Issued on behalf of Avaí Bio, Inc.

VANCOUVER, BC, March 3, 2026 /CNW/ -- USANewsGroup.com News Commentary — The global cell therapy market is projected to surpass $8.2 billion in 2026, driven by a wave of clinical breakthroughs and manufacturing milestones reshaping regenerative medicine^[1]. CAR T-cell therapy alone is valued at nearly $7 billion this year, expanding at an 18% compound annual growth rate as off-the-shelf platforms eliminate the logistical barriers that once limited patient access^[2]. Among the companies advancing next-generation cell-based treatments are Avaí Bio (OTCQB: AVAI), FibroBiologics (NASDAQ: FBLG), Fate Therapeutics (NASDAQ: FATE), Mesoblast (NASDAQ: MESO), and Longeveron (NASDAQ: LGVN).

The broader cell and gene therapy sector is forecast to surge from $10.4 billion to more than $45 billion by 2035, with North America commanding over half the global market as clinical pipelines mature and reimbursement pathways solidify^[3]. With more than 40 FDA-approved cell and gene therapy products now available and dozens more advancing through late-stage trials, institutional capital is accelerating into the companies building scalable manufacturing platforms^[4].

Avaí Bio (OTCQB: AVAI) recently announced a production milestone alongside joint venture partner Austrianova, initiating manufacturing of a Master Cell Bank (MCB) of genetically modified cells that overexpress the α-Klotho protein. These cells will enable Klothonova, the parties' joint venture, to advance its anti-aging product candidate within the ongoing α-Klotho development program.

A Master Cell Bank is a GMP-compliant, fully characterized collection of vials derived from a single clone, forming the critical starting material for scale-up and production of cell therapies. It serves as the primary source for all working cell banks, ensuring product consistency while reducing risk by safeguarding against contamination, degradation, extraneous agents, and genetic instability. Establishing a high-quality MCB under Good Manufacturing Practices positions the partners for long-term success by supporting a reliable and sustainable supply chain.

This milestone supports the joint venture'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. All preparatory activities were completed in February, enabling the partners to move directly into the production phase.

"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, CEO 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."

The banked cells will be used to produce the final Cell-in-a-Box® encapsulated cell product, intended for innovative therapies targeting age-related diseases such as Alzheimer's and cancer, while advancing anti-aging and longevity treatments. Peer-reviewed research has linked higher Klotho levels to reduced risk of neurodegenerative disease and certain cancers, drawing growing scientific interest to the protein's therapeutic potential.

Back in September, Avaí Bio and Austrianova established Klothonova as a Nevada-based entity equally owned by both companies. The JV focuses on sustainable production of α-Klotho, a key regulatory protein documented for its anti-aging and protective effects on organs, using encapsulated cell-based therapies.

Following its recent rebrand from Avant Technologies, Avaí Bio has fully pivoted to biotechnology, concentrating on sourcing, developing, and protecting advanced cellular therapies through strategic joint ventures and licensing agreements. The company's dual-program approach targets both the Insulinova diabetes program and the Klothonova α-Klotho anti-aging program, each leveraging Austrianova's proprietary Cell-in-a-Box® encapsulation technology.

CONTINUED… Read this and more news for Avaí Bio at: https://usanewsgroup.com/avai-profile/

In other industry developments:

FibroBiologics (NASDAQ: FBLG), a clinical-stage biotechnology company with more than 270 patents issued and pending, recently announced the issuance of a new U.S. patent covering fibroblast cell therapy for the treatment of osteoporosis. The patent covers methods of treating bone diseases through the administration of fibroblast cells, including modified fibroblasts designed to modulate bone remodeling by inhibiting osteoclast activity and promoting osteoblast activity.

"This patent is more than a milestone, it's a bold step forward in our mission to rethink what's possible in regenerative medicine," said Pete O'Heeron, CEO of FibroBiologics. "Osteoporosis impacts millions of lives across the globe, often quietly and profoundly. We see fibroblasts not just as cells, but as catalysts for change, with the potential to transform the way we treat bone degeneration by tackling both inflammation and the rebuilding process at its core. That's the kind of innovation that truly excites us."

The patent further strengthens the company's intellectual property portfolio in regenerative medicine and bone-related disorders. FibroBiologics is developing a pipeline of treatments using fibroblast cells and fibroblast-derived materials across multiple clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, and cancer. The Houston-based company represents the next generation of medical advancement in cell therapy and tissue regeneration.

