Ainos Announces Successful Manufacturing of VELDONA GMP Clinical Batch by Swiss Pharmaceutical
Subsequent Phase Involves Completion of Chemistry, Manufacturing, and Controls (CMC) Information
Ainos Intends to Submit Investigational New Drug Applications to the U.S. FDA for Multiple Candidates During the First Half of 2024
Candidates include HIV Oral Warts Orphan Drug, Sjogren's Syndrome, the Common Cold, and COVID-19
SAN DIEGO, CA / ACCESSWIRE / November 28, 2023 / Ainos, Inc. (NASDAQ: AIMD, AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that its contract manufacturer, Swiss Pharmaceutical Co., Ltd. (Taiwan) ("Swiss Pharma"), has completed manufacturing of a Good Manufacturing Practice ("GMP") Clinical Batch of the Company's VELDONA® investigational new drugs.
Mr. Chun-Hsien (Eddy) Tsai, Chairman, President and CEO of Ainos, commented, "This marks another important milestone for Ainos. We have been collaborating with Swiss Pharma since August 2022 with the ultimate goal of building a high-quality, cost-effective manufacturing solution for VELDONA®. This cooperation enables Ainos to advance our key programs so that we can facilitate delivery of high-quality, safe, and effective therapeutics to individuals seeking relief from immunity issues or viral infections."
"Ainos has dedicated nearly four decades to the development of VELDONA®, accumulating a wealth of clinical data from 68 studies across 16 disease indications. Recognizing immunity as the root of many health issues, Ainos has developed VELDONA® to boost the immune response against disease and infection. Our team continues to explore these assets' latent values, including two drugs with U.S. FDA Orphan Drug Designation: oral warts in HIV-seropositive patients and Behçet's disease. We look forward to continuing our collaboration with Swiss Pharma as we advance our portfolio of VELDONA® product candidates."
Swiss Pharma has conducted testing, manufacturing, and packaging of VELDONA®'s GMP Clinical Batch for Ainos under both Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice ("PIC/S GMP") and the United States Food and Drug Administration's (the "U.S. FDA") Current Good Manufacturing Practice regulations.
Following release of the GMP Clinical Batch by Swiss Pharma, Ainos intends to initiate the preparation of Chemistry, Manufacturing, and Controls ("CMC") information for submission of Investigational New Drug ("IND") applications for several programs. The Company will initially submit an IND application for conducting Phase II studies for treatment of mild COVID-19 symptoms during the first quarter of 2024. After this, Ainos intends to submit a number of additional IND applications during the first half of 2024, including Phase III studies for treatment of oral warts in HIV-seropositive patients (designated an orphan drug by the U.S. FDA), Phase III studies for Sjögren's syndrome, and Phase III studies for the common cold.
"Type I interferon (IFN) has demonstrated immunomodulating effects and an ability to interfere with viral replication, making it potentially an effective antiviral agent. Our prior studies have demonstrated that VELDONA® could inhibit respiratory virus infections, including influenza and the common cold. Patients with severe and critical COVID-19 conditions seem to be affected by an impairment in type I IFN response (no IFN-beta and low IFN-alpha production and activity). We are investigating whether impaired type I IFN could be related to persistent high blood viral loads and inflammatory responses in COVID-19 cases." stated Mr. Albert Yu, Ph.D., Ainos' VP of Drug Development.
Following promising results from preclinical studies of VELDONA® against COVID-19, Ainos is ready to initiate "A Multicenter, Randomized, Parallel, Phase II Study to Evaluate the Efficacy of VELDONA® in Patients with Mild COVID-19" in Taiwan. This study aims to evaluate the efficacy of VELDONA® in subjects presenting mild symptoms of COVID-19. Subjects will receive either a daily oral dose of VELDONA® or a standard of care (SoC) for a duration of five days, and will be evaluated throughout a 28-day study period.
About Ainos, Inc.
Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on the development of novel point-of-care testing ("POCT"), low-dose VELDONA® interferon therapeutics, and synthetic RNA-driven preventative medicine. The company's products include VELDONA® clinical-stage human therapeutics, VELDONA® Pet cytoprotein health supplements, and telehealth-friendly POCTs powered by its AI Nose technology platform. The lead POCT candidate, Ainos Flora, is intended to be a telehealth-friendly POCT for women's health and certain common sexually transmitted infections ("STIs"). To learn more, visit https://www.ainos.com.
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About Swiss Pharmaceutical Co., Ltd (Taiwan)
Swiss Pharmaceutical was established in the 1950s with a mission to develop and manufacture quality pharmaceutical products. It operates with a commitment to continuous improvement and advancement. Headquartered in Tainan City, Taiwan, its facilities have been PIC/S GMP certified by the Taiwan Food and Drug Administration and inspected by the U.S. Food and Drug Administration. To learn more, visit http://www.swisspharm.com.
Forward Looking Statements
This press release contains "forward-looking statements" about Ainos 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 the use of words such as "anticipate," "believe," "estimate," "approximate", "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's 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 the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements.
Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the planned drug treatments announced in this press release; the Company's dependence on projected revenues from the sale of COVID-19 test kits and its VELDONA® Pet line of supplements; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; 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; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company's success in managing growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' Annual Report on Form 10-K for the year ended December 31, 2022 and other reports filed with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's reports filed with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release.
The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.
Investor Relations Contact
Tel: +1 646-224-6971
SOURCE: Ainos, Inc.
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