A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects With Advanced Solid Tumors

The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount.

Start Date02 Jul 2024

Sponsor / Collaborator

GSK Plc

NCT06336707 / RecruitingPhase 1

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors

HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6.
This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors.

Start Date11 Apr 2024

Sponsor / Collaborator

Shanghai Hansoh Biomedical Co. Ltd.

CTR20241023 / RecruitingPhase 1

注射用HS-20089 联合治疗在晚期实体瘤受试者中的安全性、耐受性、药代动力学和有效性的I期临床研究（队列1：本品联合阿得贝利单抗、队列3：本品联合贝伐珠单抗）

[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetics and efficacy of HS-20089 for injection in combination therapy in subjects with advanced solid tumors (cohort 1: HS-20089 combined with adebelimumab, cohort 3: HS-20089 combined with bevacizumab)

评价HS-20089 联合治疗在晚期实体瘤受试者中的安全性和耐受性。

[Translation]

To evaluate the safety and tolerability of HS-20089 combination therapy in subjects with advanced solid tumors.

Start Date11 Apr 2024

Sponsor / Collaborator

Shanghai Hansoh Biomedical Co. Ltd.

[+1]

100 Clinical Results associated with HS-20089

100 Translational Medicine associated with HS-20089

100 Patents (Medical) associated with HS-20089

News (Medical) associated with HS-20089

21 Dec 2023

·pipelinereview.com

GSK enters exclusive license agreement with Hansoh for HS-20093

LONDON, UK I December 20, 2023 I GSK plc (LSE/NYSE: GSK) and Hansoh Pharma (HKEX: 03692), a Chinese biopharmaceutical company committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders, today announced that they have entered into an exclusive license agreement for HS-20093, a B7-H3 targeted antibody-drug conjugate (ADC) utilising a clinically validated topoisomerase inhibitor (TOPOi) payload. Under the agreement, GSK will obtain exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) to progress clinical development and commercialisation of HS-20093. Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said: “B7-H3 is highly expressed in a broad range of solid tumours where there remains a significant need for novel treatment options. We look forward to progressing this potential new treatment across several indications and in future potential combination approaches with our established portfolio.” This agreement provides GSK with a second clinical-stage ADC that complements GSK’s existing capabilities and strengths in developing medicines to address unmet medical needs in various solid tumours. HS-20093 is currently being investigated in ongoing phase I and II trials in China. Data from the ARTEMIS-001 phase I trial (NCT05276609), for HS-20093 in advanced solid tumours, was presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting in which initial clinical activity was observed in small cell lung cancer, non-small cell lung cancer and sarcoma with multiple confirmed responses and a manageable safety profile. 1 Eliza Sun, Executive Director of Board, Hansoh Pharma, said: “HS-20093 is a novel B7-H3 targeting antibody-drug conjugate showing encouraging early clinical signals in lung cancer. We are excited to enter this new license agreement with GSK, our existing licensee on HS-20089, furthering Hansoh’s goal of bringing a potentially transformative treatment option to cancer patients globally.” GSK plans to begin phase I trials for HS-20093 outside of China in 2024. In October 2023, GSK and Hansoh entered into an agreement for HS-20089, a B7-H4 targeted ADC currently in phase II clinical trials in China. HS-20089 has best-in-class potential in ovarian and endometrial cancer with opportunities in other solid tumours. Terms of the agreement Under the terms of this agreement, GSK will pay $185 million upfront. In addition, Hansoh will be eligible to receive up to $1.525 billion in success-based milestones for HS-20093. Upon commercialisation of HS-20093, GSK will pay tiered royalties on global net sales outside of China’s mainland, Hong Kong, Macau, and Taiwan. This agreement is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US. About HS-20093 HS-20093 is a novel B7-H3-targeted antibody-drug conjugate composed of a fully humanised anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPOi) payload. HS-20093 is being developed for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumours in multiple phase I and II clinical trials in China. About Hansoh Hansoh Pharma, one of the largest biopharmaceutical companies in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Founded in 1995, Hansoh Pharma has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions across a broad range of therapeutic areas, including oncology, central nervous system disorders, metabolic diseases, infectious diseases, and autoimmune diseases, among others. GSK in oncology GSK is committed to maximising patient survival through transformational medicines, with a current focus on breakthroughs in immuno-oncology and tumour-cell targeting therapies, and development in haematologic malignancies, gynaecologic cancers and other solid tumours. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References SOURCE: GlaxoSmithKline

Phase 1License out/inASCOADCPhase 2

21 Dec 2023

·www.pmlive.com

GSK gains rights to Hansoh’s ADC candidate in deal worth more than $1.7bn

GSK has entered into an agreement to exclusively licence another of Hansoh Pharma's clinical-stage antibody-drug conjugates (ADCs), in a deal worth more than $1.7bn. HS-20093 is a novel B7-H3-targeted ADC being developed for a range of solid tumour types, including lung cancer, sarcoma, and head and neck cancers. The candidate has already demonstrated clinical activity in small cell lung cancer, non-small cell lung cancer and sarcoma, according to data from the early-stage ARTEMIS-001 trial presented at this year’s American Society of Clinical Oncology annual meeting. “B7-H3 is highly expressed in a broad range of solid tumours where there remains a significant need for novel treatment options,” explained Hesham Abdullah, senior vice president, global head oncology, research and development, GSK. Under the terms of the agreement, GSK will obtain exclusive worldwide rights outside mainland China, Hong Kong, Macao and Taiwan to progress the clinical development and commercialisation of HS-20093. In exchange, the company will pay Hansoh $185m upfront, up to $1.525bn in success-based milestones, as well as tiered royalties. Abdullah said the company “[looks] forward to progressing [HS-20093] across several indications and in future potential combination approaches” with its own portfolio. Eliza Sun, executive director of board, Hansoh, said: "HS-20093 is a novel B7-H3 targeting ADC showing encouraging early clinical signals in lung cancer. “We are excited to enter this new licence agreement with GSK… furthering Hansoh’s goal of bringing a potentially transformative treatment option to cancer patients globally.” The deal comes just two months after the companies entered into an agreement for Hansoh’s ADC, HS-20089, currently in mid-stage development. HS-20089 targets the B7-H4 surface antigen, which is overexpressed in ovarian and endometrial cancers and is often associated with a poor prognosis. The earlier agreement, which included an upfront payment of $85m and potential milestone payments of $1.485bn, also gives GSK rights to the candidate outside mainland China, Hong Kong, Macao and Taiwan. Abdullah, said at the time of the announcement: “Given early clinical data, we believe that HS20089 has best-in-class potential in ovarian and endometrial cancer, with opportunities in other solid tumours. “This agreement is in line with our approach to advancing novel treatment options for patients with gynaecologic cancers.”

