Rocakinogene Sifuplasmid

Biologics License Application (BLA) for INO-3107 accepted for review under the Accelerated Approval Program as a potential treatment for adults with Recurrent Respiratory Papillomatosis (RRP) by the U.S. Food and Drug Administration (FDA); target Prescription Drug User Fee Act (PDUFA) date October 30, 2026 INO-3107 immunological and long-term clinical and safety data published in Nature Communications and The Laryngoscope Advanced promising next-generation DNA medicine technology: Phase 1 proof-of-concept trial of DNA-encoded Monoclonal Antibodies (DMAbs) published in Nature Medicine Promising preclinical data on novel DNA-encoded protein (DPROT) technology presented at the World Federation of Hemophilia Global Forum Announced clinical trial collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab for the potential treatment of glioblastoma (GBM) in a Dana-Farber Cancer Institute-sponsored trial PLYMOUTH MEETING, Pa., March 12, 2026 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2025 and provided an update on recent company developments. "With our first BLA now under review by the FDA, we are focused on delivering INO-3107 to RRP patients who are desperate for treatment options that reduce reliance on surgery to control this rare and devastating disease," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "Our top priority is advancing INO-3107, and to do so, optimizing and extending our financial resources towards our target PDUFA date of October 30, 2026. We are excited about the opportunities ahead as we prepare to become a commercial-stage company and work to leverage the power of partnerships to advance other promising candidates in our pipeline. I look forward to providing more updates on our progress with these efforts in the coming months." Operational Highlights INO-3107 – Recurrent Respiratory Papillomatosis (RRP) In December 2025, the FDA accepted INOVIO's BLA for INO-3107 for review under the accelerated approval program as a potential treatment for adults with RRP. As part of the submission, INOVIO requested a priority review, which is typically 6 months. Instead, the FDA granted a standard 10-month review with a PDUFA target date set for October 30, 2026. While the BLA was accepted under the accelerated approval program, in the file acceptance letter the FDA noted as a potential review issue its preliminary conclusion that the company had not provided adequate information to justify eligibility for the accelerated approval pathway. INOVIO continues to strongly believe that INO-3107 fulfills the criteria for accelerated approval, meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments. The FDA has agreed to a yet-to-be-scheduled meeting to discuss eligibility for review under the accelerated approval program. During 2025, INOVIO published clinical and immunological results from its Phase 1/2 trial (RRP-001) in Nature Communications showing that INO-3107 induced new populations of T cells in the blood that traveled to airway tissue and were associated with significant clinical