FDA Clears IND Application for a UNITE®-Based Self-Amplifying RNA Vaccine for TNBC
“Preclinical data have demonstrated enhanced efficacy in animal models without additional safety concerns. The FDA’s clearance of our IND application for ITI-5000 marks a significant milestone for us as we advance this program into its first clinical trial,” said DG Kim, Chief Executive Officer of ITI. “This achievement reflects years of innovative research and the dedication of our scientific and technical teams, and it brings us another step closer to offering a potentially transformative therapy for patients with TNBC.”
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