标新生物(Gluetacs Therapeutics)完成A轮融资,加速蛋白降解药物临床转化

文摘   2024-05-31 08:03   上海  

     今日,标新生物(Gluetacs Therapeutics)宣布获得A轮融资,由黄埔生物医药基金领投,粤民投基金、南湾百澳、司南园科跟投。本轮融资将重点用于公司产品管线GT919和GT929的临床I期推进和临床前项目的开发。



标新生物是一家孵化自上海科技大学免疫化学研究所,专注于开发口服蛋白降解小分子药物的生物科技公司。标新生物聚焦肿瘤和自身免疫疾病等疾病领域尚未被满足的临床需求,拥有独特的分子胶和双功能降解剂交叉融合的GlueTacs®双研发平台,目前已成功推动两条分子胶降解剂管线进入临床阶段。

公司拥有自主知识产权的高度多样化的专有E3泛素连接酶配体文库,通过高通量多维度的实验数据,综合运用人工智能辅助的机器学习模型归纳和指导药物设计,并在湿实验中进一步筛选,积累了大量分子胶构效关系的专有知识。平台开发出的分子胶管线具有高E3连接酶亲和力和高靶点选择性,目前已有两条产品管线获得中美临床批准,其中GT919GT929其对应的复发难治血液瘤适应症观察到了疗效,并安全可控正在进一步临床爬坡中。

在双功能降解剂领域,标新生物聚焦多种实体瘤和自身免疫疾病等领域,重点关注现有疗法无效或耐药的细分患者人群,将专有的E3泛素连接酶配体与连接子和靶蛋白配体连接,获得降解选择性高、口服生物利用度优异的候选化合物,将陆续提交新药研究申请。

公司GlueTacs®双研发平台还拥有大量可用于抗体偶联降解剂的有效载荷候选分子,在多种血液瘤、实体瘤中展现了优秀的体内外活性。
                         

标新生物创始人、董事长兼首席执行官杨小宝博士表示:“非常感谢四家生物医药专业投资机构对标新生物的全力支持和助力,通过本轮投资人对技术平台、管线数据和运营团队的全面梳理尽调,让企业有了进一步提升的空间,也让我进一步对企业自身在行业中的地位有了更加坚定的信心,未来只能通过企业不断地里程碑进展回报所有股东。目前标新生物两个临床管线GT919和GT929的临床预期进展进一步验证了公司在蛋白降解领域扎实的科研基础、转化能力和平台化能力,将继续探索和挑战未满足临床需求靶点的管线开发,进一步提高执行力和效率。本轮融资将加快标新生物临床前和临床管线的进程,进一步助力企业‘标新立异、开拓创新、造福病患’的企业愿景的实现。”
黄埔生物医药基金董事长伍朝阳先生表示随着蛋白降解技术在临床应用中的不断深入,多个分子胶和PROTAC产品管线在临床中日渐展现了在不同适应症中的潜力,并接连受到跨国药企的垂青,这也是我们一直在关注蛋白降解领域的原因。标新生物在分子胶及PROTAC技术领域拥有长时间的技术积累,这是其持续创新和发展的坚实基础。我们注意到,标新生物在近期管线临床推进过程中取得了积极的临床数据,这充分体现了该产品的潜力。作为一家专注于生物医药领域的投资机构,黄埔生物医药基金非常看好标新生物在蛋白降解新药研发领域的未来前景,并期待其能够加速管线推进,尽早实现产品上市,凭借特有创新的药物产品进入欧美市场,打造国际化发展战略,为全球患者带来福音。

粤民投基金表示分子胶是一类小分子化合物,具备高度特异性,有望通过蛋白降解的方式攻克‘不可成药’靶点,目前已成为创新药研发前沿方向。标新生物由上海科技大学免疫化学研究所孵化,具备自主知识产权的分子胶和PROTAC双平台的核心专利群,团队核心成员均为蛋白降解领域权威科学家,具备药物全流程先进开发平台建设的实力。依托于其平台在药物筛选上的独特优势,目前在分子胶研发上已取得两项IND,首例患者已实现入组给药,我们期待与标新生物共同成长,实现更多里程碑。

