Licensing agreement, combined with the results of Pre-IND meeting, keeps TT-01 on schedule for Phase I/II clinical trials.
BOSTON (PRWEB) November 20, 2019
Temprian Therapeutics Inc., a Chicago-based startup company dedicated to developing therapies for autoimmune disease, announced today the in-licensure of a pending composition-of-matter patent for a DNA-based drug encoding the modified heat shock protein, HSP70i, from Northwestern University. The patent forms the backbone for TT-01, a drug under development by Temprian Therapeutics. The initial program for the technology is to reverse loss of skin color in the skin disorder vitiligo, which is caused by the immune system attacking melanocytes (pigment producing cells). The announcement was made at the Drug Development Summit in Boston, Massachusetts.
Vitiligo is progressive and can lead to total loss of pigmentation over time. The disease affects in excess of 50 million people worldwide; in the United States over 2.5 million people suffer from vitiligo. Comorbidities include hypothyroid disease, alopecia and depression. Vitiligo is highly stigmatizing, often resulting in discrimination.
The lead inventor of the licensed technology Dr. Caroline Le Poole, is a professor of Dermatology, Immunology and Microbiology at Northwestern University, Feinberg School of Medicine. The National Institute of Health (NIH) has awarded over $4.5M to research and develop this technology. Dr. Le Poole co-founded Temprian with the objective to bring the technology to a clinical application.
Earlier this year Temprian completed a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) and raised $325,000 of seed financing, according to the company’s CEO Dr. Kettil Cedercreutz. “We are planning to start clinical trials in 2021. Upon attaining FDA approval TT-01 would secure market exclusivity for twelve (12) years as a new biologic.”
Vitiligo is a familial disease typically triggered by stress. The stress causes affected cells to express HSP70i, a heat shock protein that triggers an immune response. TT-01 would be administered via needle-less injections of DNA coding for the modified HSP70i. The treatment tempers the immune response systemically, allowing the skin to repigment. The technology has been tested in mice and swine models, as well as in vitro and ex vivo in humans. Research results have been reported in Science Translational Medicine and The Journal of Investigative Dermatology. The figure below shows repigmentation in swine over 27 weeks.
ABOUT THE COMPANY: Temprian Therapeutics Inc. is an early stage company dedicated to developing treatments for autoimmune disease, most notably vitiligo. The company is incubated at MATTER, Chicago. Temprian Therapeutics works closely with the patient community in the development of a market-oriented solution for the treatment of vitiligo.