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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Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.
“Many solid tumors remain difficult to treat despite advances in immunotherapy,” said Rustam Esanov, CEO and co-founder of Reprogram Biosciences. “Our approach is differentiated by its reprogramming of the tumor itself into a site of immune activation, rather than relying on exogenous immune cells or broadly acting systemic agents.”
Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, today announced that the first patient has been dosed in a Phase III clinical trial evaluating its novel Nectin-4-targeting ADC (Bulumtatug Fuvedotin, or BFv, R&D code: 9MW2821) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).