Tempo Therapeutics, Inc. has announced the dosing of the first patients in a clinical trial evaluating TT101, a novel tissue regeneration therapy based on the company's proprietary Microporous Annealed Particle (MAP) technology. The open-label, randomized, first-in-human trial, known as the MOSAIC Trial, is designed to assess the safety and potential of TT101 to regenerate tissue and reduce scarring in patients undergoing surgical removal of Basal Cell Carcinomas (BCC) or Squamous Cell Carcinomas (SCC).
TT101 represents a first-in-class, flowable, and integrative scaffold that has demonstrated promising non-immunogenic and regenerative tissue responses in preclinical studies involving soft tissue repair in large animals. The current clinical trial aims to translate these findings to humans, with a focus on evaluating TT101's ability to regrow surgically removed tissue and minimize disfiguring scars, potentially reducing the need for further interventions.
Addressing Unmet Needs in Surgical Oncology
BCCs and SCCs are common skin cancers, affecting over 5 million individuals annually in the United States alone. Surgical resection, often involving Mohs surgery, is a frequent treatment approach. However, a significant proportion of these surgeries result in complex surgical sites with exposed bone, muscle, or fascia, leading to challenging and costly recovery processes. These complications can interfere with secondary cancer therapies and negatively impact patient outcomes, particularly in immunosuppressed or immunocompromised individuals.
Tempo Therapeutics believes that TT101 and its MAP technology hold the potential to revolutionize treatment outcomes for surgical oncology patients with complex surgical sites, addressing a substantial unmet medical need for rapid tissue healing.
How MAP Technology Works
The Microporous Annealed Particle (MAP) technology is a first-in-class volumetric flowable porous scaffolding designed for regenerative medicine. It allows Tempo Therapeutics to repurpose established hydrogel polymer components, known for their safety profiles, by assembling them into a hyper-porous, flowable scaffold format. MAP-based products facilitate immediate tissue ingrowth and integration upon application.
Unlike conventional approaches, MAP technology promotes a regenerative immune response, leading to accelerated formation of vascularized tissue volume while evading the typical inflammatory and scar-forming Foreign Body Response (FBR). This unique mechanism drives tissue reformation without requiring patient inflammation, unlocking new biological pathways for building tissue inside patients without delivering cells or biologic therapy.
Leadership Perspective
"Enrolling patients in this first clinical trial is a significant milestone for Tempo representing many years of hard work and innovation in bringing the MAP technology from the bench to the bedside," said Westbrook Weaver, PhD, Tempo’s Chief Executive Officer and company co-founder. "I am immensely proud of our great team of scientists, engineers, and physicians at Tempo, as well as our investors and partners that have all come together to bring this first-in-class technology to human trials for the first time."
