On September 5, 2024 Tempo Therapeutics, Inc. ("Tempo"), a leading innovator in tissue engineering and regenerative medicine, reported the dosing of the first patients in a clinical trial of TT101 (the MOSAIC Trial), the company’s lead pipeline candidate for tissue regeneration based on its proprietary MAP technology (Press release, Tempo Therapeutics, SEP 5, 2024, View Source [SID1234646384]). TT101 is a first-in-class, flowable and integrative scaffold that has demonstrated non-immunogenic and regenerative tissue responses in large animal studies of soft tissue repair. Based on these compelling preclinical data, TT101 is now being tested in humans to evaluate safety and gather additional information on its ability to potentially regrow large volumes of surgically removed tissue while allowing patients to avoid the formation of disfiguring scars that currently require further intervention.
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"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."
The open label, randomized, first-in-human trial is evaluating the safety of TT101 when applied to acute surgical oncology resection sites in the skin after the resection of Basal Cell Carcinomas (BCC) or Squamous Cell Carcinomas (SCC), frequently addressed with Mohs surgery. BCCs and SCCs affect over 5 million patients every year in the United States alone. A significant number of these patients require surgical resection that exposes bone, muscle, or fascia. The recovery of these surgical sites is challenging, costly, and requires continued intervention that can interfere with secondary cancer therapy and negatively affect patient outcomes, especially in those patients also undergoing immunosuppressive treatments or in an immunocompromised state. The Company believes that TT101 and MAP technology have the potential to revolutionize treatment outcomes for surgical oncology patients with complex surgical sites, addressing a large unmet medical need for rapid tissue healing in complex surgical sites.
About MAP Technology:
The Microporous Annealed Particle (MAP) technology is a first-in-class volumetric flowable porous scaffolding for regenerative medicine. The MAP technology enables Tempo to repurpose established hydrogel polymer components with strong safety profiles by assembling them into a hyper-porous, flowable scaffold format. MAP-based products immediately allow tissue ingrowth and integration upon application. Tissue implants using MAP technology are able to evade the typical inflammatory and scar-forming Foreign Body Response (FBR) and instead promote a regenerative immune response that leads to accelerated formation of vascularized tissue volume. Unlike normal biology and current available products, MAP drives tissue reformation without requiring patient inflammation, unlocking new biological pathways for building tissue inside patients without delivering cells or biologic therapy.