Imugene will test its reformulated therapeutic cancer vaccine, HER-Vaxx, in gastric cancer at trial sites in Asia. The Phase Ib/II trial is expected to start in mid-2016. HER-Vaxx aims to replicate or improve on the combination of two proven therapeutic antibodies, Herceptin and Perjeta (Roche). Imugene aims to gain a major pharma deal following Phase II data in the buoyant cancer immunotherapy area. A$3.0m raised in October gives it sufficient funds to undertake the Phase Ib component of the trial.
Imugene is moving its upcoming Phase Ib/II study to trial sites in Asia. The previous strategy had been to do the trial in Australia and Eastern Europe, but government plans to subsidise Herceptin treatment for HER2 positive gastric cancer patients would have made recruitment in Australia difficult. Novotech has been appointed as the CRO to manage the trial at a number of leading cancer centres in Asia. The level of HER2 antibodies produced after treatment with HER-Vaxx will be measured in the Phase Ib trial, which will be an important pointer towards potential efficacy
Imugene’s new HER-Vaxx formulation uses the vaccine carrier protein CRM197 plus an adjuvant, in place of the virosomes used in previous formulations. This new formulation is easier to manufacture and stimulates faster immune responses and greater antibody production than the original vaccine. A patent application filed in April based on the new formulation could extend IP protection by six years to 2036.
HER-Vaxx aims to stimulate a strong antibody response targeting normal HER-2 proteins, which are overexpressed in ~20% of breast and gastric cancer patients and are a proven cancer target. In a previous Phase I conducted with the original formulation in 10 breast cancer patients, eight developed antibodies against HER2. Global gastric cancer incidence is 952,000 cases with few therapeutic options and low survival. A potent vaccine would be a major advance in gastric cancer therapy.
The additional cash from the recent capital raise sees our valuation increase slightly to A$56m (3.2c/share) from A$53m, with the impact on valuation of a 12- month later expected launch date offset by the likely extension of market exclusivity to 2036. The additional shares and options in issue following the capital raise and issue of loyalty options sees our diluted per share valuation fall to 2.9c per share (vs 4.1c). Pro forma cash is A$4.9m following the A$3m capital raise in October.