Leading Health and Life Sciences in Nova Scotia
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.
______________________________________________ 
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]
]]>

News Release: Immunovaccine Announces Positive Interim Phase 1 Data for DepoVax™-based Respiratory Syncytial Virus Vaccine Candidate

Jul 6, 2016 | IMV Inc., News

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]]>

Life Sciences offers solutions for growth in Nova Scotia after 2016-17 budget release

Apr 21, 2016 | DSM, IMV Inc., Innovative Medicines Canada, News

NEWS RELEASE HALIFAX, April 21, 2016 — On Tuesday the Nova Scotia government tabled its 2016-17 Budget with a surplus of $17.1 million and a commitment to work collaboratively with industries with big potential in the province. As part of the Budget address, the province called for a collaborative approach model to boost the economy. “This government understands that we cannot solve our economic problems alone. We need to work together to create a stronger economy, a stronger Nova Scotia,..” stated the- Hon. Randy Delorey, Minister of Finance as part of Budget 2016-2017 The life sciences industry in Nova Scotia has indicated it is ready to work with government and is poised as a growth facilitator for the province’s future economic and social prosperity. Generating nearly $300 million in revenues for the province and exporting up to 90% of products, the sector offers a strong and sustainable economic strategy. “With further support from the province for the life sciences community to develop their ideas, commercialize their technologies and build links within the region and internationally we will continue to be a wealth generator for the province,” said Scott Moffitt, Managing Director of BioNova, the life science industry association. The industry has also been fostering valuable collaborative relationships with national associations such as Innovative Medicines Canada to accelerate the development of local pharmaceutical companies, as evidenced by the recent signing of a memorandum of understanding to enhance Nova Scotia’s medical technology portfolio. In recent years, the local life sciences industry has also seen a significant increase in innovation and potential coming from Nova Scotia companies. Immunovaccine Inc. is a good example of this, with a greater than $60 million market cap and a new CEO focused on industry collaborations to continue down the path of growth. The $540 million acquisition of Nova Scotia-based Ocean Nutrition Canada by Royal DSM, a global life science and material sciences company, is another example of growth in the sector. “It’s easy to imagine what more growth in this sector could lead to for Nova Scotians. We look forward to building strong links with the Government of Nova Scotia to further innovation in Nova Scotia’s life sciences sector,” said Russell Williams, President of Innovative Medicines Canada. ABOUT BIONOVA BioNova is Nova Scotia’s life sciences industry association and sector development organization. BioNova leads and supports its members as we build a successful, self-sustaining life sciences industry in Nova Scotia. By promoting the industry and its successes, building relationships both inside and outside the province and creating networking and educational opportunities BioNova aims to accelerate the commercialization success of Nova Scotia’s life sciences businesses and organizations. ABOUT INNOVATIVE MEDICINES CANADA Innovative Medicines Canada is the national voice of Canada’s innovative pharmaceutical industry. We advocate for policies that enable the discovery, development and commercialization of innovative medicines and vaccines that improve the lives of all Canadians. We support our members’ commitment to being valued partners in the Canadian healthcare system.   – 30 – For further information: Shana McRae Marketing & Communications Officer, BioNova Telephone: 902-421-5705 ext. 2 E-mail: [email protected] Sarah Douglas Media Relations, Innovative Medicines Canada Telephone: 613-883-7250 E-mail: [email protected]]]>