GENEREX BIOTECHNOLOGY CORPORATION (OTCMKTS:GNBT) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry a Material Definitive Agreement

In June, 2017, the Company’s wholly owned subsidiary, Antigen Express, Inc. (“Antigen”) entered into a Clinical Trial Collaboration and Supply Agreement (the “Collaboration Agreement”) with Merck Sharpe & Dohme B.V. (“Merck”). The Collaboration Agreement provides for Phase I clinical trial to evaluate the pharmacokinetics, pharmacodynamics and preliminary efficacy of administering Merck’s Keytruda® (pembrolizumab) in combination with Antigen’s AE37 cancer vaccine in patients with triple negative breast cancer.

The Collaboration Agreement provides for Antigen to sponsor the study and to make the regulatory filings for approval of the trial. Merck will supply Antigen with Keytruda® for the trial. Antigen will provide its AE37 cancer vaccine and will generally be responsible for the costs of the trial.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

The list of exhibits called for by this Item is incorporated by reference to the Exhibit Index filed with this report.

GENEREX BIOTECHNOLOGY CORP Exhibit
EX-10.1 2 ex10_1.htm EXHIBIT 10.1 EXECUTION COPY                         CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT       by and among       Merck Sharp & Dohme B.V.       and       Antigen Express,…
To view the full exhibit click here

About GENEREX BIOTECHNOLOGY CORPORATION (OTCMKTS:GNBT)

Generex Biotechnology Corporation is a development-stage company. The Company is engaged primarily in the research and development of drug delivery systems and technologies. The Company is focused on its technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a hand-held aerosol applicator. Its buccal delivery technology is a platform technology that has application to various large molecule drugs and provides a non-invasive way to administer such drugs. The Company focuses its development efforts on Generex Oral-lyn, an insulin formulation administered as a fine spray into the oral cavity using its hand-held aerosol spray applicator known as RapidMist. Its subsidiary, Antigen Express, Inc., focuses on developing vaccine formulations that work by stimulating the immune system to either attack offending agents, such as cancer cells, bacteria and viruses, or to stop attacking benign elements, such as self proteins and allergens.