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Immunovaccine Announces Dosing of First Patient in Investigator-Sponsored Phase 1b/2 Clinical Trial Evaluating Immuno-Oncology Candidate Targeting Incurable HPV-Related Cancers

Immunovaccine Announces Dosing of First Patient in Investigator-Sponsored Phase 1b/2 Clinical Trial Evaluating Immuno-Oncology Candidate Targeting Incurable HPV-Related Cancers


Study Demonstrates Broad Applicability of Immunovaccine’s DepoVax™ Platform for Delivering Cancer Antigens
Halifax, Nova Scotia; April 18, 2017 – Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced that the first study participant has been treated in a Phase 1b/2 clinical study evaluating Immunovaccine’s investigational cancer vaccine, DPX-E7, in combination with low-dose cyclophosphamide in patients with incurable oropharyngeal, cervical and anal cancers related to the human papillomavirus (HPV).
Dana-Farber Cancer Institute (Dana-Farber) is leading the DPX-E7 study through a $1.5 million research grant from Stand Up To Cancer and the Farrah Fawcett Foundation to clinically evaluate collaborative translational research that addresses critical problems in HPV-related cancers.
“Because DPX-E7 is formulated with the same DepoVax™ platform technology as our DPX-Survivac candidate, this trial further demonstrates the broad applicability of DepoVax™ to deliver cancer antigens appropriately,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “It is also an important step forward in developing therapies for the high-risk HPV infections that have been linked to cancers associated with poor patient outcomes. We are pleased to be working with the Dana-Farber Cancer Institute in this endeavor, and we look forward to continuing to fully leverage our platform’s potential to address high unmet medical needs, delivering more options to patients and creating more opportunities to generate value for our shareholders.”
The Dana-Farber study is a single center, open label, non-randomized clinical trial that will investigate the safety and clinical efficacy of DPX-E7 in combination with low-dose metronomic oral cyclophosphamide in a total of 44 treated participants. Its primary objectives are to evaluate changes in CD8+ T cells in peripheral blood and tumor tissue, and to evaluate the safety of DPX-E7 vaccination in HLA-A2 positive patients with incurable HPV-related head and neck, cervical or anal cancers. DPX-E7 targets an HPV viral protein known as E7. Immunovaccine has the option to produce the DPX-E7 vaccine if it proves successful in the clinic.
“We are excited to offer this new therapy for our patients with HPV-related head and neck, anal and cervical cancers that have recurred after standard therapy,“ said Robert Haddad M.D., disease center leader, head and neck oncology program at the Dana-Farber Cancer Institute.
This trial marks another milestone in the expansion of Immunovaccine’s growing pipeline of immuno-oncology candidates. Currently, Immunovaccine has multiple early-stage trials evaluating DepoVax™-based clinical candidates in ovarian cancer. The Company most recently announced that Princess Margaret Cancer Centre had received Health Canada clearance to begin an investigator-sponsored Phase 2 ovarian cancer study evaluating Immunovaccine’s DPX-Survivac with Merck’s pembrolizumab.
Individuals interested in enrolling in the Phase 1b/2 clinical trial evaluating DPX-E7 can find more information via clinicaltrials.gov.
About HPV-related Cancers
Approximately 30 to 40 types of human papillomaviruses (HPV) are transmitted through sexual contact and infect the anogenital region and oropharynx. About 15 of these are designated “high-risk” (i.e., oncogenic); more than five percent of all new cancers are attributed to high-risk HPV infections. iHPV is the cause of virtually all cases of cervical cancer, the second leading cause of cancer deaths among women worldwide, and has been linked to anal, vulva, vaginal, penile and oropharyngeal cancers.ii,iii,iv
About DepoVax™ 
DepoVax™ is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system, resulting in a strong, specific and sustained immune response with the potential for single-dose effectiveness. The DepoVax™ platform is flexible and can be used with a broad range of target antigens for preventative or therapeutic applications. The technology is designed to be commercially scalable, with the potential for years of shelf life stability. Fully synthetic, off-the-shelf DepoVax™-based vaccines are also relatively easy to manufacture, store, and administer. These characteristics enable Immunovaccine to pursue vaccine candidates in cancer, infectious diseases and other vaccine applications.
About Immunovaccine
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 infectious diseases. Immunovaccine develops T cell activating cancer immunotherapies and infectious disease vaccines based on DepoVax™, the Company’s patented platform that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 1b study with Incyte Corporation assessing lead cancer therapy, DPX-Survivac, as a combination therapy in ovarian cancer. The Company is also exploring additional applications of DepoVax™, including DPX-RSV, an innovative vaccine candidate for respiratory syncytial virus (RSV), which has recently completed a Phase 1 clinical trial. Immunovaccine also has ongoing clinical projects to assess the potential of DepoVax™ to address malaria and the Zika virus. Connect at www.imvaccine.com.
Immunovaccine 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 Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law.
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News Release: Immunovaccine Announces Positive Year-Long Immunogenicity Data from Phase 1 Clinical Trial for Respiratory Syncytial Virus Vaccine Candidate

