Ainos, Inc. announced it entered into a Development and Sales Agreement with InnoPharmax, Inc. Ainos and InnoPharmax agreed to jointly develop and promote an orally administered cytotoxin-induced complementary combined therapy (“CICCT”) for the treatment of COVID-19 and potentially other viral infections. The companies plan to develop this combined therapy leveraging Ainos' VELDONA® drug platform based on low-dose oral interferon along with InnoPharmax's orally administered antiviral drug, GemOral®. The companies plan to jointly perform animal and investigator-initiated trials for safety and efficacy testing in Taiwan early next year and conduct a subsequent Phase III clinical trial with the goal of applying for regulatory approvals, including U.S. emergency use authorization if available, sometime in the third quarter of 2022.

Upon commercialization, Ainos will be responsible for global sale in countries for which the product is approved for uses, and InnoPharmax will be responsible for drug production and manufacturing. The two parties will share profits on drug sales. Ainos' VELDONA® is a low-dose oral interferon alpha (IFN-a) therapeutic, with the ability to “interfere” with viral replication by protecting cells from virus infections, spread and cancer cell division.

Interferon alpha (IFN-a) also has various antitumor activities including the direct induction of cytotoxicity and the activation of NK cells and antibody-dependent cell-mediated cytotoxicity. Studies have shown that type I interferon, IFN-a, (B lymphocytes and monocyte) and IFN-ß (fibroblast) not only directly inhibits the replication of virus cells but also stimulates the operation of the immune system. Type II interferons, including IFN-?

(T lymphocyte), have the functions of antivirus, activating phagocytes and inducing expression of MHC molecular. Plan to investigate combining the functions of type I and type II interferons with the hopes of more effectively inhibiting the replication of virus and enhance immunoreaction. Are focused on reducing the continuous secretion of inflammatory cytokine to avoid severe pneumonia reactions and cytokine storms. InnoPharmax's oral drug D07001 GemOral® inhibits inflammatory cytokine, such as IL-6 and CCL2, and also induces the production of interferon-stimulated gene (ISG) and interferon (IFN-b and IFN-?).

Gemcitabine, a key compound in GemOral®, can improve the performance of type II interferon-? and CD8+ of immune cells. Gemcitabine can replace cytidine to be embedded in DNA or RNA during the process of nucleotide replication, resulting in failure of nucleic acid replication and cytotoxicity which is beneficial to inhibit the replication and the growth of virus in the body.