SCG Cell Therapy FDA Approval
SCG Cell Therapy Pte Ltd (SCG) is a biotech company developing novel immunotherapies for infectious diseases and their associated cancers, announced that United States FDA has approved its 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.
From SCG Cell Therapy
Christy Ma, Chief Executive Officer of SCG Cell Therapy said, “This FDA IND approval of another TCR T cell therapy candidate generated from our proprietary GianTCRTM platform is an important milestone fo SCG. It marks the advancement of our TCR-based therapeutic program to treat unmet needs in different major cancer indications. 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 armored 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 favorable 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 invitro and in vivo models, indicating CD8 co-receptor independent T cell functionality, as well as promoting long-term persistence of memory T cells.
Dr. Ke Zhang, Chief Scientific Officer of SCG Cell Therapy said, “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 co-stimulatory signal. This process is essential for effective immunotherapy treatment of solid tumors. With this next generation design, SCG142 represents a groundbreaking innovation that translates from our in-house discovery platforms into clinics.
About Human Papillomavirus and Cancers
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. 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.
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 GianTCRTM novel TCR screening platform and AutocellTM 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.
For media enquiries, please contact:
SCG Cell Therapy Pte. Ltd. HP: +65 6829 7180 Email: [email protected]
Prohost Observations
The reason Prohost followed up on this private firm is the FDA approval of the firm’s IND application to initiate Phase 1/2 clinical trial for its product SCG142.
We will continue to post other biotech firms’ developing products for the treatment of HPV and HPD- associated solid cancers under News & Comments.
SCG Cell Therapy: FDA Approved IND Application of Product SCG142 to Initiate Phase 1/2 Clinical Trial for A Next Generation HPV and its cancers.
SCG Cell Therapy FDA Approval
From SCG Cell Therapy
Christy Ma, Chief Executive Officer of SCG Cell Therapy said, “This FDA IND approval of another TCR T cell therapy candidate generated from our proprietary GianTCRTM platform is an important milestone fo SCG. It marks the advancement of our TCR-based therapeutic program to treat unmet needs in different major cancer indications. 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 armored 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 favorable 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 invitro and in vivo models, indicating CD8 co-receptor independent T cell functionality, as well as promoting long-term persistence of memory T cells.
Dr. Ke Zhang, Chief Scientific Officer of SCG Cell Therapy said, “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 co-stimulatory signal. This process is essential for effective immunotherapy treatment of solid tumors. With this next generation design, SCG142 represents a groundbreaking innovation that translates from our in-house discovery platforms into clinics.
About Human Papillomavirus and Cancers
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. 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.
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 GianTCRTM novel TCR screening platform and AutocellTM 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.
For media enquiries, please contact:
SCG Cell Therapy Pte. Ltd. HP: +65 6829 7180 Email: [email protected]
Prohost Observations
The reason Prohost followed up on this private firm is the FDA approval of the firm’s IND application to initiate Phase 1/2 clinical trial for its product SCG142.
We will continue to post other biotech firms’ developing products for the treatment of HPV and HPD- associated solid cancers under News & Comments.
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