Sorrento announced positive data from a combined Phase 2 & 3 clinical study of STI-004, an anti-IgE biosimilar antibody

May 26, 2016 9:31 AM

Sorrento Therapeutics, Inc., an antibody-centric, clinical-stage biopharmaceutical company developing new therapies for cancer and other unmet medical needs announced that its partner, Mabtech Ltd., has successfully completed a combined Phase 2 & 3 clinical study in China for STI-004, a biosimilar antibody for Omalizumab (Xolair).

STI-004 met its primary endpoint in a multicenter, randomized, double-blind, placebo-controlled clinical trial.

STI-004 is a humanized monoclonal antibody produced in CHO cells that neutralizes immunoglobulin E (IgE), preventing the inflammatory events that lead to asthma exacerbations. In the recently completed combined Phase 2 & 3 clinical study, STI-004 proved to be safe and efficacious in both adult and adolescent patients suffering from allergic asthma when compared to placebo. In the 32-week study, asthma exacerbation was experienced by 21% of patients taking STI-004 as compared to 55% in the placebo group. In addition to significantly reducing asthma exacerbations, STI-004 demonstrated improved quality of life and pulmonary function while also reducing the dosage of budesonide and the use of asthma rescue medications. When compared to the currently marketed product, Xolair®, the types and incidence rates of adverse events were similar.

“STI-004 has demonstrated clinical efficacy and safety during the Phase 2 & 3 clinical trial conducted by our partner MabTech. This antibody is comparable to the currently marketed product and is expected to provide a much needed biosimilar option for patients,” commented Dr. Henry Ji, President and CEO of Sorrento Therapeutics. Sorrento licensed four biosimilar/biobetter antibodies, including STI-004, from Mabtech in August 2015. “We are making progress with the development of these products in Sorrento’s territories, which include North America, the EU, and Japan, while Mabtech seeks market approval for STI-004 in China. We are encouraged by the interest and excitement we have received from the biopharmaceutical industry regarding potential collaborations for development and commercialization of these biosimilar/biobetter antibodies in our portfolio,” added Dr. Ji.

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