The Advanced Research Projects Agency for Health (ARPA-H), part of the U.S. Department of Health and Human Services, has announced up to $37 million to restore function to the thymus through funding to the biotechnology company, Thymmune Therapeutics.

“We’re thrilled to announce this recent support from ARPA-H. This funding will empower us to reshape drug development by harnessing cutting-edge advancements in thymus biology, iPSC technology, and machine learning,” said Stan Wang, MD, PhD, founder & CEO of Thymmune. “Drawing from decades of dedicated research on the thymus gland, our approach has the potential to revolutionize immunology through the creation of innovative therapies for patients in need with a range of immune system disorders.”

Thymmune is developing a machine learning-enabled thymic cell engineering platform to restore normal immune function in aging and disease. The Cambridge, MA-based company uses iPSC-thymic cell manufacturing to generate off-the-shelf cells at scale. It is developing a pipeline of therapies to treat immunodeficiencies, transplant related, and autoimmune diseases.

The thymus is not only responsible for supporting normal immune cell development, but may also potentially restore immune system function as people age. More than 10,000 new patients are diagnosed each year with a thymus disorder, often related to congenital defects or cancer treatments. More broadly, thymus function naturally declines with age, which can contribute to poorer immune system function, and lead to increased vulnerability to illness and poorer health outcomes.

The thymus is a critical organ in the immune system that regulates and develops T cells, which are essential for fighting infection and disease, along with mounting effective responses to vaccines. As part of the natural aging process, the functional thymus begins to shrink and its ability to produce naïve T cells decreases, leading to immune dysfunction and disease. For children born without a thymus, those with thymus defects, and elderly patients with failing immune function, restoring thymus function could be a game changer in their health and quality of life.

Thymmune Therapeutics is developing scalable thymic cell therapies to restore immune function in aging and disease through the Thymus Rejuvenation project which aims to restore damaged or non-functional thymus tissue. The Thymus Rejuvenation project is divided into two phases. The goal of the first phase is to make best-in-class human induced pluripotent stem cell-derived thymic epithelial cells (iPS-TECs) to restore T-cell development in thymic deficient animals, and slow immune decline in animal models of aging. In the second phase, Thymmune plans to scale up the production of iPS-TECs for transplantation and engraftment in animal models to achieve effective immune function, demonstrating a clinical pathway to treat patients lacking a functional thymus.

“For children born without a thymus, those with thymus defects, and elderly patients with failing immune function, restoring thymus function could be a game changer in their health and quality of life,” explained Amy Jenkins, PhD, director of the ARPA-H Health Science Futures office. “ARPA-H looks to support cutting-edge technologies like this one that, if successful, could have applications beyond just one disease.”

Thymmune’s disease-agnostic approach to combat thymus dysfunction by bolstering immune responses against pathogens, cancer, and vaccines presents a potentially revolutionary means to reboot immunity. Thymmune has the potential to rescue patients lacking a functional thymus from morbidity and mortality and address a crucial unmet need to rejuvenate immunity in the aging population.

This is the first industry project funded by the ARPA-H Open Broad Agency Announcement (Open BAA) which seeks transformative ideas for health research or technology breakthroughs. Continued support of each award is contingent on projects meeting aggressive milestones. The Open BAA began accepting abstracts in March 2023 and is open until March 2024. Future projects will be funded on a rolling basis.

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