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COVID-2019 infections vaccine - Generex Biotechnology

Drug Profile

COVID-2019 infections vaccine - Generex Biotechnology

Alternative Names: 'Ii-Key-nCOV peptide vaccine - Generex Biotechnology; complete vaccine - Generex Biotechnology; Ii-Key-SARS-CoV-2 vaccine; SARS-CoV-2 virus vaccines - Generex Biotechnology

Latest Information Update: 04 Jan 2021

At a glance

  • Originator Generex Biotechnology Corporation
  • Class Peptide vaccines; Viral vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 04 Jan 2021 Generex announces intention to submit regulatory filings to NMPA for the phase I, II and III clinical programs for COVID-2019 infections
  • 04 Jan 2021 Pharmacodynamics data from a preclinical trial in COVID-2019 infections released by NuGenerex Immuno-Oncology
  • 31 Dec 2020 Generex files for patent protection for COVID-2019 infections

Development Overview

Introduction

COVID-2019 infections vaccine is being developed by Generex Biotechnology for the prevention of coronavirus infection (COVID-19 strain). The company will utilise li-Key peptide vaccine platform of NuGenerex Immune-Oncology (subsidiary of Generex Biotechnology). Major histocompatibility complex (MHC) class II associated invariant chain (Ii) derived Ii-Key peptide is involved in the regulation of the formation, trafficking, and antigen-presenting functions of MHC class II complexes, essential for the activation of T cells in the immune response. When the peptide is linked to an antigenic epitope, it displaces the resident antigens from the antigen binding grove on MHC Class II molecules. This renders the MHC molecules to present the Ii-Key epitope to selectively activate T-helper type 1 cells responses. These events increase the duration and intensity of the immune responses. The interaction reduces the binding affinity of the antigenic binding groove on the MHC class II molecule and any previously resident epitope is discharged. Early research is underway in China and the US.

Generex Biotechnology is seeking partnership opportunities to expand development of its COVID-2019 infections vaccine [1] .

Company Agreements

In November 2020, Generex Biotechnology announced that their Ii-Key COVID-19 vaccine development partner Bintai Kinden Corporation 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. NuGenerex Immuno-Oncology, in October 2020, closed its licensing & distribution agreement with Bintai Kinden Corporation of Malaysia for the development and commercialisation of the Ii-Key-SARS-CoV-2 coronavirus vaccine. Under the terms of the agreement, Bintai will have an exclusive license to distribute the Ii-Key-SARS-CoV-2 vaccine in Southeast Asia, including Malaysia, Vietnam, Indonesia, and the Philippines. Additionally, Bintai has been given an option, with right of first refusal for distribution in Australia and New Zealand using its extensive connections to secure contracts in the region.In exchange for the license and distribution exclusivity, Bintai has paid an up-front licensing fee of $US2.625 million and has committed to funding 100% of the commercial development costs for the Ii-Key-CoV-2 vaccine including laboratory and pre-clinical work, GMP manufacturing in the US, and global phase I, phase II, and phase III clinical trials, and all clinical and regulatory work required for approval in each of the licensed Australasian countries. Earlier, in August 2020, Generex Biotechnology signed a memorandum of understanding (MOU) with Bintai Kinden Corporation of Malaysia for the development and commercialisation of the Ii-Key SARS-CoV-2 coronavirus vaccine of Generex. Bintai agreed to pay Generex upfront development fees and back-end licensing payments, and will pay 100% of the funding required for the commercial development of the vaccine. The development activities will include laboratory work, manufacturing, regulatory filings and the clinical development program for regulatory approval of the vaccine in Malaysia. In addition, upon approval of the vaccine in Malaysia, Generex will receive royalties on sales of the vaccine with potential revenues of up to $US150 million. Under terms of the MOU, Generex and Bintai agreed to collaborate and develop strategy with primary goals including streamlining of vaccine development process, conducting clinical trials globally and building global manufacturing capacity. Later, in September 2020, Generex Biotechnology and Bintai Kinden Corporation of Malaysia signed an addendum binding the terms of the previously signed MOU for the development and commercialisation of the Ii-Key SARS-CoV-2 coronavirus vaccine. Under the terms of the Addendum, Bintai and Generex will finalise the legal and contractual documentation for the contract, partnership, and licensing & research agreement, and Bintai will pay Generex an up-front licensing fee of $US2.5 million within two weeks. Additionally, Bintai will pay 100% of the funding required for the commercial development of the vaccine in Malaysia. Also, upon approval of the vaccine in Malaysia, Bintai will pay Generex a $US17.5 million milestone payment and Generex will earn royalties on sales of the vaccine equal to $US3 per dose on government sales and $US4.50 per dose in the private sector. Further, under this new Addendum, Bintai will have the right of first refusal for the vaccine in Australia, New Zealand, and the global HALAL markets, particularly in Southeast Asia. [2] [3] [4] [5]

