台北、舊金山、上海，2023年4月17日
漢康生技（HanchorBio Inc.），一家專注於腫瘤免疫治療新藥研發與臨床的全球生技公司，今日宣佈其自主研發的創新融合蛋白HCB101獲得美國食品藥物管理局（FDA）授予新藥臨床試驗（IND）許可，即將開展多地區多中心的臨床試驗。此藥將用於治療晚期實體瘤及復發難治癒的非霍奇金淋巴瘤。
漢康生技總經理兼研發長卓宗顯博士也說道：“基於我們在15種不同的小鼠異株移植腫瘤模型的研究，無論是在血液瘤或實體瘤，HCB101於單一療法還是與其他藥物聯用治療上都顯示出卓越的抗癌功效；尤其是把HCB101與目前正進行臨床試驗的同類型藥物作對比後，其優勢更加明顯。不僅如此，相對於其他抑制CD47的藥物比較上，HCB101在靈長類動物食蟹猴毒理學試驗中表現出優秀的安全性，更是沒有觀察到紅血球及血小板的異常；這是一個安全性的重要指標。我們將儘快推展HCB101的臨床試驗，並繼續致力於創新藥品的研發，進而開拓腫瘤免疫治療的領域，並解決多數病患對現今療法仍無法獲益的需求”。
關於HCB101
利用結構導向的蛋白質設計和工程改造，並輔以相對應的篩選技術，HCB101為一個以IgG4-Fc為基底，嵌上工程優化的SIRPα融合蛋白後所創造的生物新藥。HCB101通過阻斷巨噬細胞和癌細胞之間的“不要吃我”信號來觸發巨噬細胞的吞噬活性。大量臨床前研究資料顯示，HCB101可成為一個比其他CD47單株抗體或SIRPα融合蛋白更為安全而且更有療效的生物製劑。此外，從定量RNA轉錄分析得知，對比於其他相關的臨床藥品，HCB101在癌細胞內及腫瘤微環境引發了明顯不同的基因表現型態，這表示HCB101可能具有獨特的作用機轉。
關於HCB101的國際多中心臨床試驗
HCB101-101是一項在美國和臺灣進行的多地區、多中心、非盲性試驗、劑量探索、首次入人體（FIH）的臨床試驗，用於治療晚期實體瘤或復發難治性非霍奇金淋巴瘤的成年患者。該研究的目標是評估每週靜脈注射HCB101的安全性、耐受性、藥物代謝動力學和初步臨床抗腫瘤療效。HCB101的臨床試驗計畫目前正經臺灣食藥署(TFDA)的審查。
關於漢康生技
漢康生技是一家臨床階段，專注於腫瘤免疫治療新藥研發的全球生物技術公司，目前公司所在地分佈於台北、上海以及美國舊金山。公司的領導團隊成員在生物製藥研發方面擁有多年跨國的豐富經驗，致力於超越現今的抗癌治療模式而更創新的突破。其專有的“Fc為基礎的多功能創新型生物製劑（FBDB™）”平臺具有多種靶向模式的獨特生物製藥，能夠充分融合先天性免疫和適應性免疫的潛力，藉以克服現有抗PD-1/L1免疫療法中遇到療效不足的挑戰。通過FBDB™平臺開發的生物製藥已經成功地在多種小鼠腫瘤模型中得到了概念性的驗證資料。通過在研發階段對創新分子構型功能上的突破、以及在工藝開發階段對生產工藝的優化與改進，漢康生技致力于以創新生物藥品來解決腫瘤免疫治療領域中尚未滿足的臨床需求。
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SHANGHAI,TAIPEI, and SAN FRANCISCO, April 16, 2023 – HanchorBio Inc., a global clinical-stagebiotechnology company developing innovative immuno-medicines, announced todaythat the US. Food and Drug Administration (FDA) has cleared its investigationalnew drug (IND) application to initiate a multinational clinical trial of itslead drug candidate, HCB101, for the treatment of patients with advanced solidtumors or relapsed and refractory non-Hodgkin lymphoma.
ScottLiu, Ph.D., Founder, Chairman, and Chief ExecutiveOfficer ofHanchorBio, commented, “Although there is demonstrated history of PD-1/L1immune checkpoint inhibitors showcasing strong efficacy in a variety of cancers,there is a large percentage of cancer patients who are either refractory to theseimmunotherapies or develop resistance. HCB101 is our leading candidate to blockthe “do not eat me” SIRPα-CD47 signaling pathway sufficiently eliminating tumor cells bymacrophage while exhibiting excellent safety profile in preclinical setting. The FDA clearance of ourfirst IND marks a significant milestone for HanchorBio and demonstrates ourteam’s focus and commitment to bringing novel immunotherapies to patients withsignificant unmet need.”
“HCB101has demonstrated superior anti-tumor efficacy, both as monotherapy and incombination with other agents. This is based on our studies in over 10 murinexenograft tumor models (including multiple solid tumor models), comparingHCB101 with other agents targeting the CD47-SIRPa pathway currently beinginvestigated in clinical trials,” said Sean Juo, Ph.D., President and ChiefScientific Officer of HanchorBio. “Unlike other CD47-blocking agents, HCB101 exhibitsgood safety profiles in the repeat-dose cynomolgus monkey toxicology studies.No abnormality of RBC or platelet levels were observed. I look forward toadvancing the clinical development of HCB101 to hopefully bring clinicallymeaningful benefits to patients as early as possible.”
AboutHCB101
Using structure-guided protein design and engineering supplemented with phage display technology, HCB101 is an engineeredextracellular domain of SIRPα fusedto the Fc region of IgG4. HCB101 triggers phagocytic activity of themacrophages by blocking the “do not eat” signal between macrophages and tumorcells. Based on the extensive in-vitro and in-vivo preclinicaldata, HCB101 is potentially a safer and more potent biologic than the anti-CD47monoclonal antibodies and SIRPa fusion proteins currently being investigated in clinical trials.Furthermore, quantitative RNA transcriptional analysis indicated that HCB101triggered distinct gene expression profiles comparing to other relevant clinicalcandidates, suggesting that HCB101 might exhibit unique mechanisms of action.”
AboutMulti-national Clinical Trial of HCB101
HCB101-101 is a multinational, multicenter,open-label, dose-finding, first-in-human (FIH) study of adults with advancedsolid tumors or relapsed and refractory non-Hodgkin lymphoma in the UnitedStates and Taiwan. The purposes of thestudy are to evaluate the safety, tolerability, pharmacokinetics, and clinicalanti-tumor activity of weekly HCB101 intravenous injections. The HCB101 IND ison track being reviewed by the Taiwan FDA.
AboutHanchorBio
Based in Taipei, Shanghai, and SanFrancisco Bay Area, HanchorBio is a global clinical-stage biotechnology companyfocusing on immuno-oncology. The Company is led by an experienced team ofpharmaceutical industry veterans with proven track-record of success inbiologics discovery and global development to rewrite cancer therapies. Committed toreactivating the immune system to fight against diseases, the proprietaryFc-based designer biologics (FBDB™) platform enables unique biologics withdiverse multi-targeting modalities to unleash both innate and adaptive immunityto overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB™platform has successfully delivered proof-of-concept data in several in vivotumor animal models. By making breakthroughs in multi-functional innovativemolecular configurations in R&D and improving the manufacturing process inCMC, HanchorBio develops transformative medicines to address unmet medicalneeds.
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