NEC Corp.

All patients in the treatment arm remain disease-free after a minimum of 2-year follow-up in the randomized Phase I trial in resected HPV-negative locally advanced head and neck cancer – Demonstrating clinical proof of principle for TG4050 Single agent TG4050 induced long-lasting neoantigen-specific CD8+ T cell responses Treatment was well-tolerated with no unexpected safety signals Data presented during rapid oral session at ASCO 2025 Conference call scheduled on Friday June 6, 2025 at 3:00 p.m. CET (in English). See details below Strasbourg, France & Tokyo, Japan, June 1st, 2025, 7:15 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, have presented new positive data on TG4050 in a rapid oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. These positive data confirm that individualized neoantigen therapeutic vaccine TG4050 is safe and feasible in the adjuvant setting of resectable HPV-negative locally advanced head and neck squamous cell carcinoma (HNSCC). TG4050 induces, as monotherapy, long-lasting immune responses to vaccine neoantigens sustained for up to 2 years, and these results met all trial endpoints (NCT04183166) including safety, feasibility, immune activation and disease-free survival (defined as survival without recurrence or death for any cause). TG4050 is based on Transgene’s myvac® platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection. Positive data from Phase I, confirming proof of principleof Transgene’s viral vector based individualized cancer vaccine TG4050in HPV-negative locally advanced head and neck cancer 100% disease free survival at a minimum of 2-year follow-up of treated patients (median follow-up: 30 months) in the Phase I part of the trial: all patients in the TG4050 treatment arm remain disease free while 3 patients in the observational arm have relapsed.Persistenceof neoantigen-specific CD8+ T cell responses over 2 years after the start of TG4050 has been observed. Dr. Alessandro Riva, CEO of Transgene, commented: “The sustained clinical and immunogenicity outcomes observed over two years of TG4050 monotherapy, along with the positive safety profile, mark an important milestone for Transgene. These results reinforce both the clinical promise of TG4050 and our commitment to accelerate the development of this individualized immunotherapy in adjuvant setting for patients with HPV-negative, locally advanced head and neck cancer.” Motoo Nishihara, Corporate EVP, and CTO, at NEC, commented: “This positive readout, combined with the durability of the efficacy data at two years, underscore the clinical potential of individualized cancer vaccine programs. It is a strong validation of our innovative AI platform and our dedication to advancing solutions that deliver meaningful, long-term value to patients and healthcare systems alike.” Ongoing Phase II part of Phase I/II clinical trial of individualized neoantigen therapeutic cancer vaccine TG4050 TG4050 is being evaluated in a randomized multicenter Phase I/II trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers (NCT04183166). Based on the promising data obtained in the Phase I part of the trial, Transgene and NEC extended the joint development of TG4050 in this indication with a Phase II extension of the trial. The Phase II part of the trial, aimed at confirming the encouraging results in a larger patient population and evaluating both immunological and clinical outcomes, is currently underway. All patients are expected to be randomized by Q4 2025. Altogether, the Phase I/II study will comprise approximately 80 patients. Dr Christian Ottensmeier, MD, PhD, FRCP (University of Liverpool, La Jolla Institute for Immunology), will discuss the data presented at ASCO 2025, the unmet medical need and current treatment landscape for patients suffering from head and neck cancers in a live virtual event taking place on June 6, 2025 (9:00 p.m. ET; 3:00 p.m. CET).

