Lion TCR 宣布其 LioCyx-M004 获得 FDA IND 批准，用于肝细胞癌

StephenW

Lion TCR 宣布其 LioCyx-M004 获得 FDA IND 批准，用于肝细胞癌发布时间：2021 年 9 月 23 日，星期四，下午 3:23ACROFAN=美通社| [email protected] |社交网络新加坡、中国广州和洛杉矶，2021 年 9 月 23 日 /美通社/ -- Lion TCR Pte Ltd 是一家专门从事 T 细胞受体 (TCR) T 细胞治疗的临床阶段生物技术公司，今天宣布已获得美国的批准美国食品和药物管理局 (FDA) 因其 LioCyx-M004 的新药研究 (IND) 申请，自体 T 细胞转染了编码乙型肝炎表面抗原 (HBsAg) 特异性 TCR 的 mRNA。Lion TCR 打算为其主要研究产品 LioCyx-M004启动一项针对晚期乙型肝炎病毒 (HBV) 相关肝细胞癌 (HCC) 患者的 1b/2 期多中心研究。这将是首个使用特异性 T 细胞受体 (TCR)-T 细胞疗法靶向 HBV 相关 HCC 的 1b/2 期研究。2020年，全球新发肝癌病例超过90万例，其中90%为肝细胞癌（HCC）。在亚洲，HBV是HCC的重要诱发因素，如中国80%～90%的HCC与HBV感染有关。 LioCyx-M004 的使用已在原发性 HBV 相关 HCC 的 1 期研究中进行了测试。 LioCyx-M004 输注耐受性良好，未发生细胞因子释放综合征 (CRS) 或神经毒性。疾病控制率为 60%，根据 RECIST 1.1 观察到部分缓解 (PR)，缓解持续时间为 27.7 个月。中位总生存期 (OS) 为 33.1 个月。即将进行的研究旨在评估 LioCyx-M004 作为单一疗法治疗以及 LioCyx-M004 与乐伐替尼联合使用的安全性和有效性。考虑到乐伐替尼作为晚期 HCC 的成熟一线治疗方法及其将免疫抑制性肿瘤微环境恢复为免疫支持谱的潜力，乐伐替尼和 LioCyx-M004 治疗的组合有望进一步改善临床结果。“LioCyx-M004 凭借其独特的作用机制、出色的安全性和放射学肿瘤反应，有可能成为 HCC 一流的 TCR T 细胞疗法。我们也有强大的科学依据来使用我们的 TCR-T 疗法与其他疗法相结合以扩大其有效性。我们为近年来取得的重大进展感到自豪，并期待在未来几周内启动 1b/2 期研究，以改善难治性或复发性 HCC 患者的益处。 Lion TCR 首席运营官兼首席营销官 Tina Tingting Wang 博士说：“目前的全身治疗。这项研究的患者招募将在美国希望之城综合癌症中心开始，这是一家领先的癌症研究和治疗中心。”“这一 1b/2 期 IND 批准是 Lion TCR 的一个非常重要的里程碑！我们将继续致力于成为世界领先的生物技术公司，使用尖端的 TCR-T 免疫疗法为有需要的患者提供创新的治疗选择。Lion TCR 拥有开发多种TCR-T技术平台，包括TCR发现平台，结合基因编辑技术的自体和异体TCR平台。凭借我们革命性的TCR-T细胞免疫疗法的潜力，我们旨在成为肝癌领域标杆的先驱公司治疗，”Lion TCR 董事总经理兼首席执行官彭晓明博士说。关于 Lion TCR 私人有限公司Lion TCR 是一家临床阶段的 T 细胞免疫治疗公司，专门从事其专有技术和工程 T 细胞产品的开发和商业化，以对抗病毒相关的癌症。作为针对 HCC 的 HBV 特异性 TCR 重定向 T 细胞疗法的世界领先者，该公司拥有新加坡 A*STAR 技术的全球独家许可。 Lion TCR开发了多种TCR-T技术平台，包括TCR发现平台、结合基因编辑技术的自体和过敏性TCR平台。关于铅产品 LioCyx-M004LioCyx-M，包括几种成熟的产品衍生物，是经过修饰以表达 HBV 特异性 TCR 的自体 T 细胞。在体内临床前研究和患者中，这些修饰的 T 细胞已被证明能够在靶标识别后裂解 HBV 感染的 HCC 细胞。Lion TCR 联系方式全球联系方式Regina Wong 博士业务发展经理邮箱：[email protected]大中华联系方式周毅博士战略与业务发展副总监电话：+86 15994719201邮箱：[email protected]

