Pique Therapeutics, Inc. today announced encouraging results in a clinical trial of PT 107, an immunotherapy developed by a renowned scientist at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine to treat non-small cell lung cancer (NSCLC), the most common form of the disease.
“We are very encouraged to see such positive results with a single agent in late stage non-small cell lung cancer,” said Christopher S. Meldrum, President of Pique Therapeutics. “The improvement in overall survival, particularly the significant 10-month benefit seen in non-squamous patients, highlight the promise of PT 107.”
Pique Therapeutics has licensed the research work of the late Eckhard R. Podack, M.D., Ph.D., one of the pioneering researchers in the field of immunotherapy. Podack was the discoverer of perforin-1 and perforin-2, two antibacterial proteins that help the body’s immune system defend against infectious diseases. He also created the technology underlying brentuximab (Adcetris®), used in the treatment of Hodgkin lymphoma.
During his distinguished career as a researcher at Sylvester from 1987 until his death in 2015, Podack made a series of scientific discoveries pointing the way toward more effective treatments for lung cancer, infectious diseases and disorders of the immune system. He also served as professor and chair of the Miller School’s Department of Microbiology and Immunology.
“Dr. Podack was one of the Miller School’s most prolific researchers and entrepreneurs,” said Norma Kenyon, Ph.D., chief innovation officer at the Miller School of Medicine, and vice provost for innovation at the University of Miami. “One of our university’s top priorities is conducting groundbreaking research, and moving those discoveries forward so they can help patients.”
While serving as director of the Miller School’s Wallace Coulter Center for Translational Research, Kenyon helped Podack take cells from the laboratory and move them to a CGMP [current good manufacturing practice] facility to advance their development for clinical use.
“Chris Meldrum understands that biomedical technologies can take eight to ten years to move from the laboratory bench to the patient’s bedside,” Kenyon said. “He has the tenacity and vision to keep moving forward with immunotherapies that can have a huge impact on patients’ lives.”
Pique’s lead product, PT 107, is a first-in-class therapeutic cellular vaccine for the treatment of NSCLC, which constitute about 85 percent of all lung cancers. In previous trials, PT 107 was well tolerated by participants, and exhibited a very good safety profile in cancer patients.
Pique’s new multicenter Phase 2 study showed meaningful improvement in length of survival for patients with stage IIIB/IV non-small cell lung cancer whose disease had progressed following previous therapy. Patients receiving treatment with PT 107 had a median overall survival of 12.5 months versus 8.4 months for patients who received a placebo. There was also a significant improvement in the time to progression of the disease. Safety results were consistent with previous clinical experience, with no drug-related serious adverse events being reported.
“We will now seek to move PT 107 forward in collaboration with a partner,” said Meldrum. “The results of this trial indicate that this first-in-class therapeutic vaccine has tremendous potential as a therapy for non-small cell lung cancer, both as a stand-alone treatment, as well as in conjunction with other treatments, such as standard of care checkpoint inhibitors.”
Miller School of Medicine