IND application amended with updated OS data from Ph 2 Actuate-1801 Part 3B trial of elraglusib + GnP versus GnP alone in 1L metastatic pancreatic cancer
“We are confident that our recently completed financing provides sufficient capital to support our corporate initiatives into the second half of 2026, and well through our upcoming anticipated interactions with the FDA and EMA. We have already updated the clinical data package on file with the FDA, and during the remainder of this year and into the first quarter of 2026, we expect to gain clarity on elraglusib’s regulatory path forward for the first-line treatment of metastatic PDAC,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “The survival benefit we’ve observed with elraglusib to date is compelling, and both its mechanism of action and safety profile support combination with chemotherapy, immunotherapy and potentially RAS inhibitors, increasing elraglusib’s potential as a backbone therapy, specifically in pancreatic cancers, where clinicians have limited options to extend and improve the lives of patients.”
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“We are pleased to evaluate the clinical combination of IDE892 with RG6505 in MTAP-deleted RAS-mutant PDAC,” said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. “This collaboration aligns with our broader clinical strategy to evaluate rational combinations with assets in our MTAP-deletion portfolio, and there remains especially high
“In the first reported data from the clinical combinations of our PRMT5 inhibitor vopimetostat and RAS(ON) inhibitors, we saw extremely encouraging early results, with 92% of patients with PDAC in the vopimetostat plus daraxonrasib arm achieving an objective response, supporting the preclinical data showing synergistic activity of PRMT5 + RAS
“Non-small cell lung cancer is the most prevalent lung disease with more than 8,000 patients in the U.S. diagnosed each year with KRAS G12D-mutations. Receiving Fast Track designation for VS-7375 reinforces both the significant unmet need and the potential of VS-7375 to improve outcomes for patients with KRAS G12D-mutated lung
“KRAS has notoriously been considered an undruggable target and patients with KRAS-driven cancers continue to face limited treatment options with survival measured in months, not years,” said John Reed, M.D., Ph.D., Executive Vice President, Innovative Medicine, Research & Development, Johnson & Johnson. “We believe the proprietary Firelink™ platform will overcome