Our R&D program focuses on the activities required to develop a novel drug for cancer treatment, based on the original work of Dr. Luis Burzio and his team, and to obtain FDA approval to start clinical studies in humans. These activities are carried out under a Technology Transfer Agreement between the start up company Andes Biotechnologies, located in the Science and Business Park, and Fundación Ciencia & Vida.
We completed the bulk GMP manufacturing of the drug substance Andes-1537, and the chemical characterization and their controls.
Formulated injectable Andes-1537 drug product in vials have been prepared, from the bulk drug, and acute and chronic toxicology studies in two animal species have been completed.
We also completed, in collaboration with Drs. Pamela Munster and Marc Shuman from UCSF, a Clinical Protocol describing the studies to be carried out at the University of California in San Francisco (UCSF) with patients with advanced unresectable solid tumors that are refractory to standard therapy.
By the middle of 2015, all of the above studies and results were summarized in an Investigational New Drug application sent to the FDA and approved in September 2015. The FDA approved Clinical Protocol together with the required Informed Consent and Investigators Brochure documents were also reviewed and approved by the UCSF Institutional Review Board composed of cancer clinical investigators from the university.
Phase-I clinical studies started at the Mount Zion Cancer Center Hospital in December 2015.