Move marks the second acquisition in recent weeks, accelerating innovation for medtech and life sciences companies INDIANAPOLIS, July 24, 2025 /PRNewswire/ -- Greenlight Guru, the leading provider of modern software solutions for the entire medical device lifecycle, announced today that it has acquired Enzyme, a modern quality management system (QMS) company for life sciences organizations. The acquisition follows a decision by Enzyme CEO and Co-founder Jared Seehafer to transition into a new career path, seeking a trusted home to support Enzyme's customers into the future. Founded in 2017, Enzyme has been recognized for its intuitive, modular QMS solutions that help life sciences companies bring safe, effective products to market. "We've long respected Enzyme and the trust they've built with their customers," said Ed Holmes, CEO of Greenlight Guru. "From our earliest conversations with Jared, it was clear that Enzyme shared our passion for helping life sciences companies navigate regulatory complexity with confidence. This acquisition allows us to carry forward Enzyme's mission while expanding the level of support and infrastructure available to its customers. Greenlight Guru is already working with Enzyme's customers aiming to ensure continuity, responsive support, and a clear roadmap for what's ahead. "I chose Greenlight Guru as the future home for Enzyme customers because I believe they're uniquely positioned to support and scale what we started. Greenlight Guru brings the size, infrastructure, and commitment needed to serve our customers long-term. I'm confident that their product, people and infrastructure places our customers in the best possible hands for continued success," said Jared Seehafer, CEO & Cofounder of Enzyme. This acquisition reflects Greenlight Guru's broader strategy to support medtech and life science innovators across the full product lifecycle, from quality and risk management to clinical and postmarket surveillance, on a purpose-built platform. This marks the second acquisition in recent weeks for Greenlight Guru, who also announced it acquired MedTech startup Ultralight Labs last month. "Welcoming Enzyme into the Greenlight Guru family, just weeks after our acquisition of Ultralight Labs, represents a significant step forward in strengthening our position in the market," said Holmes. "These moves not only further consolidate the competitive landscape but also enhance our differentiation with expanded integrations, and greater flexibility. Customers—including those building SiMD and SaMD products—will benefit from faster, simpler implementations supported by our trusted brand, deep domain expertise, and strong industry presence. We're energized by the innovation these acquisitions unlock and look forward to sharing more in the near future." About Greenlight Guru Greenlight Guru is the leading provider of modern software solutions for the entire medical device lifecycle. Trusted by over 1,100 medical device companies worldwide—including NEC Corporation, W.L. Gore, Whoop, Candid Care, and FridaBaby—Greenlight Guru combines intuitive software with deep industry expertise to help companies streamline operations, mitigate compliance risks, and scale efficiently. With automated quality processes and proactive risk management, Greenlight Guru keeps teams audit-ready and compliant at every stage of the product lifecycle, from design and development to post-market surveillance. Backed by JMI Equity, Greenlight Guru continues to scale its impact to support the success of medical device companies globally. Media Contact April Mullen 636-675-1773 [email protected] SOURCE Greenlight Guru WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

