In a Jan. 29 research note, analyst Andre Uddin reported IMV Inc. (IMV:TSX; IMMVD:NASDAQ) had a "positive outcome" from its Type B meeting with the FDA regarding the immunotherapy developer's DPX-Survivac as a monotherapy for advanced ovarian cancer.
At the meeting, the agency acknowledged that, based on the objective response rate and duration of response shown in DeCidE1 study patients so far, accelerated approval of DPX-Survivac might be warranted for the advanced ovarian cancer indication. This development is "a potential game changer," Uddin noted, because a faster path to approval would mean the immunotherapy could be brought to market earlier, as early as 2021 versus 2025, Mackie's current, conservative estimate.
IMV's DeCidE1 is an ongoing, open-label trial evaluating DPX-Survivac as a monotherapy in 18-plus, platinum-sensitive or platinum-resistant ovarian cancer patients who have a baseline tumor burden of less than 5 centimeters.
"Very key data" from the DeCidE1 Phase 2 study are expected in Q1/19, Uddin indicated. If those results are positive, IMV will again consult with the FDA to finalize design of a pivotal trial with DPX-Survivac as a standalone therapy for advanced ovarian cancer.
Mackie Research maintains its Speculative Buy rating and CA$10.40 per share target price on IMV, whose stock is currently trading at around CA$7.25 per share.[NLINSERT]
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Disclosures from Mackie Research Capital Corp., IMV Inc., Update, January 29, 2019
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1. On January 9, 2015, Andre Uddin visited Immunovaccineís headquarters and operations in Halifax, and viewed the laboratories, administrative offices, research centres, animal facilities, and small scale manufacturing area. MRCC paid all expenses.
2. MRCC is a market maker of Immunovaccine Inc.
Each analyst of Mackie Research Capital Corporation whose name appears in this report hereby certifies that (i) the recommendations and opinions expressed in this research report accurately reflect the analystís personal views and (ii) no part of the research analystís compensation was or will be directly or indirectly related to the specific conclusions or recommendations expressed in this research report.