SCG Cell Therapy Announces FDA IND Clearance of SCG142, a next-generation HPV-specific TCR T cell therapy for patients with HPV-associated solid tumors

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SINGAPORE, June 30, 2024 /PRNewswire/ -- SCG Cell Therapy Pte Ltd (SCG), a biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, today announced that U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate 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 for patients with HPV-associated solid tumors.

"This FDA IND approval of another TCR T cell therapy candidate generated from our proprietary GianTCR^TM 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", said Christy Ma, Chief Executive Officer of SCG Cell Therapy. "We are ready to commence multi-center Phase 1/2 clinical trials, assessing the potential benefits for patients via our proprietary TCR T technology."

SCG142 is a high-avidity fully natural HPV-specific TCR armoured with a TGFβRII-41BB chimeric switch receptor. In May 2024, SCG presented preclinical data of SCG142 at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. The data indicates SCG142 had exhibited high polyfunctional avidity. It recognized both HPV-16 and HPV-52 genotypes, with a favourable safety profile with no alloreactivity or off-target toxicity. In addition, SCG142 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, as well as promoting long-term persistence of memory T cells.

"SCG142 is a novel and differentiated HPV-specific TCR T cell therapy. By armoring the TCR T cells with the chimeric switch receptor, it overcomes the hostile tumor microenvironment and converts inhibitory effects into a co-stimulatory signal. This process is essential for effective immunotherapy treatment of solid tumors. With this unique next-generation design, SCG142 represents a groundbreaking innovation that translates from our in-house discovery platforms into clinics", said Dr. Ke Zhang, Chief Scientific Officer of SCG Cell Therapy.

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About Human Papillomavirus and Cancers

Human papillomavirus (HPV) is the most common sexually transmitted infection. Nearly all sexually active people will be infected with HPV at some point in their lives.   Approximately half of these infections are with a high-risk HPV type, which can lead to cancer^[1]. HPV infection accounts for more than 90% of anal and cervical cancers, about 70% of vaginal and vulvar cancers, and 60% of penile and oropharynx cancers. An estimated 630,000 new cancer cases and 350,000 deaths worldwide each year are resulted from HPV (related) infection.^[2]

About SCG Cell Therapy

SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, HPV, HBV and EBV, and develops a broad and unique pipeline of TCR-based cellular immunotherapy products against infections associated cancers. With the proprietary GianTCR^TM novel TCR screening platform and Autocell^TM fully closed and automatic cell therapy manufacturing system, the company covers the entire value chain, from new target research and discovery, manufacturing, and clinical development. For more information about SCG, please visit us at www.scgcell.com.

SOURCE SCG Cell Therapy Pte Ltd