Mr. Frederic Ors reports

IMV INC. PRESENTS UPDATED POSITIVE DATA FROM PHASE 1B/2 COMBINATION CLINICAL TRIAL IN ADVANCED OVARIAN CANCER AT 2018 ESMO IMMUNO-ONCOLOGY CONGRESS

Investigators shared new positive data from IMV Inc.'s continuing DeCidE1 (DPX-Survivac with low-dose cyclophosphamide and epacadostat) clinical trial at the 2018 ESMO immuno-oncology congress. The phase 1b/2 study is evaluating the safety and efficacy of the combination of IMV's lead candidate DPX-Survivac, low-dose cyclophosphamide, and 100 milligrams or 300 mg of Incyte's IDO1 enzyme inhibitor epacadostat in patients with advanced recurrent ovarian cancer.

In a poster presentation, Dr. Oliver Dorigo, MD, PhD, associate professor of obstetrics and gynecology (oncology), Stanford University Medical Center, who served as the trial's lead investigator and author on the poster, shared top-line safety results from 53 enrolled patients and efficacy data from the 32 participants evaluable for immune-related and clinical responses, as well as blood sample and tumour biopsy analyses.

Key findings include:

• Evidence of a clinical marker based on baseline tumour burden (BTB), a measure of tumour size predictive of patient response to DPX-Survivac:
  • 37.5 per cent (12/32) of evaluable study subjects began treatment with a non-bulky disease defined as BTB under five centimetres;
  • 73 per cent (8/11) of tumour regressions and 80 per cent of clinical responses (4/5) observed in subset of patients with BTB less than five cm.
• Responders thus far showing prolonged duration of clinical benefits reaching up to more than two years, surpassing the progression-free interval from their previous chemotherapy treatment;
• Robust systemic survivin-specific T-cell responses and evidence of survivin-specific T cells tumour infiltration correlated with clinical benefits:
  • 100 per cent of durable clinical responses correlated with T-cell infiltration.
• Epacadostat triggered inhibition of the conversion of tryptophan into kynurenine that was dose dependent;
• Cohort demographics were balanced and the combination yielded a tolerable safety profile.

"This data set provided meaningful information on how the potential benefits of DPX-Survivac may best be translated to patients, including the connection between tumour regressions and T-cell infiltration in the tumour microenvironment," said Frederic Ors, chief executive officer at IMV. "We believe that DPX-Survivac is the first targeted T-cell therapy to induce significant tumour regressions in challenging tumours such as those seen in ovarian cancer. We remain committed to developing DPX-Survivac for patients with significant unmet medical needs, and look forward to our upcoming discussions with regulatory authorities in the USA, Canada and Europe."

Updated clinical response and safety data for DeCidE1

At the time of data cut-off, 53 patients were enrolled in the phase 1b clinical trial, including 14 from the 100 mg epacadostat dosing cohort and 39 from 300 mg epacadostat cohort. Based on 300 mg cohort results, IMV and Incyte agreed to stop dosing patients with epacadostat before completion of the study. Patients who completed at least one CT scan, as required per the trial protocol, were evaluable for response analysis.

Seventy-one per cent of patients were evaluable for responses in the 100 mg cohort and 56 per cent in the 300 mg dose cohort. At time of data cut-off, eight participants remained on treatment and were being evaluated for clinical responses.

Efficacy parameter       Total target lesion size under five cm           Total target lesion size over five cm 
                      100 mg (N=5)  300 mg (N=7)  All (N=12) N (%)  100 mg (N=5)  300 mg (N=15)   All (N=20) N (%)^

Regression                 5 (100)      3 (42.9)          8 (66.7)         0 (0)       3 (20.0)           3 (15.0)
PR (1)                    3 (60.0)      1 (14.3)          4 (33.3)         0 (0)        1 (6.7)            1 (5.0)
SD (2)                    2 (40.0)      4 (57.1)          6 (50.0)      2 (40.0)      10 (66.7)          12 (60.0)
DCR (3)                    5 (100)      5 (71.4)         10 (83.3)      2 (40.0)      11 (73.3)          13 (65.0)
        
                                                                                                              
(1) Partial response (PR) is defined as greater than or equal to 30-per-cent decrease in sum of target lesions.  
(2) Stable disease (SD) is defined as less than 30-per-cent decrease and less than or equal to 20-per-cent 
increase in sum of target tumour lesions.                                  
(3) Disease control rate (DCR) refers to the total number of patients achieving complete response, partial 
response and stable disease.

"Recurrent ovarian cancer treatment remains a significant unmet need and represents a challenge for immunotherapy," said Gabriela Nicola Rosu, MD, chief medical officer at IMV. "What we have showed here is that the dynamic interaction between the survivin-specific T cells induced by DPX-Survivac, and the tumour size and its growth kinetics can be a determinant of clinical responses. We believe that this information is significant for the future development of DPX-Survivac and may indicate a pathway to more efficacious immunotherapeutic treatments for patients."

Poster session details

Session title:  Poster Display Session

Location:  Foyer, Geneva Palexpo

Poster ID:  87P; abstract ID 262

Abstract title:  "New clinical data from the DeCidE1 trial: Results on DPX-Survivac, low dose cyclophosphamide (CPA), and epacadostat (INCB024360) in subjects with advanced recurrent epithelial ovarian cancer"

Date:  Dec. 14, 2018, to Dec. 15, 2018

Time:  12:30 p.m. to 1 p.m. (local time)

Presenter:  Dr. Oliver Dorigo, DeCidE1 clinical investigator and lead author

Investor call information

IMV will host a webcast and conference call on Thursday, Dec. 13, at 8:30 a.m. ET to provide an overview of its ESMO-IO presentation.

Dial-in:  844-461-9932 (United States and Canada) or 636-812-6632 (international)

Conference ID:  6192578

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:

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

The primary end points 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 tumours.

Secondary end points 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 conducted the phase 1b/2 study in collaboration with Incyte Corp. IMV recently announced that, based on the 300 mg cohort results, IMV and Incyte have agreed to stop dosing patients in this trial with epacadostat. IMV is continuing the phase 2 portion of the trial as a monotherapy study evaluating DPX-Survivac in the advanced and recurrent ovarian cancer subpopulation with BTB under five cm.

IMV intends to report updated results from the phase 1b when data from at least 16 evaluable participants in the second dosing cohort are available. Investigators plan to submit final results for publication in a peer-reviewed journal.

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 (18th most common cancer over all), with 239,000 new cases diagnosed in 2012.

About IMV Inc.

IMV, formerly Immunovaccine, 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.

We seek Safe Harbor.