SCG142 / SCG Cell Therapy - LARVOL DELTA

11 Class 1 innovative drugs were approved for clinical trials in China for the first time! From Sanofi, Hengrui Medicine and other companies [Google translation] (Sina Corp) - "The Class 1 new drug S095029 applied by Servier has been approved for clinical trials and is intended to be developed to treat locally advanced unresectable or metastatic MSI-H/dMMR gastroesophageal junction cancer/gastric cancer...The lyophilized preparation of BM230, a Class 1 new drug applied by Biomins, has been approved for clinical trials and is intended to be developed to treat HER2-related solid tumors...Hengrui Medicine 's Class 1 new drug SHR-4375 injection has been approved for clinical trials and is intended to be developed to treat solid tumors....The Class 1 new drug SCG142 autologous T cell injection submitted by Xinghand Bio has been approved for clinical trials and is intended to be developed to treat HPV16 or HPV52-related malignancies."

New trial • Cervical Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Microsatellite Instability • Oral Cancer • Penile Cancer • Solid Tumor • Vulvar Cancer • HER-2

Next-generation T-cell receptor T cell therapy (SCG142) against human papilloma virus (HPV) for patients with recurrent or metastatic HPV16/52-positive carcinomas (ESMO Asia 2024) - "SCG142 at 3 dose levels (1 × 10 7 , 5 × 10 7 or 1 × 10 8 cells/kg), administered intravenously following three days of cyclophosphamide (500 mg/m 2 /day) and fludarabine (25 mg/m 2 /day) were evaluated. Exploratory endpoints include biomarkers and immunogenicity. A phase I/2 study with similar study design to evaluate SCG142's safety and preliminary efficacy in patients with recurrent/metastatic HPV16/52- positive carcinomas that progressed after at least one line of systemic therapy has received FDA IND approval, and currently open for recruitment."

Clinical • IO biomarker • Metastases • Oncology • HLA-A • TGFB1

SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: The Affiliated Hospital of Qingdao University

Metastases • New P1 trial • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Penile Cancer • Solid Tumor • Vaginal Cancer • Vulvar Cancer

Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma (clinicaltrials.gov) - P1/2 | N=66 | Not yet recruiting | Sponsor: SCG Cell Therapy Pte. Ltd.

New P1/2 trial • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • Vulvar Cancer

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 (PRNewswire) - "SCG Cell Therapy Pte Ltd (SCG)...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."

IND • New P1/2 trial • Solid Tumor

SCG Cell Therapy Presented New Preclinical Data in an Oral Presentation at ASGCT 2024 Annual Meeting Highlighting Superior Tumor Inhibition of its Immunoswitch Armored HPV-TCR T Cell Therapy (SCG142) against a Broad Range of HPV-associated Cancers (PRNewswire) - "SCG Cell Therapy Pte Ltd (SCG)...announced first preclinical data of its novel human papillomavirus (HPV)-specific T cell receptor-engineered T (TCR T) cell therapy armored with an TGFβRII-41BB immunoswitch - SCG142 – in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting....In preclinical studies, SCG142 demonstrated superior CD8+ and CD4+ TCR T cell proliferation and tumor inhibition both in-vitro and in-vivo compared to conventional TCR T without immunoswitch, including tumor rechallenge models....In addition, SCG142 exhibited high functional avidity and can recognize both genotypes HPV-16 and HPV-52, with a favorable safety profile with no alloreactivity or off-target toxicity in relevant toxicology models."

Preclinical • Solid Tumor