Huahai Pharmaceutical's CD73-Targeting ADC HB0052 Receives NMPA Approval for Clinical Trials in Advanced Solid Tumors

May 03, 2024 07:21 CST Updated 07:21

Huahai Pharmaceutical

Medical and Health Product Provider

Huaota

Biological New Drug Developer

May 3, 2024

eMedClub News

Recently, Shanghai Huaota Biopharmaceutical Co., Ltd., a subsidiary of Huahai Pharmaceutical Co., Ltd. (hereinafter referred to as "Huaota"), announced that it has received a notification from China's NMPA approving the clinical trial application for HB0052, a third-generation antibody-drug conjugate (ADC) project targeting the CD73 antigen developed by Huaota. This isHuaota Biopharmaceutical's First Antibody-Drug Conjugate Project Approved by NMPA for Clinical Trials。

HB0052 is a First-in-Class innovative ADC targeting immunosuppression, with a topoisomerase inhibitor as its payload. It features a dual anti-tumor mechanism and shows potential application across multiple solid tumor indications, demonstrating global competitiveness. It was selected for the "Shanghai 2023 Annual Science and Technology Innovation Action Plan - Rising Star Project" (Project No.: 23QB1400400) implemented by the Shanghai Science and Technology Commission.

HB0052 molecule exhibits excellent CMC properties 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 treatments.HB0052's clinical approval this time marks HuaHuaota has established a comprehensive antibody-drug conjugate (ADC) development platform, laying the foundation for the subsequent development of more ADC projects.

November 2023,Huaota Announces FDA Approval for HB0052 Candidate Drug to Enter Clinical Trials

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CD73 is highly expressed in the tumor microenvironment and is associated with tumor growth and suppression of immune cell function. CD73 is widely expressed on the surface of endothelial cells, lymphocytes (such as Tregs), and other cells in the human body. It can convert ATP, which has immune-activating functions, into adenosine, which has immunosuppressive effects. Adenosine downregulates immune activity by binding to downstream adenosine receptors (A2AR). In the tumor microenvironment, hypoxia induces overexpression of CD73 on the surface of cancer cells, hydrolyzing AMP into adenosine. Adenosine can inhibit immune cell function and promote tumor growth. Blocking CD73's enzymatic activity with antibodies can relieve its immunosuppressive function and enhance anti-tumor effects.

The CD73 protein consists of three domains: the N-terminal domain contains two zinc ion binding sites, the C-terminal domain contains the substrate AMP binding site, and the N-terminal and C-terminal domains are connected by a short helix that controls the movement of CD73. CD73 exists in two conformations, "open" and "closed," and its enzymatic activity is achieved through the cyclic transition between the open and closed conformations (as shown in Figure 1).

Figure 1 Schematic diagram of CD73 catalyzing AMP to generate adenosine

HB0052 can simultaneously exert antibody-mediated immune system modulation and the cytotoxic effects of small molecules on tumor cells, demonstrating synergistic antitumor activity. Preclinical animal model studies have shown that HB0052 has excellent antitumor efficacy; studies conducted in non-human primates further support its potential.Preclinical pharmacokinetic results showed that HB0052 exhibited linear pharmacokinetic characteristics, good plasma stability, low non-specific shedding levels, a long half-life, and satisfactory pharmacokinetic properties.；Toxicology studies show that HB0052 has good safety and tolerability. HB0052 is expected to become a new generation of cancer treatment drug.

Figure 2 Mechanism of ADC drugs against tumors

Competitive Landscape

At present, both in China and abroad,Drugs targeting CD73 have not yet been marketed.Multiple monoclonal antibody projects are in the clinical research stage, with indications under development including solid tumors such as non-small cell lung cancer, breast cancer, pancreatic cancer, and prostate cancer.Among them, AstraZeneca developedOleclumab (anti-CD73 monoclonal antibody) has the fastest R&D progress and is currently in Phase III clinical trials, used after concurrent chemoradiotherapy.UnresectableNSCLC Treatment.Huaota's HB0052 is the second CD73-ADC drug globally to enter clinical trials.

About Huaota

Huaota Biopharmaceutical was established in September 2013 as a subsidiary of Zhejiang Huahai Pharmaceutical Co., Ltd. Since its inception, Huaota has continuously focused on innovation and development, building a comprehensive integrated biologics R&D platform, including monoclonal antibodies, bispecific antibodies, fusion proteins, ADC drug discovery platforms, and GMP-compliant pilot platforms for drug substance and formulation.

Huaota Biopharmaceutical drives internal innovation through independent research and development. The company boasts a rich product pipeline, covering major disease areas such as oncology, autoimmune diseases, and ophthalmic diseases. Currently, it has over 20 projects in development, 11 of which are in clinical research stages, with clinical trials being conducted in the United States, New Zealand, and China. In 2019, Huaota was recognized as a "National High-tech Enterprise" and has undertaken and completed multiple scientific and technological projects in Shanghai and Zhejiang Province. It has filed numerous domestic and international patent applications.

Huaota is currently actively seeking domestic and international partners to jointly advance and co-develop., looking forward to providing high-quality and high-level biopharmaceuticals to the global market, meeting the needs of a wide range of patients for accessible and affordable biopharmaceuticals, and practicing the vision of innovation changing the world!

To seize the opportunities currently facing the industry and promote the common development of the industry.MedCareer willJune 14-15, 2024Held in Nanjing2024 IBI EXPO Biopharmaceutical Innovation Industry Conference, and convene "XDC Conjugate Drug Development Session (ADC/Peptide/Nuclear Medicine)". This conference will invite pioneers and leaders in this field, focus on the latest research trends and advancements, and deeply discuss and forecast the future development trends of antibody-drug conjugates.

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References:

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Statement:This article aims to convey industry development information and explore the frontier progress of biopharmaceuticals.The content of the article represents the author's views and does not represent the position of EurekaMed, nor does it constitute any value judgment, investment advice, or medical guidance. If necessary, please consult a professional for investment or visit a正规 hospital for medical advice.

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