TSLP Antibody Approved for Clinical Trials: Efficacy Extends Beyond Asthma to COPD!

On February 5, 2024, Harbour BioMed announced that the IND application for HBM9378 (SKB378), a TSLP-targeting monoclonal antibody jointly developed with Kelun-Biotech Medicine for the treatment of Chronic Obstructive Pulmonary Disease (COPD), has been approved by the National Medical Products Administration (NMPA) in China. This marks the official entry of the innovative antibody into clinical development, offering a potential new treatment option for COPD patients.

Image source: Harbour BioMed Official Website News Center

(https://www.harbourbiomed.com/news/232.html)

HBM9378 is the second global fully human monoclonal antibody targeting TSLP, jointly developed by Harbour BioMed and Kelun-Biotech Medicine, with both companies holding rights in Greater China and select Southeast Asian and Middle Eastern markets. This antibody is developed using Harbour BioMed's proprietary H2L2 Harbour Mice® platform, it works by blocking the TSLP signaling pathway to intervene in the development of immune diseases such as asthma and COPD. Compared to existing products, HBM9378 has optimized immunogenicity, bioavailability, and half-life, with a half-life 2-3 times longer than Tezepelumab, significantly improving dosing convenience. On January 10 this year, the two companies signed a global licensing agreement worth up to $1 billion with Windward Bio AG to drive the exclusive development and commercialization of HBM9378 outside Greater China. Currently, the antibody has completed Phase I clinical trials for moderate to severe asthma in China.

TSLP: The Next Immune Frontier Surrounded by MNC

TSLP is an IL-2 class cytokine homologous to IL-7, playing a crucial role in immune responses, particularly type 2 immunity. Mechanistically, TSLP regulates immune responses by stimulating type 2 inflammatory cells to secrete pro-inflammatory cytokines such as IL-4, IL-5, and IL-13. Elevated TSLP expression can trigger immune diseases like asthma, atopic dermatitis, and chronic obstructive pulmonary disease (COPD), showcasing significant target potential.

Currently, the only TSLP monoclonal antibody approved is Tezepelumab (Tezepelumab) by Amgen/AstraZeneca, which received FDA approval in December 2021 for treating severe asthma in patients aged ≥12 years. In November 2024, the drug was submitted for approval in China. Besides asthma, Tezepelumab has clinical studies ongoing for multiple indications, including chronic sinusitis with nasal polyps, atopic dermatitis, and COPD. Sales of Tezepelumab have grown significantly, with global sales reaching $170 million in 2022, $570 million in 2023, and $840 million in the first three quarters of 2024.

The successful launch of Tezepelumab has confirmed the drugability and commercial potential of the TSLP target, attracting multiple multinational pharmaceutical companies. Approximately 27 TSLP-related pipelines are under development globally, with notable companies like Sanofi, GSK, AstraZeneca, and Pfizer involved. Among these, Sanofi's IL-13/TSLP bispecific antibody Lunsekimig is progressing rapidly, with phase 3 clinical trials for asthma and chronic sinusitis with nasal polyps.

In recent years, Chinese biotech companies have played a leading role in TSLP pipeline transactions, with firms like Hengrui Medicine and Qsine Biosciences driving the diversification of TSLP drug development collaborations through equity sales and NewCO models.

Business Development Transactions of the TSLP Drug Pipelines

From a market development perspective, it is expected that the asthma market in China will reach $9.7 billion by 2030, and the atopic dermatitis market will grow to $4.3 billion, which greatly drives domestic companies to accelerate their TSLP pipeline layout. BSI-045B from BIOSION demonstrated excellent performance in the Phase IIa single-arm proof-of-concept trial in the U.S., showing its potential first-in-class value. As a result, the stock price of Bio-Design's partner, Aclaris Therapeutics, rose by 53% on the same day. With technological innovation and product advantages, Chinese biotech companies are emerging as key players in the global TSLP field. As the TSLP target continues to gain momentum, companies that focus on differentiated innovative layouts in this field are expected to become the industry's future focal point.

High-quality TSLP Tools Support Drug Development for Allergic and Inflammatory Diseases

ACROBiosystems launches a series of high-quality biopharmaceutical development tools covering TSLP, TSLPR, IL-7 R alpha & TSLP R, meeting the drug development needs for allergic and inflammatory diseases, including asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, and chronic obstructive pulmonary disease.

•  TSLP recombinant proteins, TSLP R recombinant proteins: Both are expressed in human-derived cells HEK293 and validated by SEC-MALS, ELISA, SPR, and BLI, featuring high purity, high activity, high batch-to-batch consistency. They are suitable for applications in immunology, antibody screening, and candidate drug functionality validation.

•  IL-7 R alpha & TSLP R heterodimer recombinant protein: High purity, high activity protein with a dimeric structure verified by SEC-MALS. It simulates the natural TSLPR complex binding with TSLP to initiate downstream signaling pathways. This product can be used to study the interactions between TSLP, TSLPR, and IL-7 R alpha, and to detect TSLP-mediated signaling pathways and biological activity in vitro.

•  TSLP [Biotinylated]: IL-7 R alpha & TSLP R inhibitor screening ELISA kit: The competitive ELISA method is used to establish an inhibitor screening platform. This high-quality inhibitor screening kit is developed using unique biotinylated proteins and has completed validation for bispecific antibody drug screening. It can be used for early-stage screening as well as QC quality control and release.

•  A variety of high-quality targeted drug development tools for allergy and inflammatory diseases, including IL-4, IL-5, IL-5 Rα, IL-13, and IgE Fc are also available, fully supporting your drug development research!

ACROBiosystems performs batch-by-batch quality control on all products, verifying properties such as purity and binding activity, and provides free protocols to streamline integrin-targeted drug development.