CONTACT US | (864) 397-5101 Seven emerging life science startups from South Carolina to Taiwan to receive guidance, mentoring and business-focused curriculum modules taught by industry experts including Charles River Labs, Deloitte, Eli Lilly, Maynard Nexsen, Medpoint, Inspire Agency and more. SOUTH CAROLINA – September 9, 2024 – SCbio, in partnership with The Massachusetts Biotechnology Council (MassBio), has selected seven emerging life sciences companies to participate in the inaugural SCbioDrive Accelerator cohort. “We are thrilled to welcome this exceptional cohort of oncology and neuroscience companies to SCbioDrive,” said SCbio President and CEO James Chappell. “With participants hailing from South Carolina, Boston, New York, Florida, and even as far as Taiwan, this is a testament to the global appeal and momentum our state is generating in the life sciences sector—especially in areas we’re becoming known for in the state: oncology and neuroscience. By bringing together these world-class innovators, we’re not only advancing critical scientific breakthroughs but also shining a spotlight on South Carolina as a hub for life sciences innovation and collaboration.” A semiannual program, SCbioDrive will lead seven seed-stage life sciences companies through an eight-week hybrid program designed to advance their platforms and technologies through expert business curricula, industry guidance and mentorship – all at no cost. “To support innovation anywhere is to help deliver for patients everywhere, and partnering with SCBio to launch their own accelerator is one way that MassBio is able to do that, and I’m thrilled to see the first cohort of companies selected to participate,” said MassBio CEO and President Kendalle Burlin O’Connell. “The Drive programs empower startups and founders at a crucial juncture in their growth, and what I love to see is what they are able to do next armed with business know-how, seasoned mentors, and access to our global network.” These startups will participate in business-focused curriculum modules taught by experts including Charles River Labs, Deloitte, Eli Lilly, Maynard Nexsen, Medpoint, Inspire Agency and more. The program will end in November with a Demo Day in Charleston, S.C., where cohort companies will present to a curated group of potential investors and industry leaders. SCbioDrive Fall 2024 Cohort Booster Biosciences (Melrose, M.A.) leverages novel biological models developed at Harvard Medical School to discover the mechanisms of resistance and engineer optimal therapeutics. Their portfolio of patented therapeutics targets resistance to conventional and immuno-oncology drugs. Cell BioEngines Inc. (New