In November 2020, Generex Biotechnology Corporation closes its a licensing agreement with consortium of partners in China including Beijing Guoxin Haixiang Equity Investment, and Beijing Youfeng International Consulting for the development and commercialisation of the (Ii-Key-SARS-CoV-2) coronavirus vaccine in China. Under the terms of the deal, Generex will receive a licensing fee of up to $US50 million for the exclusive use of the Ii-Key vaccine platform for infectious disease and cancer in China and its territories. For each product developed using the Ii-Key technology under the platform license, Generex will receive an upfront payment, full funding for product development, regulatory approval, and commercialisation in China, a success fee upon product approval, and a royalty to be determined on a case-by-case basis [6] [7]

In March 2020, Generex Biotechnology entered into a licensing agreement with Beijing Zhonghua Investment Fund Management and Sinotek-Advocates International Industry Development for the development of coronavirus vaccine (COVID-19 strain), using the Ii-Key peptide vaccine platform of NuGenerex immune-Oncology (NGIO), a Generex’s majority owned subsidiary. According to the terms of the agreement Ii-Key peptides linked with nCOV-2019 coronavirus epitopes will be generated by Generex Biotechnology through NGIO and will be tested against the blood samples of the patients in China recovered from coronavirus infection by the Chinese partners. The data obtained will indicate the Ii-Key-nCOV epitopes recognised by the human immune system, that will eventually be developed as the potential coronavirus vaccine by Generex Biotechnology. The human clinical trials will be conducted in China and the USA. The Chinese partners will have exclusive rights to use and commercialise the products in China and will make payments to Generex Biotechnology that include upfront payment of USD$ 1 million, development expenses, royalty on each dose of vaccine produced and $USD 5 million as a licensing fee for the Ii-Key technology upon completion of development and testing. Generex Biotechnology will may payments to NuGenerex Immuno-Oncology after the receipt of the licensing payments, since the intellectual property resides with the later. [8]

In August 2019, Generex Biotechnology announced for a planned spin-out of its subsidiary NuGenerex Immuno-Oncology (formerly Antigen Express), which will include the Ii-Key technology and AE37 immunotherapeutic vaccine program. Based on this spin-out, NuGenerex Immuno-Oncology will separate and work as a public company. [9]

Key Development Milestones

In December 2020, NuGenerex Immuno-Oncology filed trademark application for COVID-2019 infections vaccine (The Complete Vaccine™) and company also released pharmacodynamics data from a preclinical trial in COVID-2019 infections [10] .

In August 2020, Generex Biotechnology reported that it intends to conduct a meeting with the Canadian National Research Council to discuss the Ii-Key-SARS-CoV-2 vaccine technology forward [11] .

In August 2020, the FDA delivered a written response to pre-IND briefing package for the clinical development program of COVID-19 vaccine in which they have agreed to the overall clinical plan and provided straight-forward guidance on protocol specifics and vaccine product data requests that will be addressed in the IND submission [12] . In July 2020, Generex Biotechnology announced that US FDA has accepted the pre-IND briefing package for the clinical development program of COVID-19 vaccine against the SARS-CoV-2 coronavirus infections [13] . Earlier in the same month Generex Biotechnology submitted a pre-IND briefing package [14] .

