Aduro BioTech, Inc., a clinical-stage biotechnology company focused on cancer immunotherapy, has announced its pancreatic cancer combination treatment of CRS-207 and GVAX Pancreas immunotherapies was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for its capacity to treat a serious or life-threatening condition alongside its preliminary clinical evidence indicating a substantial improvement on a clinically significant endpoint over available therapies.
The FDA designation resulted from data presented earlier this year at the ASCO Gastrointestinal Cancers Symposium conference, regarding a randomized, controlled, multi-center Phase 2 clinical trial in which 93 patients suffering from metastatic pancreatic cancer who failed or refused prior therapy showed a significant survival benefit when receiving the combination of GVAX Pancreas and CRS-207 cancer vaccines (median overall survival of 6.1 months), compared to GVAX Pancreas vaccine alone (median overall survival of 3.9 months).
CRS-207 is a live-attenuated double-deleted (LADD) Listeria monocytogenes immunotherapy that stimulates both innate and adaptive immune responses, and expresses the tumor-associated antigen mesothelin, an antigen commonly over-expressed in multiple types of cancers, such as pancreatic, non-small cell lung, ovarian, and gastric cancers. Like CRS-207, GVAX Pancreas also expresses mesothelin, however, it consists of allogeneic irradiated pancreatic cell lines that secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-stimulatory cytokine that elicits a broad antigenic response.
A breakthrough therapy designation is a way to advance drug development for therapies that treat serious or life-threatening conditions, providing more intensive FDA guidance and eligibility for rolling review and priority review of the company’s Biologics License Application when submitted.
“We are extremely pleased to receive Breakthrough Therapy Designation and the high degree of FDA collaboration toward advancement of our program that it confers,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “This designation underscores the potential of our combination immunotherapy approach to make a difference in the lives of patients with pancreatic cancer, which remains a very difficult cancer to treat. We are encouraged by our Phase 2 results and look forward to completing enrollment in our Phase 2b ECLIPSE trial by end of 2015.”
Aduro’s ongoing randomized, controlled 3-arm Phase 2b clinical trial has already enrolled 240 patients suffering from metastatic pancreatic cancer who have progressed after at least one line of therapy.
This clinical study involves over 20 clinical trial sites in the U.S. and Canada and will evaluate the safety, immune response and efficacy of the combination immunotherapy of GVAX Pancreas and CRS-207 compared to either chemotherapy or CRS-207 alone, with the primary endpoint set to overall survival.
Patients interested in registering with the ECLIPSE trial can contact the Pancreatic Cancer Action Network’s Patient & Liaison Services (PALS) program that provides patients and families with information.