Sinocelltech's Next-Generation TCR-T Therapy SCG142 Receives FDA Approval for Phase I/II Clinical Trial in HPV-Associated Solid Tumors

Jul 01, 2024 09:27 CST Updated 09:27

SCG Cell Therapy

Innovative Immunotherapy Developer

On July 1, SCG Science announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for Phase I/II clinical trials of its next-generation human papillomavirus (HPV)-specific T-cell receptor (TCR) engineered T-cell therapy (SCG142). It is reported that SCG142 is being developed for the treatment of patients with HPV-related solid tumors.

Human Papillomavirus (HPV) is a virus that causes various benign or malignant tumors. It can infect the skin and mucous membranes of the human body, affecting areas such as the oral cavity, throat, cervix, vulva, vagina, penis, and anus. E7 is one of the major oncogenes encoded by HPV, and its integrative expression in host cells is a core factor in the occurrence, development, and metastasis of cervical cancer and other cancers. It is a key driver and dependency factor for tumors. Therefore, TCR-T targeting HPV E7 is a crucial option for treating advanced malignant tumors related to HPV, with significant value for product development and application.

As a best-in-class new drug under development globally, SCG142 is a next-generation chimeric switch receptor-enhanced TCR-T cell therapy product. The core technology utilizes GianTCR, exclusively owned by SCG SCIENCE (DALIAN) CO., LTD.^TMThe technology platform successfully screened and isolated natural high-affinity HPV-specific TCR, which is combined with a chimeric switch receptor. Compared with traditional TCR-T cell therapy, it significantly enhances T-cell proliferation and tumor suppression effects. It exhibits specific tumor-killing activity against various tumors related to HPV-16 and HPV-52 genotypes, such as cervical cancer, and is suitable for various malignant tumors caused by HPV, including cervical cancer, oropharyngeal cancer, head and neck cancer, vaginal cancer, vulvar cancer, and penile cancer.

In May this year, at the 27th Annual Meeting of the American Society of Gene and Cell Therapy held in Baltimore, USA, SCG Science (Dalian) Co., Ltd. presented the research data of SCG142 in an oral report. The results showed that SCG142 TCR-T cell therapy demonstrated excellent antitumor activity and good safety in HPV-related tumor models. Without relying on CD8 co-receptor signaling, SCG142 can simultaneously activate both CD8+ and CD4+ TCR-T cells, triggering potent antitumor activity in an immunosuppressive tumor microenvironment and promoting the long-term persistence of memory T cells, which is a key factor for sustaining the efficacy of immune cell therapy. Additionally, the high-affinity characteristic of SCG142 enables it to effectively recognize various HPV virus-related tumors induced by HPV-16 and HPV-52 genotypes, significantly increasing patient population coverage.

Dr. Ke Zhang, Chief Scientific Officer of SCG SCIENCE (DALIAN) CO., LTD, stated:"SCG142 represents a completely new, differentiated next-generation TCR-T cell therapy, following SCG's exclusive and leading GianTCR."^TMFollowing the development of the TCR-T product SCG101 for HBV-related liver cancer, another TCR-T cell product approved by the FDA for the treatment of HPV-related cervical cancer and other solid tumors marks an important milestone in the cellular treatment of solid tumors. This signifies that our TCR products have successfully brought new hope to unmet clinical needs across different cancer indications. Moving forward, we will apply innovative TCR-T therapies to the development and clinical trials of more treatment-resistant solid tumors, benefiting more cancer patients."

About Human Papillomavirus and Cancer

Human Papillomavirus (HPV) is the most common sexually transmitted infection, and nearly all sexually active individuals are infected with HPV. HPV infections can lead to cellular changes, forming precancerous lesions in the cervix, vagina, vulva, anus, or throat, which may develop into cervical cancer, vaginal cancer, vulvar cancer, anal cancer, and throat cancer. Nearly 100% of cervical cancer cases are caused by HPV infection.In 2022, there were 660,000 new cases of cervical cancer globally, with approximately 350,000 deaths, making it one of the most common malignant tumors among women worldwide.^［1，2^］。

About SCG

SCG SCIENCE (DALIAN) CO., LTD is a leading biotechnology company focused on developing novel immunotherapies for infections and their associated cancers. The company is developing a broad and unique range of TCR-T cell therapies targeting the most common cancer-causing infections: Helicobacter pylori, human papillomavirus, and hepatitis B, with the goal of preventing and curing infections and their related cancers. Headquartered in Singapore, with its R&D center located at the IZB Innovation Center in Munich, Germany, the company leverages regional advantages across Singapore, China, and Germany, covering the complete industry value chain from innovative drug research and development, manufacturing, clinical trials, to commercialization. For more information about SCG, please visit www.scgcell.com. Media inquiries can be directed to info@scgcell.com.

References

[1] World Health Organization official website: Human Papillomavirus and Cancer

[2] National Cancer Center, National Clinical Research Center for Cancer: Chinese Expert Consensus on the Use of Human Papillomavirus Nucleic Acid Testing for Cervical Cancer Screening (2022)

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