30 October 2018 - - US-based Generex biotechnology Corp. (OTCQB: GNBT) has filed an investigational new drug application with the US Food and Drug Administration to initiate A Phase II Clinical Trial of Pembrolizumab (Keytruda) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer, the company said.

The trial, sponsored by Generex wholly-owned subsidiary Antigen Express, Inc. and conducted in conjunction with research partners US-based Merck (NYSE: MRK) and the NSABP Foundation, Inc. (NSABP), is scheduled to initiate sites in 4Q18 and to begin enrolling patients in 1Q19.

AE37 is an investigational therapeutic cancer vaccine being developed to treat cancer in women with certain types of breast cancer.

It is a combination of portions of two proteins that together stimulate the immune system to fight cancer cells.

Up to 80 % of breast cancers express some level of a protein called HER2. While treatments exist to target HER2 in breast cancer patients with the highest level of HER2 expression (roughly 25%), the majority of patients who have lower levels of expression have more limited treatment options.

AE37 consists of a protein derived from the HER2 protein combined with a portion of the MHC class II associated invariant chain which has been termed Ii-Key.

It does not directly target HER2, but instead acts as a vaccine to activate the immune system to recognize the HER2 protein that is expressed on cancer cells as foreign.

AE37 ensures activation of CD4-positive lymphocytes, immune cells that are important in stimulating both the antibody response (antibodies against HER2) and cellular responses directed against the HER2 protein in breast cancer cells.

The Ii-Key peptide is coupled with the HER2 protein to ensure a more robust and long-lasting response.

Generex is a healthcare holdings company with offerings in a range of services, diagnostics, medical devices, and pharmaceutical development.

The company's direct-to-patient services support its strategy of all-inclusive access to doctors, diagnostics, therapeutics, and additional health-related services to greatly improve the patient experience in receiving care.

On the provider side, Generex's management services remove administrative burdens in multiple provider settings, including private practice and hospital, allowing doctors to devote more time to patient care.

Revenue from the company's subsidiaries will support clinical advancement of its wholly owned therapeutic products with a focus in immunotherapeutics based on stimulating critical members of the immune response, known as T helper cells, and its proprietary buccal administration of insulin.