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Immunovaccine is Making Progress in Advancing its Clinical Programs
By Grant Zeng, CFA
Positive Interim Results from Phase I Study of DPX-Survivac Reported
On October 9, 2012, Immunovaccine Inc. () announced positive interim results from the Company’s Phase I clinical trial of DPX-Survivac, an ovarian cancer vaccine candidate.
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 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.
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.
Immunovaccine has completed the first cohort of the Phase I trial. The first cohort consists of three patients given three doses of DPX-Survivac over a period of six weeks. Results from the first cohort demonstrated that DPX-Survivac was well tolerated with no serious adverse events reported, and that the vaccine is immunogenic as a monotherapy.
Current interim results showed that, to date, all nine patients receiving DPX-Survivac in combination with cyclophosphamide produced a targeted immune response following only one or two vaccine administrations. Patients receiving a higher dose (0.5 mL) of DPX-Survivac in combination with cyclophosphamide (n=3) produced immune responses after only one vaccination and generally exhibited higher antigen specific immunity than those receiving the combination with a lower (0.1 mL) DPX-Survivac dose (n=6), suggesting dose-related activity. Importantly, patients in the two cohorts experienced consistent immune responses that were detected at two consecutive time points. Specifically, the first three patients enrolled in the 0.5 mL dose cohort in combination with low dose cyclophosphamide demonstrated an average stimulation factor of 350 times (350x) following the second vaccination, and in one patient greater than 850 times (850x), over baseline responses.
Additional results from the interim analysis showed that patients receiving DPX-Survivac without cyclophosphamide were capable of producing antigen specific immune responses. The interim analysis also showed the vaccine to be safe and well tolerated with no systemic side-effects or dose limiting toxicities reported to date. Adverse events were limited to expected local reactions at the site of vaccination.
Final results from the study, including a more extensive safety and immunogenicity analysis of all cohorts, are expected by the end of the year.
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.
The reported interim results provide important support for the ongoing DPX-Survivac development program as they clearly demonstrate that the vaccine can activate the desired immunity in target patient population.
Based on the progress Immunovaccine has made so far and the fundamentals of the Company, we think current valuation is attractive. We encourage investors to collect shares at this point.
Please visit Grant Zeng's coverage page at scr.zacks.com to access a free copy of the full research report.