Sanofi's Bispecific Nanobody Lunsekimig Granted New Clinical Trial Approval in China for High-Risk Asthma

Nov 13, 2024 08:17 CST Updated 08:17

Sanofi

Pharmaceutical R&D Developer

▎WuXi AppTec Content Team Report

The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration recently announced,Sanofi's申报的1类新药lunsekimig注射液获得一项新的临床试验默示许可，拟开发用于TreatmentAdult High-Risk Asthma. The product has previously been approved for IND in China, targeting the indication ofAdults with moderate to severe asthma.

Public information shows that Lunsekimig (previously known as SAR443765)Is aNanobody Connecting the Heavy Chain Variable Region (VHH) Targeting IL-13 and the Heavy Chain Variable Region (VHH) Targeting TSLP. Sanofi in the previousR&D DayThe above indicates that the product has the potential to become a blockbuster drug.

Image Source:CDE Official Website

Public data shows that asthma is a chronic lung disease that affects people of all ages.It is a disease caused by inflammation around the airways and muscle tightening, making breathing more difficult.Many factors may exacerbate the risk of asthma.Such as exposure to a series of environmental allergens and irritants, other family members (especially close relatives) also having asthma issues, and viral respiratory infections that affect lung development, etc.

Lunsekimig is aThymic Stromal Lymphopoietin（TSLP) andInterleukin-13（IL-13）Dual Blockers.IL-13 and TSLP are both validated targets in the fields of immunology and inflammation, as well as key mediators in the pathophysiology of asthma. Simultaneously inhibiting these two signaling pathways may produce a synergistic effect, leading to enhanced efficacy.

▲Lunsekimig Overview (Image Source:Sanofi Official Website)

In a Phase 1b clinical trial for the treatment of asthma patients,Lunsekimig significantly improved patients' fractional exhaled nitric oxide (FeNO), an indicator reflecting airway inflammation, compared to monotherapy targeting IL-13 or TSLP.This result shows the potential synergistic effect of blocking these two signaling pathways.

According to the official website of the Chinese Drug Clinical Trials and Information Disclosure Platform, Sanofi is conducting two projects targetingAdult Subjects with Moderate to Severe AsthmaPhase 2 clinical study to explore the dose range of lunsekimig and evaluate the long-term safety and efficacy of the product.

According to the pipeline information on Sanofi's official website, lunsekimig is currently in Phase 2 clinical development internationally, with proposed indications includingAsthmaAndChronic Rhinosinusitis with Nasal Polyps。

Sanofi has multiple bispecific nanobodies based on Nanobody technology under development. Besideslunsekimig，Anti-GPC3/TCR NanobodySAR444200Previously approved for clinical trials in China, intended for the development of solid tumor treatments;Bispecific Nanobody Targeting TNFα and OX40LSAR442970Has also recently filed an IND in China.

References:

[1] Website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Nov 11, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]Sanofi R&D day. Retrieved December 7, 2023, from https://www.sanofi.com/assets/dotcom/content-app/events/investor-presentation/2023/r-and-d-day-2023/Presentation.pdf

[3] Sanofi Official Website Pipeline Information. From https://www.sanofi.com/en/our-science/our-pipeline

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