GSK Initiates Phase I Clinical Trial of B7-H4 ADC GSK5733584/HS-20089 in Advanced Solid Tumors

May 29, 2024 11:56 CST Updated 11:56

GSK

Pharmaceutical R&D Manufacturer

Recently, GSK registered a new clinical trial on the ClinicalTrials website.B7H4 ADC Drug GSK5733584/HS-20089 in Patients with Various Advanced Solid TumorsPhase 1 Clinical TrialNCT06431594, expected to beLaunched on May 29, 2024, with a planned enrollment of 240 cases.。

Figure 1: GSK registered a Phase 1 clinical trial for GSK5733584/HS-20089

In October 2023, GlaxoSmithKline Intellectual Property (No.4) Limited, a wholly-owned subsidiary of GSK, andHansoh Bio, a wholly-owned subsidiary of Hansoh Pharma, has entered into a licensing agreement granting GSK an exclusive global license (excluding mainland China, Hong Kong, Macao, and Taiwan) to develop, manufacture, and commercialize HS-20089.AndHansoh Bio will receive an upfront payment of $85 million., and is qualified toThe ProductCollectMilestone payments of up to $1.485 billion upon the achievement of relevant eventsAfter the commercialization of the product, GSK will also pay tiered royalties on global net sales outside of mainland China, Hong Kong, Macao, and Taiwan.

HS-20089 is a novel B7-H4-targeted antibody-drug conjugate (ADC) with a topoisomerase inhibitor (TOPOi) as its payload. In July 2021, Hansoh filed for the drug's clinical trial for the first time.October of the same year, itsAnnounced the first clinical trial of HS-20089；2023In August of the year, the Phase II clinical trial of the drug was announced.ThusThe drugBecoming the world's first drug of the same mechanism to register for Phase II clinical trialsThis study enrolled 460 participants in China, targeting ovarian cancer and endometrial cancer.In addition, at the 2023 ESMO conferenceHansoh announced positive clinical results for HS-20089-101。

Figure 2-3: HS-20089-101 Clinical Positive Results

GSK previouslyAccording to the early clinical data of HS-20089,The drug has BIC potential in ovarian and endometrial cancers, with additional development opportunities in other solid tumors.. The introduction of this pipeline complements GSK's existing pipeline and also holds potential for future combination therapies. GSK plans to initiate Phase I trials outside of China in 2024.

TargetedB7-H4Pipeline under research

B7-H4 belongs to the B7 family and is a type I transmembrane protein, with relatively low expression levels in normal tissues.Most commonly expressed in endometrial cancer, cholangiocarcinoma, breast cancer, and ovarian cancer.. Studies have shown that B7-H4 can enhance the proliferation, invasion, metastasis, and anti-apoptotic abilities of tumor cells by participating in various cell signaling pathways, thereby promoting tumor progression, thus becomingOne of the potential targets for anticancer drug development。

Figure 4: Expression of B7-H4 in Various Human Tumors

Currently, the B7-H4 target has not yet been developed into a drug and is still in clinical research.Targeted B7H4 therapies include various treatments such as monoclonal antibodies, bispecific antibodies, and ADCs. According to incomplete statistics,Currently, this targeted therapy has at least 7 ADC pipelines, 5 bispecific antibody pipelines, and 3B7H4 Monoclonal Antibody Pipeline.

Among them,The fastest progress mainly includes the aforementioned.HS-20089AndAstraZeneca's AZD-8205AZD-8205 is an ADC targeting B7H4 developed by AstraZeneca using its self-developed TOPO1i platform, after investing heavily to acquire multiple ADC pipelines from Daiichi Sankyo. As early as October 2021, AstraZeneca...A Phase I/II clinical trial (NCT05123482) evaluating the efficacy and safety of AZD8205 in patients with advanced or metastatic breast cancer (BC), biliary tract cancer (BTC), ovarian cancer (OVC), and endometrial cancer has been initiated, with a planned enrollment of 248 patients. In addition,Pfizer, Mersana, Bioatla, DualityBio / BeiGeneAndHarbour BioMedCompanies like these have layouts here.

Table 1: Pipeline Therapies Targeting B7H4

References:

[1] 240 Cases: GSK Launches Phase I Clinical Trial of B7H4 ADC Introduced by Hansoh. UmabsDB. 2024-05-29.

[2]ADC | GSK Acquires B7-H4 ADC from Hansoh Pharma for $1.57 Billion: Who Else is Investing in This Promising Field?.CPHI Online Pharma.2023-10-25.

[3] $1.57 Billion! GSK Acquires Hansoh Pharma's B7-H4 ADC. Insight Database. 2023-10-21.

[4]B7H4 Target Competition Landscape: Monoclonal Antibodies, Bispecific Antibodies, and ADC. Chuanliu Peak. 2024-05-17.

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