The prevalence of allergic rhinitis in China has risen from 11.1% to 17.6%, with approximately 200 million patients suffering from the disease[1]. On January 12, Sino Biopharm (1177.HK) announced that TQC2938 (ST2 monoclonal antibody), independently developed by Chia Tai Tianqing, has completed its Phase II clinical trial for seasonal allergic rhinitis (SAR). The study results showed that under treatment with the expected recommended Phase 2 dose (RP2D) of TQC2938, both the primary and secondary endpoints were met with positive results in a specific population with a baseline blood eosinophil count (EOS) <0.3×109/L. All dose groups demonstrated good safety and tolerability. 

Primary and Secondary Endpoints Met with Positive Results, Good Safety Profile.

This study is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study led by Professor Zhang Luo and Professor Wang Chengshuo from Beijing Tongren Hospital, Capital Medical University, as principal investigators (PI). It aims to evaluate the efficacy and safety of TQC2938 injection combined with background therapy in patients with seasonal allergic rhinitis (SAR). The primary endpoint was the mean change from baseline in the daily reflective Total Nasal Symptom Score (rTNSS) at 2 weeks of treatment. The study ultimately enrolled 136 patients, who were administered either TQC2938 injection (at low, medium, and high doses) or a placebo once every 4 weeks.

Efficacy data showed that the rTNSS of patients in the low, medium, and high-dose groups all showed a downward trend from baseline at 2 weeks of treatment. At the expected RP2D dose, in the population with a baseline EOS <0.3×10⁹/L, the mean change from baseline in rTNSS at 2 and 4 weeks after a single dose exceeded 1.4 compared to the placebo group. Both the primary and secondary endpoints achieved positive results, showing clinically and statistically significant improvement (p<0.05). Furthermore, all dose groups of TQC2938 showed good safety and tolerability. The overall incidence of adverse events was similar to that of the placebo group, and no new safety risk signals were identified. 

Specifically Binds to ST2, Precisely Blocking the Inflammatory Pathway.

Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa in atopic individuals after exposure to allergens, primarily mediated by immunoglobulin E (IgE). Typical symptoms include sneezing, clear rhinorrhea, nasal itching, and nasal obstruction, and may be accompanied by symptoms such as itchy eyes, tearing, and red eyes. 40% of patients may also have concomitant bronchial asthma. Based on the type of allergen, it can be divided into seasonal allergic rhinitis (SAR) and perennial allergic rhinitis.

Studies have shown that serum soluble ST2 (sST2) concentrations are elevated in patients with AR, especially in those with multisystem allergic rhinitis (MSAR), where elevated sST2 levels are associated with clinical severity as recorded by symptom rating scales^[2]. Previous studies also suggest that targeting IL-33/ST2 can simultaneously inhibit both type 2 and non-type 2 inflammation^[3-6]. TQC2938 is a humanized IgG2 monoclonal antibody independently developed based on the human ST2 sequence. It can precisely "recognize" and bind to the ST2 protein in the body, prevent the binding of IL-33 and ST2, inhibit the activation of the NF-κB and MAPK signaling pathways, and thereby blocking both type 2 and non-type 2 inflammatory pathways to improve allergic rhinitis symptoms and quality of life. 

Breaking Through Existing Treatment Limitations to Benefit Specific Patient Groups.

The treatment principle for AR is "a four-in-one approach combining prevention and treatment". First, environmental control is needed to avoid allergens. Second, intranasal corticosteroids (INCS), and second-generation oral and nasal spray antihistamines are commonly used for symptom control in AR. Furthermore, specific immunotherapy is the only treatment method that can potentially alter the course of disease progression in patients with allergic rhinitis. When drug therapy and/or desensitization therapy is ineffective, nerve block surgery may be considered.

Currently, only one biologic agent is approved in China for the treatment of moderate-to-severe uncontrolled SAR, with the key clinical subjects being the population with a peripheral blood EOS ≥0.3×10⁹/L. A Phase II study of this biologic agent for SAR showed that in the test group with a baseline blood EOS <0.3×10⁹/L, the mean change from baseline in the rTNSS at 2 weeks of treatment was only 0.7 compared to the placebo group^[7], indicating relatively limited clinical improvement. The positive progress of the TQC2938 Phase II clinical study in patients with seasonal allergic rhinitis and a baseline blood EOS <0.3×10⁹/L is expected to provide a better treatment option for this patient population, injecting new momentum into improving the treatment for nearly 200 million patients with allergic rhinitis in China. 

References:

[1] Chinese guidelines for diagnosis and treatment of allergic rhinitis (2022, revision). Chinese Journal of Otorhinolaryngology Head and Neck Surgery 57.02(2022):106-129.

[2] Zhu K, Xia C, Chen J, et al. Serum Soluble ST2 Correlated with Symptom Severity and Clinical Response of Sublingual Immunotherapy for House Dust Mite-Induced Allergic Rhinitis Patients.Mediators Inflamm.2021;2021:5576596.

[3] Xi Y, Tao ZZ. Biological characteristics of interleukin-33 and its relationship with allergic rhinitis [J]. Chinese Journal of Allergy & Clinical Immunology, 2020, 14(5):485-489.

[4] [Smithgall MD, Comeau MR, Yoon BR, Kaufman D, Armitage R, Smith DE. IL-33 amplifies both Th1- and Th2-type responses through its activity on human basophils, allergen-reactive Th2 cells, iNKT and NK cells.Int Immunol.2008;20(8):1019-1030.

[5] Zhou Y, Xu Z, Liu Z. Role of IL-33-ST2 pathway in regulating inflammation: current evidence and future perspectives.J Transl Med. 2023;21(1):902.

[6] Dwyer GK, D'Cruz LM, Turnquist HR.Emerging Functions of IL-33 in Homeostasis and Immunity.Annu Rev Immunol.2022;40:15-43.

[7] Zhang Y, Yan B, Zhu Z, et al.Efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial.EClinicalMedicine.2024;69:102467.

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3.The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific information about disease diagnosis and treatment, please follow the advice or guidance of a doctor or other healthcare professional. 

Forward-Looking Statements:

This press release contains certain forward-looking statements, including statements regarding the clinical development plan, expectations of clinical benefits and advantages, commercialization outlook, the likelihood of clinical benefit for patients, and potential commercial opportunities for [TQC2938]. Words such as "expect", "believe", "continue", "may", "estimate", "hope", "intend", "plan", "potential", "predict", "project", "should", "will", "propose", and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. These forward-looking statements are predictions or expectations made by the company based on currently available data and information, and actual results may differ materially from these forward-looking statements due to uncertainties or risks such as policy, R&D, market, and regulatory factors. Current or potential investors are advised to carefully consider the potential risks and should not place undue reliance on the forward-looking statements in this press release, which contain information only as of the date of this press release. Unless required by law, the company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events, or other circumstances. 

Source: Sino Biopharmaceutical Limited official website, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. official WeChat account