SAN DIEGO, CA / ACCESSWIRE / November 3, 2021 / Ainos, Inc. ("we", "our", or the "company"), (OTC PINK: AIMD), announced today that the company has recently achieved early stage milestones in its mRNA vaccine research and development initiative. The company’s mRNA vaccine is designed against the Delta variant of SARS-CoV-2.
"We are extremely encouraged by the recent progress in our synthetic RNA research initiative since it is a major focus of our newly formed Preventive Medicine division. We are committed to developing a SARS-CoV-2 mRNA vaccine and facilitating the establishment of other synthetic RNA technology platforms," commented Mr. Chun-Hsien Tsai, Chairman and CEO of Ainos, Inc.
Synthetic RNA (SRNA), which primarily includes artificial messenger RNA (mRNA) and short inhibitory RNAs (siRNA), is a novel therapeutic approach for gene remedy or modulation. Establishing an SRNA technology platform capable of extensively producing mRNAs and/or siRNAs, together with a liposome formulation for effective sRNA delivery is critical in potential vaccine development and disease intervention.
As a short-term goal to develop a 2nd generation SARS-CoV-2 mRNA vaccine, Ainos has designed a plasmid (pEF-Vacc1) for universal viral gene expression in eukaryotic cells. This pEF-Vacc1 harbored a transgene cassette that is driven by EF1α and T7 promoters and is suitable for massive in vivo or in vitro mRNA expression. The mRNA was devised with modified gene sequence and regulatory elements to evade innate immune attacks, which was composed of a modified cap structure, a 5’ untranslated region (UTR), a 3’ UTR, an open reading frame encoding a sequence-modified spike gene of a SARS-CoV-2 delta strain, and a poly-A tail as shown below. A control plasmid pEF-eGFP expressing fluorescent eGFP had been confirmed for its feasibility in expressing protein antigens in Lung A549 cells.
We have also preliminarily determined the formulation of liposome particles (LNPs), which will be synthesized for testing their delivery efficiency in cell lines (in vitro) and animal models (in vivo). Briefly, in vitro transcribed mRNAs will be mixed with LNPs that are formulated by ionizable lipids, PEG-lipids, and helper lipids to investigate antigen expression and presentation of the mRNA-LNPs in transfected cells. The mRNA-LNPs will also be delivered into mice through intramuscular/intravenous/intranasal immunization to examine the safety, delivery efficacy and immunogenicity of the mRNA-LNPs. The humoral and cellular immunity generated by mRNA-LNPs will be analyzed through antigen-stimulated immune assays. Immunized mice with or without immunization will be challenged with SARS-CoV-2 variants to assess the protective efficacy of the mRNA-LNPs. We anticipate that the mRNA-LNPs may elicit protective neutralizing antibodies and generate potent immunological memory against SARS-CoV-2 variants in a mouse model with a Th1-biased immune response and without antibody-dependent pathogenic enhancement effect in lungs.
About Ainos, Inc.
Ainos, Inc., a Texas corporation (f/k/a Amarillo Biosciences, Inc.), is a diversified healthcare company engaged in the discovery and development of pharmaceutical and biotech products. Our goal is to introduce novel products that actively stimulate and rejuvenate the human body to combat disease and enhance the ability to heal. The Company is currently focusing on point-of-care testing rapid test kit products that include diagnostics for COVID-19 (SARS-CoV2-Antigen Rapid Test), pneumonia, vaginitis and helicobacter pylori (H. pylori) bacterial infection. The Company currently has offices in the United States and Taiwan.
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This press release contains 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'plan,' 'predict,' 'project,' 'target,' 'future,' 'seek,' 'likely,' 'strategy,' 'may,' 'should,' 'will,' and similar references to future periods. Forward-looking statements are based only on our current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements.
Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others, the following: the cost of production and sales potential of the Covid-19 Test Kit; the impact of final approvals from the Taiwan Food and Drug Administration (the “TFDA”) for the Covid-19 Test Kit subsequent to emergency use authorization; the Company's limited cash and history of losses; the Company's ability to achieve profitability; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the impact of competitive or alternative products, technologies and pricing; the Company's ability to manufacture any products it develops; general economic conditions and events and the impact they may have on the Company and its potential customers, including but not limited to the impact of Covid-19; the Company's ability to obtain adequate financing in the future; the impact of promulgation and implementation of regulations by the World Health Organization, the TFDA and by other governmental authorities with functions similar to those of the TFDA on the Company's operations and technologies; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; the Company's ability to secure regulatory approvals for its products; and our success in managing the risks involved in the foregoing items. Readers should also review the risks and uncertainties listed in our most recent Annual Report on Form 10-K and other reports we file with the U.S. Securities and Exchange Commission.
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SOURCE: Ainos, Inc.