IMV Moves to Develop DPX-Survivac as Monotherapy for Recurrent Ovarian Cancer
20 November 2018 - 11:05PM
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology
corporation, today announced an amendment to its phase 1b/2
clinical trial evaluating the safety and efficacy of IMV’s lead
candidate, DPX-Survivac, in combination with either 100 mg or 300
mg of epacadostat in patients with recurrent ovarian cancer.
Review of new data from the phase 1b portion of the clinical
trial demonstrate a high response rate and a durable clinical
benefit in a subpopulation of patients with a clinical marker
predictive of a response to DPX-Survivac and correlated to its
novel mechanism of action (MOA). New data include:
- Efficacy signals in the subpopulation of patients who received
100 mg dose epacadostat (n=5) included 100% tumor regressions and
100% disease control rate; and 60% of these patients (3/5) reached
a best response of a partial response (PR);
- Long duration of clinical benefit observed in responders with a
median duration of 590 days, including one patient that has passed
the two-year mark without disease progression;
- Clinical benefit correlated to DPX-Survivac’s MOA and clinical
study primary endpoints: survivin-specific T cells in the blood and
T cell infiltration into tumors; and,
- The safety profile of DPX-Survivac is consistent with the
profile observed in the Company’s previously reported
studies.
Based on 300 mg cohort results, IMV and Incyte have agreed to
stop dosing patients with epacadostat. IMV will continue the phase
1b/2 trial as a monotherapy study evaluating DPX-Survivac in the
recurrent ovarian cancer subpopulation. IMV will inform and work
with investigators to appropriately modify the study in a manner
consistent with the best interests of each patient.
IMV and Incyte will continue to explore the potential of
additional combination studies.
“The goal of the trial was to evaluate combination therapies.
However, the new data indicate that DPX-Survivac shows activity as
a monotherapy in late-stage patients, which can potentially
translate into clinical benefit,” said Frederic Ors, Chief
Executive Officer, IMV. “In parallel to the amended monotherapy
trial, we will continue to investigate other combinations with our
lead product candidate as we continue our work to deliver new
immunotherapy options that may benefit more patients in multiple
cancers.”
IMV is planning to meet with the U.S. Food and Drug
Administration (FDA) in December 2018 to present results specific
to the subpopulation identified in the phase 1b/2 clinical trial.
IMV will also discuss a proposed clinical path to support
registration for DPX-Survivac (with intermittent low-dose
cyclophosphamide as a conditioning regimen) as a monotherapy in
recurrent ovarian cancer.
“We are very pleased that the phase 1b trial results to date
validate the mechanism of action of DPX-Survivac, helping us to
identify patients more likely to benefit from our drug candidate,”
said Gabriela Nicola Rosu, MD, Chief Medical Officer at IMV.
“Identifying which patients have the greatest potential for
responding to a drug candidate is key for the success of
immunotherapy clinical trials, and we look forward to continued
work with investigators and trial sites to advance the study of
DPX-Survivac to help address the significant unmet medical needs of
these patients.”
Lead Investigator Oliver Dorigo, MD, PhD, Associate Professor of
Obstetrics and Gynecology (Oncology), Stanford University
Medical Center will present full topline data from this phase 1b
study in December at the 2018 European Society for Medical Oncology
– Immuno-Oncology (ESMO I-O) Conference.
Conference call and webcast at 8 a.m. ET
today
IMV will host a conference call and webcast today at 8 a.m. ET.
The dial-in number for the conference call is 844-461-9932 (United
States and Canada) or 636-812-6632 (international) with the
conference ID: 2263829. The live audio webcast is available at
https://edge.media-server.com/m6/p/n3g4evwk. The webcast will be
recorded and available on the IMV website for 30 days following the
call.
About IMV
IMV Inc., formerly Immunovaccine Inc., is a clinical
stage biopharmaceutical company dedicated to making immunotherapy
more effective, more broadly applicable, and more widely available
to people facing cancer and other serious diseases. IMV is
pioneering a new class of immunotherapies based on the Company’s
proprietary drug delivery platform. This patented technology
leverages a novel mechanism of action that enables the programming
of immune cells in vivo, which are aimed at generating
powerful new synthetic therapeutic capabilities. IMV’s lead
candidate, DPX-Survivac, is a T cell-activating immunotherapy that
combines the utility of the platform with a target: survivin. IMV
is currently assessing DPX-Survivac as a combination therapy in
multiple clinical studies with Incyte and Merck. Connect
at www.imv-inc.com.
IMV Forward-Looking Statements
This press release contains forward-looking information under
applicable securities law. All information that addresses
activities or developments that we expect to occur in the future is
forward-looking information. Forward-looking statements are based
on the estimates and opinions of management on the date the
statements are made. However, they should not be regarded as a
representation that any of the plans will be achieved. Actual
results may differ materially from those set forth in this press
release due to risks affecting the Corporation, including access to
capital, the successful completion of clinical trials and receipt
of all regulatory approvals. IMV Inc. assumes no
responsibility to update forward-looking statements in this press
release except as required by law. These forward-looking statements
involve known and unknown risks and uncertainties and those risks
and uncertainties include, but are not limited to, our ability to
access capital, the successful and timely completion of clinical
trials, the receipt of all regulatory approvals and other risks
detailed from time to time in our ongoing quarterly filings and
annual information form Investors are cautioned not to rely on
these forward-looking statements and are encouraged to read IMV’s
continuous disclosure documents, including its current annual
information form, as well as its audited annual consolidated
financial statements which are available on SEDAR
at www.sedar.com and on EDGAR
at www.sec.gov/edgar.
Contacts for IMV:
MEDIA Mike Beyer, Sam Brown
Inc.T: (312) 961-2502 E: mikebeyer@sambrown.com
INVESTOR RELATIONSPierre Labbé, Chief
Financial OfficerT: (902) 492-1819
E: info@imv-inc.com
Patti Bank, Managing Director, Westwicke
PartnersO: (415) 513-1284T: (415) 515-4572 E:
patti.bank@westwicke.com
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