Avaí Bio and Austrianova Successfully Encapsulate GMP-Quality Klotho-Producing Cells, Achieve Robust Klotho Secretion
The program will next evaluate capsule expansion, long-term cell functionality and production performance through optimization studies.
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Rhea-AI Summary
Avaí Bio (AVAI) and joint venture partner Austrianova successfully encapsulated GMP-quality Klotho-producing cells in Cell-in-a-Box capsules, completing a development milestone.
Initial studies showed that the encapsulated cells remained viable and produced and secreted high levels of Klotho protein into surrounding culture media. The results provide the first confirmation that cells manufactured and banked under Austrianova’s GMP process, a manufacturing quality standard, can be incorporated into the delivery platform while maintaining biological function. Testing for adventitious agents and viruses in the Master Cell Bank was completed, and a Working Cell Bank was recently established. The program belongs to Klothonova, equally owned by Avaí Bio and Austrianova affiliate SG Austria.
Positive
- Minor pointSuccessful encapsulation completed a development milestone for the joint venture’s Klotho cell therapy program.
- Minor pointInitial studies showed encapsulated cells remained viable and produced and secreted high levels of Klotho.
- Minor pointMaster Cell Bank testing for adventitious agents and viruses was completed; a Working Cell Bank was recently established.
- Minor point. Forward-looking: it has not happened yet and may not happen.Planned expansion and optimization studies will evaluate growth characteristics, long-term functionality and production performance.
Negative
- None.
News Explained
The next disclosed phase for the joint venture’s Klotho program is capsule expansion and optimization studies, which will assess the encapsulated cells’ growth, long-term functionality and production performance under conditions designed to support future development milestones.
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LAS VEGAS, NEVADA, Sept. 30, 2026 (GLOBE NEWSWIRE) -- Avaí Bio, Inc. (OTCQB: AVAI) (“Avaí” or the “Company”), an emerging biotech developing transformative cell-based therapies for diabetes, age-related disorders, and anti-aging, together with its joint venture partner Austrianova, today announced the successful encapsulation of GMP-quality Klotho-producing cells in the joint venture’s signature technology, Cell-in-a-Box® capsules.
After the successful completion of comprehensive adventitious agent and viral testing of its GMP Master Cell Bank (MCB), from which its Working Cell Bank (WCB) was recently established, Avaí Bio and global biotech, Austrianova, have completed an important milestone in the development of the Company’s genetically modified α-Klotho-producing cell line. Initial studies have demonstrated that the encapsulated cells remain viable, produce, and secrete high levels of the Klotho protein from within the capsules into the surrounding culture media.
This is a key functional objective of the platform. These results indicate that the capsule membrane supports both long-term cell containment and effective release of the therapeutic protein.
The achievement represents a significant technical milestone for the joint venture’s Klotho cell therapy program, providing the first confirmation that Klotho-expressing cells manufactured and banked under Austrianova’s GMP process can be successfully incorporated into the Cell-in-a-Box® delivery platform while maintaining their biological function.
“Our latest results demonstrate that Klotho-producing cells from the Working Cell Bank can be successfully encapsulated and express (produce) and secrete substantial amounts of the Klotho protein following encapsulation,” said Chris Winter, Chief Executive Officer of Avaí Bio. “These findings validate a critical component of our development strategy by confirming that the therapeutic cells remain functional within the Cell-in-a-Box® capsules and can release the target protein into the surrounding environment.”
Walter H. Gunzburg, Chairman and Chief Scientific Officer of Austrianova, said, “With successful encapsulation and confirmation of Klotho secretion now achieved, the program will advance to capsule expansion and optimization studies. These activities will evaluate growth characteristics, long-term functionality, and production performance of encapsulated Klotho-producing cells under conditions designed to support future development milestones.”
This latest milestone reported by the joint venture, Klothonova, a Nevada-based company equally owned by Avaí Bio and Austrianova’s affiliate, SG Austria Pte. Ltd, place the company well on track to develop a sustainable, long term production and delivery of α-Klotho—often referred to as the “longevity protein,” a central regulatory protein that is well documented for its anti-aging and protective effects on organs—in patients using Cell-in-a-Box® encapsulated cell-based therapies.
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
More information about Austrianova can be found at https://austrianova.com
You can also follow us on social media at:
https://x.com/AvaiBio
https://Facebook.com/AvaiBio
https://YouTube.com/@AvaiBio
https://Facebook.com/Austrianova
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.
Avaí Bio, Inc. info@avaibio.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Avaí Bio’s encapsulated Klotho cell studies demonstrate?
Initial studies showed that encapsulated Klotho-producing cells remained viable and produced and secreted high levels of Klotho into surrounding culture media. This confirmed that cells manufactured and banked under Austrianova’s GMP process could retain biological function within the Cell-in-a-Box delivery platform.
What is the next development step for Avaí Bio’s Klotho cell therapy program?
The program will advance to capsule expansion and optimization studies, Austrianova said. These studies will evaluate growth characteristics, long-term functionality and production performance of encapsulated Klotho-producing cells under conditions designed to support future development milestones.