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Just a few months after raising $200 million in third-round financing, immunology specialist Zenas BioPharma has filed an initial public offering in the US seeking to add another $100 million to the pot.The five-year-old Waltham, Massachusetts-based company is developing a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, called obexelimab, which is in a phase 3 trial as a treatment for IgG4-related disease (IgG4-RD), phase 2/3 in warm autoimmune haemolytic anaemia (wAIHA), and phase 2 in multiple sclerosis (MS) and systemic lupus erythematosus (SLE).Zenas acquired worldwide rights to obexelimab from its original developer Xencor in a $480 million deal agreed in 2021, The drug was a flagship project at Xencor until it failed a phase 2 trial in SLE in 2018, albeit with a trend towards efficacy that the company said warranted further investigation.The company is now waiting for the results of the INDIGO trial in IgG4-RD in 2025, aiming to become the first FDA-approved treatment for the progressive, fibroinflammatory disease, which can cause damage to organs throughout the body and affect 1 to 5 out of every 100,000 people in the US and is more common in men.It has some rivals in its push to the IgG4-RD market, notably Amgen which reported positive topline results from a phase 3 trial of its CD19-directed antibody Uplizna (inebilizumab), acquired as part of its $27.8 billion takeover of Horizon Therapeutics last year.Last year, Zenas licensed certain rights to the drug in Asia to Bristol-Myers Squibb for $50 million upfront plus undisclosed milestones.According to a prospectus on the IPO, Zenas ended the second quarter with around $184 million in cash and has earmarked most of the IPO proceeds for obexelimab's clinical trials programme, although its pipeline als.
这家位于马萨诸塞州沃尔瑟姆的五岁公司正在开发一种靶向CD19和FcγRIIb的双功能单克隆抗体,称为obexelimab,正在进行3期试验,用于治疗IgG4相关疾病(IgG4-RD),温热自身免疫性溶血性贫血(wAIHA)的2/3期和多发性硬化症(MS)和系统性红斑狼疮(SLE)的2期。Zenas在2021年达成的一项4.8亿美元的协议中从其原始开发商Xencor获得了奥贝昔单抗的全球权利,该药物是Xencor的旗舰项目,直到2018年SLE的2期试验失败,尽管该公司表示有一种疗效趋势需要进一步调查。该公司目前正在等待2025年在IgG4 RD上进行的INDIGO试验的结果,旨在成为FDA批准的第一种治疗进行性纤维炎性疾病的方法,这种疾病可能对全身器官造成损害,影响美国每10万人中就有1至5人,并且在男性中更为常见。它在推动IgG4-RD市场方面有一些竞争对手,特别是安进公司,该公司报告了其CD19定向抗体Uplizna(inebilizumab)的第三阶段试验的阳性结果,该试验是去年以278亿美元收购Horizon Therapeutics的一部分。去年,Zenas以5000万美元的预付款和未披露的里程碑向百时美施贵宝(Bristol-Myers Squibb)授予了该药物在亚洲的某些权利。根据首次公开募股的招股说明书,Zenas在第二季度以约1.84亿美元的现金结束,并已将大部分首次公开募股收益用于奥贝昔单抗的临床试验计划,尽管其管道als。