benefit as measured by reduced need for surgery. INOVIO also published data from a retrospective study (RRP-002) investigating the long-term safety and clinical response of patients treated with INO-3107 in The Laryngoscope. Data demonstrated that the majority of patients experienced continued improvement beyond the initial 12-month study period of the previously published Phase 1/2 trial (RRP-001), as measured by a reduction in the number of surgical procedures needed after treatment with INO-3107. INOVIO also continued to advance commercial readiness plans, including conducting critical market research supporting a positively differentiated product profile, developing a pricing strategy, finalizing our go-to-market model, and advancing the build-out of our commercial organization. We've also selected key commercial partners including a third-party logistics provider, Agency of Record, specialty distributor, specialty pharmacy, and patient HUB. INO-5412/INO-5401 INOVIO announced a clinical trial collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 (INO-5401 plus INO-9012 in a single vial) in combination with cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, for the potential treatment of GBM. The combination therapy will be studied as a part of the INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT), the innovative Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute and conducted by Mass General Brigham Cancer Care Inc. that is designed to quickly and efficiently find new treatments for GBM. The novel combination of INO-5412 with cadonilimab builds on INOVIO's previous promising research in GBM and could potentially benefit patients by providing additional checkpoint inhibition through CTLA-4 binding. INOVIO also continues to dose patients in the GBM-001 Phase 1/2 trial in newly diagnosed glioblastoma that combines INO-5401 plus INO-9012 with Regeneron's PD-1 checkpoint inhibitor Libtayo®. INOVIO's partners at the Basser Center at the University of Pennsylvania continue to evaluate the tolerability and immunogenicity of INO-5401 plus INO-9012 in a Phase 1 study exploring the potential to prevent cancer in people with BRCA1 or BRCA2 mutations. Next Generation DNA Medicine Candidates Results from a Phase 1 proof-of-concept trial evaluating next generation DMAbs for COVID-19 were published online in Nature Medicine, demonstrating the technology's potential as a long-acting, scalable and tolerable alternative to traditional monoclonal antibody therapies. The study is being led by The Wistar Institute in collaboration with INOVIO, AstraZeneca, and clinical investigators at the Perelman School of Medicine at the University of Pennsylvania. This was the first demonstration that DNA plasmid encoded monoclonal antibodies, which are complex proteins, can be durably and tolerably expressed in humans. INOVIO also presented promising Factor VIII preclinical data from its DPROT program at the World Federation of Hemophilia Global Forum in November 2025. This technology aims to address some of the shortcomings of conventional