GT 101 / Grit Biotechnology - LARVOL DELTA

GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Grit Biotechnology | Trial completion date: Jul 2024 ➔ Jul 2025 | Trial primary completion date: Jul 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Grit Biotechnology Receives U.S. FDA Clearance of Investigational New Drug Application for GT201, a genetically engineered TIL, following its Chinese IND Approval (PRNewswire) - "Grit Biotechnology...has achieved a major milestone with its genetically engineered TIL product, GT201. Following its investigational new drug (IND) approval in China in July 2023, GT201 has now also received IND clearance from the U.S. FDA, paving the way for clinical trials in the United States....GT201 IND is approved by both U.S. FDA and China Center for Drug Evaluation (CDE) to enter clinical trials in both countries for advanced solid tumor patients....In addition, Grit's non-gene-engineered TIL program, GT101, is currently in Phase 2 (pivotal) trials and is on track to file for Biologics License Application (BLA) in 2025, making it the leading TIL pipeline in China."

China filing • IND • Solid Tumor

Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Grit Biotechnology | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor

Phase 1 study of GT101 as an autologous tumor infiltrating lymphocyte (TIL) therapy in advanced solid tumors. (ASCO 2024) - P1 | "In the GT101 Phase 1 study, no treatment-related SAEs and DLT were observed. In patients with heavily pretreated advanced or metastatic solid tumors, GT101 exhibited a manageable safety profile under the treatment protocol of lymphodepletion and high-dose IL-2 and a favorable clinical profile, particularly in cervical cancer, with an encouraging ORR and sustained response duration."

Metastases • P1 data • Tumor-infiltrating lymphocyte • Anemia • Cervical Cancer • Hematological Disorders • Lung Cancer • Melanoma • Oncology • Small Cell Lung Cancer • Solid Tumor

GRIT and Quangang Forge Strategic Partnership to Accelerate Localization of Interleukin-2 (PRNewswire) - "Shanghai Grit Biotechnology Co., Ltd...and Shandong Quangang Pharmaceutical...announced the establishment of a formal strategic partnership to leverage both parties' R&D capabilities in innovative T-cell therapy. The objective is to jointly develop a globally standardized IL-2 for solid tumor patients receiving T-cell therapy, aiming to localize the global standard IL-2 with accessible prices for Chinese patients...The focus of the collaboration will be on expanding the indications of Quanqi (125SER) Interleukin-2 (I) products for solid tumors...Both parties will collaborate to develop a domestically produced substitute to the globally recognized immune-regulating cytokine IL-2 in T-cell therapy, addressing the significant unmet medical needs for Chinese cancer patients....Grit's non-gene-engineered TIL program GT101 is in Phase 2 (pivotal) trial -- it is the fastest TIL pipeline in China and plans for BLA filing in 2025."

China filing • Licensing / partnership • Oncology • Solid Tumor

Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: Grit Biotechnology

Metastases • New P2 trial • Cervical Cancer • Oncology • Solid Tumor

GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Grit Biotechnology

Metastases • New P1 trial • Oncology • Solid Tumor

GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors (clinicaltrials.gov) - P1 | N=31 | Recruiting | Sponsor: Grit Biotechnology | Trial primary completion date: Aug 2023 ➔ Aug 2025

Metastases • Trial primary completion date • Oncology • Solid Tumor

Grit Biotechnology Announces Closing of $60 Million Series B Financing (PRNewswire) - "On September 8, 2023, Grit Biotechnology announced the completion of a Series B financing round, raising over 60 million USD....The financing will support Grit Biotechnology's Tumor-Infiltrating Lymphocyte (TIL) pipeline development, including the pivotal Phase II trial for GT101 and the advancement of next-gen gene-edited TIL products....GT101 is currently the fastest-developing TIL therapy in China and will enter a Phase II trial by the end of 2023."

Financing • New P2 trial • Oncology • Solid Tumor

A Single-arm Phase I Clinical Study of GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors (clinicaltrials.gov) - P1 | N=31 | Recruiting | Sponsor: Grit Biotechnology

New P1 trial • Oncology • Solid Tumor

Grit Biotechnology Completes Series A+ Financing to Accelerate Development of its Tumor Infiltrating Lymphocyte (TIL) Therapy Pipeline (GlobeNewswire) - "The company anticipates IND filing for GT101 in China early 2022, as well as development of its next generation TIL program in the coming years."

Non-US regulatory • Oncology

[VIRTUAL] Stem cell properties of GT101, a tumor infiltrating lymphocyte (TIL) product with multiple indications. (ASCO 2021) - "In general, GT101 demonstrates good stemness with a higher percentage of Tcm and TCF1+ than equivalent products previously reported across the world, suggesting better performance in persistence and proliferation in clinic."

Oncology • Solid Tumor • CD4 • CD8 • PD-1