FDA OKs Phase 2 Trial of AE37-Keytruda Combo in Metastatic Triple-negative Breast Cancer

FDA OKs Phase 2 Trial of AE37-Keytruda Combo in Metastatic Triple-negative Breast Cancer
Generex Biotechnology is planning a Phase 2 trial to test a combination of its AE37 peptide vaccine and Keytruda (pembrolizumab) in patients with advanced triple-negative breast cancer, after the U.S. Food and Drug Administration approved its investigational new drug application. The study will be conducted under a collaborative agreement with Merck (known as MSD outside the U.S. and Canada) and the NSABP Foundation. “We are gratified to see this important trial moving forward,” Eric von Hofe, president of Generex subsidiary NuGenerex Immuno-Oncology, said in a press release. “While we have tested AE37 in breast and prostate cancer patients, there is good rationale for inclusion of AE37 in the treatment regimen of a variety of additional cancer types of high unmet need." AE37 is an investigational anti-cancer vaccine that combines a small portion of the HER2 protein, found in about 80% of breast cancers, with GM-CSF, a protein that activates immune T-cells. The approach helps the immune system recognize HER2 as foreign and promote responses that might more robustly kill cancer cells. The FDA's decision was based on results from a p
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