Huaota Biopharma's CD73-Targeting ADC HB0052 Receives FDA Clearance for Clinical Trials in Advanced Solid Tumors

Nov 07, 2023 14:04 CST Updated 14:05

Huahai Pharmaceutical

Medical and Health Product Provider

Huaota

Biological New Drug Developer

▎WuXi AppTec Content Team Report

On November 6, Huahai Pharmaceutical announced that its subsidiary, Huaota, received approval from the U.S. FDA.NoteHB0052 Injection for Advanced Solid TumorsThe IND application for HB0052, a third-generation antibody-drug conjugate (ADC) targeting the CD73 antigen, marks the first ADC project developed by Huaota to be approved by the FDA for clinical trials.

Public data shows that the CD73 antigen is expressed on various cells within the tumor microenvironment, especially with high expression on tumor cells and some infiltrating immune cells. In the tumor microenvironment, hypoxia induces the overexpression of CD73 on the surface of cancer cells, which hydrolyzes AMP into adenosine. Adenosine can suppress immune cell function and promote tumor growth.Blocking the enzymatic activity of CD73 through antibodies can relieve the immunosuppressive function of CD73 and enhance anti-tumor effects.

According to the announcement by Huahai Pharmaceutical, HB0052 is exactlyAn ADC product targeting the CD73 antigen, with a topoisomerase inhibitor as the payload.It can simultaneously exert the immune system regulatory function mediated by antibodies and the cytotoxic effects of small-molecule toxins on tumor cells, demonstrating a synergistic anti-tumor effect. Preclinical animal model studies have shown that this product has excellent anti-tumor efficacy. Preclinical pharmacokinetic results conducted in non-human primates indicate that HB0052 exhibits linear pharmacokinetic characteristics, with good plasma stability, low non-specific shedding levels, a long half-life, and satisfactory pharmacokinetic properties. Toxicology studies show that the product has good safety and tolerability. This product has potential applications across multiple solid tumor indications.

According to the press release from Huaota Biopharmaceuticals, HB0052 demonstrates favorable CMC characteristics and significant anti-tumor effects, with the potential to benefit a wide range of cancer patients in clinical settings, especially those who are resistant or unresponsive to PD-1/PD-L1 inhibitor treatments. Additionally, the approval of HB0052 for clinical trials marks that Huaota Biopharmaceuticals has established a comprehensive ADC (Antibody-Drug Conjugate) R&D platform, laying the foundation for the subsequent development of more ADC projects.

References:

[1] Announcement of Huahai Pharmaceutical Co., Ltd. on Subsidiary's Receipt of Drug Clinical Trial Approval. Retrieved Nov 6， 2023. From http://www.cninfo.com.cn/new/disclosure/detail?stockCode=600521&announcementId=1218259283&orgId=gssh0600521&announcementTime=2023-11-06

This article was compiled and edited by the WuXi AppTec content team based on publicly available information. Individuals are welcome to share it on their social media circles. For authorization to repost, please leave a message on the "MedView" WeChat Official Account to contact us. For other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biomedicine and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article. This article is not a recommendation for treatment plans. If you need guidance on treatment options, please visit a regular hospital.