Transcenta Holding Limited, a China-based clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announced on Wednesday that it has received Orphan Drug Designation from the United States Food and Drug Administration (FDA) for its TST001, an anti-Claudin18.2 monoclonal antibody currently in Phase I clinical trial, to treat patients with gastric cancer or gastroesophageal junction.
According to preclinical and clinical data, the product indicated potent anti-tumour activities in tumour model of gastric cancer or patient of gastric cancer expressing Claudin18.2.
The product is the second Claudin18.2 aimed at antibody therapeutic candidate being developed globally after Zolbetuximab (IMAB362). It is a high-affinity recombinant humanised monoclonal antibody aimed at Claudin18.2 generated by Transcenta's Immune Tolerance Breaking Technology platform.
Circio unveils circVec proof-of-concept
GSK releases decade-long data on Shingrix efficacy
BiVictriX receives FDA Orphan Drug Designation for AML treatment candidate
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Amneal announces launch of PEMRYDI RTU, a ready-to-use oncology injectable
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
GSK's meningitis vaccine candidate accepted for FDA review
Medivir and Vetbiolix report positive results from VBX-1000 Proof-of-Concept clinical study
Norgine submits first marketing authorisation application submissions for approval of eflornithine
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
ProAxsis secures GBP1.8m investment
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients