SCG Cell Therapy Pte Ltd (SCG), a Singapore-based biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, announced on Sunday that it has received approval from US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application to commence a Phase 1/2 clinical trial for SCG142, a novel next-generation human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T) cell therapy intended for treatment of patients with HPV-associated solid tumours.

SCG142, a high-avidity fully natural HPV-specific TCR, is armoured with a TGF Beta RII-41BB chimeric switch receptor.

During May this year, the company revealed preclinical data for SCG142 at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. The data indicates that the product had exhibited high polyfunctional avidity and recognised both HPV-16 and HPV-52 genotypes, with a favourable safety profile with no alloreactivity or off-target toxicity. The product also demonstrated dual CD8 and CD4 TCR T cell proliferation and tumour inhibition in both in vitro and in vivo models, indicating CD8 co-receptor independent T cell functionality, and promoting long-term persistence of memory T cells.

Christy Ma, SCG Cell Therapy chief executive officer, said, 'This FDA IND approval of another TCR T cell therapy candidate generated from our proprietary GianTCRTM platform is an important milestone for SCG. It marks the advancement of our TCR-based therapeutic program to treat unmet needs in different major cancer indications. We are ready to commence multi-centre Phase 1/2 clinical trials, assessing the potential benefits for patients via our proprietary TCR T technology.'