Fate Therapeutics (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to induced pluripotent stem cell-derived off-the-shelf cellular immunotherapies, recently reported that patients in its FT819 clinical trial have been successfully treated with off-the-shelf CAR T-cell therapy as same-day hospital discharge, a milestone that eliminates the extended hospitalization requirements seen with traditional CAR T-cell programs. FT819 is enrolling across 16 clinical sites in the U.S., U.K. and E.U., with 15 systemic lupus erythematosus patients and four systemic sclerosis patients treated to date. The first systemic sclerosis patient reaching the three-month evaluation timepoint showed meaningful disease improvement using less-intensive conditioning chemotherapy.

"I am extremely proud of the progress the Fate team delivered in 2025, including bringing to fruition the treatment of FT819 off-the-shelf CAR T cells as outpatient therapy, eliminating the need for extended hospital stay requirements seen today with other CAR T-cell programs, which now uniquely expands autoimmune patient access, including in underserved regions, while significantly improving health system economics," said Bob Valamehr, CEO of Fate Therapeutics. "We have a well-capitalized balance sheet ensuring runway through 2027 and believe we are uniquely positioned to drive long-term value creation."

The company ended fiscal 2025 with $205 million in cash and investments, projecting operating runway through year-end 2027. Fate Therapeutics expects to commence its first planned Phase 2 clinical trial in lupus nephritis while actively expanding clinical site activation and patient enrollment across multiple autoimmune indications, including systemic sclerosis, vasculitis, and inflammatory myositis.

Mesoblast (NASDAQ: MESO), a global leader in allogeneic cellular medicines for inflammatory diseases, recently presented data showing that Ryoncil® achieved similarly high survival outcomes in steroid-refractory acute graft-versus-host disease regardless of whether used in children or adults, and whether as second or third line treatment. The results, presented at the Tandem Meetings of the American Society for Transplantation and Cellular Therapy in Salt Lake City, demonstrated that adult patients treated under the Emergency Investigational New Drug program had at least as favorable day-100 survival as pediatric patients.

"Treatment initiation as early as possible is essential in order to give Ryoncil® the best chance to save as many precious lives as possible," said Dr. Silviu Itescu, CEO of Mesoblast. "The Phase 3 trial in adults with SR-aGvHD will position Ryoncil® as the earliest treatment regimen for severe disease after steroid resistance."

Ryoncil® is the first mesenchymal stromal cell product approved by the FDA for any indication. Mesoblast plans to commence enrollment this quarter in a pivotal trial of early second-line Ryoncil® in adults with severe SR-aGvHD, targeting a population approximately three times the size of the pediatric market. The company holds over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions, manufacturing methods, and indications.

Longeveron (NASDAQ: LGVN) recently announced that results of its Phase 2b clinical trial were published in Cell Stem Cell, demonstrating that intravenous laromestrocel improved the physical condition of patients with age-related frailty after nine months compared to placebo. The randomized trial of 148 ambulatory individuals showed clinically meaningful, dose-dependent increases in the six-minute walk test, the primary endpoint.

"We are highly encouraged by these Phase 2b results that demonstrate the potential of stem cell therapy to improve the condition of patients with aging-related frailty," said Joshua M. Hare, MD, Chief Science Officer at Longeveron. "Those with Aging Frailty are disproportionately compromised in their ability to cope with every day and acute stressors, are at high vulnerability to disease and injury, and are at increased risk for poor outcomes and death after surgery. This development area is at the core of Longeveron's mission – advancing stem cell therapies addressing life threatening conditions in the most vulnerable populations - children and the elderly."

Patients receiving laromestrocel showed a 63.4-meter improvement in six-minute walk distance at nine months. Longeveron is developing regenerative cell therapy for life-threatening rare pediatric and chronic aging-related conditions, with programs spanning hypoplastic left heart syndrome, Alzheimer's disease, and pediatric dilated cardiomyopathy. Laromestrocel has received five FDA designations across its pipeline, including Orphan Drug, Fast Track, Rare Pediatric Disease, and Regenerative Medicine Advanced Therapy.

Article Source: usanewsgroup.com

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SOURCES:

1. https://straitsresearch.com/report/cell-therapy-market
2. https://www.grandviewresearch.com/industry-analysis/car-t-cell-therapy-market-report
3. https://www.precedenceresearch.com/cell-and-gene-therapy-market
4. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products

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