SCG Cell Therapy Receives FDA IND Clearance for SCG142, Next-Gen HPV TCR Therapy

SCG Cell Therapy Pte Ltd (SCG), a biotechnology firm based in Singapore, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Investigational New Drug (IND) application to commence Phase 1/2 clinical trials for SCG142. SCG142 is an innovative T-cell receptor-engineered T (TCR T) cell therapy designed to target human papillomavirus (HPV) E7-specific proteins in patients with HPV-associated solid tumors.

Christy Ma, the Chief Executive Officer of SCG Cell Therapy, stated that this FDA approval is a significant achievement for the company. She emphasized that this milestone propels SCG's TCR-based therapeutic program forward, addressing unmet needs across several major cancer indications. Ma confirmed that the company is prepared to initiate multi-center Phase 1/2 clinical trials to evaluate the potential benefits of their proprietary TCR T technology for patients.

SCG142 is distinguished by its high-avidity, fully natural HPV-specific T-cell receptor (TCR) equipped with a TGFβRII-41BB chimeric switch receptor. This receptor enhances the therapy's effectiveness by converting the inhibitory signals from the tumor microenvironment into stimulatory signals, an essential process for successful immunotherapy against solid tumors. SCG had previously presented preclinical data for SCG142 in May 2024 at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. The data showed that SCG142 exhibited high polyfunctional avidity, recognizing both HPV-16 and HPV-52 genotypes, and displayed a favorable safety profile with no alloreactivity or off-target toxicity. SCG142 also demonstrated dual CD8 and CD4 TCR T cell proliferation and tumor 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.

Dr. Ke Zhang, the Chief Scientific Officer of SCG Cell Therapy, highlighted the novel and differentiated aspects of SCG142. He noted that by equipping the TCR T cells with the chimeric switch receptor, the therapy could overcome the challenging tumor microenvironment and convert inhibitory effects into co-stimulatory signals. This unique design makes SCG142 a groundbreaking innovation, transitioning from SCG's in-house discovery platforms to clinical applications.

Human papillomavirus (HPV) is the most common sexually transmitted infection, affecting nearly all sexually active individuals at some point. Approximately half of these infections involve high-risk HPV types, which can lead to cancer. HPV infection is responsible for over 90% of anal and cervical cancers, around 70% of vaginal and vulvar cancers, and 60% of penile and oropharynx cancers. Annually, HPV-related infections result in an estimated 630,000 new cancer cases and 350,000 deaths worldwide.

SCG Cell Therapy is a prominent biotechnology company dedicated to developing novel immunotherapies for infectious diseases and their associated cancers. The company focuses on the most common cancer-causing infections, including helicobacter pylori, HPV, HBV, and EBV. SCG has a broad and unique pipeline of TCR-based cellular immunotherapy products targeting infection-associated cancers. Utilizing its proprietary GianTCRTM TCR screening platform and AutocellTM automated cell therapy manufacturing system, SCG covers the entire value chain from new target research and discovery to manufacturing and clinical development.