Immunovaccine is on Track to Advance Clinical Programs

Zacks Small Cap Research

By Grant Zeng, CFA

Immunovaccine Reports Financial Results for First Quarter of 2013

On May 16, 2013, Immunovaccine Inc. (IMV.V) announced its financial and operational results for the quarter ended March 31, 2013.

There was no revenue for the first quarter of Q1 2013 ended March 31, 2013.

Total R&D expenses for the first quarter of 2013 were $839,000, less government loans and assistance of $41,000 and investment tax credits of $70,000. This represented a $181,000 increase of net R&D expenses over the three months ended March 31, 2012.

G&A expenses were $614,000 for 1Q13 compared to $567,000 for the three months ended March 31, 2012, an overall increase of $47,000. Total business development expenses of $221,000 in Q1 Fiscal 2013 represented a decrease of $24,000 compared to the three months ended March 31, 2012.

Net loss for 1Q13 was $1.6 million, increased from a loss of $1.4 million during the quarter ended March 31, 2012. This relates mainly to a $308,000 decrease in government loans and assistance.

At March 31, 2013, Immunovaccine had cash and cash equivalents of $2.5 million and working capital of $2.1 million as compared to $2.0 million in cash and $2.1 million in working capital at December 31, 2012.

As of March 31, 2013, the number of issued and outstanding common shares was 68,412,996. On March 31, 2013, the number of stock options outstanding was 5,229,650 and the number of outstanding warrants was 3,732,550.

While we think the financial results releasing is a non-event for Immunovaccine, we are glad to see that Immunovaccine is making progress in its clinical programs.

Balance Sheet Boosted By New Financing

On March 5, 2013, Immunovaccine closed a private placement of its securities, raising gross proceeds of $1,603,880.  Under terms of the financing, a total of 4,860,244 common shares were sold at a price of $0.33 per share.

Net proceeds from the financing will be used to fund preclinical research and development efforts in the areas of infectious diseases, including respiratory syncytial virus (RSV), malaria and anthrax.  These ongoing efforts will support Immunovaccine’s Phase I clinical trials for these infectious diseases programs. The proceeds will also support preparatory work to advance IMV's clinical stage oncology program, DPX-Survivac, into Phase II development, as well as ongoing efforts to establish alliances, collaborations and strategic transactions with parties including government entities, academic medical centers and other companies in order to secure additional financing to advance its current clinical programs and to expand its pipeline of strategic assets.

As of March 31, 2013, IMV had cash and cash equivalents of $2.5 million. Immunovaccine will continue to use a combination of strategic partnerships, non-dilutive financing and equity to support its development programs and in turn drive value creation.

Positive Results Reported for DPX-Survivac in Phase I Ovarian Cancer Study

On January 7, 2013, Immunovaccine Inc. (TSX-V:IMV) reported positive results from a Phase I clinical study of the Company’s cancer vaccine, DPX-Survivac, for the treatment of ovarian cancer.

As a reminder, Immunovaccine initiated a Phase I clinical trial of DPX-Survivac and vaccinated the first patient in December 2011. The Phase I clinical trial is being conducted in eight clinical sites in the US and Canada. The Phase I is an open label clinical trial designed to evaluate sequentially the safety of two DPX-Survivac dosing regimens (0.5 ml and 0.1 ml) in approximately 15 patients. The goal of the Phase I clinical trial is to establish the safety and immune activity of DPX-Survivac in patients with advanced ovarian cancer.

Under the study protocol, these patients each received a total of three DPX-Survivac vaccinations three weeks apart with a total of 18 ovarian cancer patients completing all three vaccinations. A lead-in cohort of three patients received DPX-Survivac alone to confirm the safety of the vaccine as a monotherapy. Two additional cohorts of six patients each received a low dose or a high dose of DPX-Survivac in combination with a low dose of cyclophosphamide. The trial’s primary objective was to evaluate the safety of the vaccine and in combination with cyclophosphamide.  A secondary endpoint was the evaluation of the immune response produced by the vaccine therapy.

IMV intends to use DPX-Survivac alone or in combination with low dose oral cyclophosphamide as a first line maintenance therapy following standard surgery/ radiation/ chemotherapy. The therapeutic cancer vaccine is intended to stimulate an immune response to attack the circulating cancer cells that remain in a patient’s body after surgery and radiation/chemotherapy. This treatment approach has the potential to combat micro-metastases and keep the cancer in remission and prevent metastasis.

