With Almost $100 Million in Financing, Bay Area’s True North Therapeutics Jumps Into Immune System Clinical Trials

Published: Dec 04, 2015

With Almost $100 Million in Financing, Bay Area's True North Therapeutics Jumps Into Immune System Clinical Trials
December 3, 2015
By Mark Terry, BioSpace.com Breaking News Staff

Bay Area company True North Therapeutics, Inc. announced today that it had closed on a Series C financing round worth $40 million. This brings the company’s total financing to $97 million.

This round was led by New Leaf Venture Partners, joined by new investors Perceptive Advisors and Cowen Private Investments. Existing investors Kleiner Perkins Caufield & Byers, MPM Capital, OrbiMed, SR One, and Baxalta Ventures also jumped in. As part of this round, Isaac Manke, Partner at New leaf Venture Partners, will join True North’s board of directors.

“We are delighted by the strong support and recognition we received in this Series C financing and to have expanded our list of recognized life science investors to include New Leaf Venture Partners as well as Perceptive Advisors, and Cowen Private Investments,” said Nancy Stagliano, chief executive officer of True North, in a statement. “We look forward to the valuable perspectives Isaac will bring to True North’s board as we rapidly execute on our clinical program for TNT009 in Cold Agglutinin Disease and to make a difference in this neglected patient population.”

True North is a spinout of iPierian Inc. Its focus is on developing therapies that selectively inhibit a part of the human immune system known as the Complement system. It is advancing a pipeline of novel monoclonal antibodies for Complement-mediated rare diseases in the hematologic, kidney transplant, and skin therapeutic areas.

True North indicates it will use the additional funding to accelerate clinical development of TNT009 through “potential registration-enabling clinical studies for CAD.” Cold Agglutinin Disease (CAD) is a rare autoimmune type of anemia where the patients immune system attacks and destroys red blood cells. This results in anemia, fatigue, and potentially fatal blood clots. It is a very rare disorder that occurs in about 20 per million people.

TNT009 inhibits the Classical Complement pathway by targeting a protease dubbed C1s. This prevents the disease process that causes phagocytosis (the process by which cells engulf particles), inflammation, and cell lysis (rupture of the cell membrane). Although CAD is rare, there are numerous diseases, autoimmune and others, that have similar mechanisms, so the company hopes its technology will be applicable to a wider array of diseases.

TNT009 is currently recruiting participants for a Phase I clinical trial. The trial is a prospective, double-blind, randomized, placebo-controlled First-In-Human study with three parts, a single ascending dose study (SAD) in normal human volunteers, a multiple ascending dose study (MAD) in normal volunteers, and a multiple dose (MD) study in patients with a disorder that is Complement-mediated. Potential conditions are Bullous Pemphigoid (BP), CAD, Warm Autoimmune Hemolytic Anemia, and End-stage Renal Disease (ESRD).

The trial is expected to begin by the end of this year with preliminary results early in 2016.

A competitor in this area, Alexion , is conducting a mid-stage study of its own drug, eculizumab, for CAD, and is expected to report data at an upcoming American Society of Hematology meeting. True North will also be providing some background on TNT009 at the meeting, which will be held in Orlando, Fla. from Dec. 5-8.

Stagliano told Forbes, “we consider the data [from Alexion] interesting, but not competitive.”

True North’s drug has a different mechanism than Alexion’s. TNT009 binds with Complement Component 3 and 5 (C3 and C5), while Alexion’s binds only to C5. With both drugs, and any drugs that directly affect the immune system, the question is whether side effects might decrease overall immune response, opening patients to infections. So far the safety issues have been positive.

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