Invictus Therapeutics and Breakthrough T1D Announce Collaboration to Support First-in-Human Trial of Next-Generation Insulin Analog

Breakthrough T1D award will fund project to advance fully automated insulin delivery

WARWICK, R.I., Jan. 12, 2026 /PRNewswire/ -- Invictus Therapeutics, a biotechnology company developing next-generation insulin analogs engineered for automated insulin delivery systems, today announced it has received an Industry Discovery and Development Partnership (IDDP) award from Breakthrough T1D (formerly JDRF), the leading global type 1 diabetes (T1D) research and advocacy organization.

The milestone-based IDDP funding will support Invictus's first-in-human clinical trial of its lead investigational insulin analog — a room-temperature stable, ultra-rapid insulin designed to more closely replicate physiological insulin kinetics and potentially enhance performance in pump- and algorithm-driven systems. This collaboration aligns with Breakthrough T1D's goal of advancing automated insulin delivery systems that do not require user attention at meals.

"We are thrilled to announce our award from Breakthrough T1D as we make this important step into the clinic," said Robyn Day, Founder and CEO of Invictus Therapeutics. "Current rapid-acting insulins remain a rate-limiting step for advanced pump and closed-loop systems. Our goal is to deliver an ultra-rapid, heat-resistant insulin analog that performs reliably within automated insulin delivery platforms and helps people achieve better glucose control with less daily burden."

First-in-Human Study to Be Conducted at Profil, Germany

The Phase 1 First-in-human study will be conducted at Profil, Germany, a world-leading clinical research organization specializing in early-phase metabolic and diabetes studies. Profil is internationally recognized for its expertise in glucose-clamp methodology, pump-based insulin evaluations, and automated insulin delivery research, making it an ideal partner for assessing next-generation insulins.

"Faster insulins can help enable automated insulin delivery systems that achieve superior clinical outcomes with minimal user engagement," said Amin Ghavami-Nejad, PhD, Senior Scientist at Breakthrough T1D. "This novel ultra-rapid insulin has the potential to improve both glucose control and quality of life for people with T1D."

Addressing Key Barriers in Automated Insulin Delivery

Invictus's investigational analog is designed to combine:

• Ultra-rapid onset and offset to better mimic physiologic insulin action
• Room-temperature stability to reduce cold-chain burdens for patients and device manufacturers
• High-concentration formulations optimized for pump efficiency and extended wear

By targeting these limitations, Invictus aims to improve performance of current and next-generation automated insulin delivery systems.

"This partnership with Breakthrough T1D enables us to bring our technology into the clinic with the speed and rigor it deserves," added Day. "We share a vision of a simpler, safer, more reliable future for people using closed-loop systems — and we believe purpose-built insulin chemistry is an essential piece of achieving that."

About the Invictus Therapeutics / Breakthrough T1D Collaboration

Under the IDDP agreement, Breakthrough T1D's funding will support manufacturing, regulatory readiness, and clinical execution of the Invictus first-in-human trial. The IDDP program accelerates industry-led development efforts that align with Breakthrough T1D's research priorities by combining nonprofit capital and scientific expertise with partners advancing transformative therapies for T1D.

About Invictus Therapeutics

Invictus Therapeutics is a privately held biotechnology company developing next-generation insulin analogs purpose-built for pump therapy and automated insulin delivery systems. These insulins build on foundational research from the lab of Michael A. Weiss, MD, PhD, MBA, a world leading expert in insulin biophysics. The company's lead investigational candidate is a temperature-stable, ultra-rapid insulin analog designed to offer faster, more predictable glucose control and seamless integration with advanced diabetes technologies. Invictus aims to redefine the performance standard for insulin in closed-loop systems and help accelerate the path to fully automated care.

For more information, please visit www.invictustx.com.

About Breakthrough T1D

As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition.

Media Contacts

Invictus Therapeutics
[email protected]

Breakthrough T1D
Casey Fielder
[email protected]

SOURCE Invictus Therapeutics, LLC