FDA Orphan Drug Designation Granted to Batiraxcept for the Treatment of Pancreatic Cancer
“Receiving Orphan Drug Designation is another important milestone for batiraxcept, and it underscores the significant unmet medical need in patients with pancreatic cancer, typically diagnosed at an incurable advanced stage with a 5-year survival rate of 11%1,” said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. “Three patients from our P1b trial are still responding to treatment with 15mg/kg batiraxcept, gemcitabine and nab-paclitaxel after 1 year and one patient has a confirmed complete response. Consistent with our other clinical trials, we noted a relationship between clinical activity and batiraxcept drug levels, however highly fibrotic tumors like PDAC may require more batiraxcept than platinum-resistant ovarian cancer and clear cell renal cell cancer patients to reach the appropriate batiraxcept drug levels. Due to this characteristic of pancreatic cancer, we are testing higher doses of batiraxcept to see if we can increase the proportion of patients who benefit from the triplet regimen.”
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