On July 31, 2017 Generex Biotechnology Corporation (www.generex.com) (OTCPink:GNBT) reported that its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com) has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada), through a wholly-owned subsidiary, to evaluate Antigen’s AE37 cancer vaccine in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with metastatic triple-negative breast cancer (Filing, 8-K, Generex, AUG 1, 2017, View Source [SID1234519959]). The study will evaluate preliminary safety and efficacy of the combination in a Phase II trial.

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The combination of AE37 plus KEYTRUDA follows previous studies, in which both therapies have individually shown encouraging results in patients with triple-negative breast cancer. In a controlled, randomized trial of AE37 in 300 breast cancer patients, the most encouraging results were observed in those with triple-negative breast cancer. Similarly, KEYTRUDA has shown encouraging activity in patients with metastatic triple-negative breast cancer. The attractiveness of the combination lies in the different mechanisms of action of the two immunotherapeutic drugs: AE37 specifically activates T cells to attack cancer cells while KEYTRUDA increases the ability of the body’s immune system to help detect and fight tumor cells.

"We are excited to be collaborating with Merck, a clear leader in cancer immunotherapy, to advance this important treatment modality in patients with triple negative breast cancer," said Dr. Eric von Hofe, Ph.D., President of Antigen Express. "Both the clinical data as well as mechanistic data on the activity of AE37 and KEYTRUDA in patients strongly argue for the potential benefit of this combination study."

Dr. Samuel Jacobs, MD of the NSABP Foundation, which is collaborating in this study with Antigen Express and Merck, noted that "with single agent immunotherapy in metastatic TNBC the response rate is low, but the benefit in responding patients is strikingly prolonged. We are hoping that with this combination we will see both an increase in the response rate and extended duration of benefit."

CMO and CSO of Generex, Dr. Jason Terrell, added, "This trial unveils our incredibly diverse Ii-key hybrid vaccine platform. AE37 is a hybrid vaccine combining the potent immune-stimulating Ii-key molecule with a breast cancer specific target. Ii-key can similarly be combined with virtually any target to create vaccines across the spectrum of disease processes."

"The agreement with Merck is a pivotal milestone in the advancement of our immunotherapy assets and marks a new phase of Antigen Express clinical development" said Joe Moscato, CEO of Generex. "Given that AE37 alone showed statistically significant efficacy in the triple-negative subpopulation of our prior Phase 2 study," he continued, "we anticipate important new development opportunities when coupled with KEYTRUDA. 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 reorganization. This collaboration highlights our commitment to Antigen Express and its assets into the future."

The collaboration agreement is between Antigen Express and Merck. Under the terms of the agreement, the trial will be sponsored by Antigen Express. Additional details were not disclosed.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

About the NSABP Foundation

The NSABP Foundation is an outgrowth of the National Surgical Adjuvant Breast and Bowel Project, instituted in 1958 as part of the National Cancer Institute’s clinical trials program. The founder, Bernard Fisher, MD, was one of the first cancer researchers to realize the value of the randomized clinical trial in answering questions about the development, progression, and treatment of this disease. From the time of the NSABP’s first studies, the randomized trial has been its primary research tool, and over the years has established record of designing and conducting clinical trials that have changed the way breast cancer is treated and prevented.

In its history the NSABP has enrolled more than 110,000 women and men in clinical trials in breast and colorectal cancer. It has research sites at nearly 700 major medical centers, university hospitals, large oncology practice groups, and health maintenance organizations in the United States, Canada, and Ireland. At those sites and their satellites, about 5000 physicians, nurses, and other medical professionals conduct NSABP treatment and prevention trials.