See original release here 100 Percent of Healthy Older Adult Volunteers Who Responded to Vaccine Achieved a Sustained Antigen-Specific Immune Response that Remains at Peak One Year Post-Vaccination with DPX-RSV; This Level of Response with a Low-dose Volume of a Small Peptide is Groundbreaking and Highlights Potential of DepoVax™ Platform Halifax, Nova Scotia; April 12, 2017 – Immunovaccine Inc. (TSX: IMV; OTCQX: IMMVF), a clinical stage immuno-oncology company, today announced updated data on its investigator-sponsored Phase 1 clinical trial testing the safety and immunogenicity of its DepoVax™-based, small B-cell epitope peptide vaccine candidate for respiratory syncytial virus (RSV). In the 25 µg dose cohort, which was the only dose tested out to one year, 100 percent of older adults (7/7 immune responders) vaccinated with DPX-RSV maintained the antigen-specific immune responses one year after receiving the booster dose. At one year, the antibody levels measured were still at peak with no sign of decrease. The 25 µg dose was delivered in a volume of 50 microliters. A standard flu vaccine is typically 60 µg delivered in 10 times this volume. “The persistence of antigen-specific, circulating immune response at such a high level at six months was intriguing enough to warrant an assessment at the one year time point,” said Joanne Langley, BA, MD, MSc, FRCPC, of the Canadian Center for Vaccinology (CCfV) based at Dalhousie University, and the trial’s principal investigator. “The persistence of immunogenicity at one year to this peptide vaccine presented in a novel adjuvanting platform suggests that it is possible to create an immune response that lasts for at least an entire RSV season.” “We believe that the strength and duration of this immune response, particularly from a peptide epitope vaccine, is truly groundbreaking,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “We have long since maintained that, to effectively deal with complex diseases such as RSV, we need to pursue a novel target and a delivery formulation that is reliable and impactful. We believe that this DPX-RSV data validates this approach, and are hopeful that our vaccine candidate may offer those who suffer from RSV an option that goes beyond what can be accomplished with other vaccines in development.” “It is encouraging to observe such a prolonged serum antibody response against this membrane protein of RSV after DPX-RSV vaccination,” said Xavier Saelens, group leader of the VIB-UGent Centre for Medical Biotechnology (VIB and Ghent University, Belgium). “We have analyzed the year-one samples blinded and in a different way compared to the measurements performed by Immunovaccine. The results obtained in the two labs align clearly and show the longevity of the antibody response,” said Bert Schepens, staff scientist in the Saelens group, which has been performing confirmatory testing of the clinical trial samples. Last year, Immunovaccine reported positive top-line results from the Phase 1 dose-escalation trial evaluating the safety and immunogenicity of DPX-RSV in 40 healthy older adults six months after vaccination. In a further follow-up, antigen-specific immune responses were detected at least six months after the last vaccination in 93 percent (15/16) of patients receiving DPX-RSV, in both low-dose (8/8 participants) and high-dose (7/8 participants) cohorts. The new data reported today are based on the high-dose cohort, which was the only dose tested out to one year. The trial was conducted at the Canadian Center for Vaccinology (CCfV), based at Dalhousie University; the IWK Health Centre; and the Nova Scotia Health Authority; and funded in an industry-academic collaboration by the Canadian Institutes of Health Research and Immunovaccine. About RSV