License out/inASCOADC

20 Dec 2023

·medcitynews.com

GSK Expands Again in Cancer, Paying Hansoh $185M for Another ADC

GSK’s cancer drug pipeline is getting bigger with the addition of another antibody drug conjugate, or ADC. It’s the second time in as many months that GSK has turned to Hansoh Pharma for one of the China-based biotech’s drugs. Per deal terms announced Wednesday, GSK is paying $185 million up front for rights to HS-20093, a Hansoh ADC that has been tested in lung cancer. GSK gains global rights to the drug candidate excluding mainland China, Hong Kong, Macau, and Taiwan. ADCs are made by chemically linking an antibody to a toxic drug payload. The targeting ability of the antibody is meant to provide a direct strike to cancer cells that spares healthy cells. Hansoh’s HS-20093 targets B7-H3, a protein expressed by many different cancers. The drug’s payload is type of chemotherapy called a topoisomerase inhibitor. Under Hansoh, HS-20093 has reached Phase 1 and Phase 2 testing China in various types of solid tumors. In explaining its rationale for selecting this ADC, GSK singled out data from a Phase study in solid tumors that showed early signs of clinical activity in small cell lung cancer and sarcoma. In addition to multiple confirmed responses to the therapy, these results also showed the drug had a manageable safety profile. Data were presented last June during the annual meeting of the American Society of Clinical Oncology. GSK plans to begin its own slate of Phase 1 clinical trials for HS-20093 outside of China in 2024. Depending on GSK’s progress with HS-20093, Hansoh could receive up to $1.5 billion in milestone payments. If this ADC reaches the market, the deal calls for GSK to pay Hansoh royalties from the product’s sales. “B7-H3 is highly expressed in a broad range of solid tumors where there remains a significant need for novel treatment options,” Hesham Abdullah, GSK senior vice president and global head oncology, R&D, said in a prepared statement. “We look forward to progressing this potential new treatment across several indications and in future potential combination approaches with our established portfolio.” That portfolio includes HS-20089, a Hansoh ADC that GSK licensed in October. This ADC targets B7-H4, a protein abundant in ovarian and endometrial cancers. GSK paid $85 million up front for HS-20089, gaining global rights except for China, Hong Kong, Macau, and Taiwan. Hansoh could receive up to $1.48 billion in milestone payments for this ADC. GSK is part of a growing group of companies that have looked to Asia to land one or more ADCs. AstraZeneca owes its ADC progress to its partnership with Japanese drugmaker Daiichi Sankyo. That alliance has commercialized Enhertu, which has regulatory approvals in breast cancer, gastric cancer, and lung cancer. In October, Merck inked its own agreement with Daiichi Sankyo, paying $4 billion up front to partner on the development of three other ADCs. BioNTech is in the ADC hunt through a partnership with MediLink, based in Suzhou, China, as well a separate alliance with Shanghai-based DualityBio. In November, Bristol Myers Squibb began a partnership on next-generation ADCs with Orum Therapeutics, a biotech that splits its operations between Massachusetts and South Korea. U.S.-based ADC biotechs are also drawing interest from big pharma companies. Last month, AbbVie struck a $10.1 billion deal to acquire ImmunoGen, which has commercialized the ADC Elahere for ovarian cancer. And last week, Pfizer closed its $43 billion acquisition of ADC specialist Seagen. Image: Getty Images

Phase 1ASCOADCAcquisitionLicense out/in

100 Deals associated with HS-20089

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Endometrial Carcinoma	Phase 2	CN	Shanghai Hansoh Biomedical Co. Ltd.	18 Dec 2023
Fallopian Tube Carcinoma	Phase 2	CN	Shanghai Hansoh Biomedical Co. Ltd.	18 Dec 2023
Ovarian Cancer	Phase 2	CN	Shanghai Hansoh Biomedical Co. Ltd.	18 Dec 2023
Primary peritoneal carcinoma	Phase 2	CN	Shanghai Hansoh Biomedical Co. Ltd.	18 Dec 2023
Advanced Malignant Solid Neoplasm	Phase 1	CN	Shanghai Hansoh Biomedical Co. Ltd.	05 Jan 2022
Female Genital Neoplasms	Phase 1	-	GSK Plc	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05263479 (ESMO2023) Manual	Phase 1	Advanced Malignant Solid Neoplasm HER2 Negative \| ER Negative \| PR Negative	44	HS-20089	(mvhtxjbrio) = leukopenia, neutropenia, nausea, anemia, thrombocytopenia, vomiting, fatigue, increased alanine aminotransferase, anorexia, increased aspartate aminotransferase and hyponatremia. umeqpxssur (jfzzqmpktc )	Positive	21 Oct 2023
				HS-20089

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