SHANGHAI, April 9, 2024 /PRNewswire/ -- BioCity Biopharma today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Phase 1 study of BC2027. BC2027, which is BioCity's second first-in-class antibody drug conjugate (ADC) approved for clinical development, targets Glypican 3 (GPC3), a proteoglycan found in the outer membrane of cancer cells.

上海，2024年4月9日/PRNewswire/--BioCity Biopharma今天宣布，美国食品和药物管理局（FDA）已批准该公司的研究性新药（IND）申请，用于BC2027的一期研究。BC2027是BioCity批准用于临床开发的第二类一流抗体-药物偶联物（ADC），其靶向磷脂酰肌醇蛋白聚糖3（GPC3），一种在癌细胞外膜中发现的蛋白聚糖。

BioCity's first ADC, BC3195, which is directed against another novel target called placental-cadherin (CDH3), a cell adhesion molecule that confers invasiveness and metastatic properties to cancer cells, is also in clinical trials..

BioCity的第一个ADC BC3195针对另一种称为胎盘钙粘蛋白（CDH3）的新靶点，这是一种赋予癌细胞侵袭性和转移特性的细胞粘附分子，也正在进行临床试验。。

GPC3 is specifically up-regulated in the most common type of liver cancer, hepatocellular carcinoma (HCC), several types of lung and esophageal cancer, and other malignancies, although rarely or not expressed in normal liver tissues, making GPC3 a rational treatment target for cancers that express it.

GPC3在最常见的肝癌，肝细胞癌（HCC），几种类型的肺癌和食道癌以及其他恶性肿瘤中特异性上调，尽管在正常肝组织中很少或不表达，这使得GPC3成为表达它的癌症的合理治疗靶点。

Recently, clinical activity has been noted with chimeric antigen receptor (CAR) T cells and other therapies targeting GPC3, demonstrating the potential of GPC3 as a therapeutic target..

最近，已经注意到嵌合抗原受体（CAR）T细胞和其他靶向GPC3的疗法具有临床活性，证明了GPC3作为治疗靶标的潜力。。

BC2027 binds with very high affinity to GPC3 and efficiently internalizes into cancer cells where it releases its cancer killing payload. In addition to directly killing cancers cells in which it enters, BC2027's cancer activity is enhanced as it kills other cancer cells indirectly via a 'bystander effect'.

BC2027以非常高的亲和力与GPC3结合，并有效地内化到癌细胞中，释放其抗癌有效载荷。除了直接杀死其进入的癌细胞外，BC2027的癌症活性还得到了增强，因为它通过“旁观者效应”间接杀死了其他癌细胞。

In preclinical studies, BC2027 was also quite safe and tolerable while demonstrating robust anticancer activity with greater than 90% inhibition of tumor growth in some well-established cancers. These findings indicate the potential for BC2027 to be a novel, safe, and effective cancer treatment..

在临床前研究中，BC2027也非常安全且可耐受，同时在一些公认的癌症中表现出强大的抗癌活性，对肿瘤生长的抑制率超过90%。这些发现表明BC2027有可能成为一种新颖，安全和有效的癌症治疗方法。。

The uniqueness of GPC3 as a target also suggests that BC2027 may in part overcome the challenges of cancer drug resistance.  Dr. Yong Jiang Hei, CEO of BioCity, noted that 'Drug resistance has increasingly become a challenge in cancer treatment. BioCity aims to develop next generation therapies with the potential to delay and overcome drug-resistance.

GPC3作为靶标的独特性也表明，BC2027可能部分克服了癌症耐药性的挑战。BioCity首席执行官Yong Jiang Hei博士指出，“耐药性越来越成为癌症治疗的挑战。BioCity旨在开发具有延迟和克服耐药性潜力的下一代疗法。

Among different strategies, developing novel ADCs is an important approach to address the inherent drug resistance of HCC and many other cancers, as well as secondary drug resistance resulting from available anticancer therapies.' He added, 'Now BioCity has two first-in-class, novel ADCs in global clinical development, thereby resulting in a competitive edge as BioCity's ADCs are clearly differentiated.

在不同的策略中，开发新型ADC是解决HCC和许多其他癌症固有耐药性以及可用抗癌疗法引起的继发性耐药性的重要方法。”他补充道，“现在，BioCity在全球临床开发中拥有两个一流的新型ADC，从而在BioCity的ADC明显分化的情况下产生了竞争优势。

The company will strive to advance the clinical development of these exciting ADC therapeutics to meet the unmet clinical needs and benefit patients worldwide as early as possible.' Dr. Hei says..

