IRNAOMICS(2257.HK):A DIFFERENTIATED BIOTECH COMPANY IN RNAI THERAPEUTICS
IRNAOMICS(2257.HK):A DIFFERENTIATED BIOTECH COMPANY IN RNAI THERAPEUTICS
Two well-verified proprietary RNAi delivery platforms. Sirnaomics is aclinical-stage RNA therapeutics company with a strong presence in both Asia and the US. Delivery platforms are critical to the intact delivery of RNA therapeutics to the cells where they are needed. Sirnaomics has developed two platforms of proprietary delivery technologies: (1) PNP delivery platform for local or systemic administration of RNAi therapeutics to target the activated endothelial cells, multiple liver cell types beyond liver hepatocyte, and (2) GalNAc-RNAi delivery platform GalAhead for subcutaneous administration of RNAi therapeutics to the liver hepatocyte. Based on the PNP platform, Sirnaomics is currently advancing RNAi therapeutics for oncology applications of two core products, STP705 and STP707. Additionally, STP122G represents the first drug candidate of GalAhead technology entering clinical development.
兩個經過充分驗證的專有RNAi交付平台。Sirnaomics是一家臨床階段的RNA治療公司，在亞洲和美國都有強大的影響力。遞送平台對於將RNA療法完整地輸送到需要它們的細胞至關重要。Sirnaomics開發了兩個專有遞送技術平台：（1）PNP交付平台，用於局部或系統地給藥RNAi療法，以靶向活化的內皮細胞，肝臟肝細胞以外的多種肝細胞類型，以及（2）GalNAC-RNAI遞送平台GalAhead，用於在肝臟肝細胞皮下給藥RNAi療法。基於PNP平台，Sirnaomics目前正在推進用於兩種核心產品 STP705 和 STP707 腫瘤學應用的核磁共振療法。此外，STP122G 是 GalAhead 技術進入臨床開發的首個候選藥物。
Prioritized innovative product pipeline. Based on the PNP delivery andGalAhead delivery platforms, Sirnaomics has developed a prioritized innovative product pipeline. Currently, the Company focuses specifically on the US and Asia markets with a strategy to conduct trials in the US first and then extending to Asian countries. The Company's lead drug candidate STP705, formulated for local administration for the treatment of Non- Melanoma Skin Cancer (NMSC), and STP707, formulated for systemic administration for the treatment of solid tumors respectively, have both achieved positive PhII clinical readouts. The Company's top priority is to bring STP705 for the treatment of isSCC toward commercialization. After completing an End-of-PhII meeting with the US FDA in 1H23, the Company is well-positioned to advance the PhIII confirmatory clinical development of STP705 for the treatment of isSCC with FDA's guidance. The PhII trial of STP705 in BCC is expected to have final data readout in 2H23. For medical aesthetics applications, with excellent safety and clear efficacy signals demonstrated in PhI study for fat reduction in adults undergoing abdominoplasty, the Company is preparing a communication package for consultation with FDA regarding the initiation of a PhII study, and is also in active discussion on potential collaborations. For STP707, with the positive interim data, the Company will explore collaboration of a PhII combination trial combining STP707 with novel approved cancer therapies such as immune checkpoint inhibitors as well as chemotherapy for solid tumors (i.e. CCA, HCC, melanoma or pancreatic cancer).
優先考慮創新產品管道。基於PNP交付和GalAhead交付平台，Sirnaomics開發了優先創新產品管道。目前，該公司專門關注美國和亞洲市場，其戰略是先在美國進行試驗，然後擴展到亞洲國家。該公司爲治療非黑色素瘤皮膚癌（NMSC）的地方藥物（NMSC）配方的主要候選藥物 STP705 和分別用於治療實體瘤的系統給藥的 STP707 均取得了陽性的 PhiI 臨床讀數。該公司的首要任務是將用於 iSSCC 治療的 STP705 推向商業化。在23年上半年完成了與美國食品藥品管理局的PHII會議結束後，該公司完全有能力在食品藥品管理局的指導下推進用於治療iSSCC的 STP705 的PhiII確認性臨床開發。在 BCC 進行的 STP705 PhiI 試驗預計將在 23 年下半年公佈最終數據。對於醫學美容應用，PhI研究顯示出卓越的安全性和清晰的療效信號，該公司正在準備一份溝通包，就啓動PhIi研究與FDA進行磋商，同時也在積極討論潛在的合作。對於 STP707，憑藉積極的中期數據，該公司將探索一項將 STP707 與獲得批准的新型癌症療法（例如免疫檢查點抑制劑以及實體瘤（即 CCA、HCC、黑色素瘤或胰腺癌）的化療相結合 PhiI 聯合試驗。
譯文內容由第三人軟體翻譯。