Genprex, Inc.a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced its intention to transfer the Company’s diabetes clinical development program and its diabetes gene therapy assets into a new, wholly-owned subsidiary. NewCo would focus on developing and commercializing GPX-002, a diabetes gene therapy drug candidate for the treatment of Type 1 (T1D) and Type 2 diabetes (T2D).

“Genprex’s diabetes program has received the attention of several potential investors, partners, collaborators and pharmaceutical companies, and we believe separating it from our oncology programs could help increase interest, expedite clinical development and unlock the value of our novel diabetes program,” said Ryan Confer, President and Chief Executive Officer at Genprex. “The new subsidiary would be positioned to be a pure-play diabetes-focused biopharmaceutical company, while Genprex would be a pure-play oncology-focused biopharmaceutical company. This contemplated separation of entities could enable potential direct investment and strategic collaboration into the advancement of the diabetes program. Diabetic patients are in need of advanced therapies, and we believe GPX-002 holds the potential for disease modification for long-term effectiveness, which could directly impact the global diabetes epidemic.”

The planned spin-out transaction would allow both Genprex and NewCo to enhance each company’s focus on meeting the needs of their respective markets, patients and stakeholders. The spin-out, if completed as presently contemplated, would result in NewCo focusing on developing GPX-002, while Genprex would retain its oncology clinical development programs and other oncology pipeline assets. The decision to pursue the reorganization demonstrates Genprex’s strong ongoing commitment to the Company’s streamlined, focused strategies and ongoing research and development prioritization initiative.  The potential formation and transfer of the clinical development program into the wholly-owned subsidiary is currently anticipated to occur by the end of 2024, subject to adequate financing, the satisfaction of customary conditions and final approval from the Genprex management and Board of Directors.

The Company’s goal for separating the diabetes clinical development program from its oncology program follows closely behind Genprex’s recent announcement to re-focus its oncology clinical development program for streamlined, expeditious regulatory submission of its lead oncology drug candidate, Reqorsa® Gene Therapy.  As previously announced, the Company continues to evaluate ways to optimize its clinical and research programs and operational strategies.  Additionally, the Company is considering various strategic alternatives and opportunities to enhance stockholder value.

GPX-002, which has been exclusively licensed from the University of Pittsburgh, is being developed using the same construct for the treatment of both T1D and T2D. The same general novel approach is used in each of T1D and T2D whereby an adeno-associated virus (AAV) vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. The diabetes product candidates are currently being evaluated and optimized in preclinical studies at the University of Pittsburgh.

“With the potential to address the entire diabetes market, we believe our gene therapy approach would position NewCo as an innovator in emerging diabetes therapies,” continued Confer. “The most significant advancement in the treatment of diabetes happened more than 100 years ago when insulin was first introduced to treat T1D patients. We believe our treatment has the potential to disrupt the diabetes market by replacing the daily burden of blood glucose monitoring and insulin replacement therapy, as well as the need for GLP-1 treatments in T2D.”

GPX-002 and Diabetes 

In T1D, GPX-002 is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In vivo, preclinical studies show that GPX-002 restored normal blood glucose levels for an extended period of time.

In February 2023, research collaborators at the University of Pittsburgh presented preclinical data in a NHP model of Type 1 diabetes highlighting the therapeutic potential of GPX-002 at the 16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023) in Berlin, Germany. 

The statistically significant study results showed the treated animals had:

• Decreased insulin requirements
• Increased c-peptide levels
• Improved glucose tolerance compared to baseline

In April 2023, Genprex hosted a Key Opinion Leader virtual event entitled “Novel Gene Therapy to Treat Type 1 Diabetes,” which discussed preclinical data reported at ATTD 2023 supporting gene therapy to treat T1D. Watch the KOL event here.

In a similar approach for T2D, GPX-002 (formerly known as GPX-003), where autoimmunity is not at play, is believed to work by replenishing and rejuvenating exhausted beta cells that make insulin.

According to the U.S. Center for Disease Control as of 2024, 38.4 million Americans, or approximately 11.6% of the U.S. population, have diabetes. It is also believed that more than 97 million Americans aged 18 years or older have prediabetes. In 2021, approximately 537 million adults (20-79 years) worldwide were living with diabetes, and the total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million in 2045. Also in 2021, diabetes caused more than 6.7 million deaths globally and diabetes resulted in approximately $966 billion dollars in health expenditures, a 316% increase over the preceding fifteen years.

 

Source: genprex.com

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