About

Our Vision and Our Mission

ANEW MEDICAL, INC. is dedicated to realizing the potential of biologic, cell and gene therapies to offer transformative patient outcomes in areas of high unmet medical need by extending the reach of protein, cell, and gene therapies to highly prevalent neurodegenerative disorders like amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease as they are universally fatal neurodegenerative diseases.

Our vision is to build a leading gene therapy company for the treatment of neurodegenerative diseases and cancer by progressing our á-Klotho gene therapy research programs and identifying, developing, and commercializing other novel gene therapy treatments and in vitro diagnostics for neurodegenerative diseases, cancer and other age-related pathologies.

We have assembled a portfolio of gene therapy candidates in partnership with leading scientific institutions and have built a team with extensive experience in the biotechnology commercialization and gene therapy space. Our team will pursue new innovations in vector design and delivery to optimize our investigational gene therapy products for safety, potency, durability, and clinical response. We plan on building integrated internal development capabilities from product development through commercialization and focus on accelerating the pace of product development in the clinic. In addition, as part of our ongoing business strategy, we continue to explore potential opportunities to acquire or license new product candidates as well as opportunities for partnership or collaboration on our existing products in development.

There are currently two licensed platform technologies managed by our team — (1) A cell therapy and gene therapy platform that uses a gene therapy approach to introduce a human gene that produces a therapeutic protein called “Klotho” inside the body to treat neurodegenerative diseases and other diseases of aging, and (2). A proprietary, patented technology platform with a library of melanocortin receptor-binding molecules.

In addition to these two platform technologies, the company has also acquired a portfolio of “generic” drugs and “biosimilar” biologics that will allow us to sell hard-to-source, difficult to find generic oncology drugs and off-patent biologic therapies.

In pursuing our mission of developing therapeutic agents based on the human á-Klotho gene, we will initially focus on the development of a diagnostic test to to measure the various isoforms and metabolic products of α-Klotho in the body fluids of humans. This will be of value to Anew both in terms of identifying suitable patients for inclusion in our future clinical trials, and also as a potential near term revenue generator.

We believe that there is currently limited competition in our pursuit of the diagnostic and therapeutic potential of the human á-Klotho gene due to our strong intellectual property position and technology know-how. Thus, our portfolio of gene therapy candidates targets a broad spectrum of indications across many age-related diseases, and potentially “aging” itself.

In summary, ANEW was founded to develop and provide disruptive new therapies to alleviate and/or reverse the progression of cancer and neurodegenerative diseases through the use of cell and gene therapy. Our goal is to develop innovative treatments for people with cancer, Alzheimer’s, Parkinson’s disease, and amyotrophic lateral sclerosis (“ALS” or “Lou Gehrig’s Disease”).

Our scientific approaches are innovative and offer the promise of significant long-lasting therapeutic effects in devastating illnesses such as ALS, Alzheimer’s, Parkinson’s and cancer.

Our α-Klotho Story

Our Key Platform Technology

Today’s biologic medicines, like antibodies and recombinant proteins, are all derived from genetic materials. The DNA (gene) known to produce a therapeutic protein is inserted into a host cell, such as a bacteria called E. coli or mammalian cells called “CHO”. The host cells then replicate and make the therapeutic protein. This is achieved using recombinant DNA technology developed in the late 1970’s and 1980’s. Biologic therapeutics are still made using this core technology.

A new era has arrived, whereby ANEW MEDICAL INC’s platform technology can introduce the genetic material directly into human cells in the body, and the patient then becomes the “factory” for protein production inside their body. This approach is called gene therapy.

ANEW MEDICAL, INC. licensed exclusive rights to develop and commercialize a key product platform technology – a human gene and protein therapy utilizing an important gene referred to as α-Klotho.

α-Klotho was named after the Greek goddess Klotho (or Clotho), the regulator of life and aging. Thus, α-Klotho is referred to as the “anti-aging” gene and protein because there is striking evidence of α-Klotho inhibiting or reversing age-related pathologies. This includes inhibiting or stopping memory loss, cognition, and other manifestations of dementia, as well as affecting neuromuscular diseases, arteriosclerosis, osteoporosis, dermal (skin) aging, sarcopenia (muscle wasting), kidney function, and cancer.

Our licensed novel gene therapy construct expresses a novel truncated protein (s+KL) with all of the activities associated with the full-length, 70 kD soluble α-Klotho protein (s-KL) and many of the properties of 130 kD transmembrane-bound α-Klotho (m-KL). It can be used as a viral-vectored product, as a lipid-complexed DNA construct, or as a recombinant protein therapeutic. Additionally, the novel gene construct can be inserted into cells from a patient, and the patient’s cells (autologous cells) can be infused back into the same patient as a cell therapy.

This website may contain forward-looking statements that involve risks, uncertainties, and assumptions. All statements other than statements of historical fact could be deemed forward-looking statements, including any projections of revenues, gross margins, earnings, or other financial items; statements regarding strategies or plans for future operations; statements concerning our products; statements relating to the expected performance or benefits of our offerings; statements about current or future economic conditions; and any other statements of expectation or belief. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements, and therefore you should not rely on any forward-looking statements that we may make.

The risks and uncertainties referred to above include, but are not limited to, our history of losses and expectations as to future losses, limited operating history, competition, management of growth, development of the market for our therapeutics, market acceptance of our products, compliance with global laws and regulations, risks associated with maintaining a global business and global economic conditions, fluctuations in our operating results, and risks associated with regulatory approvals and compliance.

Anew Medical assumes no obligation for, and does not intend to update, any forward-looking statements.