China-based Transcenta Holding Limited (HKG: 6628) announced that its TST003, a first-in-class, high affinity humanized monoclonal antibody (mAb) targeting Gremlin1, has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA). This milestone allows Transcenta to proceed with clinical trials for this novel cancer treatment.
Gremlin1 and Its Role in Carcinomas
Gremlin1, a member of the TGF-β super family, is highly expressed by stromal cells in diverse human carcinomas, including esophageal, pancreatic, gastric, colon, lung, breast, and prostate cancers. It is associated with tumorigenesis, contributing to the proliferation, migration, invasion, and metastasis of cancer cells. Preclinical studies have shown that TST003 has significant anti-tumor activities both in vitro and in vivo, positioning it as a potential new treatment option for various cancers.
Potential Applications and Synergistic Effects
In May 2022, Nature Cancer published study results by Transcenta and Shanghai Jiao Tong University scientists on the potential application of the first-in-class Gremlin1-targeted antibody in the treatment of androgen receptor-negative/low prostate cancer. The study revealed that Gremlin1 protein can promote lineage plasticity and drive castration resistance in prostate cancer. Gremlin1-specific antibodies were shown to effectively control tumor growth in androgen receptor-negative/low prostate cancer. The study also demonstrated synergistic activity between the anti-Gremlin1 antibody and enzalutamide against patient-derived castration-resistant prostate cancer models in vitro and in vivo.
Future Development
With the IND clearance from the FDA, Transcenta is poised to advance TST003 into clinical development. The company plans to explore the potential of TST003 both as a monotherapy and in combination with immune checkpoint inhibitors and/or other anti-tumor agents. This development underscores Transcenta’s commitment to innovation in oncology and its ongoing efforts to address unmet medical needs in cancer treatment.-Fineline Info & Tech
