TCR-T Therapy Cleared for Lung, Gastric Cancer Trial

The FDA has granted investigational new drug application clearance to Biosyngen’s phase 1/2 clinical trial of the company’s T-cell receptor T-cell (TCR-T) therapy BRL03 for patients with lung cancer, gastric cancer and other advanced solid tumors.¹

BRL03 will be the company’s first TCR-T therapy to enter clinical trials, although Biosyngen stated that the preliminary safety and efficacy of BRL03 have been demonstrated in data from exploratory clinical trials.

Taking together small cell and non-small cell lung cancer, lung cancer is the leading cause of cancer deaths worldwide. In 2020, there were 2.21 million new cases and 1.8 million deaths due to the disease. Gastric cancer is the third most deadly of all malignant tumors, with 1.27 million new cases and almost 1 million deaths per year due to the disease. 

In July 2023, Biosyngen announced that the FDA had granted both fast track and orphan drug designations to another T-cell therapy, BRG01, for the treatment of Epstein-Barr virus (EBV)-positive relapsed/metastatic nasopharyngeal carcinoma.2 The chimeric antigen receptor (CAR) T-cell therapy previously received orphan drug designation in June 2023 for the same indication, and in April 2023 was cleared for a clinical trial in patients with EBV-positive lymphoma.^3,4 The therapy is being evaluated in a phase 1 clinical trial (NCT05864924) for safety and efficacy in patients with EBV-positive nasopharyngeal carcinoma that the company expects to complete by the end of 2023.

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With the announcement of the IND clearance, Biosyngen shared an update that it is in the progress of filling an IND for BST02, a tumor-infiltrating lymphocyte therapy for the proposed indication of liver cancer.¹

BRL03’s development was supported by the use of its IDENTIFIER technology platform that discovers and identifies antigens, antibodies, and TCRs. The company selected TCRs with high specificity and affinity for a wide range of solid tumors with the IDENTIFIER platform to target a broad patient base. Biosyngen also used its MSE-T platform to mitigate T-cell exhaustion of its therapy.

REFERENCES

1. Biosyngen received FDA approval for Phase I/II Clinical Trials for BRL03, targeting Lung Cancer, Gastric Cancer and other advanced Solid Tumors. News release. September 11, 2023. https://www.biosyngen.com/index.php?m=home&c=View&a=index&aid=104
2. Biosyngen’s first-in-class cell therapy BRG01 receives FDA Fast Track designation. News release. Biosyngen. July 10, 2023. https://www.biosyngen.com/index.php?m=home&c=View&a=index&aid=107
3. Biosyngen's Cell Therapy BRG01 Granted Orphan Drug Designation by the U.S. FDA for Treatment of Nasopharyngeal Cancer. News release. Biosyngen. June 6, 2023. https://www.asiaone.com/business/biosyngens-cell-therapy-brg01-granted-orphan-drug-designation-us-fda-treatment
4. Biosyngen announces FDA IND approval of its second product for EBV-positive lymphoma. News release. Biosyngen. April 14, 2023. https://www.biosyngen.com/index.php?m=home&c=View&a=index&aid=99