Respiratory syncytial virus (RSV) is a common virus that infects the lungs and breathing passages. While it usually leads to mild, cold-like symptoms, it can be severe in the elderly, infants and patients with compromised immune systems. It is second only to influenza as the most commonly identified cause of viral pneumonia in older persons. Globally, it is estimated that 64 million cases of RSV infection occur annually in all age groups, with 160,000 deaths. There is no vaccine currently available to prevent RSV.
About DPX-RSV
DPX-RSV is Immunovaccine’s prophylactic, small B-cell epitope peptide vaccine candidate designed specifically to address the unmet medical needs in respiratory syncytial virus (RSV). DPX-RSV targets the SH antigen of RSV, which may provide additional immunogenic benefit over traditional approaches for high risk populations, including infants and the elderly. Scientists from VIB and Ghent University (Belgium) demonstrated the protective potential of the ectodomain of the small hydrophobic (SH) protein of RSV as a vaccine antigen.i  In addition, the concentrated dosage enabled by the DepoVax™ delivery system may help mitigate injection site point-of-pain, which has been a limitation for other potential treatments. The Company reported Phase 1 data for DPX-RSV at the six-month time point, which indicated that the vaccine demonstrated a tolerable safety profile and induced a measurable immunogenic response in 93 percent of healthy adult volunteers across both dose cohorts. Immunovaccine holds exclusive worldwide license on applications that target the SH ectodomain antigen in RSV from VIB and Ghent University.
About Immunovaccine
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 infectious diseases. Immunovaccine develops T cell activating cancer immunotherapies and infectious disease vaccines based on DepoVax™, the Company’s patented platform that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 1b study with Incyte Corporation assessing lead cancer therapy, DPX-Survivac, as a combination therapy in ovarian cancer. An investigator-sponsored Phase 2 study will assess the safety and efficacy of DPX-Survivac combined with an approved anti-PD-1 drug in advanced ovarian cancer. The Company is also exploring additional applications of DepoVax™, including DPX-RSV, an innovative vaccine candidate for respiratory syncytial virus (RSV), which has recently completed a Phase 1 clinical trial. Immunovaccine also has ongoing clinical projects to assess the potential of DepoVax™ to address malaria and the Zika virus. Connect at www.imvaccine.com.
Immunovaccine 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 Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law.
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Contacts for Immunovaccine:
 
MEDIA 
Mike Beyer, Sam Brown Inc.
T: (312) 961-2502 E: [email protected]
INVESTOR RELATIONS
Pierre Labbé, Chief Financial Officer
T: (902) 492-1819 E: [email protected] 
Patti Bank, Managing Director, Westwicke Partners
O: (415) 513-1284
T: (415) 515-4572 E: [email protected]
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iSchepens B et al., (2014) Protection and mechanism of action of a novel human Respiratory Syncytial Virus vaccine candidate based on the extracellular domain of Small Hydrophobic protein. EMBO Mol. Med., 6:1436-1454. DOI: DOI: 10.15252/emmm.201404005
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Immunovaccine’s Lead Immuno-Oncology Candidate to Enter Investigator-Sponsored Phase 2 Clinical Trial in Ovarian Cancer in Combination with Approved Anti-PD-1 Drug

Original Press Release University Health Network (UHN) in Toronto to Launch Triple-Combination Study Evaluating the Potential for Enhanced Anti-Cancer Activity of Currently Marketed Checkpoint Inhibitor When Combined with DPX-Survivac