司南园科基金项目负责人吴梁梓认为标新生物是在临港新片区成长起来的企业,创始人杨小宝教授及团队在分子胶及PROTAC技术领域拥有长时间的技术积累,多发性骨髓瘤与非霍奇金淋巴瘤的管线临床推进展示了扎实的临床数据,期待标新生物能够加速管线推进,尽早实现产品上市,造福国内外患者。司南园科是上海临港集团旗下专注于早期科创型企业的私募股权投资基金管理人,面向前沿科技领域,围绕坡长雪厚赛道,孵化培育创新企业,打造产业创新生态。本次司南园科以旗下基金投资标新生物,是在蛋白降解新药研发领域的一次重点布局。


关于黄埔生物医药基金
黄埔生物医药基金是一家专业的私募股权投资管理机构,主要发起人为广州开发区控股集团、力鼎资本、百济神州、国聚创投,专注生命科学领域和医疗健康产业投资,在生物药、创新医疗器械、合成生物等领域广泛投资布局。旗下基金依托百济神州生物药研发优势,立足粤港澳大湾区,承接中国乃至全球学术资源,专注生命科学、创新医疗及合成生物领域的项目孵化,共同研发并推出卓越产品。基金目标是携手共创,为人类战胜疾病、促进健康福祉做出积极贡献。


关于粤民投基金

粤民投私募基金管理有限公司为广东民营投资股份有限公司(广东省政府推动设立的)旗下控股的唯一股权投资平台,重点投资方向包括生命科学、新能源、泛消费、农业等领域,以“挖掘优质企业、陪伴企业成长”为使命,致力于为投资人进行长期的财富管理。



关于南湾百澳基金
南湾百澳基金是力鼎资本旗下的专业化医疗基金,专注生命科学领域和医疗健康产业投资,在生物药、IVD及创新医疗器械等领域广泛投资布局,基金致力于早期生命科学及创新医疗项目的孵化赋能,与杰出的创业者紧密合作,共创一流产品,为人类战胜疾病促进健康造褔。


关于司南园科基金
司南园科基金是临港集团发起与专业资本共同合作设立的市场化科创系列基金,通过打造科技孵化体系服务早期科创型企业。司南园科基金面向前沿科技领域,围绕坡长雪厚赛道,孵化培育创新企业,打造产业创新生态。在生命科技领域,司南园科基金重点聚焦于早期创新制药、高端器械和智能医疗的投资及孵化,为初创企业进行有效赋能。



Today, Gluetacs Therapeutics announced that it has secured Series A Funding, led by Huangpu Biopharmaceutical Fund and followed by Gortune Investment, Nanwan Baiao, and Synlinx. This round of financing will be primarily used to advance the clinical Phase I trial of Gluetacs' product pipelines GT919 and GT929 and the development of pre-clinical projects.


Gluetacs is a biotechnology company incubated from Shanghai Institute for Advanced Immunochemical Studies of ShanghaiTech University, focusing on the development of orally-administered small molecule protein degrader. With an attention to unmet medical needs in the areas of oncology and autoimmune diseases, Gluetacs possesses a unique dual research and development platform of GlueTacs®, which mixes and matches the skills and advantages of both molecular glue and bifunctional degraders. Gluetacs has successfully advanced two molecular glue degrader pipelines into the clinical stage.


Gluetacs has a highly diversified proprietary E3 ubiquitin ligase ligand library with its own intellectual property rights, and has accumulated a large amount of know-how on molecular glue structure–activity relationships through high-throughput multi-dimensional experimental data, the comprehensive use of AI-aided machine-learning models for generalization and guidance of drug design, and further screening in wet laboratories. The molecular glue pipeline developed by the platform has high E3 ligase affinity and high target selectivity, and two product pipelines have already received clinical approval from NMPA and FDA, both GT919 and GT929 have observed response in their corresponding indications of relapsed or refractory hematologic tumors, and both are safe and manageable, and are in the process of further dose escalation.


