Generex Biotechnology Provides Update on AE37 Immuno-Therapeutic Clinical Development Program

Generex Biotechnology Corporation (
is pleased to announce 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
(KeytrudaA®) in Combination with the AE37 Peptide Vaccine in Patients
with Metastatic Triple Negative Breast Cancer
. It is anticipated
that the trial will initiate sites in the fourth quarter and begin
enrolling patients in the first quarter of 2019.

Also, as previously announced, AE37 is being developed for the treatment
of prostate cancer by the Companya??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

"We are excited to launch the clinical development of our HER2/neu
immunotherapeutic vaccine AE37 in combination with Mercka??s anti-PD-1
therapy, Keytruda, for the treatment of patients with triple-negative
breast cancer,a?? 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.a??
See also:
Leave a comment
  • Latest
  • Read
  • Commented
Calendar Content
«    Сентябрь 2019    »