SCG Cell Therapy Pte. Ltd, a Singapore-headquartered biotechnology company with a presence in Shanghai, has announced that it has received clearance from the US Food and Drug Administration (FDA) to proceed with a Phase I/II clinical study for its investigational therapy, SCG142. This therapy is a human papillomavirus (HPV) specific T cell receptor (TCR) designed to treat HPV-related solid tumors.
SCG142, a candidate for best-in-class status, represents a next-generation chimeric switch receptor enhanced TCR-T cell therapy. The proprietary technology employed by SCG enables the screening and isolation of naturally occurring high-affinity HPV-specific TCRs using the GianTCR technology platform. These TCRs are then integrated with chimeric switch receptors. This approach is shown to markedly enhance T cell proliferation and tumor suppression capabilities compared to conventional TCR-T cell therapies. It has demonstrated specific tumor-killing effects on various HPV-related tumors, including cervical cancer associated with HPV-16 and HPV-52 genotypes.
The therapy is applicable to a range of malignant tumors induced by HPV, encompassing cervical, oropharyngeal, head and neck, vaginal, vulvar, and penile cancers. Prior research has indicated that SCG142 exhibits robust anti-tumor activity and favorable safety in preclinical HPV-related tumor models. It can activate CD8+ and CD4+ TCR-T cells, bypassing the need for CD8 co-receptor signaling, which triggers potent anti-tumor responses even in suppressive tumor microenvironments. Furthermore, it promotes the long-term survival of memory T cells, a critical factor for the enduring efficacy of immunotherapies. The high-affinity nature of SCG142 also allows it to effectively target a variety of HPV-induced tumors, thus expanding the potential patient population that could benefit from this treatment.- Flcube.com