York, N.Y.) is a clinical-stage biotech company focused on developing allogeneic ‘off-the-shelf’ stem cells and their derived therapies as ‘drugs’ for human disease treatment. Its lead product is currently in Phase 1 trials for the treatment of hematopoietic neoplasms not curable with available therapies. Define Therapeutics Inc. (Arlington, M.A.) discovers and develops innovative therapeutics for tough-to-treat prostate cancers, such as castration-resistant prostate cancer (CRPC) and neuroendocrine prostate cancer (NEPC). Define plans to develop an orally available small molecule intended primarily for CRPC and NEPC in the clinic but can also be further explored for other cancer indications. Jaya Biosciences Inc. (Greenville, S.C.) is developing CNS-directed gene therapies for genetically defined neurodegenerative diseases, including Alzheimer’s, Parkinson’s, and frontotemporal dementia. Jaya’s platform is based on the groundbreaking discovery that carriers of loss-of-function mutations in genes for lysosomal enzymes have an increased risk of neurodegeneration, including early onset of symptoms. RephImmune Biotechnology (Taipei, Taiwan) is a preclinical-stage startup specializing in fully self-innovated engineered cellular immunotherapy to combat solid tumors. RephImmune is developing a novel cell therapy called RACE to provide late-stage cancer patients, who are running out of treatment options, with a low-dose, single-administration treatment that is more efficient, safer, and long-lasting. Unlike convention CAR-T, RACE offers a more potent and balanced immune response by bypassing conventional T cell signaling pathways. Torpedo Bio (Charleston, S.C.) is developing technology to address the unmet need of efficacious and safe cellular immunotherapy for solid tumors. Current chimeric antigen receptor (CAR) T cell therapies have had outstanding results in liquid tumors, such as leukemias and lymphomas. Unfortunately, liquid tumors are only 10% of total cancer cases and CAR T cells do not work well for solid tumors. Torpedo Bio’s approach is to use engineered anti-tumor regulatory T cells, which have the potential to be a much-needed efficacious and safe treatment for solid tumors. Vova Ida Therapeutics Inc. (VIT) (Jupiter, F.L.) is developing disease-modifying treatments for age-related neurodegenerative disorders. VIT’s lead program is at the IND-enabling stage and focuses on restoration of neuronal nicotinamide adenine dinucleotide homeostasis and cell recovery. VIT’s preclinical data and clinical development plan are supported by use of proximal biomarkers that show target engagement and that are relevant to disease pathogenesis To learn more about the