FDA clears IND application for IKS014 in patients with advanced HER2+ solid tumours
Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics commented, “The FDA clearance of our IND application for IKS014 represents a significant milestone in our mission to address the critical unmet needs of patients with HER2-positive cancers, particularly those who have exhausted current standard-of-care options. Early clinical data has been extremely encouraging, and we are excited to expand our program to reach more patients. The early efficacy signals that have been observed, particularly in patients that have relapsed after receiving prior treatments of Kadcyla and Enhertu, suggest IKS014 could potentially offer a new treatment option for patients who currently have limited alternatives. We look forward to working with our clinical partners to further evaluate the potential of IKS014.”
Share:
More News
“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