StephenW

Lion TCR Announces FDA IND Clearance for its LioCyx-M004 for Hepatocellular Carcinoma
Published : Thursday, September 23, 2021, 3:23 pm
ACROFAN=PRNewswire | [email protected] | SNS       

SINGAPORE and Guangzhou, China and LOS ANGELES, Sept. 23, 2021 /PRNewswire/ -- Lion TCR Pte Ltd, a clinical-stage biotech company specialized in T Cell Receptor (TCR) T cell therapy today announced that it has received clearance from U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) Application for LioCyx-M004, autologous T-cells transfected with mRNA encoding Hepatitis B surface antigen (HBsAg) specific TCR.

Lion TCR intends to initiate a Phase 1b/2 multi-center study for its lead investigational product, LioCyx-M004, for patients with advanced Hepatitis B Virus (HBV)-related hepatocellular carcinoma (HCC). This will be the first Phase 1b/2 study that uses specific T cell receptor (TCR)-T cell therapy to target HBV-related HCC.

In 2020, there are more than 900,000 new cases with liver cancer worldwide, of which 90% been hepatocellular carcinoma (HCC). In Asia, HBV is an important inducer of HCC, for example, 80% - 90% of HCC is related to HBV infection in China. The use of LioCyx-M004 has been tested in Phase 1 study in primary HBV-related HCC. LioCyx-M004 infusions were well-tolerated with no occurrence of cytokine release syndrome (CRS) nor neurotoxicity. Disease control rate was 60% and partial response (PR) as per RECIST 1.1 was observed with a duration of response of 27.7 months. Median overall survival (OS) was 33.1 months.

The upcoming study aims to evaluate LioCyx-M004 as a monotherapy treatment and the safety and efficacy of LioCyx-M004 in combination with lenvatinib. Considering lenvatinib as a well-established first-line treatment for advanced HCC and its potential to revert the immunosuppressive tumor microenvironment towards an immune-supportive profile, the combination of lenvatinib and LioCyx-M004 treatment is expected to further improve clinical outcome.

"LioCyx-M004, with its unique mechanism of action and its excellent safety profile and radiological tumor response, has the potential to become a first-in-class TCR T cell therapy for HCC. We also have a strong scientific rationale for the use of our TCR-T therapy in combination with other therapies to extend its effectiveness. We are proud of our significant progress in recent years and look forward to initiating the Phase 1b/2 study in the upcoming weeks for the benefits of HCC patient refractory or relapsed to current systemic treatment. Patient recruitment for this study will begin at City of Hope Comprehensive Cancer Center in United States, a leading research and treatment center for cancer," said Dr Tina Tingting Wang, COO and CMO of Lion TCR.

"This Phase 1b/2 IND clearance is a very important milestone for Lion TCR! We will continue our dedication to be the world leading biotech company using cutting-edge TCR-T immunotherapy to provide innovative therapeutic options for patients in need. Lion TCR has developed various TCR-T technology platform including TCR discovery platform, autologous and allogeneic TCR platform incorporating with gene editing technologies. With the potential of our revolutionary TCR-T cell immunotherapy, we aim to be the pioneer company for benchmarking in the field of liver cancer treatment," said Dr Peng Xiaoming, Managing Director & CEO of Lion TCR.

About Lion TCR Pte Ltd

Lion TCR is a clinical-stage T cell immunotherapy company specialized in the development and commercialisation of its proprietary technologic and engineered T cell products against viral-related cancers. As the world leader in HBV specific TCR redirected T cell therapy against HCC, the company has global exclusive licenses of the technologies from Singapore A*STAR. Lion TCR has developed various TCR-T technology platform including TCR discovery platform, autologous and allergenic TCR platform incorporating with gene editing technologies.

About Lead Product LioCyx-M004

LioCyx-M, including several well-established product derivatives, are autologous T cells modified to express HBV-specific TCR. These modified T cells have been shown to be able to lyse HBV-infected HCC cells upon target recognition in in-vivo pre-clinical studies and in patients.

Lion TCR contact

Global contact
Dr Regina Wong
Manager, Business Development
Email: [email protected]

Great China contact
Dr Zhou Yi
Associate Director, Strategy & Business Development
Phone: +86 15994719201
Email: [email protected]