PIN Pharma Announces Initiation of its First Phase 1 Study

On November 15, 2017 Pharma reported the initiation of a Phase 1 clinical trial for its novel immune-modulator, PIN-2 (Press release, PIN Pharma, NOV 15, 2017, View Source [SID1234522102]).

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This first-in-human, proof-of-concept study is being conducted in oncology patients with solid tumors by PIN Pharma’s wholly owned Australian subsidiary, PIN Pharma Pty Ltd. The study is designed to show changes in the human immune system utilizing specific biomarkers that will both demonstrate and support PIN-2’s ability to link the innate and adaptive immune systems via antigen presenting cell activation (monocyte-derived dendritic cells) resulting in the generation of endogenous killer T cell immunity (CD8 cells).

"This study is supported by physiological and immunological data generated in our preclinical studies as well as in silico. We are confident that the study will confirm PIN-2’s mechanism of action and validate our preclinical models," said Colin Bier, President and CEO. "We anticipate having interim data by the upcoming JP Morgan conference this January, and are already seeing interest from pharma and venture funds to discuss the potential of this next generation immune-oncology therapy."

With the recent issues arising out of the current generation of immune-oncology compounds both in the clinic and on the market, PIN-2 has the potential to improve response rates that will allow better safety and tolerability either alone or in combination with existing treatments by enhancing innate immunity.