 Halifax, Nova Scotia; February 6, 2017 – Immunovaccine Inc. (TSX: IMV; OTCQX: IMMVF), a clinical stage immuno-oncology company, today announced that the UHN’s Princess Margaret Cancer Centre (PM) will conduct a Phase 2 clinical trial to evaluate the use of a combination of immunotherapies from Immunovaccine and Merck (known as MSD outside the United States and Canada).
Clinical investigators will assess the safety and efficacy of Immunovaccine’s DPX-Survivac cancer vaccine candidate in combination with Merck’s checkpoint inhibitor Pembrolizumab in patients with recurrent, platinum-resistant ovarian cancer. Study participants will also receive metronomic cyclophosphamide, which is a low-dose regimen with immuno-modulating effects. PM listed the trial on www.clinicaltrials.gov and expects to initiate active enrollment following completion of the contract between Immunovaccine and UHN, and pending regulatory clearance from Health Canada. “Ovarian cancer is a main focus for Immunovaccine as we continue to develop DPX-Survivac,” said Frederic Ors, Immunovaccine’s Chief Executive Officer.  “Combination therapies — particularly those with anti-PD-1 activity — are emerging as increasingly promising approaches for hard-to-treat cancers. We believe that the robust immunogenic and safety clinical profile for DPX-Survivac, along with its unique complementary activity to anti-PD-1 agents, which may boost their response rates, position our immuno-oncology candidate as an optimal co-therapy in this disease area.” The non-randomized, open-label trial is designed to evaluate the potential anti-tumor activity of the combination of Pembrolizumab, DPX-Survivac, and low-dose cyclophosphamide. It is expected to enroll 42 subjects with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. The study’s primary objective is to assess overall response rate (ORR). Secondary study objectives include progression free survival (PFS) rate, overall survival (OS) rate, and potential side effects, over a five-year period.
 Amit M. Oza, Bsc (Hons), MBBS (Lon), MD (Lon), FRCPC, FRCP, Senior Staff Physician and Associate Professor of Medicine at PM is the lead investigator. Merck is funding this study and contributing materials. Immunovaccine is also contributing its product candidate as well as a related portion of analytical assays.
“Ovarian cancer is among the most challenging cancers to treat, as it is associated with poor response rates to currently available medical interventions,” said Dr. Oza. “To support the tens of thousands of women battling this disease, we need to develop new and novel approaches. With this trial, we have the opportunity to explore a novel combination of promising immunotherapies.” DPX-Survivac is Immunovaccine’s lead immuno-oncology candidate, generated by its novel proprietary DepoVax™ adjuvanting technology platform. The DPX-Survivac target, survivin, is present in more than 20 types of solid tumor and hematologic cancers. It is involved in multiple critical pathways of cancer cell growth and survival. Prior results from a Phase 1/1b study indicated that DPX-Survivac combined with a low dose of cyclophosphamide was highly immunogenic in individuals with high-risk ovarian cancer, inducing survivin- specific T cell immune responses in most trial participants. The company has shown in other studies that a combination immunotherapy using a DepoVax™-based vaccine could enhance the anti-tumor effects of a PD-1 blockade. Even tumors previously non-responsive to treatment with anti-PD-1 agents alone exhibited controlled cancer growth when combined with Immunovaccine’s DepoVax™-based compound. In addition to this Phase 2 trial, Immunovaccine is conducting a Phase 1b trial with Incyte Corporation to evaluate the triple combination of DPX-Survivac with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, Epacadostat (INCB24360), and low-dose oral cyclophosphamide in patients with platinum sensitive or resistant ovarian cancer. Immunovaccine expects to announce top-line interim results for this Phase 1b trial by the end of March 2017. About DPX-Survivac
DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ adjuvanting platform. The National Cancer Institute (NCI) has recognized survivin as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in multiple cancer types in addition to ovarian cancer, including breast, colon and lung cancers. Survivin plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in a higher percentage of tumors than other TAA’s.
The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T-cell immune response against cells presenting survivin peptides. This targeted therapy attempts to use the immune system to search actively and specifically for tumor cells and destroy them. Survivin-specific T-cells have been shown to target and kill survivin-expressing cancer cells while sparing normal cells. DPX-Survivac received Fast Track designation by the FDA as maintenance therapy in individuals with advanced ovarian, fallopian tube, and peritoneal cancer who have no measureable disease following surgery and front-line platinum/taxane chemotherapy to improve their progression-free survival. The FDA also granted orphan drug status to DPX-Survivac for the treatment of ovarian cancer. This designation is valid for all applications of DPX-Survivac in ovarian cancer without restriction to a specific stage of disease.   About the Princess Margaret Cancer Centre of the Toronto Hospital
 The Princess Margaret Cancer Centre has achieved an international reputation as a global leader in the fight against cancer and delivering personalized cancer medicine. The Princess Margaret, one of the top five international cancer research centres, is a member of the University Health Network, which also includes Toronto General Hospital, Toronto Western Hospital, Toronto Rehabilitation Institute and the Michener Institute for Education; all affiliated with the University of Toronto. For more information, go to www.theprincessmargaret.ca or www.uhn.ca.
About Immunovaccine
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 infectious diseases. Immunovaccine develops cancer immunotherapies and infectious disease vaccines based on the Company’s DepoVax™ platform, a patented delivery agent that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 1b study with Incyte Corporation assessing lead cancer therapy, DPX-Survivac, as a combination therapy in ovarian cancer, as well as a Phase 2 study in recurrent lymphoma. The Company is also advancing an infectious disease pipeline including innovative vaccines for respiratory syncytial virus (RSV) and currently has clinical projects ongoing to assess the potential of DepoVax™ to address malaria and the Zika virus. Connect at www.imvaccine.com.
 
Immunovaccine 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 Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law.
 
 Contacts for Immunovaccine:
 
MEDIA 
Mike Beyer, Sam Brown Inc.
T: (312) 961-2502 E: [email protected]
INVESTOR RELATIONS
Frederic Ors, Chief Executive Officer
T: (902) 492-1819 E: [email protected] 
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Researchers to Present Data on Immunovaccine’s Infectious Disease Pipeline at Three International Conference

Presentations at RSV16, World Vaccine Congress Europe and IDWeek Conferences Highlight Company’s Progress in Using DepoVax™-based Agents to Address Respiratory Syncytial Virus (RSV) and Life-Threatening Malaria 

