October 18, 2016
By Mark Terry, BioSpace.com Breaking News Staff
South San Francisco – True North Therapeutics announced it has completed a Series D equity financing round worth $45 million. It was led by new investors HBM Healthcare Investments and Redmile Group, and existing investor Perceptive Advisors. New investor Franklin Templeton Investments participated, along with existing investors.
To date, the company has raised about $142 million.
True North is focused on developing drugs that selectively inhibit a part of the immune system called the Complement system. The overall focus is on developing drugs for rare diseases. Its lead compound is a complement inhibitor, TNT009, for Cold Agglutinin Disease (CAD), in addition to other rare diseases related to Complement. CAD is a rare autoimmune disease, in which the body’s immune system, usually IgMs, attack the body’s red blood cells.
The company indicates it will use the extra funding to continue development of TNT009 beyond the ongoing Phase Ib clinical trial, and to push forward with other pipeline programs.
“With this oversubscribed financing, we are grateful for the strong support from high-quality crossover investors who share our long term vision for the company to advance life-changing medicines for patients with limited treatment options,” said Nancy Stagliano, True North’s chief executive officer, in a statement. “The momentum behind our business continues to be strong. This financing follows encouraging clinical data, enabling a clear strategy to advance our lead program TNT009 in CAD and to expand our pipeline for other Complement-mediated rare diseases. There has been widespread excitement about TNT009 since our initial clinical data were presented, which showed that TNT009 rapidly resulted in benefit to CAD patients and represents a potential new therapeutic option for this rare and underserved hematologic disease.”
So far, TNT009 has been tested on five patients with CAD. Interim results were announced in June 2016. Just last week, the U.S. Food and Drug Administration (FDA) granted TNT009 Orphan Drug Designation. It also received Orphan Drug Designation in February 2016 in Europe.
The interim data shows promise. Each of the first five CAD patients received an initial dose of 10 mg/kg followed by a full 60 mg/kg dose one to four days later, and three more weekly doses of 60 mg/kg. Of those five, four responded within the first day. Of the four, three achieved a Complete Response after the 4-week dosing period. No serious adverse events were observed.
“We have great confidence in the True North leadership team and the potential of the company’s pipeline of Complement inhibitors for rare diseases,” said Andreas Wicki, chief executive officer of HBM Healthcare Investments, in a statement. “In particular, we are very encouraged by the interim Phase Ib data reported for its lead program, TNT009, in CAD patients and look forward to working with True North as it further advances development of this drug candidate and other pipeline programs.”
TNT009 is also being evaluated in Phase Ia/Ib clinical trials in warm autoimmune hemolytic anemia, antibody-mediated rejection, Bullous Pemphigoid, and in preclinical work in other diseases that aren’t specified. The company also indicates it has a next-generation anti-C1s antibodies in preclinical development.
The company doesn’t share much detail about its pipeline or its plans for the future. Stagliano, when asked by John Carroll, writing for Endpoints News, what the plans were for the funds raised, said, “It gives us a lot of good options in whatever way to finance the company that makes sense.”
Carroll writes, “But you can be sure that there’s been plenty of thought being put into planning at True North. Stagliano was handed a failed company when she took over iPierian, built a new research focus and then split the company, eventually selling off the restructured iPierian and its work on Alzheimer’s to Bristol-Myers Squibb for $175 million down and up to $550 million in milestones.”
