▎Edited by the WuXi AppTec content teamThe official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration disclosed that Puzhong Discovery Pharmaceutical Technology (Shanghai) Co., Ltd. (Multitude Therapeutics) submittedNew Class 1 Drug AMT-562 for Injection Approved for Clinical Trials, Intended for Development in Treating Advanced Solid Tumors. Public information indicates that this is aNovel Antibody-Drug Conjugate (ADC) Targeting HER3。Screenshot source: CDE official websiteHER3 is a member of the receptor tyrosine kinase EGFR family, which is widely expressed in solid tumors and is associated with tumor growth, metastasis, drug resistance, and poor prognosis.According to literature reports,AMT-562 is composed of aNovel Anti-HER3 Antibody Ab562And aThe hydrophilicity-enhanced linker MC-VA-PABCCombinePayload exatecan(Ixitecan)Composition.Among them, the antibody portion Ab562 has the potential to reduce potential toxicity and improve tumor penetration, while the payload exatecan exhibits higher cytotoxic potency than its derivative deruxtecan (DXd).According to the publication inMolecular Cancer TherapeuticsA study onWhether it is monotherapy or combination therapy, AMT-562 in HER3 low-expression patient-derived xenograft/organoid models (including digestive system and lung tumors with significant unmet clinical needs)All showed potent and durable antitumor responses。In cynomolgus monkeys, AMT-562 demonstrated favorable pharmacokinetics and safety profiles, with the highest dose showing no severe toxicity at 30 mg/kg.Research shows that AMT-562 has the potential to become a HER3-targeted ADC with a wider therapeutic window, capable of overcoming drug resistance.Moreover, in tumors that are insensitive to another HER3-targeted ADC product, AMT-562 also demonstrated a higher percentage of response and more durable relief.
ClinicalTrialsInformation on the official website shows that AMT-562 is currently undergoing a non-randomized, open-label, multi-center first-in-human Phase 1 clinical study in Australia for advanced solid tumors. In addition, according to information from the CDE’s official website, Puzhong Discovery Pharmaceutical Technology (Shanghai) Co., Ltd. has received clinical approval for several ADC products for the treatment of advanced solid tumors. Apart from AMT-562, which recently received clinical approval, there are also AMT-707 (targeting CDH6), AMT-253 (targeting MUC18), and AMT-151 (targetingFRα), etc.
References:
[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Feb 26, 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
[2] Weng W, Meng T, Pu J, et al. (2023) AMT-562, a
Novel HER3-targeting Antibody-Drug Conjugate, Demonstrates a Potential to
Broaden Therapeutic Opportunities for HER3-expressing Tumors. Mol Cancer Ther. https://pubmed.ncbi.nlm.nih.gov/37302522/This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media feeds, but unauthorized reproduction by media or institutions in any form to other platforms is strictly prohibited. For authorization to reproduce, please contact us by leaving a message on the "MedView" WeChat Official Account. For other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.
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