IMV IMV Inc

Combination Immunotherapy Continues to Show Tolerable Safety Profile and Promising Activity With Second Dosing Cohort Showing 6 of the First 8 Evaluable Participants Exhibiting Stable Disease at First CT Scan

IMV Inc. (Nasdaq:IMV) (TSX:IMV), a clinical stage immuno-oncology corporation, today announced that investigators shared new positive data in an oral presentation for its DeCidE1 (DPX-Survivac with low dose CyclophosphamIDe and Epacadostat) clinical study at the 2018 American Society for Clinical Oncology (ASCO) annual meeting. These data from the ongoing Phase 1b/2 trial evaluated the safety and efficacy of the combination of IMV’s lead candidate DPX-Survivac and low dose cyclophosphamide, with Incyte’s IDO1 enzyme inhibitor epacadostat, in patients with advanced recurrent ovarian cancer.

During the presentation, Oliver Dorigo, M.D., Ph.D., Associate Professor of Obstetrics and Gynecology (Oncology), Stanford University Medical Center, provided an update on the clinical benefits from the first 18 evaluable participants among 26 enrolled (including 10 from 100mg epacadostat dosing cohort and 8 from 300mg epacadostat cohort), as well as blood sample and tumor biopsy analyses from the study’s first dosing cohort. IMV is conducting the Phase 1b/2 trial in an ongoing collaboration with Incyte Corporation.

”We continue to be impressed by the safety and efficacy signals we see from this clinical trial, especially in this heavily pre-treated patient population with advanced ovarian disease and very limited treatment options,” said Frederic Ors, Chief Executive Officer, IMV Inc. “We designed DPX-Survivac to program immune cells in vivo in order to heighten and sustain anti-cancer T cell responses. Thus, we are especially pleased to be able to demonstrate, for the first time, a clear correlation between partial regressions and T cell infiltration in the tumors. Ovarian cancer represents one of the highest unmet medical needs in today’s cancer treatment landscape, and we are committed to advancing this program as quickly and safely as possible.”

Updated Clinical Response and Safety Data for DeCidE1At the time of data cut-off, 39 patients were enrolled (including 25 new participants in the 300mg cohort with 8 evaluable from day 56 first CT scan). Data from the first 18 evaluable patients across both dosing cohorts showed:

• 7 tumor regressions, including 4 Partial Responses (PR) reported so far (PR, defined as ≥30% decrease in tumor lesion size);
• Study participants were generally tolerating treatments well, with no related significant adverse events (SAEs) reported.             

Data from the first 8 evaluable participants in the 300mg epacadostat dosing cohort at first CT scan included:

• 6 patients demonstrated stable disease (SD) at day 56, with 4 of these SDs still on trial at data cut-off;
• 2 patients with tumor regressions observed so far, including one PR with a tumor regression ongoing for more than 9 months.

IMV plans to report updated results on these patients and others enrolled in the trial when data from at least 16 evaluable participants in the second dosing cohort are available.

Researchers also analyzed patient data to study the combination’s mechanism of action (MOA). They examined blood samples and tumor biopsies for the 10 evaluable patients treated in the first dosing cohort. These data showed:

• Survivin-specific T cell responses detected in 100% (10/10) of patients
• Increase in T cell infiltration post treatment in 37% (3/8) of the analyzable tumor biopsies based on two complementary testing methodologies (RNA sequencing and immunohistochemistry)
• 2 of the 3 patients with T cell infiltration showed PRs with significant and durable tumor regressions lasting more than one year.
• The third patient with T cell infiltration exhibited Progressive Disease (PD) with evidence of down regulation of the major histocompatibility (MHC) presentation pathway and significant increases in suppressive markers, both indicative of mechanisms of resistance.

“We know how important T cells are to controlling gynecological cancers, particularly in advanced ovarian disease, where it has been estimated that less than 20 percent of patients are responsive to monotherapies like checkpoint inhibitors,” said Gabriela Nicola Rosu, M.D., Chief Medical Officer at IMV Inc. “IMV’s approach to program T cells in vivo is showing promising results that have been able to connect the dots between T cell infiltration and tumor response in these patients, many of whom have rapidly growing tumors. We believe this data is an important milestone toward our goal of significantly increasing the number of individuals able to benefit from immunotherapy treatments.”

