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扩大合作 药明合联赋能Cidara Therapeutics加速抗肿瘤偶联药物(DFC)开发

扩大合作 药明合联赋能Cidara Therapeutics加速抗肿瘤偶联药物(DFC)开发 药明生物
2023-02-02
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导读:Swipe Left For English News内容摘要本次扩大合作将聚焦在肿瘤药物开发,此前双方已达


Swipe Left For English News


内容摘要


本次扩大合作将聚焦在肿瘤药物开发,此前双方已达成流感治疗候选药物小分子-Fc偶联药(DFC)CD388的CMC开发和GMP生产合作



中国上海和美国加利福利亚州圣地亚哥,

2023年2月2日


全球领先的生物偶联药CRDMO服务公司药明合联(WuXi XDC)与致力于改善重疾患者疾病治疗的生物技术公司Cidara Therapeutics (以下简称Cidara,纽交所股票代码: CDTX)今日宣布扩大双方合作关系。根据协议,药明合联将为Cidara公司提供其肿瘤项目新药临床试验申请相关的CMC开发服务。


Cidara公司的肿瘤治疗项目靶向CD73腺苷通路,该通路通过肿瘤微环境产生的腺苷(一种有效的免疫细胞抑制剂)促进实体肿瘤的免疫逃避。CD73在多种肿瘤细胞、基质细胞以及免疫抑制细胞群中高度表达,如调节性T细胞和骨髓来源抑制细胞(MDSCs)。Cidara的小分子-Fc偶联药CD73 旨在突破靶向CD73的小分子和单抗候选药物活性、有效性、药代动力学和安全性瓶颈。



Jeff Stein

博士

Cidara Therapeutics

总裁、CEO




“药明合联是我们在研流感项目小分子-Fc偶联药CD388 的杰出开发和生产合作方。非常高兴双方进一步扩大合作,结合药明合联在生物药生产制造上的核心优势与我们在DFC领域的精深造诣,合力加速推进同类最佳肿瘤药物的开发进程。”





李锦才博士

药明合联

首席执行官




“我们非常高兴进一步扩大与Cidara公司的合作。此次扩大合作是药明合联行业领先业务能力与丰富经验的又一力证。我们将再接再厉,继续以高质量、高标准,为全球客户提供开放式技术平台,共筑生物偶联药的创新生态圈,支持和赋能全球合作伙伴实现疗法的突破创新,造福全球病患。”





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关于Cloudbreak® 

DFCs


凭借其专利Cloudbreak® 平台,Cidara致力于开发新一代免疫疗法。该平台能够将有效药物与人抗体片段(Fc)结合开发高活、长效的Fc偶联药物(DFCs),靶向特定的疾病治疗靶点,并同时激活免疫系统。除了肿瘤项目,Cidara还与杨森合作推进其抗病毒Fc偶联药物 CD388的临床Ⅰ期和Ⅱa期临床试验,用于预防和治疗普通流感。其他在研项目还包括治疗SARS-CoV-2等其他危及生命的DFC候选药物。






关于Cidara Therapeutics


Cidara致力于开发长效疗法,旨在改善罹患严重疾病患者的疾病治疗。公司产品线由多个旨在改变现有治疗和预防方式的新型疗法组成,拳头项目为处于临床Ⅲ期阶段的抗真菌候选药物rezafungin,其他项目包括通过Cidara专利平台Cloudbreak®开发的抗病毒和肿瘤治疗药物Fc偶联药物(DFCs)。Cidara总部位于美国加利福尼亚州圣地亚哥。


如需了解更多信息,请访问www.cidara.com






关于药明合联


药明合联(WuXi XDC)是药明生物和合全药业成立的合资公司,专注于提供抗体偶联药物(ADC)等生物偶联药物端到端CRDMO服务,服务涵盖抗体和其他偶联生物药、连接子/化学有效载荷、偶联原液及制剂等研发和生产领域。药明合联已成功赋能多个ADC药物在15个月以内完成从DNA到新药临床试验申请(IND),相比传统开发时间几乎缩短了一半。截至2022年9月30日,药明合联帮助客户进行和完成的各类项目高达270个,其中包括29个已提交IND的项目和8个处于II/III期临床试验的项目。


