Klotho Neurosciences initiates manufacturing of gene therapy candidate

NEW YORK - Klotho Neurosciences, Inc. (NASDAQ:KLTO), a $44 million market cap biotech company whose shares have surged 144% over the past six months according to InvestingPro data, has signed a binding agreement to begin manufacturing and development of its KLTO-202 gene therapy candidate using AAVnerGene Inc.’s platform technology, according to a press release statement issued Tuesday.

The agreement leverages AAVnerGene’s "AAVone" platform technology and engineered HEK293 cell line to produce adeno-associated virus (AAV) vectors for gene delivery. This technology reportedly enables higher titer concentration, fewer impurities, and faster production compared to traditional methods.

"The initiation of manufacturing is a key milestone in the development of any biotech product, and the manufacturing of gene therapy products presents particular complications," said Dr. Joseph Sinkule, KLOTHO CEO.

The collaboration will also utilize AAVnerGene’s "ATHENA" platform technology, which creates tissue-specific targeting AAVs. This approach aims to address challenges with current AAV-vectored gene therapies that tend to target the liver and potentially cause inflammatory responses.

AAVnerGene’s one-plasmid AAV packaging system differs from the traditional "triple transfection" method that has been standard in gene therapy manufacturing for the past two decades. The company claims this simplified approach increases production efficiency while reducing impurities and development costs.

Klotho Neurosciences focuses on developing therapies using a protein derived from a patented form of the human Klotho gene. The company aims to create treatments for neurodegenerative and age-related disorders including ALS, Alzheimer’s disease, and Parkinson’s disease.

The press release did not disclose financial terms of the agreement or specific timelines for clinical development of the KLTO-202 candidate. With KLTO currently trading at $0.83 per share and showing weak financial health metrics according to InvestingPro analysis, investors seeking deeper insights into the company’s valuation and growth prospects can access over 10 additional ProTips and comprehensive financial metrics through an InvestingPro subscription.

In other recent news, Klotho Neurosciences, Inc. announced it has regained compliance with NASDAQ’s continued listing requirements, meeting both the minimum bid price and stockholders’ equity thresholds. The company also received a significant boost when the U.S. Food and Drug Administration granted Orphan Drug Designation to its KLTO-202 treatment for Amyotrophic Lateral Sclerosis (ALS), offering benefits such as tax credits and market exclusivity. Additionally, Klotho Neurosciences has entered a partnership with AAVnerGene Inc. to manufacture gene therapy candidates for neurological diseases, leveraging AAVnerGene’s expertise in virus manufacturing and targeted delivery.

In its strategic moves, Klotho is evaluating acquisitions of complementary technologies to support brain function and longevity, expanding beyond its current focus on neurodegenerative diseases. The company also terminated its Share Exchange Agreement with SkyBell Technologies, avoiding significant dilution of its shares. These developments highlight Klotho’s active engagement in strengthening its position in the biogenetics field.

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