NEWS

HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immuno-biomedicines, announced today that the Taiwan Food and Drug Administration (TFDA) has approved its investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently-developed novel drug candidate, HCB101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.

以開發創新免疫生物藥物的全球臨床階段生物技術公司-漢康生技今天宣布，台灣衛生福利部食品藥物管理署 (TFDA) 已批准其在研新藥申請 (IND)，以開展獨立研發的新藥候選物 HCB101 的多區域臨床試驗，用於治療晚期實體瘤或復發難治性非霍奇金淋巴瘤患者。

"HCB101 is our first program in our pipeline which recently received IND clearance by US FDA and now obtained IND approval from TFDA of this multi-regional, multi-center clinical trial.  HCB101 project was initiated in December, 2021, and the U.S. IND was submitted in March, 2023; the 2.3 year from inception to IND was a record for a biotech company of our size.  The opportunity to bring this potential fusion protein to cancer patients who have such a high unmet medical need is at the core of what drives us as a company,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “With a strong pipeline targeting both the adaptive and innate immunity and the Fc-based designer biologics (FBDB™) platform we have built, HanchorBio is well positioned to make important impacts in delivering innovative, cutting-edge immunotherapies.”

漢康生技的創辦人、董事長兼執行長 Scott Liu博士表示：「HCB101是我們研發進行中的第一個項目，最近獲得了美國FDA的IND批准，現在又獲得了台灣食藥署對這個多區域、多中心臨床試驗的IND批准。HCB101項目於2021年12月啟動，並於2023年3月提交美國IND，僅用2.3年的時間，對於我們這種規模的生物技術公司來說是創紀錄的。為了那些有高度醫療需求的癌症患者帶來這種有潛力的融合蛋白質，是我們的核心驅動力。憑藉我們針對適應性免疫和先天性免疫開發的項目以及建立的以Fc為基底設計的生物技術平台（FBDB™），漢康生技已做好充分的準備在提供創新、尖端免疫療法方面，產生重要影響。」

Sean Juo, Ph.D., President and Chief Scientific Officer of HanchorBio, commented, “Beside the excellent preclinical safety profiles of HCB101 leveraging the “do not eat” signal pathway, HCB101 has demonstrated superior anti-tumor efficacy in our extensive preclinical studies of murine xenograft tumor models when comparing head-to-head with other agents targeting the same pathway currently being investigated in clinical trials.” “IND approval from TFDA within 23 working days (a speed record) is a testament to our in-house drug development capabilities and strong clinical operations through our partnership with global CRO companies. Our team already initiated this clinical trial in the US, and I look forward to enrolling the first patient soon,” said Dora Weng, R.N., Clinical Operations Head of HanchorBio.

漢康生技總經理兼首席科學官Sean Juo博士表示：「HCB101在“別吃我”信號路徑有重要影響，除了有出色的臨床前安全性外，在我們對小鼠異種移植腫瘤模型進行的廣泛臨床前研究中，與目前在臨床試驗中的其他相同路徑的藥物對比， HCB101表現出更卓越的抗腫瘤功效。」 漢康生技臨床資深總監 Dora 翁表示：「在 23 個工作日內即獲得台灣食藥署的 IND 批准，證明了我們的內部藥物開發能力以及通過與全球 CRO 公司的合作而實現的強大臨床運營能力。 我們的團隊已經在美國啟動了這項臨床試驗，我期待盡快招募第一位患者。」

Using structure-guided protein design and engineering supplemented with relevant screening technologies, HCB101 is an engineered extracellular domain of SIRPα fused to the Fc region of IgG4. HCB101 triggers phagocytic activity of the macrophages by blocking the “do not eat” signal between macrophages and tumor cells. Based on the extensive in-vitro and in-vivo preclinical data, HCB101 is potentially a safer and more potent biologic than the anti-CD47 monoclonal antibodies and SIRP fusion proteins currently being investigated in clinical trials. Furthermore, quantitative RNA transcriptional analysis indicated that HCB101 triggered distinct gene expression profiles inside the tumor and in the tumor microenvironment comparing to other relevant clinical candidates, suggesting that HCB101 might exhibit unique mechanisms of action. Using HCB101 as the foundation, our pipeline will include other arms targeting both adaptive and innate immunity to help revolutionize the treatment of patients with cancer and other debilitating diseases.

HCB101 採用結構導向的蛋白質設計和工程，並輔以相關篩選技術，它是SIRPα的工程化細胞外區域與IgG4的Fc區域融合而成。 HCB101通過阻斷巨噬細胞和腫瘤細胞之間的“別吃我”信號來觸發巨噬細胞的吞噬活性。 基於廣泛的體外和體內臨床前數據，HCB101可能是比目前臨床試驗中的抗CD47單株抗體和SIRPα融合蛋白更安全、更有效的生物製劑。 此外，定量RNA轉錄分析表明，與其他相關臨床候選藥物相比，HCB101在腫瘤內部和腫瘤微環境中觸發了不同的基因表現譜，這表明HCB101可能表現出獨特的作用機制。 以 HCB101 為基礎，我們的產品線將包括針對適應性和先天性免疫的其他武器，以幫助徹底改變癌症和其他衰弱疾病患者的治療。

HCB101-101 is a multi-regional, multi-center, open-label, dose-finding, first-in-human (FIH) study of adults with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma in the United States and Taiwan.  The purposes of the study are to evaluate the safety, tolerability, pharmacokinetics, and clinical anti-tumor activity of weekly HCB101 intravenous injections. The US sites initiation of the HCB101-101 is on track within Q3-2023.

HCB101-101是一項多區域、多中心、開放標籤、劑量探索、首次人體（FIH）研究，對象是美國和台灣的晚期實體瘤或複發難治性非霍奇金淋巴瘤成人患者。 該研究的目的是評估每週一次靜脈注射HCB101的安全性、耐受性、藥物動力學和臨床抗腫瘤活性。 HCB101-101 的美國站點啟動工作將於 2023 年第三季度按計劃進行。

Based in Taipei, Shanghai, and San Francisco Bay Area, HanchorBio is a global clinical-stage biotechnology company focusing on immuno-oncology. The Company is led by an experienced team of pharmaceutical industry veterans with proven track-record of success in biologics discovery and global development to transcend current cancer therapies. Committed to reactivating the immune system to fight against diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables unique biologics with diverse multi-targeting modalities to unleash both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. 

漢康生技總部位於台北、上海和舊金山灣區，是一家專注於免疫腫瘤學的全球臨床階段生物技術公司。 該公司由經驗豐富的製藥行業資深人士領導，他們在生物製劑發現和全球開發以超越當前癌症療法方面擁有成功的記錄。 專有的以Fc為基底設計的生物製劑 (FBDB™) 平台致力於重新激活免疫系統來對抗疾病，使獨特的生物製劑具有多種多靶向模式，以釋放先天性和適應性免疫，以克服當前抗 PD1/L1 免疫療法的挑戰。 FBDB™ 平台已成功在多種體內腫瘤動物模型中提供概念驗證數據。 通過在研發上突破多功能創新分子構型以及改進CMC製造工藝，漢康生技開發轉化性藥物來解決未滿足的醫療需求。

For more information, please visit: www.HanchorBio.com

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