Biostax Corp Announces the FDAs Acceptance of Three Investigational New Drug Applications (IND) Transfers for JKB-122 for the Treatment of NASH, NAFLD and AIH

Rhea-AI Summary

Biostax Corp. (OTC Pink: IMUN) has finalized the transfer of three Investigational New Drug Applications (IND) for the drug candidate, JKB-122, from TaiwanJ Pharmaceuticals. The U.S. Food and Drug Administration (FDA) has approved the transfers, including INDs for the treatment of NASH, NAFLD, and Autoimmune Hepatitis. JKB-122 is a TLR4 antagonist targeting autoimmune and inflammatory conditions in chronic liver diseases.

Orlando, FL, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. d/b/a Biostax Corp. (OTC Pink: IMUN) ("Biostax"), a hub-and-spoke biotech development engine, announces that they have accepted the transfer of three Investigational New Drug Applications (IND) for the drug candidate, JKB-122 and the U.S. Food and Drug Administration (FDA) has finalized those transfers. The INDs that were transferred to Biostax include IND 146955 for the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis, IND 147347 for the treatment of Nonalcoholic Liver Disease (NAFLD) and IND 127303 for the treatment of Autoimmune Hepatitis along with the Orphan Designation for Autoimmune Hepatitis. These INDs were transferred from TaiwanJ Pharmaceuticals, who licensed the development and commercialization of JKB-122 to Biostax Corp in 2022.

JKB-122 is a small molecule and a long-acting TLR4 antagonist that has been shown to play a prominent role in the pathogenesis of certain autoimmune and inflammatory conditions including the treatments of chronic liver diseases such as Non-Alcoholic Fatty Liver Disease (NAFLD), Autoimmune Hepatitis (AIH), and Non-Alcoholic Steatohepatitis (NASH).

“As we continue to build out and diversify our development pipeline, which has a focus on immunology and nephrology, we are excited to complete this milestone," said Kelly Wilson, President of Biostax. "This transaction is transformational for Biostax as it allows us to support a balanced pipeline and advance innovative therapeutic solutions that help people living with autoimmune diseases and chronic illness.”

About Biostax

Biostax Corp. is a pioneering pharmaceutical company involved in the acquisition, development, and commercialization of pharmaceutical and biotechnology products that have a well-defined path to market. By utilizing a biotech portfolio hub-and-spoke engine, we plan to advance focused and efficient small-scale biotechnology and pharmaceutical programs through subsidiaries, investment vehicles or partnerships, and deploy products from those programs in markets both in the U.S. and internationally for initial commercialization.

Forward Looking Statement

This press release may contain information about our views of future expectations, plans and prospects that constitute forward-looking statements. All forward-looking statements are based on management’s beliefs, assumptions, and expectations of Immune’s future economic performance, considering the information currently available to it. These statements are not statements of historical fact. Although Immune believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Immune does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. No assurances can be made that Immune will successfully acquire its acquisition targets. Forward-looking statements are subject to several factors, risks, and uncertainties, some of which are not currently known to us, that may cause Immune’s actual results, performance, or financial condition to be materially different from the expectations of future results, performance, or financial position. Actual results may differ materially from the expectations discussed in forward-looking statements. Factors that could cause actual results to differ materially from expectations include general industry considerations, regulatory review and approval of our prospective products, changes in local or national economic conditions and other risks set forth in “Risk Factors” included in our filings with the Securities and Exchange Commission.

Disclaimer

The information provided in this press release is intended for general knowledge only and is not a substitute for professional medical advice or treatment for specific medical conditions. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition. This information is not intended to diagnose, treat, cure, or prevent any disease.

Biostax Contact:

Kelly O. Wilson

President

ir@biostax.net

1-888-391-9355

FAQ

What is the significance of the transfer of INDs for JKB-122 to Biostax Corp?

The transfer of INDs for JKB-122 to Biostax Corp signifies a significant milestone in the development of innovative therapeutic solutions for autoimmune diseases and chronic illness.

What are the specific conditions that JKB-122 is targeting?

JKB-122 is targeting Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Liver Disease (NAFLD), and Autoimmune Hepatitis, with an Orphan Designation for Autoimmune Hepatitis.

Who has licensed the development and commercialization of JKB-122 to Biostax Corp?

TaiwanJ Pharmaceuticals has licensed the development and commercialization of JKB-122 to Biostax Corp.

What is the role of JKB-122 in the treatment of chronic liver diseases?

JKB-122 is a small molecule and a long-acting TLR4 antagonist that has been shown to play a prominent role in the pathogenesis of autoimmune and inflammatory conditions in chronic liver diseases.