Generex Biotechnology has entered into an agreement with the NSABP Foundation to manage a possible Phase 2 clinical trial testing an anti-cancer vaccine in patients with metastatic triple negative breast cancer.
Sponsored by Generex and conducted in collaboration with Merck, the trial will evaluate the safety and anti-cancer activity of the company’s AE37 peptide vaccine in combination with Keytruda (pembrolizumab), an immunotherapy marketed by Merck.
An investigational new drug application (IND) has been filed with the U.S. Food and Drug Administration, and plans for this trial are under FDA review. If accepted, patient enrollment is expected to start in early 2019.
“We are very pleased to be working with the NSABP Foundation on this important trial combining AE37 and Keytruda in triple-negative breast cancer patients,” Eric von Hofe, president of Generex’s wholly owned subsidiary Antigen Express, said in a press release. “The extensive expertise of the NSABP Foundation and their network of sites and investigators will be a great asset in this development effort.”
Up to 80% of breast cancers have some level of HER2. But available therapies targeting this protein are only recommended for patients with the highest HER2 levels, amounting to about 25% of all cases. Treatment options for other patients are more limited.
AE37 is an investigational anti-cancer vaccine that does not target HER2 directly, but triggers the immune system to recognize cancer cells producing this protein.
The treatment combines a small portion of HER2 with another protein that activates immune T-cells, helping these immune cells to recognize HER2 as foreign and promote responses that might more robustly kill cancer cells.
In a prior Phase 2 trial (NCT00524277), investigators reported that patients who received the AE37 vaccine showed an antibody response directed to HER2, evidence that it induced an immune response. They also reported that the vaccine was safe and well-tolerated. Long-term data on 298 enrolled breast cancer patients (median follow up of 55 months) showed a trend toward improved disease-free survival among subgroups of women divided by cancer stage and level of HER2 expression. The trial main goal, disease-free survival at 25 months post-treatment, did not find a significant difference between vaccinated and control patients.
Its researchers recommended further clinical testing, noting “the efficacy of cancer vaccines may require more time than other therapies.”
“This contract with our research partners at the NSABP Foundation provides cost and timeline certainty to our AE37 development program in combination with Keytruda,” said Richard Purcell, executive vice president of research and development at Generex.
The NSABP Foundation is a nonprofit working to improve the care and treatment of people with breast and colorectal cancer in part through promoting clinical research.