FDA Fast Track Designation for Pancreatic Cancer Dendritic Cell Vaccine
“This second FDA Fast Track designation of our autologous dendritic cell vaccines for pancreatic cancer is another acknowledgement of the incredible potential of this innovative immunotherapy for treating the most deadly cancers,” said Mike Wicks, Diakonos CEO. “We are thrilled to have Dr. Von Hoff join us as an advisor as we pursue clinical development of our vaccine in this deadly disease,” Mr. Wicks added. “The first designation was for our lead vaccine for glioblastoma multiforme (GBM) which successfully completed dosing for the Phase 1 trial and has significantly improved 12 month survival in those patients to well over what would be expected with the standard of care.”
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“This research collaboration with AbCellera directly aligns with Jazz’s rare disease strategy, expanding our focus on GI cancers and building on our existing expertise in oncology,” said Josh Allen, Ph.D., chief scientific officer, oncology, Jazz Pharmaceuticals. “We look forward to collaborating with AbCellera to progress potential best-in-class TCE multispecific antibodies
AIM Chief Executive Officer Thomas K. Equels stated: “AIM hopes to utilize the exploratory biomarker data generated through DURIPANC to design a Phase 3 study involving Ampligen in the treatment of pancreatic cancer. We are particularly interested in evaluating whether specific biomarkers may help to identify ‘super-responder’ patient subsets most
“We are committed to improving the treatment of glioblastoma and are grateful to our investigators and the patients and families who made the TRIDENT trial possible,” said Uri Weinberg, MD, PhD, Chief Medical and Innovation Officer, Novocure. “The study did not meet its primary endpoint, but the results from TRIDENT
“Fast Track Designation is a valuable step forward for givastomig and for patients with first-line HER2-negative metastatic gastric cancer,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. “Phase 1b results demonstrate robust efficacy and favorable overall tolerability in combination with immunochemotherapy. Responses were deep and durable across a