Orphan Drug Designation for IMM-1-104 by FDA in the Treatment of Pancreatic Cancer
“The FDA’s granting of orphan drug designation for IMM-1-104 underscores the urgent need for new therapies that meaningfully improve outcomes for pancreatic cancer patients and represents an important milestone in the development of our lead asset,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “I believe our recently announced positive initial Phase 2a data, from our arm investigating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in pancreatic cancer, speaks to IMM-1-104’s potential to improve upon the current standard of care in this indication. Importantly, in the same trial we are also studying IMM-1-104 in combination with modified FOLFIRINOX, as well as in monotherapy for pancreatic cancer. We look forward to providing initial data from at least one additional arm of the Phase 2a portion of our Phase 1/2a trial before the end of the year.”
Share:
More News
“We are excited to have restarted our Phase 2 study in presurgical triple-negative breast cancer. Triple-negative is a deadly and aggressive form of breast cancer, and patients having local disease currently undergo a harsh six-month regimen whereby a small percentage can die from the SOC before their surgery,” said Intensity
“TRAVERSE represents a potential breakthrough for both Allogene and the broader CAR T field,” said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. “CAR T has transformed hematologic malignancies while solid tumors have remained one of the field’s most difficult challenges. When we designed ALLO-316 with the
“We continue to be very encouraged by the longer-term data from our Phase 2 J201 study, and today’s announcement marks a pivotal step forward in our mission to bring safusidenib as a comprehensive treatment option for patients with all types of IDH1-mutant glioma,” said David Hung, M.D., Founder, President, and
“As the data continue to mature, we are increasingly encouraged by the preliminary findings emerging from both cohorts, particularly the overall survival trends observed in the cohort with MGMT unmethylated glioblastoma,” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “These findings further reinforce our belief that targeting mitochondrial