Avaí Bio and Austrianova Complete Adventitious Agent Testing of Master Cell Bank, Establish Working Cell Bank for α-Klotho Anti-Aging Therapy
Completion of clean safety testing on Avaí Bio’s α‑Klotho cell banks clears the way for Klothonova to advance process development toward clinical products.
Rhea-AI Summary
Avaí Bio (AVAI) and joint venture partner Austrianova completed comprehensive adventitious agent and viral testing of Avaí’s GMP Master Cell Bank (MCB) and established a Working Cell Bank (WCB) for its genetically modified α‑Klotho‑producing cell line.
The accredited third‑party lab found the MCB and WCB free of more than 30 tested human and animal viruses, including HIV, SIV, HCMV, and hepatitis B and C, as well as bacteria, mycoplasma, fungi, and yeast, following applicable FDA and industry guidelines. These cells, in‑licensed from Klothea Bio and engineered to overexpress α‑Klotho, underpin an anti‑aging and age‑related disease program.
Klothonova, the 50/50 Nevada‑based joint venture between Avaí Bio and SG Austria’s affiliate, is now progressing further cell characterization and process development for a Cell‑in‑a‑Box® encapsulated clinical product aimed at healthy aging and longevity therapies.
Positive
- Comprehensive safety testing completed on MCB and WCB, covering 30+ viruses and multiple contaminants
- All tested viruses and contaminants reported negative, supporting safety and quality of the α‑Klotho cell banks
- Working Cell Bank established, enabling process development for Cell‑in‑a‑Box® encapsulated products
- Joint venture structure in place via Klothonova, equally owned by Avaí Bio and SG Austria affiliate
Negative
- None.
AI-generated analysis. How Rhea-AI works. Not financial advice.
LAS VEGAS, NV, Sept. 15, 2026 (GLOBE NEWSWIRE) -- 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 company Austrianova, 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. With the testing completed and the WCB now successfully established, Avaí Bio and Austrianova have completed an important milestone in the development of the Company’s genetically modified α-Klotho-producing cell line.
The testing confirmed that the MCB, and in turn, the WCB are free of a broad range of potentially contaminating viruses and other adventitious agents. The testing included more than 30 viruses, including significant human and animal pathogens such as human immunodeficiency virus (HIV), simian immunodeficiency virus (SIV), human cytomegalovirus (HCMV), and hepatitis B and C viruses. Additional testing confirmed the absence of other potential contaminants, including bacteria, mycoplasma, fungi, and yeast.
The testing was conducted by an experienced, accredited third-party laboratory in accordance with applicable industry guidelines, including those established by the U.S. Food and Drug Administration (FDA).
The completion of this testing represents an important step in the development and characterization of the Company’s α-Klotho-producing cell line. The cells, which were in-licensed from Klothea Bio, have been genetically modified to overexpress α-Klotho, a protein associated with healthy aging and protection against age-related disease.
Klothonova, the joint venture company formed by Avaí Bio and Austrianova, is now focused on further characterization of the Klotho-producing cells and on using the WCB to establish optimal production parameters for the development of the Cell-in-a-Box® encapsulated cell product.
“We are pleased to announce the successful completion of this important testing milestone,” said Chris Winter, Chief Executive Officer of Avaí Bio. “The results provide additional confirmation of the safety and quality of our Master and Working Cell Banks and allow us, together with our partner, to advance the next stages of development. We remain focused on progressing toward our goal of developing long-term, safe and effective cell-based therapies for healthy aging and longevity.”
Dr. Brian Salmons, Chief Executive Officer of Austrianova, added, “Comprehensive testing of cell banks for viruses and other adventitious agents is an essential component of biomanufacturing and an important prerequisite for advancing cell-based products toward clinical development. We are pleased that the independently conducted testing confirmed that the MCB, and by default, the WCB were negative for all viruses included in the testing panel. With this milestone completed, we are advancing toward the next steps in the development and production of the Cell-in-a-Box® encapsulated clinical product.”
This latest milestone follows the joint venture agreement signed in September 2025, which established Klothonova as a Nevada-based company equally owned by Avaí Bio and Austrianova’s affiliate, SG Austria Pte. Ltd. The joint venture was established to develop a sustainable approach to the production and delivery of α-Klotho—often referred to as the “longevity protein,” a key 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://www.facebook.com/AvaiBio
https://www.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 types of agents were the α‑Klotho cell banks tested for?
The Master Cell Bank and, by extension, the Working Cell Bank were tested for more than 30 human and animal viruses, including HIV, SIV, HCMV, and hepatitis B and C. Additional assays confirmed the absence of bacteria, mycoplasma, fungi, and yeast, using methods aligned with applicable FDA and industry guidelines.
Who conducted the testing on Avaí Bio’s Master Cell Bank?
The adventitious agent and viral testing was carried out by an experienced, accredited third‑party laboratory operating in accordance with applicable industry guidelines, including those established by the U.S. Food and Drug Administration.
What is Klothonova and how is it owned?
Klothonova is a Nevada‑based joint venture formed in September 2025 to develop α‑Klotho‑based therapies using Cell‑in‑a‑Box® encapsulation. It is equally owned by Avaí Bio and Austrianova’s affiliate, SG Austria Pte. Ltd.
What are the next development steps after establishing the Working Cell Bank?
With the Working Cell Bank established and testing completed, Klothonova is focusing on further characterization of the α‑Klotho‑producing cells and on using the WCB to define optimal production parameters for the Cell‑in‑a‑Box® encapsulated clinical product.