In May 2020, Generex Biotechnology submitted a contract proposal to Biomedical Advanced Research and Development Authority (BARDA) to fund and support the development of a COVID-2019 vaccine against the SARS-CoV-2 coronavirus using the Ii-Key vaccine technology [15] .

In May 2020, Generex Biotechnology completed identification and selection of SARS-CoV-2 epitopes for development of vaccines. The company also commenced GLP manufacturing of synthetic Ii-Key-SARS-CoV-2 peptides for screening in ex vivo assays like cellular assays, antibody and virus neutralisation tests, and a in vitro cytokine storm cellular assay, using blood samples from COVID-2019 convalescent patients, in order to assess and select Ii-Key peptides that activate the immune system [15] .

Generex Biotechnology has initiated early research in coronavirus infections in China and the US [8] .

Financing information

In August 2020, Generex Biotechnology signed a letter of intent (LOI) with potential partners in China to develop the Ii-Key-SARS-CoV-2 vaccine for China with a proposed $US5 million upfront payment upon contract signing and minimum of $US400 million if the vaccine is proven successful in clinical trials [11] .

Patent Information

In December 2020, Generex filed an extensive patent application that covers our Ii-Key-SARS-CoV-2 vaccine and provides the foundation for a new patent estate for the Ii-Key platform [10] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Peptide vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Preclinical USA Parenteral / unspecified Generex Biotechnology Corporation 31 Dec 2020
COVID 2019 infections - Prevention Research China Parenteral / unspecified Generex Biotechnology Corporation 09 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Generex Biotechnology Corporation Originator Canada
Generex Biotechnology Corporation Owner Canada
Bintai Kinden Corporation Market Licensee Indonesia, Malaysia, Philippines, Vietnam
Beijing Zhonghua Investment Fund Management Co., LTD Licensee China
Beijing Youfeng International Consulting Licensee China
Beijing Guoxin Haixiang Equity Investment Licensee China
Sinotek-Advocates International Industry Development (Shenzhen) Co., LTD Licensee China
NuGenerex Immuno-Oncology Technology Provider USA

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Generex Biotechnology Corporation - Unspecified - 02 Oct 2020

Scientific Summary

Pharmacodynamics

Summary

T Cell assays and HLA typing of blood samples from 46 convalescent COVID-19 patients and 30 healthy pre-COVID donors (from 2017 and 2018) demonstrated that numerous Ii-Key epitopes activated CD4+ Th1 and CD8+ responses that are necessary for long-term immune memory and none of the Ii-Key epitopes tested activated any negative Th2 responses [10] .

Future Events

Expected Date Event Type Description Updated
31 Mar 2021 Trial Update Generex Biotechnology plans a clinical trial for COVID-2019 infections in early 2021 in the US (700319548) [4] 13 Oct 2020
31 Jan 2021 Regulatory Status Generex announces intention to submit IND to US FDA for COVID-2019 infections in early 2021 [10] 04 Jan 2021

