Shanghai, China, Mar, 17th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the filing of a Phase 1 clinical trial for HLX301, a Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody (BsAb), in Patients with advanced tumours has been approved by the National Medical Products Administration (NMPA). At present, no bispecific antibody targeting PD-1/PD-L1 and TIGIT has been approved for marketing globally. In February 2022, the first patient was dosed in Australia in Phase 1 clinical trial of HLX301, ahead of the same class of BsAb targeting PD-L1×TIGIT, making HLX301 potentially the first-in-class anti-PD-L1×TIGIT BsAb.
TIGIT (T cell immunoreceptor with immunoglobulin and ITIM domains) is an inhibitory receptor, mainly expressed on natural killer (NK) cells and activated CD8+ T cells, CD4+ T cells, and T regulatory cells. As an inhibitory receptor, TIGIT can inhibit innate and adaptive responses in various mechanisms of action and act as a “brake” like PD-1/PD-L1 does to stop T cells from attacking tumours. Pre-clinical studies reported that HLX301 can simultaneously block both PD-1/PDL1 and TIGIT/PVR pathways, restore TCR signaling, inhibit tumour growth, and has good tolerance and safety, paving the way for further clinical development to against a variety of advanced tumours, including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, etc.
Underpinned by the patient-centric strategy, Henlius has built an innovative product pipeline with many emerging targets, including PD-1/L1, LAG-3, TIGIT, BRAF, etc., and has been pushing its early R&D research capabilities further while also upgrading the technology platform. The company is currently taking effort to explore different forms of antibody conjugates based on our own core antibody technologies and by using of novel conjugating technologies. Looking forward, Henlius is actively accelerating its evolution to an innovative Biopharma and improving efficiency through innovations. It will preserve its momentum for innovation by further strengthening the in-licensing and collaboration on external innovative assets and bringing more high-quality and affordable therapies to patients worldwide.