Avaí Bio clears cell bank safety testing for Klotho therapy
Avaí Bio and its joint venture partner Austrianova have completed adventitious agent and viral testing of their GMP Master Cell Bank, confirming it is free of contamination ahead of the next manufacturing phase for an encapsulated cell therapy designed to deliver the longevity-associated protein α-Klotho.
The testing, conducted by an accredited third-party laboratory in line with FDA guidelines, screened for more than 30 viruses including HIV, simian immunodeficiency virus, human cytomegalovirus, and hepatitis B and C. It also confirmed the absence of bacteria, mycoplasma, fungi, and yeast. A Working Cell Bank has since been established from the same Master Cell Bank.
What the milestone means
The confirmation clears a prerequisite for advancing the programme toward clinical development. Under GMP manufacturing rules, cell banks used in biologics and cell-based products must be characterised and shown to be free of adventitious agents before they can be used to produce material for human trials. Passing this stage does not itself constitute regulatory approval or a trial filing, but it is a necessary box to check before an IND application can be submitted.
The cell line, in-licensed from Klothea Bio, has been genetically modified to overexpress α-Klotho, a protein with a documented role in healthy ageing and organ protection. The joint venture vehicle, Klothonova, was incorporated in Nevada in September 2025 and is equally owned by Avaí Bio and Austrianova's affiliate SG Austria Pte. Ltd. Klothonova will now focus on characterising the cells further and establishing optimal production parameters for the Cell-in-a-Box encapsulated format, a proprietary platform owned by Austrianova.
Austrianova chief executive Brian Salmons said: "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."
Market and competitive context
The α-Klotho space sits within a broader and growing field of longevity biology, where a number of academic groups and early-stage companies are exploring protein supplementation, gene delivery, and cell-based approaches to raise circulating Klotho levels. The protein's association with kidney function, bone metabolism, and cognitive protection has attracted significant research interest, though no α-Klotho product has yet reached late-stage clinical trials. Cell encapsulation as a delivery mechanism is also being explored in other metabolic and endocrine disease settings, including islet-cell approaches to insulin replacement in diabetes.
Avaí Bio trades on the OTCQB market and describes itself as an emerging company working primarily through joint venture and licensing structures. The programme remains at a preclinical characterisation stage, and investors will be watching for an IND timeline and a named clinical indication as the next meaningful milestones. The company has previously stated broader ambitions in diabetes and age-related disorders, but the Klothonova venture is its most publicly advanced programme at present.