ASCO Presentation DetailsSession Title: Engaging the Immune System in Ovarian CancerLocation: S406Abstract Number: 5510Title: “Clinical data from the DeCidE1 trial: Assessing the first combination of DPX-Survivac, low dose cyclophosphamide (CPA), and epacadostat (INCB024360) in subjects with stage IIc-IV recurrent epithelial ovarian cancer.”Presentation Date and Time: Sunday, June 3, 2018, 9:57 a.m. - 10:09 a.m. CTPresenter: Dr. Oliver Dorigo, DeCidE1 Clinical Investigator and Lead Author

Conference Call and Webcast Information IMV will host a webcast and conference call to provide an overview of its ASCO presentation:

• Date: Sunday, June 3, 2018
• Time: 5:30 p.m. CT
• Title: ASCO 2018 Presentation of Phase 1b/2 Combination Clinical Trial Results in Advanced Ovarian Cancer
• Access: The conference line is (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (International), and the conference ID# is 3089163.
• Webcast: A live audio webcast and presentation is available via this link, or by pasting this URL in an internet browser: https://edge.media-server.com/m6/p/3xhqbfbx

About the DeCidE1 Phase 1b/2 Trial The Phase 1b/2 trial is an open label, uncontrolled, safety and efficacy study for individuals with advanced, platinum-sensitive and resistant ovarian cancer. The Phase 1b portion has two dosing cohorts:

• The first with 100mg of epacadostat twice daily (BID), with DPX-Survivac and low dose cyclophosphamide,
• The second with 300mg of epacadostat BID in combination with DPX-Survivac and low dose cyclophosphamide.

Investigators have completed enrollment of the first dosing cohort. At the time of data cut off, 25 patients are enrolled in the second dosing regimen, and investigators expect to continue enrollment until at least 16 evaluable patients are available.

The Phase 1b arm primary endpoints are to determine:

• The safety profile of the combination regimen,
• Induction of systemic survivin specific T cells in the blood,
• Induction of T cell infiltration into tumors.

Secondary endpoints include objective response rate (ORR) using modified RECIST v1.1 criteria; duration of response based on modified RECIST criteria; time to progression (TTP); and overall survival (OS.)

IMV announced positive top line data from the first dosing cohort in December 2017. The Company also recently announced that it would expand this clinical program with Incyte to include a Phase 2 component. The Phase 2 arm will assess the safety and efficacy of DPX-Survivac and cyclophosphamide with and without epacadostat in individuals with advanced recurrent ovarian cancer. In accordance with regulatory guidelines for combination trials, the goal of the Phase 2 component is to evaluate the clinical contribution of each investigational drug in the combination regimen.

About Ovarian Cancer According to the American Cancer Society (ACS), ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Often diagnosed in its advanced stages, about 21,290 women received a new diagnosis of ovarian cancer in 2015; approximately 14,180 women would die from the disease, according to ACS estimates.

Ovarian cancer has a significant impact globally as well. The World Cancer Research Fund reports that ovarian cancer is the seventh most common cancer in women worldwide (18 most common cancer overall), with 239,000 new cases diagnosed in 2012.

About DPX-Survivac DPX-Survivac consists of survivin-based peptide antigens formulated in IMV’s proprietary DPX drug development platform. DPX-Survivac is believed to work by eliciting a cytotoxic T cell immune response against cells presenting survivin peptides. Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to anti-cancer therapies. IMV has identified over 15 cancer indications in which the over-expression of survivin can be targeted by DPX-Survivac. DPX-Survivac received Fast Track designation from the U.S. Food & Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

About IMVIMV 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 conducting three clinical studies with Incyte and Merck assessing DPX-Survivac as a combination therapy in ovarian cancer and diffuse large B-cell lymphoma. Connect at www.imv-inc.com.

IMV Forward-Looking StatementsThis 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.

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