SINGAPORE, Sept. 11, 2023 /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.

新加坡，2023年9月11日/PRNewswire/-2023年9月9日，Biosyngen Pte Ltd（以下简称“Biosyngen”）宣布美国FDA已批准研究性新药（IND）申请进行I/II期临床试验BRL03治疗肺癌，胃癌和其他晚期实体瘤。

The approval granted to BRL03, the company's third first-in-class therapy, marks another breakthrough Biosyngen made in the CGT field..

BRL03是该公司第三大一流疗法，获得批准标志着CGT领域取得的另一项突破性生物科技。。

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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.

值得注意的是，BRL03也是Biosyngen开发的第一个进入临床试验的TCR-T产品。这一重大成就归功于公司多年来的尖端技术和广泛的能力和资源积累。

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.

标识符是Biosyngen独立开发的技术平台，为抗原，抗体和TCR的发现和鉴定提供了坚实的支持。目前，利用成千上万个体的TCR和肿瘤蛋白质组数据库，Biosyngen可以在两周内从筛选到优化，以发现针对不同治疗需求的最佳发展。

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..

通过标识符，Biosyngen选择了对广泛的实体瘤具有高特异性和亲和力的TCR，针对广泛的患者群。此外，该公司的MSE-T技术平台允许T细胞不易在实体瘤的微环境中消耗，并通过额外的功能模块组件更持久地发挥肿瘤抑制作用。。

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.

回顾过去，2022年12月，Biosyngen为鼻咽癌开发的EBV靶向CAR-T细胞疗法BRG01获得了NMPA的IND批准。2023年2月，BRG01获得美国FDA批准，用于开始I/II期临床试验的相同适应症。预计BRG01的I期临床试验将于2023年底完成.BRG01用于治疗EBV阳性淋巴瘤的IND应用也已获得NMPA和美国的批准。

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.

FDA今年4月早些时候提交.BRL03的成功提交标志着该公司采用多种管道的战略的一个重要里程碑。除CAR-T疗法外，BRL03将成为Biosyngen在TCR-T领域的旗舰资产，临床研究和监管咨询正在取得进展。Biosyngen目前正在提交BST02的IND申请，BST02是该公司管道中的第四个申请。

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 BRL03Lung cancer is the leading cause of cancer deaths worldwide, with 2.21 million new cases and 1.8 million deaths in 2020.

随着这种TIL疗法的加入，该公司巩固了其作为具有全球雄心壮志的有前途的生物制药公司的地位，拥有所有三种主要T细胞治疗类型的资产，即CAR-T，TCR-T和TIL.Biosyngen仍然致力于解决患者未满足的临床需求，并追求成为创新药物开发全球领导者的目标。关于BRL03肺癌是全球癌症死亡的主要原因，2020年新增病例221万例，死亡180万例。

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 i.

作为一种异质性疾病，肺癌分为两大类：小细胞肺癌（SCLC）和非小细胞肺癌（NSCLC）。胃癌每年在全球约有127万新病例和957000人死亡，占所有恶性肿瘤中致命的第三位。胃癌也是较常见的恶性实体瘤之一。