cohorts of patients with bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC) cancers as well as tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.
The first patients have been dosed in the ovarian and lung cancer cohorts and IMV expects to report preliminary clinical results on several of the solid tumor indications before the end of 2019.
The following table indicates IMV expected milestones between now and the first half of 2020 as at the date of this release.
Milestones
Key dates
Initiation of Basket trial in 5 solid tumor indications
September 2018 x
First preliminary Phase 2 clinical results with Merck Keytruda in DLBCL
September 2018 x
Phase 1b/2 clinical results in Ovarian with Incyte
December 2018 x
Meeting with FDA on Ovarian cancer program
December 2018 x
Dosing of first patient in Basket trial
March 2019 x
Phase 2 monotherapy results in Ovarian – ASCO (Free ASCO Whitepaper) June 2019
Phase 1/1b monotherapy long term follow-up – ASCO (Free ASCO Whitepaper) June 2019
Phase 2 clinical results with Merck Keytruda in DLBCL – ICML June 2019
Preliminary clinical results Basket trial in 5 indications H2 2019
Potential registration trial in Ovarian and/or DLBCL for FDA
accelerated/breakthrough designation
H2 2019
Top line clinical results for Basket trial H1 2020
Meeting with FDA on potential accelerated registration trial from Basket trial H1 2020