Acepodia Biotechnologies, Ltd.

IND clearance paves the way for Acepodia to enter the clinic for the first time with its autoimmune program ACE1831 is an allogeneic gamma delta T cell therapy candidate targeting CD20-expressing cells currently being investigated in non-Hodgkin's lymphoma (NHL) The planned clinical study will be executed as part of strategic clinical collaboration with Pfizer Ignite ALAMEDA, Calif. and TAIPEI, Nov. 15, 2024 /PRNewswire/ -- Acepodia (6976:TT), a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms, announced today that it has received U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for the company's lead candidate ACE 1831 in IgG4-related disease (IgG4-RD), a multi-organ, fibro-inflammatory autoimmune condition. This IND clearance allows Acepodia to investigate the safety and efficacy of Acepodia's ACE1831 in patients with IgG4-RD, as its first step in autoimmune disease. ACE1831 utilizes bioorthogonal chemistry to link CD20-targeting antibodies to gamma delta T cells, creating an off-the-shelf, non-genetically engineered version of T cell therapy that is more easily scaled and may potentially mitigate side effects associated with autologous CAR-T cell therapies, such as T cell malignancies. ACE1831 is also in a Phase 1 dose escalation study for non-Hodgkin's lymphoma (NHL). "Based on the observation of clinical benefits of CAR-T in autoimmune diseases, we hope to prove that ACE1831 can deliver 'deeper' B cell depletion than antibody drugs, critical for longer remission in autoimmune diseases," said Sonny Hsiao, PhD, Chief Executive Officer, President and Co-Founder of Acepodia. "We've engaged accomplished IgG4-RD research physicians worldwide, excited by our innovative approach. This clearance enables us to launch the study, offering participants a promising new treatment," commented Jerry Liu, MD, Head of Clinical Development of Acepodia. The Phase 1b/2a study of ACE1831 will be executed in collaboration with Pfizer Ignite, a service that offers biotech companies access to Pfizer's significant resources, scale, and expertise to accelerate the progression of potential breakthrough medicines for patients. The study will be led by Dr. John Stone, MD, MPH, of Massachusetts General Hospital, Executive Chairman of The IgG4ward! Foundation and an eminent IgG4-RD researcher whose work identified the potential of targeted B-cell depletion with rituximab. Dr. Stone said, "A crucial finding for people living with IgG4-RD now has been the efficacy in disease control exerted by B cell depletion. I'm enthusiastic now not only about the possibility of deeper B cell depletion with Acepodia's approach, but also about its ease of use and potential for fewer adverse effects than other cell-based approaches." About Acepodia Acepodia is a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care. Leveraging its ACC technology, the company links tumor-targeting antibodies to its proprietary immune cells, such as natural killer and gamma delta T cells, to create novel ACE therapies, which have increased binding strength against tumors that express low levels of tumor antigens as well as pathogenic B cells causing autoimmune disease. Acepodia is composed of seasoned leaders and scientific experts dedicated to advancing its robust pipeline of ACE therapies with the potential to bring innovative, effective, and affordable cell therapies to a broad population of patients across a variety of solid tumors and hematologic cancers. For more information, visit and follow Acepodia on Twitter and LinkedIn. SOURCE Acepodia Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

