Generex Biotechnology Corporation has received a green light form the U.S. Food and Drug Administration to proceed with the clinical study of its Triple Negative Breast Cancer treatment.
The study titled, “A Phase II Clinical Trial of Pembrolizumab (Keytruda) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer,” is sponsored by Generex and conducted under a collaboration agreement with Merck and a clinical trial agreement with the NSABP Foundation, Inc. (NSABP).
The combination study builds on previous clinical studies of both AE37 and Keytruda. AE37, a cancer vaccine, was the subject of a 300 patient prospective, randomized, and single-blinded Phase II study in patients with breast cancer.
That study showed a strong trend toward reduced relapses, particularly in patients with triple negative breast cancer. Keytruda also has shown encouraging results in patients with triple negative breast cancer when used as monotherapy. The complementary mechanisms of action of the two drugs suggest the combination may have the potential to be better than either alone.
AE37 is unique among therapeutic cancer vaccines in that it ensures specific activation of CD4+ T helper cells, which are critical in generating an effective immune response. Its improved immunological potency, along with an excellent safety profile, offers particular advantages for combination studies.
In addition to the Phase II study in breast cancer patients, AE37 also has been tested in a Phase I study in prostate cancer patients. AE37 treated patients have consistently displayed a robust, long-lasting, and specific response to the vaccine.
“So far, metastatic triple negative breast cancer patients treated upfront with immunotherapy benefit clinically from immune checkpoint immunotherapy only if their tumors contain PDL1+ cells,” Liesha Emens, M.D., Ph.D., principal investigator for the study and professor of medicine at the University of Pittsburgh Medical Center, said. “Increasing the number of patients with immune-activated tumors should bring the benefit of immunotherapy to even more patients. This Phase II trial will test whether the AE37 vaccine may trigger immunity in triple negative breast cancer patients, priming them for clinical benefit from immune checkpoint blockade.”
(Source: Generex Biotechnology Corporation)
Filed Under: Oncology
