GENEREX BIOTECHNOLOGY CORPORATION (OTCMKTS:GNBT) Files An 8-K Entry into a Material Definitive AgreementItem 1.01. Entry a Material Definitive Agreement
On November 20, 2018, , the Company’s wholly owned subsidiary, Antigen Express, Inc. (“Antigen”) entered into a Clinical Trial Agreement with NSABP Foundation, Inc. (“NSABP”). to the Clinical Trial Agreement, NSABP will conduct a Phase II Study to evaluate efficacy of administering Merck Sharpe & Dhome’s (‘Merck”) Keytruda® (pembrolizumab) in combination with Antigen’s AE37 cancer vaccine for the treatment of metastatic triple negative breast cancer. While Merck is not a party to the Clinical Trail Agreement, Merck is expected to provide Keytruda® for the study to the Clinical Trial Collaboration and Supply Agreement between Antigen and Merck.
An initial payment from Generex in the amount of $340,000 is due by December 20, 2018. If the study runs the full anticipated term, Generex will be responsible for an aggregate $2,118,461.
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 ExhibitEX-10.1 2 ex10_1.htm EXHIBIT 10.1 Clinical Trial Agreement PHASE II STUDY between NSABP Foundation,…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.