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
CEO Snehal Patel commented, “We are very encouraged to see that the preliminary results from FLAMINGO-01 show immune responses in both HLA-A*02 and non-HLA-A*02 patients. We are now considering the merits of adding a randomized placebo arm for non-HLA-A*02 patients, transforming this current open label third arm into effectively a
“At Ferring, we are committed to meeting the unmet needs in bladder cancer care and equipping uro-oncologists with critical evidence they need to deliver effective, and life-changing treatment,” said Joern Jakobsen, M.D., Ph.D., Vice President and Head of Global Research and Medical for Uro-Oncology and Urology, Ferring Pharmaceuticals. “These new
“We recognise the significance of Mosaic’s platform, which has identified these two assets as anchor components of a pipeline of potential combination products,” said Dr. Harren Jhoti, co-founder, president and chief executive officer of Astex. “Both drug targets are well-characterised drivers of many cancers, and we are excited to be
“We do not view today’s unsatisfactory outcome as a failure of Globo H,” Dr. Heidi Wang, CEO of OBI Pharma added. “There may come a time, with a deeper scientific understanding of the Globo H function, it may play a meaningful role once again.”
