Throne Biotechnologies: Exemplary Treatment Approach to Type 1 Diabetes, Alopecia, and Other Autoimmune Diseases

Throne Biotechnologies (Throne) is a clinical-stage therapeutics company with disruptive stem cell technology. The technology can reverse autoimmune diseases like type 1 diabetes (T1D). alopecia areata (AA), and others through immune education of Stem Cell Educator therapy.

In 2011, Throne was established by Dr. Yong Zhao (CEO and Founder), an assistant professor at the University of Illinois at Chicago (UIC). As a formal physician, immunologist, and inventor of Stem Cell Educator technologies, Dr. Zhao was greatly excited about his new discovery of cord blood stem cells (CB-SC). These ethically derived stem cells are more powerful than any other previously discovered multi-potent stem cells due to their “immune educating abilities”. CB-SC have the capability to restore autoimmunity and completely eliminate the requirement for stem cell genetic matching because of their low immunogenicity. After overcoming the financial hurdles, he developed the Stem Cell Educator therapy through many international multicenter clinical trials.

Over the last 10 years, Throne’s international multicenter clinical trials in Spain, China, and the United States have strongly demonstrated the clinical safety and efficacy of Educator therapy in more than 200 patients aged from 3 to 70 years old. Currently, Throne has received two FDA-approved phases 2 INDs for using Educator therapy to treat T1D and AA patients. The company’s globally patented technology is recognized as the leading “Practical Cure Project” for T1D out of 590 global projects (Juvenile Diabetes Cure Alliance (JDCA) 2021, New York). Additionally, Throne anticipates the commercialization of Educator therapy in the next few years.

Innovative Treatment Approach to Autoimmune Diseases

Currently, Throne is developing Stem Cell Educator therapy to treat T1D and other autoimmune or inflammation-associated diseases. To address the key issues such as autoimmunity and shortage of islet beta cells in T1D, the company has developed a unique and novel procedure, called the Stem Cell Educator therapy (Educator therapy) which is based on the immune education by cord-blood-derived stem cells (CB-SC). Using the patented technology, a patient’s blood is circulated through a blood cell separator, where the immune cells are co-cultured with adherent CB-SC in vitro, and return “educated” immune cells to the patient’s circulation.

Over the past years, Throne’s technology has been evaluated through international multi-center clinical studies, where it has demonstrated the clinical efficacy and safety of Educator Therapy. Moreover, Educator therapy is the only therapy to date to safely and efficiently correct autoimmunity and restore beta-cell function in T1D patients.

Guided by Ingenious Innovator

At the forefront of Throne, Dr. Yong Zhao is the inventor of the Stem Cell Educator therapy. From the discovery of cord blood-derived stem cells from human cord blood in 2005 to international multi-center clinical trials in the United States, China, and Spain and FDA Approvals in 2019, Dr. Zhao has robustly spearheaded every development stage of the company.

During this journey, he and his team overcame various issues such as funding support and regulatory approval, to become one of the few innovative immune therapies that have made it to phase 2 of FDA approval.

The ‘Throne Business Model’

Marketing is fundamental for the growth and success of every organization. With that said, Throne’s business model will successfully market its disruptive technology worldwide. Unlike the traditional model for drug marketing where a product is distributed through established channels, delivery of Educator Therapy will require the establishment of multiple treatment centers around the world through the Throne Business Model. The Throne Business Model combines an apheresis/infusion facility with a GMP production/treatment facility.

Currently, the Throne GMP facility (Paramus, NJ) is applying for the FACT (Foundation for the Accreditation of Cellular Therapy) accreditation, which establishes standards for Throne to accomplish the high-quality medical and laboratory practice in cellular therapies. In the next few years, the Throne GMP facility is planned to commence, and the company anticipates major expansion of the Throne business.

Seeking Future Proliferations

Throne has currently received two US FDA approvals for phase 2 clinical trials by using Stem Cell Educator therapy. Through this, the company is seeking treat the following ailments in collaboration with the following respective universities:

T1D (IND 019247) with Hackensack University Medical Center (Hackensack, NJ)
Alopecia areata (IND 019246) at Yale University School of Medicine (New Haven, CT).

Currently, the company is pursuing two key milestones. Firstly, Throne is aiming to set up the Throne Infusion Center which can offer the Stem Cell Educator therapy for patients with type 1 diabetes and other autoimmune diseases. Secondly, Throne is anticipating to begin the clinical trial of Stem Cell Educator therapy to treat patients with type 1 diabetes and alopecia areata.

About the Leader:

Dr. Yong Zhao is an internationally acclaimed scientist and doctor who specializes in immunology and stem cell biology. He is the first scientist to discover the CB-SC stem cells from human cord blood and is the inventor of Stem Cell Educator therapy to treat type 1 diabetes and other autoimmune diseases. He has held scientist and professorship positions at Hackensack Meridian Health and the University of Illinois at Chicago.

Dr. Zhao holds 9 patents and 60 publications and received his post-doctoral training from the University of Chicago. He has been featured on CNN, USA Today, CBS, and additional major international news networks. As a former physician, he aims to bring non-invasive and sustainable cures to people with type 1 diabetes, autoimmune diseases, and other life-threatening diseases.