Halifax, Nova Scotia, September 23, 2016 – Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX: IMV; OTCQX: IMMVF), a clinical-stage vaccine and immunotherapy company, today announced planned data presentations at upcoming scientific meetings in conjunction with collaborators at VIB, the Flemish life sciences research institute, and the Canadian Center for Vaccinology (CCfV). These presentations will focus on DPX-RSV, Immunovaccine’s lead infectious disease candidate in development for the prevention of respiratory syncytial virus (RSV).
In addition, researchers will present the first results from the Company’s preclinical collaboration with the University ofEdinburgh’s Center for Immunity, Infection and Evolution (CIIE) on life-threatening malaria.
Details for the presentations are as follows:
Presentation at 10th International Respiratory Syncytial Virus Symposium (RSV16), September 28-October 1, 2016 in Patagonia, Argentina 
Session: Poster Session 1; Poster 393
Session Date: September 28-29, 2016
Session Location: Llao Llao Hotel, Tronador Room in Bariloche, Argentina
Session Time: Afternoon of September 28 – Afternoon of September 29
Presentation Title: “Live Cell Imaging of Antibody Dependent Phagocytosis and Trogocytosis of RSV And Influenza Virus Infected Cells”
 
Presentations at World Vaccine Congress Europe, October 10-12, 2016 in Barcelona, Spain
Session: Respiratory
Session Date: Monday, October 10, 2016
Session Location: Fairmount Rey Juan Caros, Barcelona, Spain
Session Time: 4:45 PM CEST
Presentation Title: “Preclinical and Clinical development of a new HRSV vaccine based on the Small Hydrophobic protein that instructs macrophages to clear infected cells”
Session: Poster Sessions 1 and 2
Session Date: Monday, October 10 – Tuesday, October 11, 2016
Session Location: Fairmount Rey Juan Caros, Barcelona, Spain
Session Time: 1:15 – 4:45 PM CEST
Presentation Title: “Single dose immunization with DepoVax™ induces potent, long-lasting antibodies to PfEMP1: a novel malaria vaccine approach”
Presentation at IDWeek, October 26-30, 2016 in New Orleans, Louisiana
Session: Clinical Infectious Diseases: Respiratory Infections
Session Date: Friday, October 28, 2016
Session Time: 12:30 PM – 2:00 PM CT
Session Location: New Orleans Convention Center Poster Hall
Presentation Title: “A Phase I randomized, observer-blind, controlled, dose escalation trial of the safety and tolerability of two intramuscular doses of DPX-RSV(A), a Respiratory Syncytial Virus vaccine containing Respiratory Syncytial Virus (RSV) SH antigen and a novel adjuvant DepoVax™, or SH antigen co-administered with aluminum hydroxide, or placebo to healthy adults ≥50-64 years of age”
More information on the RSV16, World Vaccine Congress Europe and IDWeek 2016 abstracts can be found on the conference websites.
About Immunovaccine
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 infectious diseases. Immunovaccine develops cancer immunotherapies and infectious disease vaccines based on the Company’s DepoVax™ platform, a patented delivery agent that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 1/1b study with Incyte Corporation assessing lead cancer therapy, DPX-Survivac, as a combination therapy in ovarian cancer, as well as a Phase 2 study in recurrent lymphoma. The Company is also advancing an infectious disease pipeline including innovative vaccines for respiratory syncytial virus (RSV), and currently has clinical projects ongoing to assess the potential of DepoVax™ to address malaria and the Zika virus. Connect at www.imvaccine.com
Forward-looking Statement
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 Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals and the matters discussed under “Risk Factors and Uncertainties” in Immunovaccine’s Annual Information Form filed on March 29, 2016. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law.
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Halifax, Nova Scotia; August 25, 2016 – Immunovaccine Inc. (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced new data from its Phase 1/1b trial in ovarian cancer, which reinforced previously reported results showing that DPX-Survivac was well tolerated, with no unexpected treatment-related serious adverse events (SAEs) and that it demonstrated the ability to generate a relevant, sustained immune response.
New data from the Phase 1/1b trial yielded positive findings on tumor clinical response—including the presence of relevant circulating T cells and increased expression of several checkpoint inhibitor molecules. New analyses from the trial indicated:
• Targeted T cell responses to survivin, the DPX-Survivac target protein, were observed in 87 percent of study participants evaluable for immune response (47 of 54 evaluable patients)
• Of participants in this trial who generated T cell responses, 79 percent (37 of 47 patients) were able to maintain durable immune responses sustained over time with repeated DPX-Survivac injections.
• While the study was not designed to assess progression-free survival (PFS), it was observed in the extended follow-up that, of the 18 participants who completed the three doses of the Phase 1 study, 50 percent achieved at least 24 months progression-free survival from the end of their last chemotherapy, with three participants being free for more than five years since their last treatment. (Historical progression-free survival in ovarian cancer is 10 to 12 months for first-line treatment and 6 to 8 months for second-line treatment)1.
• Additional blood and tumor analysis performed on one participant showed increased levels of expression of several inhibitory checkpoint molecules after DPX-Survivac treatment
• Researchers concluded an optimal dosing schedule for upcoming clinical studies involving DPX-Survivac in ovarian cancer, consisting of two ‘priming’ injections with a booster administered every eight weeks over the duration of up to one year of treatments.
