FDA Fast Track Designation for BI-1808 to Treat Cutaneous T-cell Lymphoma
“Receiving FDA’s Fast Track Designation following the recent Orphan Drug Designation underscores the potential of this novel immunomodulatory agent and reflects the urgent need for new, safe and durable treatment options for patients with CTCL”, said Martin Welschof, Chief Executive Officer of BioInvent. “It’s very encouraging that the FDA confirms that the presented BI-1808 data meet expectations to address this important unmet medical need”. To date, BI-1808 demonstrated early clinical efficacy in heavily pretreated patients with an excellent safety and tolerability profile. We are committed to continue advancing the development of BI-1808 and look forward to providing an update from the ongoing Phase 2a by mid-2025.”
Share:
More News
“Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumors harbor a KRAS G12C mutation face limited options once their disease progresses,” said Jacob Van Naarden, executive vice president, and president of Lilly Oncology. “This Breakthrough Therapy designation reflects the early potential we’re seeing with
“This financing reflects the confidence our investors and strategic partners have in the progress we have made to date and the opportunities that lie ahead,” said Dr. Jack Hoppin, Chief Executive Officer of Ratio Therapeutics. “As we march the ATLAS trial forward and prepare for our 5th IND filing, these
“We are excited to initiate monotherapy expansion evaluating IDE892 in MTAP-deleted PDAC and NSCLC. We designed IDE892 to be a potential best-in-class PRMT5 inhibitor, including approximately 1,400-fold selective MTA-PRMT5 cooperative binding versus SAM-PRMT5 cooperative binding, lack of brain penetrance, and favorable drug-like properties intended to maximize its therapeutic window as
“The data presented at ASCO provided important insight into the potential clinical path for CRB-701 in 2L oropharyngeal cancer, a distinct tumor-type that is on the rise due to HPV infections,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “Unfortunately, current treatment options have shown limited efficacy underscoring the