▎药明康德编者按：恶性脑肿瘤俗称“脑癌”，胶质母细胞瘤（GBM）是中枢神经系统最常见、最具侵袭性的恶性脑癌之一。因患者致死率高、生存期短，其被认为是“致命脑癌魔咒”。过去20多年，美国FDA批准了多款脑胶质瘤相关疗法，改善了部分患者的生存状况。为攻克GBM治疗挑战，当前全球有大量创新药物管线正在推进。作为医药创新的赋能者，药明康德依托一体化、端到端的CRDMO平台，也在持续助力全球合作伙伴，加速以GBM疗法为代表的突破性疗法更快走向病患。今年以来，胶质母细胞瘤（Glioblastoma Multiforme，GBM）新药研发领域迎来了一些新的进展，涉及小分子、多肽、细胞疗法等。这些最新研发进展，为GBM患者带来了新的曙光。GBM是成人中枢神经系统中最常见、且最具侵袭性的恶性肿瘤之一。其可怕的侵袭性在于，肿瘤细胞会像树根一样深入大脑组织，难以彻底清除。而且，作为中枢神经系统肿瘤，血脑屏障的存在也让许多药物难以到达病灶，使治疗效果大打折扣。目前，GBM的治疗方法包括手术、放疗、化疗以及新兴的靶向治疗和免疫疗法，如小分子靶向疗法、抗体靶向疗法等。尽管GBM治疗近年来有所进步，但由于其高度侵袭性、高复发率和治疗耐药性等，整体临床治疗仍面临严峻挑战。数据显示，GBM患者确诊后的中位总生存期仅12～15个月，五年生存率不足10%。图片来源：123RF上百条临床管线推进，形成多元化抗脑癌“组合拳”近年来，随着科学界对胶质母细胞瘤病理生物学认识的不断深入，全球涌现出更丰富的创新研发管线。据公开资料，目前全球针对GBM的临床在研项目超过200个，覆盖小分子、抗体药物、各类偶联药物、细胞和基因疗法、核酸药物以及多肽药物等多种治疗模式。在众多GBM临床管线中，小分子占据近半数比例。它们主要针对已在其他瘤种治疗领域得到验证的靶点，包括EGFR、CDK4/6、XPO1、FGFR、PARP等。上半年小分子领域有多项进展：例如，Kazia Therapeutics年初宣布正与FDA讨论其具血脑屏障穿透能力的PI3K/Akt/mTOR通路小分子抑制剂paxalisib在治疗新诊断GBM患者的潜在注册途径。该产品已在2/3期GBM临床研究中取得积极结果，达到总生存期的主要终点。再例如，百时美施贵宝从Mirati Therapeutics收购获得的PRMT5抑制剂MRTX1719（BMS-986504）于今年3月启动了针对MTAP基因缺失的复发性GBM患者的美国1期临床研究。与此同时，包括免疫检查点抑制剂在内的抗体疗法以及相关联合疗法，是GBM临床研究的重要探索方向。数据显示，当前有几十款抗体药物正在探索用于治疗GBM的潜力，涵盖了多种在其他癌种经过验证的靶点。比如Vaximm公司今年3月公布了口服抗VEGFR-2试验性疫苗VXM01联合抗PD-L1单抗avelumab治疗胶质母细胞瘤的2a期试验积极结果，支持其进一步的临床研究。细胞和基因疗法也是GBM在研管线的重要组成部分，涵盖了DC细胞疗法、NK细胞疗法、CAR-γδ T细胞药物等类型。上半年这一领域也取得多项进展。比如Genenta Science公布的Temferon长期随访数据显示，该疗法在治疗新确诊的具未甲基化MGMT基因启动子（uMGMT）的GBM患者中，两年生存率稳定维持在29%，中位总生存期保持17个月。这是一种通过将体外基因转到自体Tie2+造血干细胞/祖细胞（HSPC）中，利用肿瘤浸润的单核细胞/巨噬细胞，将免疫调节分子递送到肿瘤微环境中的疗法，从而重塑肿瘤免疫环境并激活持续性免疫应答。放射性疗法近年来在癌症治疗领域也大放异彩。Telix Pharmaceuticals在4月公布的TLX101 2期临床试验初步结果表明，这款靶向L型氨基酸转运蛋白1（LAT-1）的放射性药物可有效穿透血脑屏障并精准辐射癌细胞，且耐受性良好。Plus Therapeutics公司今年3月宣布，其放射治疗药物Rhenium（186Re）obisbemeda治疗胶质母细胞瘤的1期临床试验结果亮眼：接受大于100 Gy该药治疗的患者的中位总生存期（OS）为17个月，是接受标准治疗患者的中位OS（8个月）的两倍多。此外，其他创新疗法也取得突破性进展。Sapience Therapeutics公司于6月公布的lucicebtide（ST101）2期临床试验数据显示，该C/EBPβ拮抗剂多肽新药在新确诊和复发性GBM患者中均表现出良好的疾病控制效果，目前已获得FDA授予的快速通道资格。此外，Laminar Pharma于3月宣布其合成油酸衍生物LAM561在新诊断GBM患者的关键性2b/3期临床试验中取得积极结果，特别是在MGMT甲基化患者中显示出无进展生存期改善趋势。MimiVax公司2月份公布的SurVaxM 2b期临床试验中期分析结果显示，这款靶向survivin的肽模拟免疫原能够有效刺激患者自身免疫反应，在控制肿瘤生长和预防复发方面展现出良好潜力。产业合力攻克挑战，力争打破致命的“脑癌魔咒”当前，GBM的新药开发过程仍面临重重挑战。作为一种中枢神经系统肿瘤，难以穿透血脑屏障、肿瘤自身的免疫抑制、肿瘤异质性、复发耐药等等，均是GBM治疗需克服的难题。当下，业界正在探索多种新的治疗策略，比如通过创新递送技术突破血脑屏障，持续探索创新药物类型的潜力，通过联合疗法改变胶质瘤免疫抑制微环境或提高疗效等等。攻克挑战，需要全行业的共同努力。作为医药创新的赋能者，药明康德多年以来通过其一体化、端到端的CRDMO平台，为包括GBM在内的广泛疾病新药研发提供全方位的支持，助力全球合作伙伴加速突破性疗法面世，早日造福病患。以突破血脑屏障挑战为例，GBM作为中枢神经系统（CNS）肿瘤，血脑屏障是药物递送的一大障碍。许多药物难以穿透血脑屏障，到达肿瘤组织，导致治疗效果不佳。因此，业界正在持续探索各种新策略。在这一领域，公开信息显示，药明康德DMPK自2009年起开始进行CNS相关研究，拥有超过15年的临床前CNS药物研发经验，建立了针对CNS药物体外血脑屏障通透性评价的特色且准确性较高的“漏斗”模型。对于主要通过被动扩散入脑的CNS药物，“漏斗”模型的评估准确性为100%。通过完善的体外、体内测试平台，药明康德DMPK能够快速、准确、高效地对CNS药物进行全方位药代动力学相关评价，筛选出具有良好的脑通透性及稳定性的CNS候选药物。根据早前公开信息，该平台已完成包括常规小分子、治疗性蛋白、寡核苷酸等新分子实体类型项目百余项，成功助力全球客户多个CNS药物进入临床阶段。 再例如，在GBM的研发管线中，也有一部分研究在探索靶向蛋白降解剂（TPD）的治疗潜力，其中包含分子胶和蛋白降解靶向嵌合体（PROTAC）分子管线。在这一新兴药物分子领域，药明康德也在持续助力全球合作伙伴加速创新分子的研发进程。公开信息显示，早在近10年前，在这项技术刚刚起步之时，药明康德就开始布局相关的能力和技术，积累了丰富的成功经验，搭建起集发现、合成、分析纯化和测试等能力的一体化赋能平台。目前，该平台已成功支持超过120款TPD分子的开发，其中20余款顺利推进至临床阶段。例如，近期发表的一项研究就报道了一种新型PROTAC分子优化策略，药明康德生物学平台为该研究成功构建了HiBiT细胞系，提供了PROTAC功能验证的细胞学检验方法，并充分验证了优化型PROTAC更强有力的IDO1降解效果，为药代动力学以及最大耐受量毒性分析奠定了基础。 科学探索的脚步从未停歇。从手术、放化疗到近年来的多种新兴疗法，每一步进展都承载着为全球GBM患者带来新生的希望。随着基础研究的深入、新技术的迭代升级，以及产业界的合力，战胜“致命脑癌”是可期的。期待未来更多突破性疗法从实验室走向临床，为患者带来更多生的希望。参考资料:[1] Pouyan, A., Ghorbanlo, M., Eslami, M. et al. Glioblastoma multiforme: insights into pathogenesis, key signaling pathways, and therapeutic strategies. Mol Cancer 24, 58 (2025). https://doi.org/10.1186/s12943-025-02267-0版权说明：本文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。转载授权或其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：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。