Development History

Event Date Update Type Comment
04 Jan 2021 Regulatory Status Generex announces intention to submit regulatory filings to NMPA for the phase I, II and III clinical programs for COVID-2019 infections [10] Updated 04 Jan 2021
04 Jan 2021 Scientific Update Pharmacodynamics data from a preclinical trial in COVID-2019 infections released by NuGenerex Immuno-Oncology [10] Updated 04 Jan 2021
31 Dec 2020 Patent Information Generex files for patent protection for COVID-2019 infections [10] Updated 04 Jan 2021
31 Dec 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) [10] Updated 04 Jan 2021
31 Dec 2020 Regulatory Status Generex announces intention to submit IND to US FDA for COVID-2019 infections in early 2021 [10] Updated 04 Jan 2021
31 Dec 2020 Regulatory Status Generex announces intention to submit NDA to FDA for COVID-2019 infections in [10] Updated 04 Jan 2021
31 Dec 2020 Regulatory Status NuGenerex Immuno-Oncology files trademark application with the USPTO in US for COVID-2019 infections [10] Updated 04 Jan 2021
23 Nov 2020 Licensing Status Generex Biotechnology Corporation and Bintai Kinden Corporation executes its exclusive distribution & licensing option for Australia and New Zealand for COVID-2019 infections vaccine [5] Updated 27 Nov 2020
18 Nov 2020 Licensing Status Generex Biotechnology closes its licensing agreement with consortium of partners in China for Ii-Key- SARS-CoV-2 vaccine [7] Updated 26 Nov 2020
09 Nov 2020 Licensing Status Beijing Guoxin Haixiang Equity Investment and Beijing Youfeng International Consulting in-licenses coronavirus vaccine from Generex Biotechnology in China [6] Updated 09 Nov 2020
07 Oct 2020 Licensing Status Ii-Key SARS-CoV-2 coronavirus vaccine market licensed to Bintai Kinden Corporation in Malaysia, Vietnam, Philippines and Indonesia [4] Updated 13 Oct 2020
07 Oct 2020 Licensing Status NuGenerex Immuno-Oncology closes its licensing & distribution agreement with Bintai Kinden Corporation to advance the clinical development of Ii-Key-SARS-CoV-2 coronavirus vaccine [4] Updated 13 Oct 2020
07 Oct 2020 Trial Update Generex Biotechnology plans a clinical trial for COVID-2019 infections in early 2021 in the US [4] Updated 13 Oct 2020
06 Oct 2020 Trial Update Generex Biotechnology plans a clinical trial for COVID-19 infections (In adolescents, In children) Updated 08 Oct 2020
02 Oct 2020 Licensing Status COVID-2019 infections vaccine is available for licensing as of 02 Oct 2020. www.generex.com [1] Updated 06 Oct 2020
18 Sep 2020 Licensing Status Generex Biotechnology and Bintai Kinden Corporation of Malaysia signs an addendum binding the terms of the previously signed memorandum of understanding for the development and commercialisation of COVID-2019 infections vaccine [3] Updated 25 Sep 2020
25 Aug 2020 Regulatory Status Generex Biotechnology plans to submit IND application for COVID-2019 infections [12] Updated 02 Sep 2020
25 Aug 2020 Regulatory Status Generex Biotechnology plans a meeting with the Canadian National Research Council to discuss the Ii-Key-SARS-CoV-2 vaccine technology [11] Updated 27 Aug 2020
18 Aug 2020 Licensing Status Generex Biotechnology Corporation signs a memorandum of understanding (MOU) with Bintai Kinden Corporation for development and commercialisation of COVID-19 vaccine in Malaysia [2] Updated 21 Aug 2020
29 Jul 2020 Regulatory Status US FDA accepts pre-IND application for COVID-19 infections vaccine for review [13] Updated 29 Jul 2020
20 Jul 2020 Regulatory Status Generex Biotechnology submits pre-IND application for clinical development of COVID-19 vaccine [14] Updated 22 Jul 2020
20 Jul 2020 Trial Update Generex Biotechnology plans a phase I/II trial in COVID-19 infections [14] [13] Updated 22 Jul 2020
04 May 2020 Company Involvement Generex Biotechnology submit proposal to Biomedical Advanced Research and Development Authority to finance and support development of COVID-2019 vaccine programme [15] Updated 22 May 2020
19 Apr 2020 Licensing Status Generex Biotechnology is collaborating with private collaborators and academic experts to evaluate a number of peptide vaccine candidates for future clinical use Updated 08 May 2020
19 Apr 2020 Licensing Status Generex Biotechnology is seeking partnership from USA and international government for the clinical development and manufacturing of COVID-19 infection vaccine Updated 08 May 2020
19 Apr 2020 Regulatory Status Generex Biotechnology is in discussion with health Canada to evaluate regulatory path for the approval of COVID-19 infections vaccines in Canada Updated 08 May 2020
16 Mar 2020 Trial Update Generex Biotechnology plans to initiate a clinical trial for regulatory approval in USA [8] Updated 16 Mar 2020
09 Mar 2020 Phase Change Early research in COVID-2019 infections (Prevention) in China (Parenteral) [8] Updated 09 Mar 2020
09 Mar 2020 Phase Change Early research in COVID-2019 infections (Prevention) in USA (Parenteral) [8] Updated 09 Mar 2020
02 Mar 2020 Licensing Status Beijing Zhonghua Investment Fund Management and Sinotek-Advocates International Industry Development in-licenses coronavirus vaccine from Generex Biotechnology in China [8] Updated 12 Mar 2020
16 Aug 2019 Company Involvement Generex Biotechnology announced a spin-out of its subsidiary NuGenerex Immuno-Oncology (formerly Antigen Express) [9] Updated 12 Mar 2020

