AURORA, CO, May 25, 2004 – GlobeImmune, Inc. today announced that the Company’s Investigational New Drug (IND) application for the GI-4000 product series, filed with the U.S. Food & Drug Administration last month, has become effective after the initial 30-day review, clearing the way for the Company to initiate a Phase 1 clinical trial of the GI-4000 products in humans.
The GI-4000 series is a new class of targeted immunotherapy products being developed for the treatment of a number of different cancers. This series was developed using the Company’s patented, yeast-based immunotherapy platform and targets a protein known as Ras that is mutated in a number of different types of tumors. The GI-4000 cancer immunotherapy represents a new approach to cancer treatment that stimulates the body’s own immune system to identify and destroy cancerous cells. The GI-4000 series consists of three products (GI-4014, GI-4015, and GI-4016) directed to five specific mutations in the Ras protein.
Products from the GI-4000 series have been successfully tested in multiple preclinical studies. In these models, GI-4000 immunotherapies significantly reduced tumor burden demonstrating efficacy, safety, and highly-specific, targeted molecular immune responses.
“We are excited by the compelling data generated in preclinical studies of the GI-4000 series,” said Timothy C. Rodell, M.D., CEO of GlobeImmune. “Initiation of this clinical trial will represent a significant milestone for our team, and we look forward to working with our clinical investigators to evaluate these products in cancer patients.”
The Phase 1 trial is a multi-center, open label, dose escalation study designed to evaluate the safety, immunogenicity, and clinical benefit of the GI-4000 series in patients with tumors expressing Ras mutations. The study, to be conducted at approximately four sites in the U.S., will enroll 15-25 patients with stage III or IV colorectal, pancreatic, or non-small cell lung cancers.
About the GI-4000 Immunotherapy Products
Products in the GI-4000 series target the mutated Ras protein which occurs in 75-90% of pancreatic cancers, 35-45% of colorectal cancers, and 30-35% of non-small cell lung cancers. Ras proteins control signaling pathways that are believed to be key regulators of both normal cell growth and malignant transformation. Mutations in Ras cause the proteins to remain in their active form, resulting in uncontrolled cell division.
GlobeImmune’s targeted molecular immunotherapies are comprised of genetically engineered yeast which deliver one or more protein antigens expressed by tumor cells. These therapies are designed so that when they are administered, the yeast stimulate the production of antigen-specific T cells, immune cells which kill malignant cells expressing the antigen target.
About GlobeImmune
GlobeImmune, Inc. is an early-stage biopharmaceutical company pioneering the development of potent, targeted molecular immunotherapies for the treatment of cancer and infectious diseases. For additional information, please visit the Company’s website at https://globeimmune.com/. GlobeImmune is headquartered at the Fitzsimons BioScience Park in Aurora, Colorado.
Contact:
Timothy C. Rodell, M.D. CEO
GlobeImmune, Inc.
720-859-4070