Immunovaccine Announces Additional Positive Topline Results from Phase 1/1b Clinical Trial Program With DPX-Survivac in Ovarian Cancer

HALIFAX, NOVA SCOTIA--(Marketwired - Aug. 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.

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.

(1) Hanker 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.