In a Jan. 29 research note, analyst Andre Uddin reported IMV Inc. (IMV:TSX; IMMVD:OTCQX) 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]
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
Disclosures from Mackie Research Capital Corp., IMV Inc., Update, January 29, 2019
RELEVANT DISCLOSURES APPLICABLE TO COMPANIES UNDER COVERAGE:
Relevant disclosures required under IIROC Rule 3400 applicable to companies under coverage discussed in this research report are available on our web site at www.mackieresearch.com.
1. On January 9, 2015, Andre Uddin visited Immunovaccine’s 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 analyst’s personal views and (ii) no part of the research analyst’s compensation was or will be directly or indirectly related to the specific conclusions or recommendations expressed in this research report.