康方生物-B(09926.HK)：PD-1/VEGF雙特異性抗體(AK112)聯合CD47單抗(AK117)獲批開展治療晚期惡性腫瘤的臨牀研究
格隆匯10月11日丨康方生物-B(09926.HK)宣佈，公司自主研發的新型腫瘤免疫治療藥物PD-1/VEGF雙特異性抗體(研發代號：AK112)獲得中國國家藥品監督管理局藥品審評中心(CDE)批准，開展治療晚期惡性腫瘤的Ib/II期的臨牀研究。
這項臨牀研究旨在評估AK112聯合AK117治療晚期惡性腫瘤的安全性、耐受性、藥物代謝動力學、免疫原性、藥效學以及抗腫瘤活性。
這是AK117繼聯合PD-1/CTLA-4雙特異性抗體(研發代號：AK104)治療晚期實體瘤，和聯合阿扎胞苷治療血液瘤之後，開展的又一項聯合雙特異性抗體治療實體瘤的聯合療法。公司充分利用自身豐富的在研管線，針對血液瘤和實體瘤，全力推動AK117多項聯合療法的臨牀研究，以加速AK117的開發進程。
CD47高表達在腫瘤細胞表面。CD47阻斷可以刺激巨噬細胞對腫瘤細胞的吞噬功能，且可通過樹突狀細胞促進適應性免疫反應。目前初步研究表明，抗PD-1藥物和靶向CD47聯合治療通過激活適應性免疫反應具有協同抗腫瘤功效，在選定的實體瘤患者中顯示了良好的抗腫瘤療效，且未增加安全性風險。
同時，相關研究也表明，CD47的上調可抑制巨噬細胞的吞噬作用和VEGF/VEGFR抑制劑的抗腫瘤作用。同時，抗VEGF/VEGFR治療也可誘導CD47上調，從而抑制巨噬細胞抗腫瘤功能。因此，同時阻斷VEGF和CD47，可有效抑制抗血管生成治療而誘導的免疫抑制途徑，同時加強巨噬細胞吞噬作用，以提高抗腫瘤療效。
目前，AK112已經在全球範圍率先進入III期臨牀研究階段，AK117也是全球臨牀研發進度領先的CD47單抗之一。AK112和AK117聯合治療將有望同時激活先天性免疫和適應性免疫通路，增強免疫系統對腫瘤的定向識別。公司相信通過這兩個藥物的聯合運用，能夠發揮出PD-1、VEGF和CD47這三個腫瘤免疫靶點的共同作用，以獲得比現有療法更佳的抗腫瘤效應。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