In the field of bifunctional degraders, Gluetacs has been focusing on areas such as multiple solid tumors and autoimmune diseases, with a particular emphasis on patient subgroups that are resistant to or have undergone failure of existing treatments. Gluetacs connects proprietary E3 ubiquitin ligase ligands with linkers and target protein ligands, obtaining candidate compounds with high degradation selectivity and excellent oral bioavailability. Gluetacs will subsequently submit investigational new drug applications.


The GlueTacs® dual R&D platform also has a large number of payload candidates that can be used as Degrader-Antibody Conjugates, which have demonstrated excellent ex vivo and in vivo efficacy in a wide range of hematological and solid tumors.


Dr. Xiaobao Yang, Founder, Chairman and Chief Executive Officer of Gluetacs, said, we are very grateful to the four biopharmaceutical professional investment institutions for their full support and assistance to Gluetacs. Through this round investors' comprehensive due diligence on the technology platform, research data and operation team, the enterprise has been conscious of room for further improvement, and it also makes me firmly confident in the enterprise's own position in the industry. I can only reward all shareholders through the company's continuous milestone progress in the future. At present, the preliminary results of two clinical pipelines, GT919 and GT929, further validates the company's solid scientific research foundation, translational capability and platformization ability in the field of protein degradation, and we will continue to explore and challenge the development of pipelines for targets that have huge unmet medical needs, and further improve the power of execution and efficiency. This round of financing will accelerate the preclinical and clinical pipeline process, and further help realize the company's corporate vision of "innovation, pioneering, and benefiting patients".

Mr. Chaoyang Wu, Chairman of Huangpu Biopharmaceutical Fund, said, as protein degradation technology continues to gain momentum in clinical applications, several molecular glue and PROTAC pipelines have increasingly demonstrated their potential for different indications in clinic and have been coveted by multinational pharmaceutical companies one after another, which is why we have been focusing on the protein degradation field. Gluetacs has a long history of technology accumulation in the field of molecular glue and PROTAC technology, which is a solid foundation for its continuous innovation and development. We note that Gluetacs has achieved positive clinical data during its recent clinical trial, which fully reflects the potential of this product. As an investment institution focusing on the biopharmaceutical field, Huangpu Biopharmaceutical Fund is very optimistic about the future prospects of Gluetacs in the field of target protein degradation and expects it to accelerate its clinical trials, realize product launch as early as possible, enter the European and American markets with its unique and innovative products, build an international development strategy and bring benefits to patients around the world.

Gortune Investment said that molecular glues are a class of small molecule compounds with highly differentiated features, which are expected to overcome undruggable targets through protein degradation, and have become the frontier field of innovative drug R&D. Gluetacs was incubated from Shanghai Institute for Advanced Immunochemical Studies of ShanghaiTech University, and has the core patents of molecular glue and PROTAC platforms with independent intellectual property rights, and the core members of the team are authoritative scientists in the field of protein degradation. Relying on the unique advantages of its platform in drug screening, two molecular glue INDs have been approved, and Gluetacs has completed first patient dosed for both two compounds. We are looking forward to growing together with Gluetacs and achieving more milestones.


According to Liangzi Wu, the project leader of Synlinx, Gluetacs is an enterprise growing up in Lingang New Area, and the founder, Prof. Xiaobao Yang, and his team have spent a long time of technical accumulation in molecular glue and PROTAC technology, and the clinical progress of multiple myeloma and non-Hodgkin's lymphoma has demonstrated solid preliminary results, and we expect that Gluetacs can accelerate the clinical trials and realize the product launch as soon as possible at home and abroad. Synlinx is a private equity fund manager under Lingang Group focusing on early-stage science and technology enterprises, incubating and nurturing innovative enterprises and creating an industrial innovation ecosystem for cutting-edge science and technology fields. Synlinx invests Gluetacs with its fund, which is a key layout in the field of protein degradation new drug development.

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标新生物GLUETACS
标新生物是一家专注蛋白降解的新药研发企业,现拥有分子胶降解剂和双机制蛋白降解剂研发平台,致力于开发及商业化针对肿瘤、自身免疫疾病等领域的治疗药物,通过自主研发和外部合作等模式,建立了有差异化竞争优势的产品管线。