References

  1. NuGenerex Immuno-Oncology Announces Shareholder Conference Call on Thursday October 8, 2020 at 8:00 AM.

    Media Release
  2. Generex Signs a Memorandum of Understanding with Bintai Kinden to Advance the Clinical Development & Commercialization of Ii-Key-SARS-CoV-2 Coronavirus Vaccine for Malaysia.

    Media Release
  3. 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.

    Media Release
  4. NuGenerex Immuno-Oncology Announces Closing of a Licensing & Distribution Agreement with Bintai Kinden to Advance the Clinical Development & Commercialization of Ii-Key-SARS-CoV-2 Coronavirus Vaccine for Global Markets.

    Media Release
  5. 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.

    Media Release
  6. Generex Announces the Signing of a Framework Agreement with The China CDC, Beijing Guoxin Haixiang Equity Investment Partnership and Beijing Youfeng International Consulting Co., Ltd on the Cooperative Development of Ii-Key Vaccines.

    Media Release
  7. Generex Inks $50 Million Licensing Deal with China Partners on the Cooperative Development of the Ii-Key Vaccine Platform.

    Media Release
  8. Generex Signs Contract with Chinese Partners Beijing Zhonghua Investment Fund Management Co., LTD and Sinotek-Advocates International Industry Development (Shenzhen) Co., Ltd. to Develop a COVID-19 Vaccine Using Ii-Key Peptide Vaccine Technology.

    Media Release
  9. Generex Biotechnology Announces Plans for NuGenerex Immuno-Oncology Spinout through a Targeted Acquisition of a Public Company and Planned Merger with Kiromic.

    Media Release
  10. Generex and NuGenerex Immuno-Oncology Provide Update on Ii-Key COVID-19 Vaccine Development Program and Files Trademark Application for The Complete Vaccine(Tm).

    Media Release
  11. Generex Biotechnology Announces New Updated Agenda for Shareholder Conference Call on Wednesday August 26th, 2020 at 9:30 AM.

    Media Release
  12. Generex Biotechnology Announces Call-in Details and Updated Agenda for Shareholder Conference Call on Wednesday August 26th, 2020 at 9:30 AM.

    Media Release
  13. Generex Biotechnology Announces That FDA has Accepted the Pre-IND Briefing Package for the Companys Ii-Key-SARS-CoV-2 Vaccine and Will Provide a Written Response by August 24, 2020.

    Media Release
  14. Generex Biotechnology Files Pre-IND Briefing Package with FDA for Ii-Key-SARS-CoV-2 Peptide Vaccine Against the COVID-19 Pandemic.

    Media Release
  15. Generex Biotechnology Initiates Peptide Manufacturing for Ii-Key- SARS-CoV-2 Peptide Vaccine Against the COVID-19 Pandemic.

    Media Release
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