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Interferon alpha therapy - Ainos/Xiamen Weiyang Pharmaceutical

Drug Profile

Interferon alpha therapy - Ainos/Xiamen Weiyang Pharmaceutical

Latest Information Update: 28 Mar 2024

At a glance

  • Originator Amarillo Biosciences
  • Developer Xiamen Weiyang Pharmaceutical
  • Class Antivirals; Interferons
  • 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

Highest Development Phases

  • No development reported COVID 2019 infections

Most Recent Events

  • 28 Mar 2024 No recent reports of development identified for research development in COVID-2019-infections in China (PO)
  • 13 Feb 2020 Early research in COVID-2019-infections in China (PO)

Development Overview

Introduction

Low-dose oral interferon alpha therapy is being developed by Xiamen Weiyang Pharmaceutical under a license agreement with Ainos (formerly Amarillo Biosciences) for the treatment of COVID-2019 infections. The oral interferon product works indirectly by boosting the immune system, making the development of viral resistance highly unlikely. When interferon is given orally the interferon reaches the mucosa of the back of the throat where the interferon attaches to receptors and activates hundreds of interferon-sensitive genes that help the immune system respond to the viral infection. Early research is underway in China.

In May 2021, Amarillo Biosciences changed its name to Ainos [1] .

As at March 2024, no recent reports of development had been identified for research development in COVID-2019-infections in China (PO).

Company Agreements

In July 2019, Amarillo Biosciences (now Ainos) announced that it entered into a into a Term Sheet outlining a licensing and royalty agreement with Xiamen Weiyang Pharmaceutical. Under the Term Sheet, Amarillo Biosciences proposes to license the right and responsibility to develop, manufacture and commercialize an IFNa related therapy to Xiamen Weiyang in China for the treatment of an undisclosed indication. In exchange, Amarillo Biosciences would receive an upfront license fee and cash or equity payments as per the achievement of specific milestones and a royalty based on gross revenues from the sale of the product in the China market. Xiamen Weiyang is to cross-license the future products, know-how, and technologies resulting from the venture for Amarillo Biosciences products and worldwide distribution outside of China to Amarillo Biosciences . [2] [1]

Key Development Milestones

As of February 2020, low-dose oral interferon alpha therapy is in early stage development for the treatment of COVID-2019 infections [3] .

Patent Information

The interferon alpha therapy has six issued patents (five in U.S. and one in Taiwan) and a registered trademark, in the US. The sixth entitled "Treatment of Thrombocytopenia Using Orally Administered Interferon", was issued on July 21, 2017, and will expire in 2033 (Amarillo Biosciences website, February 2020).

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation unspecified
  • Class Antivirals, Interferons
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

Biomarker

Drug Name Biomarker Name Biomarker Function
Interferon alpha therapy - Ainos/Xiamen Weiyang Pharmaceutical Alpha-fetoprotein (AFP) Eligibility Criteria
Interferon alpha (IFN-alpha) Brief Summary, Brief Title, Official Title
Interleukin-2 (IL-2) Arm Group Description, Brief Title, Eligibility Criteria, Official Title
Mannitol Eligibility Criteria
serine dehydratase Eligibility Criteria
Thyroglobulin Eligibility Criteria
Thyroid stimulating hormone beta (TSH) Eligibility Criteria
Thyroxine (T4) Eligibility Criteria
TPO Eligibility Criteria
TPO Auto-antibodies Eligibility Criteria
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - No development reported (Research) China PO / unspecified Xiamen Weiyang Pharmaceutical 28 Mar 2024

Commercial Information

Involved Organisations

Organisation Involvement Countries
Amarillo Biosciences Originator USA
Ainos Owner USA
Xiamen Weiyang Pharmaceutical Licensee China

Development History

Event Date Update Type Comment
28 Mar 2024 Phase Change - No development reported No recent reports of development identified for research development in COVID-2019-infections in China (PO) Updated 28 Mar 2024
24 May 2021 Company Involvement Amarillo Biosciences is now called Ainos Updated 07 Jan 2022
13 Feb 2020 Phase Change Early research in COVID-2019-infections in China (PO) [3] Updated 25 Feb 2020
31 Jul 2019 Licensing Status Amarillo Biosciences enters into a Term Sheet outlining a licensing and royalty agreement with Xiamen Weiyang Pharmaceutical for interferon alpha therapy [2] Updated 25 Feb 2020
21 Jul 2017 Patent Information Amarillo Biosciences has patent protection for interferon alpha therapy in USA and Taiwan (Amarillo Biosciences website, February 2020) Updated 25 Feb 2020
07 Mar 2008 Biomarker Update Biomarkers information updated Updated 09 Jan 2022

References

  1. Ainos Announces FINRA Approval of Name Change and Ticker Symbol Change to "AIMD", Engages Firm to Explore Listing Requirements of National Securities Exchanges.

    Media Release
  2. Amarillo Biosciences and Xiamen Weiyang Pharmaceutical Sign Term Sheet Outlining China Licensing and Royalty Agreement.

    Media Release
  3. Amarillo Biosciences to Explore Low-Dose Oral Interferon Therapeutics in China as a Line of Defense Against Coronavirus and Other Viral Indications.

    Media Release
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