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信達生物(01801.HK)抗CD47/PD-L1雙特異性抗體1期臨牀研究完成中國首例患者給藥
格隆匯 08-03 07:58

格隆匯 8 月 3日丨信達生物(01801.HK)發佈公告,公司自主開發的潛在首創重組抗CD47/ PD-L1雙特異性抗體(IBI-322)的1期臨牀研究完成中國首例患者給藥。

該研究是一項在中國開展的評估IBI-322治療晚期惡性腫瘤受試者的1a/1b期臨牀研究,該研究主要目的為評估IBI-322在標準治療失敗的晚期惡性腫瘤患者中的安全性、耐受性和初步的抗腫瘤活性。

臨牀前研究顯示,IBI-322可有效阻斷SIRP-α與CD47結合,誘導巨噬細胞對CD47 和PD-L1共表達的腫瘤細胞發揮吞噬作用,效用與抗CD47單抗相當。初步研究結果顯示,IBI-322較單特異性抗CD47抗體有更高的有效性和安全性。另一方面, IBI-322可有效阻斷PD-1與PD-L1結合,激活CD4+T淋巴細胞,效用與抗PD-L1單抗相當。雖然免疫檢查點抑制劑在多種腫瘤的治療中已展現出顯着的療效,但臨牀上已出現了一部分對其耐藥的患者,免疫檢查點抑制劑的療效也有需要進一步提高。此外,與單克隆抗體藥物聯合用藥治療相比,雙特異性抗體可以為患者創造更低的用藥成本。因此,開發下一代抗腫瘤免疫雙特異性抗體有很大價值,抗 CD47/PD-L1雙特異性抗體將有望為患者提供新型、全面、有效且經濟的治療方案。

IBI-322是公司自主研發的重組抗CD47/PD-L1雙特異性抗體。IBI-322屬於1類創新藥,具有首創潛力分子,能夠有效誘導吞噬腫瘤細胞及刺激T細胞活化,發揮抗腫瘤活性。IBI-322更易親和腫瘤組織,從而減少靶點對正常組織的毒性並延緩耐藥的發生,為腫瘤患者提供更有效的治療方案。IBI-322已獲得中國國家藥品監督管理局和美國食品藥物管理局的IND批准,我們正在全球積極準備開發它。

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