therapeutic protein replacement treatments, including gene therapy approaches. INOVIO is developing additional DPROT indications and is actively seeking partners to accelerate development of this promising program. General Corporate INOVIO remains focused on financial discipline, directing resources to advance the INO-3107 program towards commercialization and a potential approval date in October 2026, and extending the cash runway. To achieve this goal, INOVIO has further prioritized programs, spending, and resource needs, and has eliminated roles that don't directly support our primary goal of advancing INO-3107 toward US approval. 2025 Financial Results Research and Development (R&D) Expenses: R&D expenses for the quarter and year ended December 31, 2025 were $10.3 million and $54.2 million, respectively, compared to $12.9 million and $75.6 million for the same periods in 2024. The decrease was due primarily to the result of lower drug manufacturing, clinical study and other expenses related to INO-3107, lower contract labor and lower expensed inventory, among other variances. General and Administrative (G&A) Expenses: G&A expenses were $7.2 million and $32.7 million, respectively, for the quarter and year ended December 31, 2025, versus $7.6 million and $37.0 million, respectively, for the same periods in 2024. The decrease in G&A expenses was primarily related to a decrease in employee and consultant compensation, including stock-based compensation, among other variances. Total Operating Expenses: Total operating expenses were $17.5 million and $86.9 million for the quarter and year ended December 31, 2025, respectively, compared to $20.5 million and $112.6 million for the same periods in 2024. Net Loss: INOVIO's net income (loss) for the quarter and year ended December 31, 2025 was $3.8 million, or $0.06 per basic and ($0.26) per diluted share, and ($84.9) million, or ($1.81) per basic and diluted share, respectively, compared to net loss of $19.4 million, or $0.65 per basic and diluted share, and $107.3 million, or $3.95 per basic and diluted share, for the quarter and year ended December 31, 2024, respectively. The net income for the fourth quarter 2025 was primarily driven by a $21.2 million non-cash gain on fair value adjustment related to our warrant liabilities. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net income (loss). Shares Outstanding: As of December 31, 2025, INOVIO had 69.0 million common shares outstanding and 109.7 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding common stock warrants, stock options, restricted stock units and convertible preferred stock. Cash, Cash Equivalents and Short-term Investments: As of December 31, 2025, cash, cash equivalents and short-term investments were $58.5 million compared to $94.1 million as of December 31, 2024. INOVIO's balance sheet and statement of operations are provided below. Additional information is included in INOVIO's annual report on Form 10-K for the year ended December 31, 2025, which can be accessed at: . Cash Guidance INOVIO estimates its current cash, cash equivalents and short-term investments balances to support the company's operations into the fourth quarter of 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the first quarter of 2026. