News | September 11, 2023

Biosyngen Received FDA Approval For Phase I/II Clinical Trials For BRL03, Targeting Lung Cancer, Gastric Cancer And Other Advanced Solid Tumors

Singapore /PRNewswire/ - On September 9th, 2023, Biosyngen Pte Ltd (hereafter as "Biosyngen") announced that the U.S. FDA has cleared the Investigational New Drug (IND) application for Phase I/II clinical trial of BRL03 for the treatment of lung cancer, gastric cancer and other advanced solid tumors. The approval granted to BRL03, the company's third first-in-class therapy, marks another breakthrough Biosyngen made in the CGT field.

Notably, BRL03 is also the first TCR-T product developed by Biosyngen to enter clinical trials. This significant achievement is attributed to the company's cutting-edge technology and extensive accumulation of capabilities and resources over the years.

IDENTIFIER, independently developed technology platform by Biosyngen, provides solid support for discovery and identification of antigen, antibody and TCR. Currently, utilizing the TCR and tumor proteome databases of thousands of individuals, Biosyngen can go from screening to optimization in two weeks to discover the optimal development for different therapeutic needs. With IDENTIFIER, Biosyngen selected TCRs with high specificity and affinity for a wide range of solid tumors, targeting a broad patient base. In addition, the company's MSE-T technology platform allows T cells to be less easily depleted in the microenvironment in solid tumors and to exert tumor suppressing effects more persistently through additional functional module components.

Looking back, in December 2022, BRG01, an EBV-targeted CAR-T cell therapy developed by Biosyngen for nasopharyngeal cancer, received IND approval from NMPA. In February 2023, BRG01 obtained U.S. FDA approval for the same indication to commence Phase I/II clinical trials. It is expected that the Phase I clinical trial of BRG01 will be completed by the end of 2023.

The IND application of BRG01 for the treatment of EBV-positive lymphoma has also been approved by NMPA and U.S. FDA earlier this year in April.

The successful filing of BRL03 marks a significant milestone for the company's strategy featuring diverse pipelines. Alongside CAR-T therapies, BRL03 will become Biosyngen's flagship asset in the TCR-T field, with ongoing progress in clinical studies and regulatory consultation.

Biosyngen is currently in the process of filing the IND application for BST02, its fourth in the company's pipeline. With the addition of this TIL therapy, the company solidifies its position as a promising biopharmaceutical company with global ambitions, boasting assets in all three major T-cell therapy types, namely, CAR-T, TCR-T, and TIL.

Biosyngen remains committed to its mission of addressing unmet clinical needs of patients and pursuing its goal to be a global leader in the development of innovation drugs.

About BRL03
Lung cancer is the leading cause of cancer deaths worldwide, with 2.21 million new cases and 1.8 million deaths in 2020. As a heterogeneous disease, lung cancer is categorized into two main groups: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). Gastric cancer has about 1.27 million new cases and 957,000 deaths globally every year, accounting for the 3rd most deadly of all malignant tumors. Gastric cancer is also one of the more common malignant solid tumors in China, with incidence and deaths accounting for 42.6% and 45.0% worldwide.

BRL03 developed by Biosyngen is an engineered T cell therapy, also known as a type of adoptive immune cell therapy for lung cancer, gastric cancer and other solid tumors. Patients' T cells were isolated and genetically modified in a GMP-compliant facility to enhance their ability to recognize and attack specific antigens on cancer cells. The modified T cells are expanded ex vivo and infused back into the patient. The infused T cells would bind to specific antigen on the cancer cells to mediate tumor killing. The preliminary safety and efficacy of BRL03 have been demonstrated in data from exploratory clinical trials.

About Biosyngen
Biosyngen is a cell and gene therapy biotechnology company, focusing on R&D in immunotherapy and drug development; to achieve the best outcome for cancer patients.

The company's R&D team consists of multinationals from Singapore, China, Germany, Australia, France and the US, many of whom received their Phd. from renowned universities. Biosyngen's strategy of dual R&D centres and dual GMP facilities in Singapore and China, firmly anchors it as an Asian company towards a global ambition. The company's product pipeline potentially addresses an estimated value of 50 billion USD in the global oncology market.

Biosyngen possesses exclusive licenses and patented therapies targeting multiple solid tumors and hematological malignancies including nasopharyngeal cancer, gastric cancer, gastrointestinal cancer and EBV-positive hematological malignancies. The company's first-in-class product BRG01 was granted IND approval by US FDA and CN NMPA for Phase I/II clinical trial. BRG01 indicated for the treatment of nasopharyngeal carcinoma has also been granted Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). Biosyngen is also one of a few biopharmaceutical companies that possess a portfolio consisting of CAR-T, TCR-T, TIL and other advanced cell therapies.

Based in Singapore and Guangzhou, Biosyngen collaborate closely with the world's leading biomedical research and clinical institutes including A*STAR, Helmholtz Zentrum München, Hannover Medical School, Sun Yat-Sen University Cancer Center and a network of hospitals to advance R&D, develop products and conduct clinical trials in Singapore, Australia and China.

Through our R&D capability and translational medicine platform, Biosyngen have been able to engage the end-to-end cycle in drug development from lead identification, preclinical studies, cell production, quality control, regulatory filing, to clinical studies - integrating the entire chain of R&D, clinical trial, GMP manufacturing and commercialization.

Source: Biosyngen

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