Sesen Bio's new bladder cancer drug, Vicinium, gets fast-track status from FDA

recently, Sesen Bio
(announced that its leadingproduct(the U.SFDA(granted fast-track eligibility) for the treatment of patients with highly graded non-muscular leachate bladder cancer (high grade NMIBC) withno remission to BCGVicinium is currently in phase 3 clinicaltrial(in which it is used to treat highly graded NMIBC patients who had previously received two courses of BCG treatment, but bcG has not been able to continue to provide remission.)about theVicinium, which consists of recombinant Fusion Proteins, integrates tumor-targeted antibody fragments and protein cytotoxic payloads into a single protein molecule designed to specifically and effectively kill cancer cells while retaininghealthy(cells)It can target epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to provide an effective protein load, the pseudomonas exotoxin A (ETA)EpCAM has been shown to be overexpressed in NMIBC cells, but rarely or not in normal bladder cellsThe components of Vicinium are connected by stable genetically engineered peptides, ensuring that the payload remains attached until it is internalized by cancer cells, thereby reducing the risk of toxicity to healthy tissue and improving safetySesen Bio also believes that Vicinium's lethality against cancer cells promotes an anti-tumor immune response and has the potential to bind well to immunotumordrug, such as checkpoint inhibitorsThe U.SNational Cancer Institute (NCI) is studying the efficacy and safety of Vicinium in conjunction with AstraZeneca's immunocheckpoint inhibitor durvalumab, which does not alleviate NMIBC patients at BCG-related researchan ongoing Phase 3 clinical trial VISTA is an open label, multi-center single-arm study designed to assess the efficacy and safety of Vicinium in patients with high-level NMIBC in situ cancer (CIS) or papilloma.comThe study recruited 129 patients who had previously been treated with BCG, and the main endpoint of the study was the patient's full remission rate (CR)3 months of mid-term results showed that 72 patients with assessable data had 39 percent of CIS patients in Coegno 1Of the 5 assessable patients in queue 2, the CR was 80%All 77 CIS patients treated 42% of CR for three monthsThe results of the three-month efficacy of papilloma cancer patients in queue 3 showed a 68% recurrence-free rate in 34 patients who could be assessedPreliminary safety results showed that Vicinium was well tolerated in the VISTA trial, with 72% of patients experiencing level 1 or 2 adverse eventsThe 12-month data for the trial are expected to be available by mid-2019Sesen Bio
Sesen Bio is a late-stage clinical company that develops next-generation antibody-drug conjugate (ADC) therapies for cancer, using the company's Targeted Protein Therapeutics platform to advance next-generation ADC therapies 's lead project, Vicinium (also known as VB4-845), is currently conducting Phase 3 clinical trial VISTA