SCbioDrive Accelerator Program, visit scbio.org/scbiodrive. About SCbio SCbio is South Carolina’s member-driven economic development organization exclusively focused on building, advancing and growing the life sciences industry in the state. SCbio represents more than 1,000 organizations employing more than 87,000 professionals across the state and supports and advances organizations in multiple arenas including pharmaceuticals, medical devices and equipment, digital health, research and medical labs, bioscience distribution, bio-ag and more. For additional information about SCbio and the life sciences industry, visit www.SCbio.org. Enjoy exclusive member content, special events, savings, networking and more

免疫疗法临床1期

2024-07-27

·药明康德

一针免去上百次治疗的基因疗法获欧盟批准；完全缓解率100%的CAR-T疗法申报上市…… | CGT周报

▎药明康德内容团队编辑近期，全球细胞和基因疗法（CGT）领域迎来系列进展。辉瑞（Pfizer）开发的一次性基因疗法Durveqtix获欧盟批准，用于治疗血友病B成人患者。精准生物CAR-T细胞疗法普基仑赛注射液的新药上市申请（NDA）获中国国家药监局（NMPA）受理，用于治疗急性淋巴细胞白血病。该疗法在一项1期临床试验中的完全缓解率达100%。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。图片来源：123RF ———✦研发进展✦——— ◇ 欧盟委员会（EC）宣布授予辉瑞所开发的一次性基因疗法Durveqtix（fidanacogene elaparvovec）有条件上市许可，用于治疗重度和中重度血友病B成人患者，这些患者体内无凝血因子IX（FIX）抑制剂，且没有检测到针对腺相关病毒血清型Rh74变异体（AAVRh74var）的抗体。此次批准主要是基于3期临床试验BENEGENE-2的结果。Durveqtix组患者的年化出血率（ABR）为1.44，接受预防性疗法患者的ABR为4.50（p=0.0084），减少幅度达68%。此外，60%的Durveqtix组患者在个体观察期间（范围：2-4年）保持无出血事件，此数值在导入期接受常规预防治疗的患者中仅为29%。患者在接受Durveqtix治疗后，使得预防性凝血因子IX的消耗量降低了92.4%。 ▲在试验中，患者接受Durveqtix输注后，体内FIX活性稳定维持（图片来源：参考资料[12]） Durveqtix是一种新型的基因疗法，含有生物工程化的腺相关病毒衣壳和编码高活性FIX变体的转基因。对于血友病B患者来说，这种基因治疗的目标是使他们能通过一次性治疗产生自体的FIX蛋白，而非像目前的标准治疗那样需要定期静脉输注FIX。辉瑞于2014年12月以2000万美元预付款从Spark Therapeutics获得该疗法。加拿大卫生部（Health Canada）于今年1月批准该疗法上市，美国FDA则在今年4月批准此基因疗法，商品名为Beqvez。 ◇ Mesoblast公司宣布，美国FDA已接受其细胞疗法Ryoncil（remestemcel-L）的生物制品许可申请（BLA）重新提交，用于治疗类固醇难治性急性移植物抗宿主病（SR-aGVHD）儿童，该申请的PDUFA日期为2025年1月7日。新闻稿指出，如果获得批准，Ryoncil将成为美国首个同种异体“现货型”细胞疗法，也是首款针对18岁以下SR-aGVHD儿童患者的细胞疗法。 Ryoncil是一种间充质干细胞，它通过抑制T细胞增殖，和下调促炎细胞因子和干扰素的产生，来调节T细胞介导的炎症反应。此前，它的生物制品许可申请已获得美国FDA授予的优先审评资格。已公开的一项3期试验结果显示，患者接受Ryoncil治疗后第28天的客观缓解率为69％，与45%的历史控制率相比，有统计学意义的显著增加。在接受至少一次输注治疗且随访100天的患者中，患者的死亡率为22％。而接受初始类固醇治疗无效的患者第100天死亡率高达70%。 ◇ 辉瑞公布了临床3期试验AFFINE的积极顶线结果，该研究评估了其在研基因疗法giroctocogene fitelparvovec用于治疗中度至重度血友病A成人患者的疗效与安全性。分析显示，该试验达成主要终点与关键次要终点，giroctocogene fitelparvovec与替代预防疗法相比在预防患者出血上具有优效性。患者在接受单次3e13 vg/kg剂量的giroctocogene fitelparvovec输注后，显示出与输注前相比平均总ABR显著降低（1.24 vs 4.73；单侧p值=0.0040）。此外，治疗后的平均需要治疗ABR显示出统计学上显著的下降，从输注前的4.08下降至输注后的0.07，降幅达98.3%（单侧p值<0.0001）。 Giroctocogene fitelparvovec是一款创新的在研基因疗法，它包含一个生物工程化的AAV6衣壳和编码人类凝血FVIII的基因，该基因经修改以删除相应蛋白的B结构域。该疗法目的是通过单次输注giroctocogene fitelparvovec让患者能够长时间产生FVIII，以提供出血保护并减少通过静脉输注进行的常规预防治疗的需要。Giroctocogene fitelparvovec已获得美国FDA授予的快速通道资格和再生医学先进疗法（RMAT）认定，以及美国和欧盟的孤儿药资格。 ◇ 《自然-医学》（Nature Medicine）杂志发表了一项评价前列腺干细胞抗原（PSCA）嵌合抗原受体（CAR）T细胞疗法治疗转移性去势抵抗性前列腺癌（mCRPC）的1期临床试验结果。结果显示，CAR-T细胞扩增和持续至输注后28天，3个剂量队列分别有1例、3例和3例患者的前列腺特异性抗原（PSA）水平下降，14例患者中有4例患者的PSA降幅＞30%。其中，队列2中有1例患者在输注CAR-T细胞后的首个28天内，PSA降幅＞90%。三个队列的疾病控制率分别为0%、67%和60%，6个月生存率分别为33%、67%和40%。该临床研究结果表明PSCA-CAR-T细胞疗法治疗mCRPC是安全的，有望成为mCRPC患者治疗新选择。 ◇ Enlivex Therapeutics公司宣布，以色列卫生部已批准启动一项1期临床试验，旨在评估Allocetra治疗银屑病关节炎患者的安全性和耐受性。败血症、骨关节炎、银屑病关节炎等疾病会使巨噬细胞失去平衡状态。这些非稳态巨噬细胞在很大程度上导致了相应疾病的严重性。Allocetra是一种通用、现货型细胞疗法，通过对巨噬细胞进行重编程，旨在恢复其稳态（homeostasis），进而治疗疾病。Allocetra提供创新的免疫调节机制，具潜力作为单药或组合疗法治疗这些具未竟医疗需求的疾病。 ◇ Nkarta公司宣布，哥伦比亚大学Irving医学中心（CUIMC）的研究人员已经启动了一项由研究者发起的试验，旨在评估Nkarta的同种异体CD19靶向CAR自然杀伤（NK）细胞疗法NKX019在系统性红斑狼疮患者中的应用。NKX019是一种异体、低温保存、现货型候选免疫疗法，它使用从健康成人供体外周血中提取的NK细胞。它采用人源化的CD19靶向CAR进行设计，增强了细胞的靶向性，并采用专有的膜结合型白细胞介素-15（IL-15），在没有外源细胞因子支持的情况下提高了持久性和活性。 ◇ 驯鹿生物宣布其自主研发的全人源BCMA靶向CAR自体T细胞注射液（伊基奥仑赛注射液）的IND申请已获得美国FDA批准，拟用于治疗多发性硬化。这是伊基奥仑赛注射液在2024年继难治性全身型重症肌无力（gMG）之后，成功获得FDA批准的第二个自身免疫疾病适应症IND。 ◇ NMPA药品审评中心（CDE）官网公示，重庆精准生物的pCAR-19B细胞自体回输制剂普基仑赛注射液已经提交NDA申请，并获得受理。2023年11月，该产品被CDE纳入突破性治疗品种，用于治疗3-21岁的CD19阳性复发/难治性急性淋巴细胞白血病患者。公开资料显示，普基仑赛注射液由精准生物自主研发，是针对CD19阳性B细胞起源的恶性血液系统疾病而开发的CAR-T细胞免疫治疗产品。该产品对CAR结构进行了优化，同时采用更为安全的基因转导载体系统，从而使其具有潜在更好的有效性和安全性。早前公布的1期注册临床数据显示，入组的9例患者均获得完全缓解，总缓解率达100%，且首次达到完全缓解的患者微小残留病变（MRD）也均为阴性，且总体安全性和耐受性良好。 ◇ 信念医药和武田（Takeda）共同宣布，NMPA已正式受理BBM-H901注射液用于治疗血友病B成年患者的NDA申请。根据信念医药新闻稿，BBM-H901是该公司自主研发和生产的首款产品，也是中国境内首个递交NDA申请的针对遗传病的基因治疗药物。该产品未来将由武田中国负责该产品在中国内地、中国香港和中国澳门地区的商业化推广工作。 BBM-H901注射液是信念医药研发和生产的重组AAV基因疗法，以静脉给药的方式将人类表达FIX的基因导入血友病B患者体内持续表达，提高并长期维持患者的凝血因子水平，用于预防血友病B成年患者出血。一项研究者发起的临床研究（IIT）结果显示，长期随访3.0-4.5年期间，9例受试者FIX持续稳定较高表达，未发生出血事件，ABR为0，且完全停止了外源性FIX产品的替代治疗。 ◇ 合源生物宣布，《新英格兰医学杂志》（NEJM）在线发表了其靶向CD19的CAR-T细胞注射液（纳基奥仑赛注射液）治疗系统性红斑狼疮相关免疫性血小板减少症（SLE-ITP）的案例报道。新闻稿指出，该病例是全球首次将CD19靶向CAR-T细胞疗法应用于SLE-ITP的治疗，显示了CAR-T细胞疗法在此类疾病中的良好疗效和巨大应用前景。在该论文中，1名此前曾接受过大量治疗的SLE-ITP女性患者在接受纳基奥仑赛注射液回输后的第28天血液中的CD19阳性B细胞被清除，第三个月时B细胞获得重建。患者的血小板计数在治疗后的六个月内持续上升，并达到临床完全缓解。此外，患者停用了糖皮质激素和所有免疫抑制剂。安全性方面，该患者仅在回输后第9天出现一过性1级发热（38.1℃），通过物理降温恢复正常。未观察到CAR-T细胞治疗相关的其他不良事件。 ———✦融资、合作、M&A✦——— 图片来源：123RF ◇ Artiva Biotherapeutics公司宣布，其扩大的首次公开募股获得了约1.67亿美元融资。该公司的主打产品AlloNK是一种同种异体、现货型、非转基因、低温保存的NK细胞候选疗法，旨在增强单克隆抗体的抗体依赖性细胞毒性效应，以驱动B细胞耗竭。AlloNK目前正处于治疗系统性红斑狼疮伴或不伴狼疮性肾炎的临床试验中，以及研究者发起的多种自身免疫疾病的篮子试验中。Artiva的管线还包括针对实体瘤和血液肿瘤的CAR-NK细胞候选疗法。 ◇ Cell BioEngines公司宣布筹集了200万美元，这笔资金将用于支持其首个针对无法找到捐赠者的血液肿瘤患者的多中心临床试验，以及寻求人类白细胞抗原（HLA）半相合造血干细胞移植的替代方案。该公司成立于2022年12月，致力于开发用于治疗人类疾病的同种异体现货型干细胞衍生疗法。该公司利用其专有的平台技术，使用从脐带获得的通用"非基因修饰"供体造血干细胞，大规模生产临床级的细胞。 ◇ 安斯泰来（Astellas）和大阪大学医学研究生院/医学院共同宣布，安斯泰来的两家全资子公司安斯泰来再生医学研究所（AIRM）和Universal Cells公司已与大阪大学达成研究合作，共同开发用于治疗椎间盘退行性疾病的创新多能干细胞衍生软骨类器官细胞疗法。 Universal Cells公司拥有Universal Donor Cell（UDC）技术的使用权，该公司利用基因编辑技术对编码HLA的基因进行基因修饰，从而利用多能干细胞制造细胞治疗产品，降低免疫排斥风险。