Rice's Biotech Launch Pad to commercialize bioelectrical implant for obesity, type 2 diabetes

Rice University, in collaboration with a research team from several universities, has received a grant of up to $34.9 million from the Advanced Research Projects Agency for Health (ARPA-H). This funding is aimed at accelerating the development of an innovative bioelectronic implant designed to improve adherence to treatment for obesity and type 2 diabetes (T2D) while also reducing manufacturing costs.

The project, named "Rx On-site Generation Using Electronics" (ROGUE), is being spearheaded by Rice University's Biotech Launch Pad for commercialization. ROGUE is a self-contained and durable implantable device housing engineered cells that produce therapies for T2D and obesity based on the patient's physiological needs. The device aims to significantly lower the costs associated with biologics-based treatments, targeting a cost of goods below $1,000 for at least a year of therapy.

Carnegie Mellon University is leading the team of researchers working on the accelerated development and testing of ROGUE. The implant operates as a "living pharmacy," making biologic drugs accessible in the body on demand, supported by closed-loop bioelectronics that monitor and adjust drug production and dosing. This technology is designed for easy deployment via a minimally invasive procedure in an outpatient setting and will be recharged weekly or less frequently using a wearable device, eliminating the need for frequent medication management.

Omid Veiseh, professor of bioengineering at Rice University, emphasized the transformative potential of ROGUE's innovative design, combining efficient biological manufacturing with long-term durability and patient-friendly features. Paul Wotton, executive director of the Rice accelerator, will oversee the project to ensure its transition from research to clinical application and eventually to an independent company.

The project team has previously received over $100 million in support for two other "living pharmacy" projects — THOR and NTRAIN — from ARPA-H and the Defense Advanced Research Projects Agency (DARPA). The substantial backing for these projects highlights their transformative potential, as emphasized by Paul Wotton.

Paul Cherukuri, Rice's vice president for innovation, expressed excitement about the strong support from ARPA-H for accelerating breakthrough bioelectronic technology from the bench to the bedside. Tzahi Cohen-Karni, a primary investigator from Carnegie Mellon, highlighted ROGUE's revolutionary bioelectronic integration for biologics production, which allows for on-demand therapeutic production in an energy-efficient manner, thereby simplifying medication delivery and enhancing patient adherence.

Jonathan Rivnay, a professor at Northwestern University, mentioned that biologics, including antibodies, hormones, growth factors, and cytokines, are generally expensive and contribute significantly to healthcare costs. ROGUE's ability to produce glucagon-like peptide 1 receptor agonist (GLP-1 RA) on site aims to address these high costs and improve patient adherence by eliminating the need for frequent injections. GLP-1 RAs are effective in enhancing insulin secretion, reducing glucose levels, and promoting significant weight loss, making them a first-line therapy for diabetes and obesity.

The collaborative efforts of multiple institutions, including Rice, Carnegie Mellon, Northwestern, Boston University, Georgia Institute of Technology, University of California Berkeley, the Mayo Clinic, and Bruder Consulting and Venture Group, are paving the way for ROGUE to become a revolutionary force in biologics. This technology offers a sustainable, long-term solution for managing chronic diseases, addressing the limitations of current biologics.

Proper preparation for the first-in-human clinical trial for patients with obesity and T2D is scheduled to begin in the fifth year of the six-year project. Rice's co-principal investigators include Jacob Robinson, who leads integration efforts, and Oleg Igoshin, who oversees pharmacokinetics and pharmacodynamics modeling.

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