▎药明康德内容团队编辑抗体偶联药物（ADC）与蛋白降解剂为近年来重要的新兴治疗模式。除了相关交易频传外，各自在临床开发上也皆有振奋人心的突破。今日，诺贝尔化学奖得主Carolyn Bertozzi教授联合创建的Firefly Bio公司正式亮相。获得9400万美元A轮融资资金后，Firefly Bio打算以其创新的蛋白降解偶联药物（DAC）平台为癌症疗法打开崭新的一页。参考阅读：克服癌症治疗挑战，《自然》子刊深度剖析下一代ADC发展方向DAC代表了两种技术的融合——ADC和蛋白降解剂。尽管这两种方法都很强大，但两者都有各自的局限性。例如，传统的ADC具有良好的生物利用度和靶向细胞的能力，但由于ADC在释放其具细胞毒性的载荷时并不稳定，这限制了ADC可安全使用的剂量，因此它们的治疗指数通常有限。此外，ADC亦缺乏敲低特定细胞内蛋白质的能力。对于蛋白质降解剂来说，情况正好相反——这些疗法具有细胞内选择性、能够敲低特定蛋白质的表达，并且具有高度催化作用。然而，它们的生物利用度较差，并且不具备细胞特异性靶向的能力。然而将两者结合开发DAC所面临的挑战在于其载荷通常具有较高的疏水性，导致整体结构过度疏水。为了确保足够的效力，可能需要较高的药物抗体比（DAR），这会进一步加剧其疏水性，从而对这些药物的药代动力学和毒性特性产生不良影响。因此，开发新型连接子设计和改良降解剂分子以解决这些问题，是增加DAC临床应用的关键。Firefly的DAC平台除了结合ADC和蛋白质降解剂各自的优势外，也克服了它们的缺陷以及两种模式结合时产生的潜在挑战。Firefly的平台使用强大的催化蛋白质降解剂作为其药物的有效载荷，并使用其所开发的专有连接子将二者相连，这种专有连接子能够减少自DAC脱离进入血液循环中的载荷，并最大限度地减少健康细胞的吸收。这样的设计使得达到最佳有效性所需的药物剂量降低，进而使得这一种新型疗法能潜在精确地对一系列细胞内生物靶点进行治疗，包含那些过往在进行全身给药时会受到治疗指数问题阻碍的靶点。根据在实体瘤和血液肿瘤的临床前研究数据，单次使用Firefly的DAC即可在极低剂量下显著缩小肿瘤体积。“在过去的20年里，ADC的主要载荷一直是毒素，我们在Firefly试图做的是引入一种新的有效载荷类别，其效力与毒素水平相同，但可以更好地区分健康与疾病细胞。”Firefly新任首席执行官Scott Hirsch先生在接受行业媒体Fierce Biotech采访时表示。Hirsch先生并指出，如果Firefly能够成功开发DAC疗法，这将解锁ADC类别药物新的生物学机制。Firefly获得创始投资者Versant Ventures、MPM BioImpact、De Cheng Capital和Eli Lilly & Company等支持。根据行业媒体Endpoints News报道，Firefly目前将专注于开发实体瘤药物，但可能在日后扩展至免疫领域。Firefly由经验丰富的高管所领导，他们在初创公司成立、ADC开发和降解剂化学方面拥有深厚的经验和专业知识。该团队由首席执行官Scott Hirsch先生领导，他曾担任Allakos公司首席运营官，负责监督多个早期和后期ADC项目以及参与商业投资组合和运营团队的管理。联合创始人兼首席科学官John Flygare博士曾领导基因泰克（Genentech）和默沙东（MSD）的ADC团队，并将ADC和降解剂推进临床。联合创始人兼首席技术官Bernhard Geierstanger博士是一位生物治疗专家，曾领导诺华（Novartis）和MSD的ADC团队，并建立了蛋白质修饰和偶联平台。▲Firefly的首席执行官与联合创始人（图片来源：Firefly Bio公司官网）值得一提的是，Firefly的另一位联合创始人Carolyn Bertozzi博士因其在生物正交化学（bioorthogonal chemistry）方面的工作而获得2022年诺贝尔化学奖，是ADC领域的世界级专家。这位斯坦福大学教授在2000年代中期专注研究位点特异性偶联技术，并据此成立了ADC生物技术公司Redwood Bioscience。她前后参与创建了十几家生物技术公司，包含与Versant合作，于2020年创建了蛋白质降解剂生物技术公司Lycia Therapeutics，该公司专注于开发溶酶体靶向嵌合体（LYTAC）疗法。此外，她还创立Acepodia并担任该公司的首席科学顾问，Acepodia致力开发抗体偶联细胞（antibody cell conjugate，ACC），将抗体偶联物与免疫细胞配对，这一技术可能扩展现货型细胞疗法的可及性，造福更为广泛的患者。参考阅读：《科学》重磅！诺奖得主Carolyn Bertozzi团队揭示LYTAC最新调控机制“我认为Firefly将会为ADC的标准树立新的典范，这一直是我的梦想。”Bertozzi博士说道。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] Firefly Bio Debuts With $94 Million Series A Financing. Retrieved February 15, 2024 from https://fireflybiologics.com/press-release-firefly-bio-debuts-with-94-million-series-a-financing/[2] Firefly Bio assembles with $94M and an ADC dream team to work on protein degraders. Retrieved February 15, 2024 from https://www.fiercebiotech.com/biotech/firefly-bio-assembles-94m-and-adc-dream-team-work-protein-degraders[3] Versant-backed Firefly Bio wants to make the next generation of ADCs. Retrieved February 15, 2024 from https://www.biopharmadive.com/news/firefly-bio-adc-protein-degraders-versant/707555/[4] Carolyn Bertozzi and Versant's new biotech breaks cover with $94M to use protein degraders in ADCs. Retrieved February 15, 2024 from https://endpts.com/carolyn-bertozzi-and-versants-new-biotech-breaks-cover-with-94m-to-use-protein-degraders-in-adcs/免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