“These results bring into focus Immunovaccine’s commitment and ability to address the high unmet need for ovarian cancer patients,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “Our industry is racing to develop novel combination therapies, and we believe that the data from our recent trial yields several significant findings—in particular the specific effects on circulating T cells and checkpoint inhibitor activity—that, in our view, advantageously position DPX-Survivac as an optimal component of future impactful combination therapies.”
DPX-Survivac targets the survivin protein, which is overexpressed in more than 20 types of solid tumor (including ovarian) and hematologic cancers, and is involved in multiple critical pathways of cancer cell growth and survival. This analysis follows the completion of enrollment and dosing in Immunovaccine’s open-label, dose-ranging Phase 1/1b program evaluating the safety and immunogenicity of its lead immuno-oncology drug candidate, DPX-Survivac in participants with stage IIc-IV ovarian cancer. Eight cohorts of patients received different doses and schedules of subcutaneous injections of the DPX-Survivac vaccine together with or without low doses of metronomic cyclophosphamide. In total, 56 high-risk participants with epithelial ovarian cancer after first or second line chemotherapy received DPX-Survivac in the study, which was conducted across multiple sites in the U.S. and Canada.
“This topline analysis provides several key insights into the novel potential of the DPX-Survivac adjuvanting therapy in ovarian cancer,” stated Dr. Jeannine A. Villella, D.O., FACOG, FACS, Chief, Gynecologic Oncology, Associate Professor, Hofstra Northwell School of Medicine, and Co-Primary Investigator for the trial. “The observed presence and maintenance of circulating cancer-specific T cells is considered critical for immunotherapy cancer treatments because these cells are the active component for eradicating cancer cells and may be complementary to checkpoint inhibitor agents. In addition, the data provides early indications that this T cell response may have meaningful impact on the tumors and translate into clinical benefit.”
As previously published, a trial participant with stable but measurable disease also achieved a partial response (PR) as measured by Response Evaluation Criteria In Solid Tumors (RECIST 1.1). The subject experienced a 43 percent tumor shrinkage and progression-free survival interval of 16 months from end of last chemotherapy treatment, during which time she received DPX-Survivac therapy. Immunovaccine plans to continue collecting long-term safety and progression-free data, even though the trial was not designed specifically to assess PFS or not placebo controlled, and is not powered to definitively conclude on long-term outcomes.
“We believe that this new data from our Phase 1/1b clinical trials further supports the combination therapy potential for DPX-Survivac in current and future immuno-oncology clinical programs, including in our ongoing combinations trials with our industry partners,” continued Mr. Ors. “Together, these findings will continue to guide our future clinical strategy.”
Immunovaccine’s ovarian cancer-focused clinical program also includes a Phase 1b trial with Incyte Corporation(NASDAQ:INCY) to evaluate the triple combination of DPX-Survivac with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360) and low dose oral cyclophosphamide in patients with platinum sensitive or resistant ovarian cancer.
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1Hanker LC, Loibl S, Burchardi N, Pfisterer J, Meier W, Pujade-Lauraine E, Ray-Coquard I, Sehouli J, Harter P, du Bois A; AGO and GINECO study group. Oct 2012. The impact of second to sixth line therapy on survival of relapsed ovarian cancer after primary taxane/platinum-based therapy. Annals of Oncology. 23(10): 2605-12. Epub 2012 Aug 21.
About DPX-Survivac
DPX-Survivac is Immunovaccine’s lead cancer immunotherapy candidate, generated by its novel proprietary DepoVax™ adjuvanting technology platform. DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ adjuvanting platform. The National Cancer Institute (NCI) has recognized survivin as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in multiple cancer types in addition to ovarian cancer, including breast, colon and lung cancers. Survivin plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in a higher percentage of tumors than other TAAs.
The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T cell immune response against cells presenting survivin peptides. This targeted therapy attempts to use the immune system to search actively and specifically for tumor cells and destroy them. Survivin-specific T cells have been shown to target and kill survivin-expressing cancer cells while sparing normal cells.
The U.S. Food & Drug Administration (FDA) granted DPX-Survivac Fast Track status as maintenance therapy in individuals with advanced ovarian, fallopian tube, and peritoneal cancer who have no measureable disease following surgery and front-line platinum/taxane chemotherapy to improve their progression-free survival. The FDA also granted orphan drug status to DPX-Survivac for the treatment of ovarian cancer. This designation is valid for all applications of DPX-Survivac in ovarian cancer without restriction to a specific stage of disease.
About Immunovaccine
Immunovaccine Inc. develops cancer immunotherapies and infectious disease vaccines based on the Company’s DepoVax™ platform, a patented formulation that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 2 study with its lead cancer vaccine therapy, DPX-Survivac, in recurrent lymphoma. DPX-Survivac is expected to enter additional Phase 2 clinical studies in ovarian cancer and glioblastoma (brain cancer). In collaboration with commercial and academic partners, Immunovaccine is also expanding the application of DepoVax™ as an adjuvanting platform for vaccines targeted against infectious diseases. Immunovaccine’s goal in infectious diseases is to out-license its DepoVax™ platform to partners to generate earlier revenues. Connect at www.imvaccine.com
Immunovaccine 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 Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law.
Contacts for Immunovaccine:
 
