SHANGHAI/BEIJING, CHINA, June 30, 2022 — Alebund Pharmaceuticals, a biopharmaceutical company dedicated to developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced a strategic partnership between its subsidiary Alezyme and Peking University First Hospital, to discover, develop and commercialize PKU308/AP308, a potential innovative and specific therapeutic for IgAN. Designed and developed by Peking University First Hospital, this compound has a completely innovative mechanism of action (MOA) as compared to currently available treatment options.
IgAN is the most common form of primary glomerulonephritis, caused by mesangial deposition of poly-IgA complexes. The disease follows a variable course of clinical progression with a high risk for developing kidney failure. Currently there is no specific therapy approved worldwide. Renin-Angiotensin-Aldosterone-System inhibtors (RAASi), oral steroids and immune-suppressive agents are mainly used in clinical practice.
PKU308/AP308 is an IgA protease fusion protein that is developed by the research team of Professor Hong Zhang and Professor Jicheng Lv from Peking University First Hospital. This protease class has demonstrated superior in vitro and in vivo enzymatic activity to human IgA1 complex and acceptable safety profile in the animal model. These proteases also have prolonged half-life in vivo, which supports them to become a potential therapeutic for IgAN. These results were recently cited by Nature as the new promising IgAN-specific target potentially [1].
“We are excited to partner with the team of Professor Zhang and Professor Lv on PKU308/AP308,” said Gavin Xia, PhD, Alebund’s Chief Executive Officer. “There is significant unmet need to delay and even stop the progression for patients with IgAN to renal failure. PKU308/AP308 is a potential first-in-class therapeutic that directly acts on the pathologic origin; it offers a huge hope to patients in need worldwide. We will continue to work closely with the Peking University research team to advance the program to clinical testing as soon as possible.”
“PKU308/AP308 has the potential to be the first Category I drug originated in China to treat IgAN. We are very pleased to partner with Alebund, and are committed to the advancement of this project.” said Professor Li Yang, Assoicate Dean and Head of Renal Division from Peking University First Hospital.
Under the agreement, Alezyme will gain an exclusive and irrevocable license of PKU308/AP308 to research, develop, and commercialize globally from Peking University First Hospital, with the right to grant sublicenses. Meanwhile, Alezyme will continue to work with Professor Zhang and Professor Lv in advancing the related research. Peking University First Hospital will receive an undisclosed amount of upfront payment and royalty payments after PKU308/AP308 is commercialized.
Reference
- Carney, E.F. A recombinant fusion protein clears IgA deposits. Nat Rev Nephrol 18, 273 (2022). https://doi.org/10.1038/s41581-022-00568-x
About IgA Nephropathy (IgAN)
IgA nephropathy (IgAN) is the most common type of primary glomerulonephritis worldwide and a leading cause of end-stage kidney disease (ESKD). Current therapies are mainly supportive treatments with RAAS blockade, oral steroids and immune-suppressive agents. Glomerular mesangial deposition of IgA1 immune complexes is the hallmark of IgAN and circulating poly-IgA complexes are considered the source of the deposits.
About Alebund
Alebund is a clinical stage biopharmaceutical company and is dedicated to the discovery and development of novel therapies and to providing better clinical solutions to patients with kidney diseases and related chronic conditions. Alebund has built a diversified and balanced pipeline of drug candidates targeting a range of renal diseases, including chronic kidney disease /dialysis complications, IgA nephropathy, diabetic kidney disease, and autosomal dominant polycystic kidney disease (ADPKD). Alebund’s pipeline comprises both small-molecule and biologic assets.
上海礼邦医药宣布与北京大学第一医院合作开发一类 IgA 肾病突破性疗法
（中国上海/北京，2022 年 6 月 30 日）上海礼邦医药，一家致力于肾脏病以及相关慢性病药物研发的生物制药公司，宣布其子公司君祉医药与北京大学第一医院达成战略合作，共同推进一款针对 IgA 肾病的潜在突破性疗法 PKU308/AP308 及同类产品的研究、开发及商业化。该项目由北大第一医院自主设计并开发，其作用机制有别于任何现有的 IgA 肾病治疗手段。
IgA 肾病是全球最常见的一种原发性肾小球肾炎，由 IgA 多聚复合物在肾小球系膜上的沉积引起。这类疾病的临床表现与疾病进展类型多样，引发肾功能衰退乃至肾衰竭的风险很高，目前临床上的治疗手段主要为肾素-血管紧张素-醛固酮系统抑制剂（RAASi），口服激素类药物和免疫抑制剂。
PKU308/AP308 药物是由该院吕继成/张宏教授提出并牵头完成的一款 IgA 蛋白酶融合蛋白。在前期大量的研究中，团队已经证实了该类蛋白酶在体内体外都对人 IgA1 免疫复合物有极高的酶活性，并且在动物模型中展示了良好的安全性，该蛋白在体内较长的半衰期也支持其可能成为 IgA 肾病的新疗法，国际著名期刊 Nature 网站专门做了报道，并指出该类机制有望开发出治疗 IgA 肾病的特异性靶向药物 [1]。
北京大学第一医院近年来重视并全力支持科研成果的转化，医院副院长、肾脏内科主任杨莉教授表示了对于该项目的强烈信心和支持：“PKU308/AP308 项目研发有望推出第一款由中国原研、特异性治疗肾炎的 I 类新药，北京大学第一医院非常高兴能够和礼邦制药达成数亿金额项目的研发合作，并全力推进和支持该项目的研发”。
“我们非常高兴能与北京大学肾脏病研究所进行 PKU308/AP308 项目的合作。”礼邦医药的首席执行官夏国尧博士说道，“延缓乃至遏止 IgA 肾病患者向肾衰竭进展，是一个非常大的未满足的临床需求。PKU308/AP308 项目直接作用于该疾病的病理源头，有望成为一款同类第一（First-in-Class）的新药，并完全改变当前的治疗格局，给全球的患者带来新的希望。接下来，我们会继续与北京大学第一医院的研究团队紧密合作，全力推进项目的研发”。
根据合作协议，君祉将获得 PKU308/AP308 研究、开发、生产、销售、分许可的全球独占许可权利。同时，君祉将继续委托吕继成/张宏教授团队进行实验室阶段的研究工作（共同开发）。北京大学第一医院将收到一笔未披露金额的首付款，并在 PKU308/AP308 商业化之后持续获得特许权使用费。
参考文献
- Carney, E.F. A recombinant fusion protein clears IgA deposits. Nat Rev Nephrol 18, 273 (2022). https://doi.org/10.1038/s41581-022-00568-x
关于 IgA 肾病
IgA 肾病是全球最常见的一种原发性肾小球肾炎，也是导致终末期肾病的主要原因。当前可用的治疗手段，主要是基于 RAAS 抑制剂、口服激素类药物和免疫抑制剂等支持性治疗。肾小球系膜中 IgA1 免疫复合物的沉积是 IgA 肾病的标志，循环中的多聚 IgA 复合物被认为是沉积物的来源。
关于礼邦医药
礼邦医药是一家处于临床阶段的生物制药公司，具有强大的新药研发和临床开发能力。公司主要致力于肾脏病以及其他相关慢性疾病的创新药物发现和开发，为肾脏病及相关慢性疾病患者提供更佳的临床解决方案。礼邦医药已经建立起了丰富且均衡的肾脏病新药产品管线，包括针对慢性肾脏病/透析并发症、IgA 肾病、糖尿病肾病和常染色体显性多囊肾病等产品，公司同时拥有小分子药物和生物制剂在研。