Avaí Bio and Austrianova Begin Production of Master Cell Bank for Klotho Anti-Aging Therapy Under GMP Standards

Rhea-AI Summary

Avaí Bio (OTCQB: AVAI) and Austrianova have begun GMP production of a Master Cell Bank (MCB) of genetically modified cells overexpressing α-Klotho to support Klothonova, their equally owned Nevada JV. The MCB will supply Cell-in-a-Box® encapsulated cells for anti-aging and age-related disease programs.

The MCB is described as GMP-compliant, fully characterized, and the foundational source for working cell banks to ensure product consistency, genetic stability, and long-term supply for clinical and manufacturing scale-up.

Positive

• GMP production of α-Klotho MCB initiated
• Klothonova formed as 50/50 JV between Avaí Bio and Austrianova affiliate
• MCB intended to secure consistent supply for Cell-in-a-Box® production

Negative

• No financial or timeline targets disclosed for clinical or commercial milestones

LAS VEGAS, March 3, 2026 /PRNewswire/ -- Avaí Bio, Inc. (OTCQB: AVAI) ("Avaí" or the "Company"), an emerging biotechnology company developing transformative cell-based therapies for diabetes, age-related disorders, and anti-aging, today announced—together with its joint venture partner and global biotechnology firm, Austrianova—the initiation of production for a Master Cell Bank of genetically modified cells that overexpress the α-Klotho protein. 

These cells will enable Klothonova, the parties' joint venture (JV), to advance its anti-aging product candidate within the ongoing α-Klotho development program, following the successful completion of all preparatory activities in February.

This milestone supports the JV's efforts to create a sustainable, cell-based approach to restoring circulating levels of the α-Klotho "longevity protein" for potential therapeutic benefits in aging and related conditions.

A Master Cell Bank (MCB) is a GMP-compliant, fully characterized, and homogeneous collection of vials derived from a single clone.  The MCB is a critical starting material that forms the foundation for the scale-up and production of cell therapies.  It serves as an essential resource, ensuring product consistency and reducing risk by safeguarding against contamination, degradation, extraneous agents, and genetic instability.  Establishing and maintaining a high-quality MCB, which serves as the primary source for all working cell banks—under Good Manufacturing Practices (GMP) standards positions Avaí Bio and Austrianova for long-term success by supporting a reliable and sustainable supply chain.  

The banked cells will ultimately be used to produce the final Cell-in-a-Box^® encapsulated cell product, intended for use in innovative cell-based therapies targeting age-related diseases, such as Alzheimer's¹ and cancer², while also advancing anti-aging and longevity treatments.

"We are excited to enter the first step in the production phase of α-Klotho producing cells as part of our commitment to deliver safe, effective treatments for aging associated diseases," said Chris Winter, Chief Executive Officer of Avaí Bio.

Prof. Walter H. Gunzburg, Chairman of Austrianova, added, "MCBs are a prerequisite for the production of Cell-in-a-Box^® encapsulated cell products. They provide the foundation for sustainable production and ensure they meet the highest quality standards."

This is the latest development as part of the JV agreement signed in September 2025, which established Klothonova as a Nevada-based entity, equally owned by Avaí Bio and Austrianova's affiliate, SG Austria Pte. Ltd.  The JV focuses on sustainable production of α-Klotho—known as the "longevity protein" and a key regulatory protein that is well documented for its anti-aging and protective effects on organs—in patients using encapsulated cell-based therapies.

1. https://jamanetwork.com/journals/jamaneurology/article-abstract/2844556
2. https://pubmed.ncbi.nlm.nih.gov/40004457/

About Avaí Bio, Inc.

Avaí Bio, Inc. is an emerging biotechnology company focused on identifying genetically modified cell lines, and through joint venture and licensing agreements developing innovative cell-based therapies.

About Austrianova (SGAustria Pte. Ltd.)

Austrianova, based in Singapore, is a leading biotechnology company specializing in cell encapsulation, GMP-grade cell products, and cell line development, backed by over 50 peer-reviewed publications and partnerships with global pharmaceutical and biotech companies.

More information about Avaí Bio can be found at https://www.avaibio.com

You can also follow us on social media at:
https://x.com/AvaiBio
https://www.facebook.com/AvaiBio

Forward-Looking Statements

Certain statements contained in this press release may constitute "forward-looking statements."  Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact.  Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (http://www.sec.gov). In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company's ability to raise capital on acceptable terms, if at all, the Company's successful development of its products and the integration into its existing products and the commercial acceptance of the Company's products.  The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change.  However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.  These forward-looking statements should not be relied upon as representing the Company's views as of any date after the date of the press release.

Contact:
Avaí Bio, Inc.
info@avaibio.com

 

 

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SOURCE Avaí Bio, Inc.

FAQ

What did Avaí Bio (AVAI) announce on March 3, 2026 about α-Klotho production?

They began GMP production of a Master Cell Bank of cells overexpressing α-Klotho to support Klothonova. According to the company, this MCB is fully characterized and will serve as the primary source for working cell banks and downstream Cell-in-a-Box® manufacturing.

How does the Master Cell Bank affect Klothonova’s cell therapy manufacturing for AVAI?

The MCB provides a GMP-compliant, homogeneous foundation for scale-up and consistent manufacturing. According to the company, it safeguards against contamination and genetic instability and underpins a reliable supply chain for Cell-in-a-Box® encapsulated therapies.

What is the ownership structure of Klothonova mentioned by Avaí Bio (AVAI)?

Klothonova is equally owned by Avaí Bio and Austrianova’s affiliate, SG Austria Pte. Ltd. According to the company, the JV was established in September 2025 and is a Nevada-based entity focused on α-Klotho production.

Which therapies will use the α-Klotho Master Cell Bank developed by AVAI and partners?

The banked cells will be used to produce Cell-in-a-Box® encapsulated products for anti-aging and age-related diseases. According to the company, indications cited include Alzheimer’s and certain cancer applications as part of the α-Klotho development program.

Does Avaí Bio (AVAI) disclose timelines or financial guidance for the α-Klotho program?

No specific clinical timelines or funding amounts were provided with the announcement. According to the company, production of the MCB followed preparatory activities completed in February and supports future scale-up and supply reliability.