隶属于 nanjing leads managment&consulting center (l.p.)
相关临床试验
20
2 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2012
已完成
7
35.0%
尚未招募
2
10.0%
招募中
11
55.0%
暂无批准数据
- Leads Biolabs announced that Opamtistomig (LBL-024), its investigational PD-L1/4-1BB bispecific antibody, received FDA Fast Track Designation for treating extra-pulmonary neuroendocrine carcinoma (EP-NEC). - This marks the third major regulatory designation for Opamtistomig, following Breakthrough Therapy Designation from China's NMPA and Orphan Drug Designation from the FDA. - The bispecific antibody is the first 4-1BB-targeting therapy globally to advance to a single-arm pivotal trial as monotherapy and aims to become the first approved therapy specifically for EP-NEC. - Opamtistomig has demonstrated promising efficacy and favorable safety profile in ongoing clinical studies in China for advanced EP-NEC patients.
- Leads Biolabs presented Phase I/II data for LBL-034, a GPRC5D/CD3 bispecific antibody, showing an 82.5% overall response rate in relapsed/refractory multiple myeloma patients. - The therapy demonstrated strong efficacy across difficult-to-treat subgroups, including 100% response rate in extramedullary disease patients at the highest dose level. - LBL-034 showed a favorable safety profile with no dose-limiting toxicities up to 1200 μg/kg and predominantly mild adverse events. - The 12-month progression-free survival rate reached 61.2% across dose levels, with median follow-up of 9.6 months indicating durable clinical benefit.
- The FDA approved Leads Biolabs' IND application for LBL-047, a first-in-class bispecific fusion protein targeting both BDCA2 and TACI pathways for autoimmune disease treatment. - LBL-047 represents a unique dual mechanism approach, simultaneously inhibiting plasmacytoid dendritic cell activity and B-cell maturation to address autoimmune conditions like systemic lupus erythematosus and Sjögren's syndrome. - This milestone marks Leads Biolabs' expansion beyond oncology into autoimmune therapeutics, with no currently approved clinical trials worldwide targeting both BDCA2 and TACI simultaneously.
- Leads Biolabs' LBL-024, a first-in-class PD-L1/4-1BB bispecific antibody, achieved a 75% overall response rate in 52 patients with advanced extrapulmonary neuroendocrine carcinoma when combined with chemotherapy. - The optimal 15 mg/kg dose demonstrated an 83.3% response rate and 100% disease control rate, significantly outperforming historical chemotherapy-alone data of 30-55%. - LBL-024 has received breakthrough therapy designation in China and orphan drug designation from the FDA, positioning it as a potential first approved treatment specifically for EP-NEC. - The drug showed manageable safety profile with no dose-limiting toxicities observed during phase Ib dose escalation, with most adverse events being Grade 1-2.
