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Generex Biotechnology Signs Clinical Trial Agreement with the NSABP Foundation for Phase II Clinical Trial of AE37 in Combination with Pembrolizumab for Treatment of Triple-Negative Breast Cancer.

M2 PHARMA-November 29, 2018-Generex Biotechnology Signs Clinical Trial Agreement with the NSABP Foundation for Phase II Clinical Trial of AE37 in Combination with Pembrolizumab for Treatment of Triple-Negative Breast Cancer

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- US- and Canada-based biopharmaceutical company Generex biotechnology Corp. (OTCMKTS: GNBT) has signed a clinical trial agreement with the NSABP Foundation, Inc. (NSABP), to manage 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 clinical trial, sponsored by Generex and conducted in conjunction with Merck, is currently being reviewed by the FDA, and clinical operations including site qualification, drug shipment and packaging, and IRB review and approval are underway, with plans to enroll patients in the first quarter of 2019.

Previously, the company reported that it 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.

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.

The NSABP Foundation is a non-profit organization devoted to improving the survival outcome and quality of life of patients with breast or colorectal cancer. The foundation has a long history of developing new treatments that have improved the standard of care for cancer patients worldwide both through NCI-sponsored studies and in collaboration with industry.

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Publication:M2 Pharma
Date:Nov 29, 2018
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