Coronado Biosciences acquired manufacturing rights to its lead product TSO (Trichuris suis ova, i.e., porcine whipworm eggs) from Ovamed for North America, South America, and Japan, Coronado's licensed territory. As part of the transaction, Coronado entered into a lease agreement to establish a manufacturing facility in Woburn, MA, to produce TSO.
Ovamed agreed to provide assistance in establishing the manufacturing facility and to continue to supply Coronado with clinical supplies until the facility is operational. Ovamed retains TSO manufacturing rights outside Coronado's territory and will act as second source suppliers to each other at agreed transfer prices.
Coronado will pay Ovamed a total of $1.5M in three equal installments in 2014-2016, and, in lieu of product supply payments that would have been payable to Ovamed as the exclusive supplier, certain fees for product manufactured and sold by Coronado.
“The acquisition of exclusive manufacturing rights for TSO in our territories is an integral piece of our strategy for our lead product in development, and enables us to control the development and commercialization of the product,” said Bobby W. Sandage, Jr., Ph.D., president and CEO of Coronado. "The amended agreement is not only cost effective, but also reduces product risk by having two qualified suppliers of TSO. We continue to move forward with our TRUST-I trial, the company’s Phase II Crohn's study, as well as our support for the recently initiated and planned investigator-initiated clinical trials evaluating TSO in a broad range of autoimmune diseases."
Dr. Sandage explained that TSO, the microscopic eggs of the porcine whipworm, is an orally administered, natural imunomodulator that regulates T-Cells and pro-inflammatory cytokines.
The use of TSO as a therapeutic is based on the “hygiene hypothesis” and numerous animal and human studies, he added, noting that TSO was chosen as the biological agent of choice because it is not a human pathogen, and is spontaneously eliminated from the body within several weeks after dosing.
In February, the company reported positive results from a Phase II study of TSO in patients with Crohn’s disease, where TSO was shown to be safe and well tolerated. The Phase I trial was a multicenter, sequential dose, dose-escalation, double-blind, placebo-controlled study of 36 patients with Crohn’s disease. In August, Coronado initiated a Phase II trial of TSO in patients with Crohn’s disease in the U.S., which is expected to be completed in the second half of 2013.
Multiple investigator-sponsored clinical trials of TSO for the treatment of Crohn's disease, ulcerative colitis and multiple sclerosis have been completed, in which TSO demonstrated benefit with regard to accepted outcome measurements of remission of disease, and was shown to be well tolerated, according to Dr. Sandage . In an open-label clinical trial with 29 patients reported in GUT in January 2005, TSO was shown to induce clinical remission in over 72% of patients with Crohn’s disease after 24 weeks of treatment using the Crohn’s Disease Activity Index as the primary outcome variable. A journal article in the American Journal of Gastroenterology in April 2005, reported that in a double-blind, randomized placebo-controlled trial in 54 patients with ulcerative colitis, TSO was shown to produce statistically significantly more responders than those treated with placebo (43.3% vs. 16.7%, p=.04).
For more on how parasitic worms are being used to treat autoimmune diseases, see "Worming Your Way Back to Health."