Positive FDA Pre-IND Feedback Announced for SVC112 Program in Advanced Solid Tumors
“We are very encouraged by the FDA’s feedback and believe this represents an important milestone in the development of SVC112,” said Antonio Jimeno, MD, PhD, CU Anschutz Professor, Medicine-Medical Oncology, and Board member of SuviCa. “The Agency’s responses support our development strategy and provide a clear regulatory path toward IND submission and initiation of our first-in-human clinical study, added Dr. Jimeno. “The innovative support network at the University of Colorado’s Boulder and Anschutz campuses has made all this possible,” said Tin Tin Su, PhD, CU Boulder Professor, lead inventor of SVC112, and co-founder of SuviCa.
Share:
More News
“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel
“The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer,” said Ben Hickey, President of RayzeBio. “The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated
“We believe these results mark a potentially important step forward in the treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer,” said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. “To address the unmet medical needs of patients and their families, we will continue working closely with
“Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies that may limit the utility in earlier lines