根据协议，三方旨在将大阪大学软骨疾病研究领域的专家Noriyuki Tsumaki教授制定的软骨组织创建方案、Universal Cells的UDC技术以及AIRM在细胞疗法方面的研发专长结合起来，共同创建一种治疗椎间盘退行性疾病的创新细胞疗法。 ◇ 微光基因与濒湖生物（Lakeshore Biotechnology）宣布就探索新型DNA编辑工具在诱导多能干细胞（iPSC）细胞领域的应用及产品开发达成专利许可协议。根据协议，濒湖生物获得微光基因自主研发的enCas12Ultra编辑蛋白在全球范围内商业化使用的非独家许可，用于iPSC细胞药物的开发及生产。 ▲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（可上下滑动查看） [1] 驯鹿生物伊基奥仑赛注射液治疗多发性硬化症新药临床试验申请获美国食品药品监督管理局默示许可. Retrieved July 25, 2024, from https://www.prnasia.com/story/455110-1.shtml [2] FDA Accepts Mesoblast’s Biologics License Application (BLA) for Ryoncil® in Children With Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD). Retrieved July 23, 2024 from https://www.globenewswire.com/news-release/2024/07/23/2917127/0/en/FDA-Accepts-Mesoblast-s-Biologics-License-Application-BLA-for-Ryoncil-in-Children-With-Steroid-Refractory-Acute-Graft-Versus-Host-Disease-SR-aGVHD.html [3] Pfizer Announces Positive Topline Results From Phase 3 Study of Hemophilia A Gene Therapy Candidate. Retrieved July 24, 2024 from https://investors.pfizer.com/Investors/News/news-details/2024/Pfizer-Announces-Positive-Topline-Results-From-Phase-3-Study-of-Hemophilia-A-Gene-Therapy-Candidate/default.aspx [4] Dorff TB, Blanchard MS, Adkins LN, Luebbert L, Leggett N, Shishido SN, Macias A, Del Real MM, Dhapola G, Egelston C, Murad JP, Rosa R, Paul J, Chaudhry A, Martirosyan H, Gerdts E, Wagner JR, Stiller T, Tilakawardane D, Pal S, Martinez C, Reiter RE, Budde LE, D'Apuzzo M, Kuhn P, Pachter L, Forman SJ, Priceman SJ. PSCA-CAR T cell therapy in metastatic castration-resistant prostate cancer: a phase 1 trial. Nat Med. 2024 Jun;30(6):1636-1644. doi: 10.1038/s41591-024-02979-8. Epub 2024 Jun 12. PMID: 38867077; PMCID: PMC11186768. [5] 中国国家药监局药品审评中心官网. Retrieved July 20, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c [6] 国内首款！信念医药针对血友病B的基因治疗药物BBM-H901注射液的新药上市申请获国家药品监督管理局受理.Retrieved July 24, 2024, from https://mp.weixin.qq.com/s/lclVflAM-h2A5apndZO7FQ [7] Enlivex Receives Regulatory Authorization For The Initiation Of A Phase I Clinical Trial To Evaluate Allocetra In Patients With Psoriatic Arthritis. Retrieved July 24, 2024 from https://www.globenewswire.com/news-release/2024/07/23/2917164/0/en/Enlivex-Receives-Regulatory-Authorization-For-The-Initiation-Of-A-Phase-I-Clinical-Trial-To-Evaluate-Allocetra-In-Patients-With-Psoriatic-Arthritis.html [8] NKARTA ANNOUNCES INITIATION OF INVESTIGATOR-SPONSORED CLINICAL TRIAL EVALUATING NKX019 FOR SYSTEMIC LUPUS ERYTHEMATOSUS. Retrieved July 24, 2024 from https://ir.nkartatx.com/news-releases/news-release-details/nkarta-announces-initiation-investigator-sponsored-clinical [9] Artiva Biotherapeutics Announces Pricing of Upsized $167.0 Million Initial