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake. Conference Call / Webcast Information INOVIO's management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO's financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO's website at . About INOVIO's DNA Medicines Platform INOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA delivery devices are designed to optimally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms. About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit . Forward-Looking Statements This press release contains certain forward-looking statements relating to our business, including the timing and success of preclinical studies and clinical trials; the ability to obtain and maintain regulatory approval of our product candidates; the FDA's acceptance of our BLA for INO-3107 with a PDUFA target action date set for October 30, 2026; and yet-to-be scheduled meeting with the FDA to discuss eligibility for the accelerated approval program; the potential benefits of INO-3107; and our other potential product candidates; the clinical collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab for the potential treatment of GBM in the INSIGhT trial; the scope, progress and expansion of developing and commercializing our product candidates; our anticipated growth strategies; our ability to establish and maintain development partnerships and the expected sufficiency of our cash resources into the fourth quarter of 2026. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2025 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law. Contacts Media: Jennie Willson, (267) 429-8567, [email protected] Investors: Peter Vozzo - ICR Healthcare, (443) 213-0505, [email protected] SOURCE INOVIO Pharmaceuticals, Inc. 21% more press release views with Request a Demo

2026年3月5 日，康方生物（港交所：9926.HK）与 INOVIO（纳斯达克：INO）联合宣布，双方已达成一项合作协议，将与全球顶级肿瘤研究机构Dana Farber Cancer Institute以及全球领先医疗集团 Mass General Brigham合作，共同探索康方生物全球首创 PD-1/CTLA-4 双特异性抗体卡度尼利联合INOVIO 旗下DNA药物 INO-5412针对胶质母细胞瘤（GBM）的创新治疗。 作为全球首个获批上市的肿瘤免疫双抗新药，卡度尼利突破性临床价值已经获得多个重磅注册III期临床研究验证，并且在真实世界被临床广泛应用。卡度尼利目前 2 项国际多中心注册性/III期临床已开展，本次与 INOVIO 达成合作，是卡度尼利多元化加速全球市场开拓的又一举措，进一步展示了卡度尼利作为IO2.0基石药物的巨大全球价值潜力。 卡度尼利联合 INO-5412 联合疗法是INSIGhT 研究的重要组成部分。INSIGhT 研究是一项创新II 期适应性平台试验(adaptive platform trial)，由美国著名癌症治疗研究机构Dana Farber Cancer Institute发起，并由美国顶尖医疗集团Mass General Brigham开展。 卡度尼利 卡度尼利目前已经获批上市 3 项适应症(全人群获益，无论 PD-L1 表达阳性和阴性)，并全部纳入国家医保目录，包括晚期一线胃癌、一线宫颈癌和二/三线宫颈癌;同时，卡度尼利已开展了超过11 项III期/注册性研究，包括了一线治疗晚期胃癌的国际多中心 III 期临床研究和治疗IO耐药肝癌的国际多中心注册性临床研究。 INO-5412 INO-5412是INOVIO研发的DNA药物，此前已在胶质母细胞瘤取得优异的临床数据。相关II期研究显示，INO-5412与免疫检查点抑制剂联用，能够激活机体针对肿瘤抗原的免疫应答，推动 T 细胞浸润至胶质母细胞瘤肿瘤微环境，诱导了强劲的免疫反应。INO-5412联合卡度尼利有望攻克单一免疫检查点疗法难以高效解决的临床治疗难题。 Dana Farber癌症研究所神经肿瘤中心主任、 哈佛大学医学院教授 David Reardon博士表示： INSIGhT试验的初衷是旨在快速推进胶质母细胞瘤的前沿疗法。胶质母细胞瘤是脑癌中最常见且最具侵袭性的类型，目前可用的或在研的有效手段均极为匮乏。我们非常兴奋能将康方生物与INOVIO的创新免疫联合疗法纳入本项研究，并对两家公司致力于改善患者预后的努力表示由衷欢迎。 