Imugene Ltd.'s gastric cancer vaccine HER-Vaxx was found to be safe and tolerable in an early-stage study, which the company said will support the advancement of the drug to a phase 2 trial.
HER-Vaxx is an add-on vaccine therapy for gastric cancer designed to trigger an immune response against cancer cells that overexpress a gene called HER-2. During the phase 1b trial, 14 participants tested doses of HER-Vaxx in combination with the typical standard of care, which includes certain chemotherapy drugs.
An increased antibody response in the patients was recorded for all dose levels. Five out of 10 patients who were examined more closely showed a partial response to the combination therapy, while four saw their disease stabilize, signifying that the cancer was neither growing or shrinking.
Based on the eight-week data from the trial, Imugene plans to enroll 68 gastric cancer patients in a phase 2 trial in 2019. The randomized phase 2 study will measure the overall survival and success of HER-Vaxx in preventing the disease's advance in patients.
According to the company, the phase 2 study will be conducted in Asia, Eastern Europe and India, where common therapies for this type of cancer made by Roche Holding AG unit Genentech Inc., Herceptin and Perjeta, are not readily available to patients.