Ii-Key Peptide-based Covid-19 vaccine / Shandong Academy of Sciences, Generex - LARVOL DELTA

Generex and NuGenerex Immuno-Oncology Ii-Key-SARS-CoV-2 Vaccine Partner Bintai Kinden Executes its Exclusive Distribution & Licensing Option for Australia and New Zealand (GlobeNewswire) - "Memorandum of Understanding (MOU) signed by both parties; Negotiating final contract terms; Upfront payment on closing; Licensing fees, expenses, and price per dose to be determined; Generex Biotechnology Corporation...announced that their Ii-Key COVID-19 vaccine development partner Bintai Kinden Corporation and its subsidiary BINTAI HEALTHCARE SDN. BHD. have executed their exclusive option to license and distribute the Ii-Key-SARS-CoV-2 vaccine in Australia and New Zealand once the vaccine is developed and approved by the FDA and relevant Malaysian authorities."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Generex Signs Binding Licensing & Research Agreement with Bintai Kinden to Advance the Clinical Development & Commercialization of Ii-Key-SARS-CoV-2 Coronavirus Vaccine for Malaysia (GlobeNewswire) - "Potential to expand the partnership and development agreement in Australia, New Zealand, and the global HALAL markets; Generex Biotechnology Corporation...is pleased to announce that the company and Bintai Kinden Corporation of Malaysia have signed an addendum binding the terms of the previously signed Memorandum of Understanding for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine....Generex and Bintai have agreed to collaborate and have developed a strategy towards the rapid development of the Ii-Key-CoV-2 vaccine for Malaysia."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Generex Biotechnology Announces That FDA has Accepted the Pre-IND Briefing Package for the Company’s Ii-Key-SARS-CoV-2 Vaccine and Will Provide a Written Response by August 24, 2020 (GlobeNewswire) - "Generex Biotechnology Corporation...today announced that the FDA has accepted their pre-IND briefing package for the Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine, and will provide a written response by August 24, 2020....With their response, the FDA will comment on the Phase I/II clinical trial plan and will provide guidance on the overall development program for the Ii-Key-SARS-CoV-2 vaccine."

FDA event • Infectious Disease • Novel Coronavirus Disease

Generex Biotechnology Files Pre-IND Briefing Package with FDA for Ii-Key-SARS-CoV-2 Peptide Vaccine Against the COVID-19 Pandemic (GlobeNewswire) - "Generex Biotechnology Corporation...today announced that the company has submitted a pre-IND briefing package to FDA requesting regulatory guidance on the Phase I/II clinical trial protocol and clinical development plan for the Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine....'We have finalized our protocol, which is comprehensive and highly focused on the safety of human subjects who enroll in our trials.'"

Cytokine storm • FDA event • Infectious Disease • Novel Coronavirus Disease