如需更多信息,请浏览:https://www.wuxibiologics.com/services-solutions/#XDC




媒体关系  PR@wuxibiologics.com

业务垂询  info@wuxibiologics.com







WuXi XDC and Cidara Therapeutics Expand Collaboration to Advance Cidara's Oncology DFC Program


Abstract


The Agreement builds upon the existing collaboration for CMC development and GMP manufacturing of Cidara's CD388 drug-Fc conjugate (DFC) for influenza to now include the oncology program


SHANGHAI, China and SAN DIEGO, California 

February 2, 2023


WuXi XDC ("XDC"), a leading global CRDMO company dedicated to end-to-end bioconjugates services, and Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced an expansion of their existing collaboration under which WuXi XDC will provide investigational new drug (IND)-enabling chemistry, manufacturing and controls (CMC) development services for Cidara's oncology program.


Cidara's lead oncology program targets CD73 in the adenosine pathway, which contributes to immune evasion in solid cancers by flooding the tumor microenvironment with adenosine, a potent immune cell suppressor. CD73 is highly expressed on a variety of tumor and stromal cells as well as immunosuppressive cell populations, such as regulatory T cells and myeloid-derived suppressor cells. Cidara's lead CD73 DFC is designed to address the potency, efficacy, pharmacokinetic and safety limitations of small molecule and monoclonal antibody candidates targeting CD73.



Jeff Stein, Ph.D.  

President and CEO 

 Cidara Therapeutics



"WuXi XDC has been an excellent development and manufacturing partner for our ongoing CD388 DFC influenza program, and we are excited to expand this relationship by combining WuXi XDC's core competencies in bioconjugates manufacturing with our expertise in DFCs to advance the manufacturing of our first-in-class oncology program. "





Dr. Jimmy Li

CEO 

WuXi XDC



"We're thrilled to expand our strategic collaboration with Cidara to further develop new bioconjugates solutions. This expanded partnership is a strong testament to our industry-leading capabilities and expertise. We're committed to building an innovation ecosystem for bioconjugates by offering global open-access technology platforms with premier quality standards to support our partners worldwide as they build their innovative ideas into transformative new treatments for patients."






About Cloudbreak® DFCs


Cidara is developing a new generation of immunotherapeutic agents from its Cloudbreak platform that couple potent drugs to a human antibody fragment (Fc). These highly potent, long-acting drug-Fc conjugates (DFCs) are designed to inhibit specific disease targets while simultaneously engaging the immune system. In addition to its oncology program, Cidara is advancing its antiviral DFC CD388 through Phase 1 and Phase 2a clinical trials in partnership with Janssen for the universal prevention and treatment of influenza. Cidara is also advancing DFC programs to target other life-threatening viruses, such as SARS-CoV-2.





About 

Cidara Therapeutics


Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company's portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncology diseases from Cidara's proprietary Cloudbreak® platform. Cidara is headquartered in San Diego, California. 

For more information, please visit www.cidara.com





About WuXi XDC


WuXi XDC, a joint venture between WuXi Biologics and WuXi STA, provides end-to-end contract research, development and manufacturing of bioconjugates, including antibody drug conjugates (ADCs). The company's services cover antibodies and other biologics, chemical payloads and linkers, as well as bioconjugated drug substance and drug product. WuXi XDC has been successful in bringing multiple ADC projects to the Investigational New Drug (IND) filing stage in 15 months or less, nearly cutting in half the traditional development timeline. As of September 30, 2022, WuXi XDC is supporting 270 integrated client projects, including 29 in post-IND and 8 in late-phase stage. 

For more information about WuXi XDC, please visit: https://www.wuxibiologics.com/services-solutions/#XDC





注:本信息不构成药明生物的信息披露或投资建议

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