Public Offering. Retrieved July 24, 2024 from https://investors.artivabio.com/News-and-Events/news/news-details/2024/Artiva-Biotherapeutics-Announces-Pricing-of-Upsized-167.0-Million-Initial-Public-Offering/default.aspx [10] Cell BioEngines Secures an Additional $2 Million in Funding From SOSV and the Empire State Development’s New York Ventures. Retrieved July 24, 2024 from https://www.globenewswire.com/news-release/2024/07/20/2916201/0/en/Cell-BioEngines-Secures-an-Additional-2-Million-in-Funding-From-SOSV-and-the-Empire-State-Development-s-New-York-Ventures.html [11] Astellas and Graduate School of Medicine / Faculty of Medicine, Osaka University Enter into Research Collaboration to Develop Pluripotent Stem Cell-Derived Cartilage Organoid Cell Therapy. 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Retrieved Jul 25, 2024, from https://mp.weixin.qq.com/s/RpyB_1OMoCCgdx_dyuOxhw 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

基因疗法临床3期上市批准优先审批细胞疗法

2024-07-22

·GlobeNewswire-Health Care

Cell BioEngines Secures an Additional $2 Million in Funding From SOSV and the Empire State Development’s New York Ventures

July 20, 2024 -- Cell BioEngines, Inc., a New York, USA-based company researching stem cells in order to develop new cell therapies unlocked $1.75 million additional funds from SOSV and the Partnership Fund through the new therapeutics seed track, available for therapeutics start-ups. In addition, Cell BioEngines raised $0.25 million from Empire State Development’s NY Ventures, the state’s venture capital arm through the Pre-Seed and Seed Matching Fund Program. “This reflects strong growth and investor confidence in our innovative approach to advancing cell therapies, particularly timely as we expand within New York State,” said Dr. Ajay Vishwakarma, Founder and CEO. “The funds will support our first multicenter clinical trial, aimed at hematological cancer patients unable to find a donor and seeking an alternative to HLA-haploidentical blood stem cell transplants. CBE-101 represents a novel approach with expanded cord blood-derived hematopoietic cell therapy, aligned with Cell BioEngines' vision to deliver 'off-the-shelf' cell-based therapies to patients”, he added. Cell BioEngines, Inc., founded in Dec 2022, is a clinical-stage biotech company focused on developing allogeneic 'off-the-shelf' stem cell-derived therapies as ‘drugs’ for human disease treatment. The company leverages its proprietary platform technology using universal 'non-gene-modified' donor blood stem cells obtained from umbilical cord to produce clinical grade cells at scale. The content above comes from the network. if any infringement, please contact us to modify.