该公司将努力推进这些令人兴奋的ADC疗法的临床开发，以满足未满足的临床需求，并尽早使全球患者受益。”Hei博士说。。

HCC and GPC3

HCC和GPC3

Liver cancers are highly prevalent worldwide with approximately 860,000 newly diagnosed cases and 750,000 ①deaths annually. Among liver cancers, 90% are HCC. In addition, the poor prognosis of the disease represents a significant unmet medical need.

肝癌在世界范围内非常普遍，每年约有860000例新诊断病例和750000例死亡病例。在肝癌中，90%是HCC。此外，该疾病的不良预后代表了严重的未满足的医疗需求。

In recent years, with the rapid development of systemic therapies for HCC, the standard of care for advanced HCC has evolved from traditional chemotherapy to multi-kinase inhibitors and immune checkpoint inhibitors, or the combination of the two. However, the efficacy of these therapies is limited and further advances in treatment are urgently needed..

近年来，随着HCC全身治疗的快速发展，晚期HCC的护理标准已经从传统的化疗发展到多激酶抑制剂和免疫检查点抑制剂，或两者的结合。然而，这些疗法的疗效有限，迫切需要进一步的治疗进展。。

GPC3 is highly expressed in more than 70% HCC and the expression level correlates with the extent of disease progression. Therefore, GPC3 is a specific tumor marker and closely related to disease prognosis, making it a promising target for the treatment of HCC②.

GPC3在70%以上的HCC中高表达，表达水平与疾病进展程度相关。因此，GPC3是一种特异性肿瘤标志物，与疾病预后密切相关，是治疗HCC的有希望的靶点②。

About BioCity

关于BioCity

Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including chronic kidney diseases (CKD).  The company has established a pipeline of more than 10 innovative drug candidates including small molecules, monoclonal and bispecific antibodies as well as ADCs..

BioCity成立于2017年12月，是一家临床阶段的生物制药公司，致力于开发针对癌症和自身免疫性疾病（包括慢性肾病（CKD））的新型且高度分化的非模态治疗剂。该公司已经建立了10多种创新候选药物的管道，包括小分子，单克隆和双特异性抗体以及ADC。。

Currently, BioCity Biopharma has six oncology assets in Phase 1 clinical development, including the first-in-class CDH3-targeting ADC and GPC3-targeting ADC, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and agents targeting the immune system, a T cell engager (CD3/EGFR BsAb) and an immune checkpoint inhibitor (TIM-3 mAb).

目前，BioCity Biopharma在第一阶段临床开发中拥有六项肿瘤学资产，包括一流的靶向CDH3的ADC和靶向GPC3的ADC，靶向DNA损伤反应（DDR）途径的WEE1和ATR抑制剂，以及靶向免疫系统的药物，T细胞接受者（CD3/EGFR-BsAb）和免疫检查点抑制剂（TIM-3 mAb）。

In addition, an endothelin A (ETA)-receptor selective antagonist for CKD is in phase 2 clinical development..

此外，CKD的内皮素A（ETA）受体选择性拮抗剂正在进行2期临床开发。。

For more information,

欲了解更多信息，

please visit www.biocitypharma.com Or LinkedIn BioCity BiopharmaContact:BD@biocitypharma.comIR@biocitypharma.com

请访问[UNK]www.biocitypharma.com或领英生物城生物制药联系方式：BD@biocitypharma.comIR@biocitypharmac.com

Reference：

参考号：

①Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024. doi:10.3322/caac.21834

① Bray F，Laversanne M，Sung H等人，《2022年全球癌症统计数据：全球185个国家36种癌症的全球发病率和死亡率估计》。CA癌症J临床。2024年。doi:10.3322/caac.21834

②Yang X, Yang C, Zhang S, Geng H, Zhu AX, Bernards R, Qin W, Fan J, Wang C, Gao Q. Precision treatment in advanced hepatocellular carcinoma. Cancer Cell. 2024 Feb 12;42(2):180-197. doi: 10.1016/j.ccell.2024.01.007. PMID: 38350421.

② Yang X，Yang C，Zhang S，Geng H，Zhu AX，Bernards R，Qin W，Fan J，Wang C，Gao Q.晚期肝细胞癌的精确治疗。癌细胞。2024年2月12日；42（2）：180-197。doi:10.1016/j.ccell.2024.01.007。PMID:38350421。

SOURCE BioCity Biopharma

SOURCE生物城生物制药