Maryland’s ValenzaBio reeled in a $70 million series A round that will propel a pair of monoclonal antibody programs toward the clinic. Those include a treatment for an autoimmune kidney disease, which is poised to start a phase 1b/2a study in the second quarter of this year, and a treatment for thyroid eye disease (TED) licensed from Pierre Fabre Medicament.
Under the licensing deal, ValenzaBio gets the worldwide development rights for the drug, VB421, outside of oncology, while Pierre Fabre picks up an equity stake in its partner. Pierre Fabre has the right to opt into development for VB421 outside North America; if it follows through on that, the companies will take on global development together, according to a statement.
The series A round comes from Fidelity Management & Research Company, Citadel’s Surveyor Capital, Ikarian Capital, LLC, Janus Henderson Investors and Opaleye Management.
Besides VB421, ValenzaBio is working on VB119, an antibody that targets CD19, a surface receptor found on B cells that secrete autoantibodies, or antibodies produced by the body against its own proteins. It’s developing the treatment for membranous neuropathy (MN), a condition that happens when the kidney’s filtering units, or glomeruli, become damaged and thickened, as well as other autoimmune diseases.
ValenzaBio will kick off a phase 1b/2a study testing VB119 in patients with membranous neuropathy in. the U.S. and file a Clinical Trial Application in the U.K. in the second quarter.
“MN can lead to disabling and, in some cases, life-threatening complications for patients; and given the lack of any FDA-approved therapies today, VB119 has an opportunity to impact the lives of patients with this rare disease,” said ValenzaBio chief scientific officer, Stephen Thomas, Ph.D., in the statement.
“Further, the addition of VB421 to our pipeline may enable us to provide a new therapeutic option for patients with TED, a debilitating and painful autoimmune disease that causes eye-bulging and risk of vision loss. With a formidable preclinical package in hand through our agreement with Pierre Fabre, we are prepared to move quickly into an IND-enabling program,” Thomas added.
Until the FDA approved Horizon Therapeutics’ Tepezza (teprotumumab) in January 2020, patients with TED relied on steroids and eye surgery to manage their disease. The approval was based on phase 3 data showing that patients taking Tepezza had, on average, a 2.82 mm reduction in eye-bulging, compared to 0.54 mm in patients on placebo. That decrease was on par with a procedure called size decompression surgery that moves the eyeball back into a normal position in the eye socket.