On October 5, 2018 Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (View Source) reported that the Company, in conjunction with its research collaborators Merck and the NSABP Foundation, will file an IND in October 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 (Press release, Generex, OCT 5, 2018, View Source [SID1234529796]). It is anticipated that the trial will initiate sites in the fourth quarter and begin enrolling patients in the first quarter of 2019.
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Also, as previously announced, AE37 is being developed for the treatment of prostate cancer by the Company’s partner, Shenzhen Bioscien. The Company has nearly completed the non-clinical toxicology and pharmacology work required by the Chinese Food & Drug Administration (CFDA) and is preparing the necessary documentation for application to obtain authorization on the regulatory path for approval in China. Pending acceptance of that regulatory package, Shenzhen plans to initiate a Phase II clinical trial in Europe in 2019, with Generex maintaining Rest-of-World, ex-China rights to AE37 for the treatment of prostate cancer.
Further, in conjunction with the launch of the AE37/KEYTRUDA combination trial, and as part of the continuing restructuring of Generex, the Antigen Express name will be changed to NuGenerex Immuno-Oncology, remaining a wholly-owned subsidiary under the umbrella of the parent Company.
"We are excited to launch the clinical development of our HER2/neu immunotherapeutic vaccine AE37 in combination with Merck’s anti-PD-1 therapy, Keytruda, for the treatment of patients with triple-negative breast cancer," said Dr. Eric von Hofe, President of NuGenerex Immuno-Oncology. "With this trial and our partnership with Shenzhen Bioscien, NuGenerex Immuno-Oncology is positioned to realize the full potential of AE37 while advancing our proprietary Ii-Key technology platform for use in other cancers and diseases."
Generex Chief Medical and Scientific Officer, Dr. Jason Terrell, added: "NuGenerex Immuno-Oncology will be an important division within our restructured and diversified organization. This represents a successful advancement of our overall strategy to improve patient care through the development of innovative products and healthcare solutions."
Generex President & Chief Executive Officer Joe Moscato stated, "NuGenerex Immuno-Oncology is being established to not only to advance the Antigen Express core technology, but also to expand the Company’s portfolio in the field of immunotherapy and personalized medicine through partnerships and acquisitions. Generex has long demonstrated a belief and commitment to immune-therapy for the treatment of cancer through our extensive Ii-Key research & development program, and we are proud to be a leader in this emerging era of personalized, immuno-therapeutic cancer care."