Biopharmaceutical company Transcenta Holding Limited (HKEX: 06628) reported on Wednesday that it has received IND (Investigational New Drug) clearance from US Food and Drug Administration (FDA) for TST003, its first-in-class, high affinity humanised monoclonal antibody targeting Gremlin1.

Gremlin1 is a member of the TGF-β super family and is highly expressed by stromal cells in diverse human carcinomas, such as oesophageal cancer, pancreatic cancer, gastric cancer, colon cancer, lung cancer, breast cancer and prostate cancer, and is associated with tumorigenesis, contributing to the proliferation, migration, invasion and metastasis of cancer cells.

According to Transcenta, TST003 has displayed significant anti-tumour activities both in vitro and in vivo in preclinical studies. TST003 has the potential to become a novel cancer treatment, either as monotherapy or in combination with immune checkpoint inhibitor and/or other anti-tumour agents.

Dr Caroline Germa, Transcenta's executive vice president, Global Medicine Development and chief medical officer, commented: "Targeting Gremlin1 with our antibody TST003 has the potential to be transformative in the treatment of high unmet need cancer indications, such as castration resistant prostate cancer. We look forward to initiating our first time in human clinical study which is designed to address key questions to optimise TST003 clinical development plan."