MEDIA 
Mike Beyer, Sam Brown Inc.
T: (312) 961-2502 E: [email protected]
INVESTOR RELATIONS
Kimberly Stephens, Chief Financial Officer
T: (902) 492-1819 E: [email protected]
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News Release: Immunovaccine Announces Positive Interim Phase 1 Data for DepoVax™-based Respiratory Syncytial Virus Vaccine Candidate

here Vaccine Demonstrated Tolerable Safety Profile, Induced Measurable Immunogenic Response in 100 Percent of Study Participants in Higher Dose Cohort  Trial Provides Immunovaccine’s First Clinical Immunogenicity Demonstration in Infectious Disease Applications  Halifax, Nova Scotia; July 6, 2016 – Immunovaccine Inc. (“Immunovaccine” or the “company”) (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced that a team of investigators has completed an interim analysis of the safety and immunogenicity of its DepoVax™ prophylactic respiratory syncytial virus (RSV) vaccine candidate (DPX-RSV) in a Phase 1 clinical trial in healthy older adult volunteers. The safety analysis indicates that the DPX-RSV was well tolerated among all study participants, with no serious adverse events (SAEs) recorded. Furthermore, immunogenicity data supported DPX-RSV’s ability to generate a relevant immune response; the vaccine candidate obtained antigen-specific antibody responses in 75 percent of subjects vaccinated with the lower dose, and 100 percent of those vaccinated with the higher dose. “Having the interim DPX-RSV data in hand marks a critical milestone for Immunovaccine. It represents our first clinical demonstration, outside of cancer trials, of the ability of DepoVax™-based vaccines to generate relevant immune responses in humans,” said Frederic Ors, Immunovaccine’s Chief Executive Officer.  “Deploying DepoVax™ in key areas of infectious disease remains a cornerstone of our strategy. We are encouraged by this data and look forward to continuing to explore the ways in which DepoVax™ can positively impact treatment developments in areas of unmet medical need in infectious diseases, including RSV.” Principal Investigator Joanne Langley, BA, MD MSc FRCPC, led the study, which was conducted at the Canadian Center for Vaccinology (CCfV) and funded in an industry-academic collaboration by the Canadian Institutes of Health Research and Immunovaccine. The DPX-RSV trial included 40 healthy older adult volunteers and two dose cohorts, with 20 subjects in each cohort. Investigators analyzed the safety and immune response data of all participants up to study day 84. Immunovaccine’s vaccine delivery approach focuses on targeting the ectodomain of the SH protein of RSV. Ectodomains are the parts of the protein exposed on the surface of the cell or virus. Prior preclinical research related to this study conducted by VIB and Ghent University scientists showed that the SH ectodomain was protective in animal models1. Targeting the SH antigen is a significant differentiator from other RSV vaccine programs for two reasons:

  1. Typical RSV vaccine efforts are focused on targeting the F and G proteins of the virus. However, people can remain susceptible to RSV infection even when they exhibit high levels of antibodies that target the F and G antigens.2
  1. During RSV infection, infected cells are shed into the respiratory tract. If not cleared by the immune system, this process can cause airway obstruction and complications that linger post-infection. Immune responses targeting SH antigen were able to recognize the target protein on the virally infected cells, and were functional in activating immune mechanisms that may act to clear infected cells from the airways.
“We are pleased that the interim data from this study indicates that DPX-RSV is generally well-tolerated, and induces a robust immune response,” said Dr. Langley. “To the best of our knowledge, this is the first clinical-phase demonstration of a vaccine targeting the SH antigen and we believe that this analysis provides the rationale to continue clinical testing DPX-RSV in future human trials.” “It is very rewarding to see that the basic research findings for an RSV vaccine candidate that was developed in my group at VIB and Ghent University contributed to this first-in-man study,” said Dr. Saelens, group leader at VIB and Ghent University (Ghent Belgium). “SH ectodomain-specific antibody responses can clearly be induced in humans by DPX-RSV and our results suggest that these antibodies can exert an anti-RSV effect.” “This is a validating study for Immunovaccine,” stated Marianne Stanford, PhD, Director of Research at Immunovaccine. “It indicates that our first infectious disease vaccine candidate, DPX-RSV, exhibits unique features that both address unmet medical need related to the RSV virus, and also overcomes limitations of other vaccine candidates in development. This creates a potential benefit for future patients as well as a competitive advantage that will drive value to our investors.” Immunovaccine has exclusive worldwide licenses on applications that target the SH ectodomain antigen in RSV. About RSV Respiratory syncytial virus (“RSV”) is a common virus that infects the lungs and breathing passages. While it usually leads to mild, cold-like symptoms, it can be severe in the elderly, infants and patients with compromised immune systems. It is second only to influenza as the most commonly identified cause of viral pneumonia in older persons. Globally, it is estimated that 64 million cases of RSV infection occur annually in all age groups, with 160,000 deaths. There is no vaccine currently available to prevent RSV. About DPX-RSV DPX-RSV is Immunovaccine’s vaccine candidate designed specifically to address the unmet medical needs in respiratory syncytial virus (“RSV”). Generated by the company’s proprietary DepoVax™-based platform, it is believed to be the first vaccine candidate in development that targets specifically the SH antigen, which may provide additional immunogenic benefit over traditional approaches for high risk populations, including infants and the elderly. In addition, the concentrated dosage enabled by the DepoVax™ delivery system may help mitigate injection site point-of-pain, which has been a limitation for other potential treatments. The company recently released interim Phase 1 data for DPX-RSV, which indicated that the vaccine demonstrated a tolerable safety profile and robust immune response in healthy adult volunteers. About DepoVax™ DepoVax™ is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system, resulting in a strong, specific and sustained immune response with the potential for single-dose effectiveness. The DepoVax™ platform is flexible and can be used with a broad range of target antigens for preventative or therapeutic applications. The technology is designed to be commercially scalable, with the potential for years of shelf life stability. Fully synthetic, off-the-shelf DepoVax™-based vaccines are also relatively easy to manufacture, store, and administer.  This would enable Immunovaccine to pursue vaccine candidates in cancer, infectious diseases and other vaccine applications. About Immunovaccine Immunovaccine Inc. develops cancer immunotherapies and infectious disease vaccines based on the Company’s DepoVax™ platform, a patented formulation that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 2 study with its lead cancer vaccine therapy, DPX-Survivac, in recurrent lymphoma. DPX-Survivac is expected to enter additional Phase 2 clinical studies in ovarian cancer and glioblastoma (brain cancer). In collaboration with commercial and academic partners, Immunovaccine is also expanding the application of DepoVax™ as an adjuvanting platform for vaccines targeted against infectious diseases. Immunovaccine’s goal in infectious diseases is to out-license its DepoVax™ platform to partners to generate earlier revenues. Connect at www.imvaccine.com Immunovaccine 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 Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. Contacts for Immunovaccine: MEDIA  Mike Beyer, Sam Brown Inc. T: (312) 961-2502 E: [email protected] INVESTOR RELATIONS Kimberly Stephens, Chief Financial Officer T: (902) 492-1819 E: [email protected]   REFERENCES 1Schepens B, Sedeyn K, Vande Ginste L, De Baets S, Schotsaert M, Roose K, Houspie L, Van Ranst M, Gilbert B, van Rooijen N, Fiers W, Piedra P, Saelens X. Protection and mechanism of action of a novel human respiratory syncytial virus vaccine candidate based on the extracellular domain of small hydrophobic protein. EMBO Mol Med. 2014 Oct 8;6(11):1436-54.2Schepens, Bert, Michael Schotsaert, and Xavier Saelens. “Small Hydrophobic Protein of Respiratory Syncytial Virus as a Novel Vaccine Antigen.” Immunotherapy 7.3 (2015): 203-06. DOI: 10.2217/IMT.15.11]]>