Generex combines AE37 with Merck’s Keytruda in Phase II trial for TNBC


Generex Biotechnology has signed a clinical trial collaboration agreement through its Antigen Express division to combine its cancer vaccine AE37 with Merck’s Keytruda (pembrolizumab) in a Phase II clinical trial for patients with triple-negative breast cancer (TNBC).

Antigen’s AE37 is designed to specifically stimulate T-cells to attack tumour cells, while Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that enhances immune system’s ability to identify and destroy cancer cells.

Based on Ii-key hybrid vaccine platform, the vaccine combines immune-stimulating Ii-key molecule with a breast cancer specific target.

To be funded by Antigen, the Phase II trial will assess the preliminary safety and efficacy of the combination therapy in metastatic TNBC patients.

"We are excited to move this study into the clinic and reinvigorate our immunotherapy work as we approach the end of our company reorganisation."

Generex CEO Joe Moscato said: “In particular, this combination study will highlight the unique value of AE37 and pave the way for additional development opportunities in other cancers.

“We are excited to move this study into the clinic and reinvigorate our immunotherapy work as we approach the end of our company reorganisation.”

The combination of the immunotherapeutic agents is based on the positive data from their individual trials in TNBC patients, where Keytruda is reported to have demonstrated favourable activity.

AE37 is also said to have indicated comparatively better results with statistically significant efficacy in TNBC subjects during a previous controlled, randomised trial in 300 patients with breast cancer.

Antigen Express develops immunotherapeutic vaccines based on specific CD4+ T-helper stimulation technologies to treat malignant, infectious, allergic and autoimmune diseases.