Generex Subsidiary NuGenerex Immuno-Oncology Announces Publication of a Review Article on Cancer Vaccines Highlighting AE37 (Ii-Key-HER2) Immunotherapeutic Vaccine

Exploring Essential Issues for Improving Therapeutic Cancer Vaccine Trial Design

• Immunotherapy with cancer vaccines explained
• Review of cancer vaccine trials: design, results, opportunities
• Cancers 2020, 12(10), 2908; https://doi.org/10.3390/cancers12102908; article can be found online: (https://www.mdpi.com/2072-6694/12/10/2908)
  

MIRAMAR, Fla., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) is happy to announce that a review article on therapeutic cancer vaccines has been published in the peer-reviewed journal Cancers. The paper highlights the importance of proper clinical design in terms of selected groups of patients, taking into consideration (a) changes in initially established standard-of-care treatments; (b) the appropriate follow-up period necessary to achieve meaningful results; (c) statistical considerations for the delay of treatment effects (i.e., time for development of an effective immune response), thus excluding irrelevant early events; and (d) appropriate biomarkers that could guide vaccinations with clinical benefits to patients.

The authors of the paper* have extensive experience with AE37 immunotherapeutic vaccine as principal investigators in the company’s breast and prostate cancer trials. The paper clearly describes why the Phase IIb clinical trial of AE37 in breast cancer demonstrated a statistically significant clinical benefit for certain subgroups of patients in the trial (advanced stage disease with low HER2 or triple negative breast cancer) while failing to meet the primary endpoint in the entire intent-to-treat (ITT) study population. The introduction of Herceptin (trastuzumab) as the standard of care during the long-term follow-up of the trial skewed the results such that the benefit of AE37 could not be detected in the statistical analysis. However, when looking at patients in subgroups that did not receive Herceptin, the positive benefits of AE37 on survival become apparent. Patient selection and protocol design that accounts for changes in standard of care are the key to future study designs.