In a March 26 research note, analyst Joseph Pantginis reported that IMV Inc.'s (IMV:TSX; IMMVD:NASDAQ) preliminary monotherapy data confirmed the efficacy of its T cell-activating immunotherapy, DPX-Survivac, in ovarian cancer.
These results came from six monotherapy patients who have completed their first CT scan follow-ups in the Phase 2 portion of the Phase 1b/2 DECIDE trial. (The trial's Phase 2 component is also evaluating DPX-Survivac in combination with epacadostat for advanced recurrent ovarian cancer in seven patients, but data from those patients are not available yet.)
Five of the six DPX-Survivac monotherapy patients, or 85%, demonstrated stable disease; two showed tumor regression. Eighty percent of the positive responses were seen in patients with a lower baseline tumor burden, including the two with tumor regression.
Further, in the monotherapy cohort, DPX-Survivac proved to be safe and well tolerated. This is in contrast to the patients on the DPX-Survivac and epacadostat combination therapy, all of whom showed disease progression at day 56 and overall decreased tolerance. In fact, two patients dropped out of the study due to adverse events.
"We believe the data are encouraging as they confirm the observations made in the Phase 1b portion of the trial and support the use of DPX-Survivac monotherapy," Pantginis commented. They also "provide further evidence of the validity of baseline tumor burden as a potential biomarker for patient selection and a prognostic indicator of positive responses."
In Q2/19, additional data from the Phase 2 monotherapy cohort, Day 140 follow-up results, should be released, possibly at this year's annual American Society of Clinical Oncology meeting.
Pantginis highlighted that the DECIDE trial could generate data that warrants accelerated approval of DPX-Survivac, given it has orphan designation and fast-track status. Accordingly, it could be the first immunotherapeutic approved as a monotherapy for ovarian cancer.
The analyst indicated that "with confirmatory Phase 2 data in hand, the company plans to request a follow-up meeting with the U.S. Food and Drug Administration in the coming months and to immediately initiate a Phase 3 program."
H.C. Wainwright has a Buy rating and a CA$11.50 per share price target on IMV, whose stock is trading now at around CA$5.35 per share.[NLINSERT]
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Disclosures from H. C. Wainwright, IMV Inc., Company Update, March 26, 2019
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Joseph Pantginis, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analystís household has a financial interest in the securities of IMV Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of February 28, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of IMV Inc.
Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.
A research analyst of the firm and/or the research analystís household has a financial interest in and own the securities of Clovis Oncology, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of February 28, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Clovis Oncology, Inc.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The Firm or its affiliates did not receive compensation from IMV Inc. and Clovis Oncology, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
The Firm does not make a market in IMV Inc. as of the date of this research report.
H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.