FDA clearance granted to begin SVV-001 Ph 1/2 trial

  • FDA clearance granted to begin a Phase I/II clinical study utilizing Seneca Valley Virus (“SVV-001”) in combination with a checkpoint inhibitor.
  • This Phase I/II study with SVV-001 is in patients that are TEM8 positive and SVV-001 permissive with neuroendocrine tumors or neuroendocrine carcinomas.
  • The study should begin enrollment early in 2023.

Share:

More News

“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is

“We are thrilled about this second collaboration with Genentech, which expands our collaborative efforts in applying induced proximity concepts to include molecular glue types beyond targeted protein degraders,” said Niko Kley, Co-Founder and CEO of Orionis Biosciences. “The expansion of our existing strategic alliance underlines a strong alignment in vision

“Dosing the first patient in the TNG456 Phase 1/2 trial marks a significant step for us and for patients with MTAP-deleted GBM,” said Adam Crystal, M.D., Ph.D., President, Research and Development of Tango Therapeutics. “People with GBM currently have few treatment options and a five-year survival rate below 10%. 45%

“The ASCENT-03 outcome represents the first clinically meaningful advance for this patient population in over 20 years versus chemotherapy,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “By addressing this aggressive and difficult to treat disease earlier, we can potentially improve treatment options for the high unmet need