Coronado Biosciences said today it will collaborate with Freie Universitat Berlin in sponsored research to identify and evaluate secretory proteins from the parasite Trichuris suis in preclinical in vitro and animal models, with the goals of advancing development of its lead compound and possibly discovering new immune regulatory drugs.
Coronado said the Trichuris suis protein research will provide further insight into the mechanism of action for lead drug candidate TSO (Trichuris suis ova or CNDO-201), a biologic made of pig whipworm eggs in Phase II clinical development. TSO is intended for autoimmune diseases, such as Crohn's disease, ulcerative colitis, and multiple sclerosis (MS).
The company’s Phase II TRUST-1(TRichUris Suis ova Trial) clinical study of TSO for Crohn’s disease in the U.S. was launched last year. Additional trials of TSO are in progress in autism and MS, with other trials planned for ulcerative colitis, psoriasis, type 1 diabetes, and other immune-mediated diseases, Coronado CEO Bobby W. Sandage, Jr., Ph.D., told GEN in December.
The company also hopes to find new targets and immune modulatory agents that can emerge as potential drug candidates against autoimmune diseases.
Research will be conducted by Susanne Hartmann, professor and head of Freie’s Institute of Immunology / Infection Immunology, for four years. Coronado will pay the university up to about $5 million in payments tied primarily to undisclosed clinical development and regulatory milestones, as well as royalties on net sales of products. In return, Coronado will receive an exclusive worldwide license to develop and commercialize any products resulting from the work.
Back in December 2012, Coronado consolidated manufacturing rights to TSO by acquiring from German-owned Ovamed such rights for North American, South America, and Japan. In return, Coronado agreed to pay Ovamed a total $1.5M in three installments from 2014–2016, plus undisclosed fees for product manufactured and sold by Coronado in lieu of product supply payments Ovamed would have received had it remained Coronado’s exclusive TSO supplier. Coronado also entered into a lease agreement to establish a manufacturing facility in Woburn, MA to produce Phase III supplies of TSO. Build out and site preparation are set to start this year, and continue throughout 2013.
Headquartered in Burlington, MA, publicly-traded Coronado is a biopharmaceutical company focused on developing immunotherapy agents for cancer and inflammatory diseases. In addition to TSO, Coronado is developing CNDO-109, a biologic that activates natural killer cells for the treatment of acute myeloid leukemia and solid tumors.
Fourth quarter and full-year 2012 results are not yet available. During the third quarter of 2012, results of which were released November 14, Coronado lost $5.9 million compared with a $3.4 million loss in Q3 2011, with much of the loss stemming from increased TSO clinical activity. For the first nine months of last year, the company’s net loss narrowed to $18.9 million from $29.6 million.
Despite the red ink, Coronado said it had sufficient cash to fund operations into Q1 2014 as a result of securing a $15 million loan from Hercules Technology Growth Capital, intended to support development of TSO and CNDO-109.