ACE2016 Is an Allogeneic Gamma Delta 2 (γδ2) T Cell Therapy Targeting the Epidermal Growth Factor Receptor (EGFR) in Patients With Solid Tumors. Phase 1 Clinical Study Expected to Begin in H2 2024. ALAMEDA, Calif. and TAIPEI, Feb. 4, 2024 /PRNewswire/ -- Acepodia (6976:TT), a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms to address gaps in cancer care, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for ACE2016, an allogeneic gamma delta 2 (γδ2) T cell therapy for the treatment of epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors. This clearance enables Acepodia to initiate a Phase 1, first-in-human trial evaluating the safety, tolerability and pharmacodynamics of ACE2016 in adults with locally advanced or metastatic EGFR-expressing solid tumors. Acepodia expects to begin the trial in the coming months and treat the first patient in the second half of 2024. "This milestone is a key step as we advance our pipeline of next generation cell therapies and explore the potential of our novel Antibody-Cell Conjugation (ACC) technology in solid tumors, which remain to be unmet medical needs in the cell therapy field," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "The rapid progression of obtaining the third IND approval within 18 months highlights the team's remarkable efficiency and dedication to advancing innovative programs swiftly. With our third program in the clinic, we are proud to continue progressing the field of cell therapy with the goal of delivering powerful, accessible treatments for patients through a first-of-its-kind approach." About ACE2016 ACE2016 is an off-the-shelf γδ2 T cell therapy candidate developed from Acepodia's proprietary ACC platform. ACE2016 targets EGFR-expressing solid tumors through antibody conjugated γδ2 T cells that target tumors driven by the cancer-causing EGFR gene. Leveraging the advantages of ACC technology and Acepodia's proprietary γδ2 T cell platform, ACE2016 has shown promising cytotoxicity against several EGFR-expressing cancers in various pre-clinical study models. The Phase 1 trial will evaluate the safety, tolerability and pharmacodynamics of ACE2016 in patients with locally advanced or metastatic EGFR-expressing solid tumors. The trial is expected to dose its first patient in the second half of 2024. About Acepodia Acepodia is a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care. Leveraging its ACC technology, the company links tumor-targeting antibodies to its proprietary immune cells, such as natural killer and gamma delta T cells to create novel ACE therapies, which have increased binding strength against tumors that express low levels of tumor antigens. Acepodia is made up of seasoned leaders and scientific experts dedicated to advancing its robust pipeline of ACE therapies with the potential to bring innovative, effective, and affordable cell therapies to a broad population of patients across a variety of solid tumors and hematologic cancers. For more information, visit and follow Acepodia on Twitter and LinkedIn. SOURCE Acepodia Inc.