 

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On October 9, 2012, IMV announced positive interim results from this Phase I clinical trial.

Current analysis, which now includes all patients enrolled in the study, confirmed previously reported results and uncovered new findings which are highlighted as follows:

·       All patients receiving the DPX-Survivac combination therapy who were evaluable by tetramer staining (n=10) produced survivin-specific CD8 T cells following one or two vaccinations. Importantly the CD8 responses were maintained with booster vaccinations. The activation and maintenance of these specific immune cells is of particular interest in immunotherapy since CD8 T cells are implicated in identifying cancer cells, infiltrating tumors and killing cancer targets. 

·       All patients receiving the DPX-Survivac combination therapy (n=12) demonstrated antigen specific immune responses as measured by at least one of the study’s three immune monitoring assays (ELISpot, tetramer analysis and multiparametric intracellular cell staining). In 11 of 12 patients, the immune responses were confirmed by two assays (five patients) or three assays (six patients) performed. These immune responses were established with one or two vaccinations and further increased or maintained with follow-up booster vaccinations. 

·       Analysis of immune responses by ELISpot showed that a cohort of patients receiving the higher dose of the vaccine therapy produced an average stimulation factor of greater than 600 times (600x) over baseline following their third vaccination.   For one of these patients, the stimulation factor reached greater than 1,200 times (1,200x) over baseline. These immune responses are in agreement with the previously reported average increase of 350 times (350x) over baseline for these same patients following their second vaccination. 

·       DPX-Survivac was deemed well tolerated with no significant systemic adverse events reported in any patients recruited in this study. Reported adverse events were restricted to injection site reactions, which were experienced by the majority of patients after repeated vaccinations.  Those patients presenting the strongest immune responses were more likely to exhibit more pronounced injection site reactions.  There were no dose limiting toxicities experienced during the trial and no patient withdrew consent due to adverse events.

The Phase I study is part of a Phase I/II trial cleared by the U.S. FDA and Health Canada. The Phase II portion of the trial will be a randomized, double-blinded, placebo-controlled study with a vaccine dose selected based on the Phase I results.  The Phase II trial will assess the clinical benefit of DPX-Survivac in patients with advanced ovarian cancer.

We are encouraged by the positive data from this Phase I study. The positive data continue to demonstrate that IMV's technology can speed up immune responses and make them stronger and longer lasting, for a wide range of vaccines. We have seen positive results from IMV’s candidates whether in cancer immunotherapy or in protection against infectious disease.

The fact that DPX-Survivac can generate and maintain this response is strong evidence to support continued advancement of this candidate.

Phase II Trial of DPX-Survivac is on Schedule

Based on existing clinical data, Immunovaccine has already received clearance from U.S. FDA and Health Canada for the initiation of a Phase II trial of DPX-Survivac immediately following the completion of the ongoing Phase I study.

The Phase II trial will be a randomized, double-blinded, placebo-controlled study with a single vaccine dose selected based on the Phase I results.  The Phase II trial will assess the clinical benefit of DPX-Survivac in patients with advanced ovarian cancer.

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Update On Other Clinical Programs

·       Signed an investigator-initiated study agreement for a Phase I/II trial of DPX-0907 in breast and ovarian cancer. The trial will be conducted at the Busto Arsizio Hospital in Italy with Marco Bregni, M.D., head of the hospital's Oncology Unit, serving as the study's principal investigator. Immunovaccine expects the Phase I/II study to be initiated during the fourth quarter of 2013. The study agreement provides critical non-dilutive funding for Immunovaccine's ongoing advancement of its clinical stage DPX-0907 cancer vaccine program. 

·       Reported positive preclinical data for DepoVax™-formulated anthrax vaccines developed in collaboration with the National Institutes of Health (NIH). Study findings suggested that the DepoVax™-based vaccines provided a more rapid and long lasting immune response as compared to the licensed anthrax vaccine BioThrax™. This immunogenicity study is part of an ongoing bio-defense research program being conducted in partnership with NIH. 

·       Received up to $407,700 in Industrial Research Assistance Program (IRAP) funding to support the development of a respiratory syncytial virus (RSV) vaccine formulated with DepoVax™. RSV is a common lung disease in children, the elderly and patients with a compromised immune system. The funding will be used to advance Immunovaccine's RSV program, including the formulation of RSV antigens in the Company's patented DepoVax™ vaccine-adjuvanting technology. The funding will help IMV prepare for the first human trial of its DepoVax™ platform technology in infectious diseases.

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