Janssen has signed a new collaboration with Protagonist Therapeutics with the potential to deliver $1.2 billion to the company founded in 2001 and spun out of the University of Queensland.
Protagonist was founded by Associate Professor Mark Smythe out of the university's Institute of Molecular Bioscience to focus on the development of treatments for inflammatory bowel disease, irritable bowel syndrome and other gastro-intestinal disorders.
Protagonist is headquartered in the US and listed on the NASDAQ stock market in 2016, raising $US90 million in its initial public offering of 7.5 million shares.
The company has now announced a new collaboration with Janssen for the co-development and commercialisation of PTG-200, its first-in-class, oral peptide IL-23 receptor antagonist for all indications including inflammatory bowel disease.
According to the company, PTG-200 is expected to enter Phase 1 clinical testing in normal healthy volunteers in the second half of 2017.
Under the terms of the agreement, Protagonist will receive an upfront payment of US$50 million from Janssen, and will also be eligible to receive up to an additional US$940 million in development, regulatory, and sales milestones.
"The development milestones represent significant payments that Protagonist would receive upon completion of each component of the Phase 2a/2b clinical trial in Crohn's disease if Janssen elects to retain its license following each of those events. Janssen will receive exclusive, worldwide rights to develop and commercialize PTG-200, and Protagonist will receive double-digit tiered royalties on net product sales," said the company in a statement.
The agreement builds upon a prior investment by Johnson & Johnson in Protagonist to support the discovery and development of its pipeline of oral peptide therapeutics.
"We are very pleased to partner with Janssen, a world-leader in the development of innovative therapies for patients suffering with chronic inflammatory and immunomodulatory diseases. As an oral IL-23 receptor antagonist, PTG-200 nicely complements Janssen's current IBD portfolio," said Protagonist president and CEO, Dr Dinesh Patel. "The funding provided by this transaction enables us to advance our platform and clinical pipeline of innovative peptide drugs, including our lead oral peptide alpha-4-beta-7 integrin antagonist, PTG-100, which is currently in a Phase 2b clinical trial as a potential treatment for ulcerative colitis."
"Our oral peptide PTG-200 works by blocking the IL-23 pathway, a mechanism which has been proven by injectable antibodies, including an approved drug and others in different stages of clinical development," said David Liu, Protagonist's chief scientific officer and head of R&D. "As evidenced by PTG-200, we believe our technology platform is validated in its ability to generate potential first-in-class oral peptides as the next generation of targeted therapy drugs for IBD."