SCG Cell Therapy receives FDA nod for novel HPV-targeting T Cell therapy

SINGAPORE—SCG Cell Therapy Pte Ltd (SCG), a Singapore-based biotech company developing immunotherapies, has announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application.

This green light allows them to initiate a Phase 1/2 clinical trial for SCG142, a next-generation T cell therapy for human papillomavirus (HPV)- positive solid tumors.

SCG142 is a unique T cell receptor (TCR) therapy engineered to recognize and attack HPV-infected cells. 

It leverages a high-avidity, naturally occurring TCR specific to HPV E7 protein. 

This TCR is further enhanced with a chimeric switch receptor (TGFβRII-41BB) to overcome the immunosuppressive tumor microenvironment and boost anti-tumor effects.

Preclinical data presented in May 2024 at the American Society of Gene & Cell Therapy (ASGCT) meeting showed that SCG142 is highly effective.

 The therapy demonstrated potent activity against both HPV-16 and HPV-52, with no signs of off-target toxicity or immune system rejection (alloreactivity). 

Furthermore, SCG142 induced the proliferation of both CD8+ and CD4+ T cells, indicating its ability to function independently of the CD8 co-receptor and potentially generate long-lasting memory T cell responses.

Commenting on the FDA approval, Christy Ma, CEO of SCG Cell Therapy, noted that this milestone marks significant progress in their TCR-based therapeutic program, which aims to address unmet needs in major cancer indications.

Ma emphasized that the approval of another TCR T cell therapy candidate, generated from their proprietary GianTCRTM platform, underscores SCG’s commitment to advancing innovative treatments.

She added that they are now prepared to commence multi-center Phase 1/2 clinical trials to assess the potential benefits of their proprietary TCR T technology for patients.

For his part, Dr. Ke Zhang, Chief Scientific Officer of SCG Cell Therapy, elaborated on the significance of SCG142.

He explained that by armoring the TCR T cells with the chimeric switch receptor, the therapy effectively overcomes the hostile tumor microenvironment, converting inhibitory effects into co-stimulatory signals

This mechanism is essential for the successful immunotherapy treatment of solid tumors.

Dr. Zhang highlighted that SCG142’s unique next-generation design represents a groundbreaking innovation, translating from their in-house discovery platforms into clinical applications.

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