康方生物创始人、董事长、 总裁兼首席执行官夏瑜博士表示： 我们非常荣幸能与INOVIO、全球领先肿瘤研究机构Dana Farber Cancer Institute 以及 Mass General Brigham医疗集团携手，共同推进卡度尼利与高潜力药物INO-5412的联合疗法探索，为各类未被满足的临床需求提供更优的迭代升级疗法。卡度尼利是全球首个获批上市的肿瘤免疫治疗双抗，康方生物正通过“自主开发+全球合作”的多元化方式，加速推动卡度尼利的全球开发，深度挖掘卡度尼利作为免疫联合基石药物的突破性临床价值和国际，推动肿瘤免疫治疗在2.0 时代的发展。 康方生物将持续坚持以患者为中心，秉持开放合作理念，以全球化视野深化布局，与国际优质伙伴共同推动肿瘤治疗格局革新，充分释放卡度尼利创新价值，惠及全球患者。 INOVIO 首席医学官  Michael Sumner 博士表示： 这是我们与康方生物以及Dana-Farber癌症研究所的一次重要携手，标志着我们的肿瘤免疫疗法开发迈出了关键一步。我们非常荣幸与两家开拓性的合作伙伴携手，推进我们后期临床管线中这一极具潜力的候选药物。INO-5412与双检查点抑制剂卡度尼利联合应用，是我们在胶质母细胞瘤研究领域的重要进展，这一探索建立在我们既往研究数据的基础之上，相关数据已展现出改善患者获益的潜力，也彰显了我们持续致力于为存在巨大未满足医疗需求的疾病领域持续开发创新疗法的坚定承诺。 说明：本文作为康方生物的新闻发布，用于披露公司最新进展，并非产品推广广告，不构成康方生物的信息披露或投资建议。 关于 INSIGhT 试验发起机构 Dana-Farber Cancer Institute 是世界顶尖的癌症治疗与研究中心，连续多年位列《U.S. News & World Report》美国癌症中心前十。其成立于1947年，是美国哈佛大学医学院附属癌症专科医院及联邦政府指定的综合性癌症治疗中心，位于马萨诸塞州波士顿。 Mass General Brigham由哈佛大学医学院的主要教学医院麻省总医院（Massachusetts General Hospital）、百瀚和妇女医院（Brigham and Women’s Hospital）等知名医疗机构组成，是一家世界领先的学术医疗系统。 关于开坦尼® （卡度尼利单抗注射液） 卡度尼利是康方生物自主研发的全球首创PD-1/CTLA-4双特异性肿瘤免疫治疗药物，2022年6月获得国家药品监督管理局的批准，用于既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗。2024年9月，卡度尼利联合方案用于局部晚期不可切除或转移性胃或胃食管结合部（G/GEJ）腺癌患者一线治疗适应症获批；2025年5月，卡度尼利加含铂化疗联合/不联合贝伐珠单抗一线治疗持续、复发或转移性宫颈癌的适应症获批。卡度尼利是世界上第一个肿瘤免疫治疗双抗新药，也是中国的第一个双特异性抗体新药。卡度尼利治疗既往接受含铂化疗失败的复发或转移性宫颈癌、一线治疗胃癌和一线治疗宫颈癌的适应症均已被纳入国家医保目录。 卡度尼利已针对胃癌、肺癌、肝癌、宫颈癌、胰腺癌等20+项适应症开展了30项以上的临床研究，11项Ⅲ期/注册性临床研究进行中，3项研究已达到研究终点。 卡度尼利是一种全新机制的肿瘤免疫治疗药物，可以同时靶向PD-1和CTLA-4，发挥协同抗肿瘤的作用，具有优异的抗肿瘤疗效，相比联合疗法的毒性显著降低，安全可耐受。多项临床研究显示，卡度尼利针对多种肿瘤疾病的PD-L1表达阳性和阴性患者均具有优异的抗肿瘤疗效，且针对IO耐药和其他各类冷肿瘤均具有突破性临床价值。目前，卡度尼利已被20+项临床治疗指南和共识重磅推荐，覆盖胃癌、妇科肿瘤、肝癌、食管癌、鼻咽癌、胆道癌等多个适应症。 关于 INO-5412 INO-5412 是一款在研 DNA 药物，它将 INO-5401 与 INO-9012 整合于单一制剂中，旨在与检查点抑制剂联合使用，发挥强大的癌症免疫治疗潜力。此前，INO-5401 联合 INO-9012 已在包括 GBM 以及携带 BRCA1/BRCA2 突变的多种癌症中开展了治疗研究。在针对 GBM 的治疗中，该组合疗法显示出能够诱导产生抗原特异性 T 细胞并使其浸润至肿瘤内部的能力。在一项针对新诊断 GBM 患者的独立 II 期试验中，INO-5401 联合 INO-9012 与 PD-1 抑制剂联用，显著延长了大部分受试者的生存期，相关成果已在 2022 年美国临床肿瘤学会（ASCO）年会上作口头报告。 INO-5401 编码了 INOVIO 特有的 SynCon® 抗原（包括 hTERT、WT1 和 PSMA），这些抗原被美国国家癌症研究所（NCI）列为免疫治疗开发的高优先级关键靶点。研究表明，这三种抗原在包括胶质母细胞瘤在内的多种人类癌症中均呈高表达或突变状态。INO-9012 则编码 IL-12，这是一种关键的 T 细胞免疫激活因子。 关于胶质母细胞瘤（GBM） GBM是最常见且最具侵袭性的脑癌类型，对患者及其照护者而言，至今仍是一种破坏性极强的疾病。其预后极差，在过去十年中，仅有少数疗法获批。 在美国，接受标准治疗的患者中，若其MGMT（O-6-甲基鸟嘌呤-DNA甲基转移酶）启动子呈未甲基化状态，则中位总生存期约为15个月，中位无进展生存期约为4至6个月。 关于康方生物 康方生物（9926.HK）是一家集研究、开发、生产及商业化全球首创或同类最佳创新生物新药于一体的领先企业。自2012年成立以来，公司始终以患者为中心，以临床价值为导向，打造了独有的端对端康方全方位新药研究开发平台，建立了以Tetrabody双特异性抗体开发技术、抗体偶联（ADC）技术、siRNA/mRNA技术及细胞治疗技术为核心的研发创新体系，国际化标准的GMP生产体系和运作模式先进的商业化体系，成为了在全球范围内具有竞争力的生物医药创新公司。 公司已开发了50个以上用于治疗肿瘤、自身免疫、炎症、代谢疾病等重大疾病的创新候选药物，26个候选药已进入临床（包括15个双抗/多抗/双抗ADC），7个新药已在商业化销售，2个新药4个适应症的上市申请处于审评审批阶段。 康方生物是全球迄今唯一拥有2个肿瘤免疫双抗新药的制药公司： 2022年6月，公司全球首创的PD-1/CTLA-4双抗卡度尼利获批上市，是全球首个获批的肿瘤免疫治疗双抗新药，也是中国第一个双特异性抗体新药。目前卡度尼利一线治疗胃癌、一线治疗宫颈癌和治疗复发/转移性宫颈癌的适应症已获批，11个注册性/III期临床正在开展。 2024年5月，公司全球首创的PD-1/VEGF双抗新药依沃西获批上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，成为全球首个获批的“肿瘤免疫+抗血管生成”机制双抗新药。同期，依沃西在与全球“药王”帕博利珠单抗的随机、双盲、对照一线治疗PD-L1阳性NSCLC的“头对头”III期临床研究中获得显著阳性结果，依沃西可降低患者疾病进展/死亡风险达49%，依沃西成为全球首个在头对头III期临床研究中证明疗效显著优于“药王”帕博利珠单抗的药物。基于该研究结果，依沃西该项适应症于2025年4月获批上市，成为一线肺癌治疗新的标准治疗方案，为患者提供全新更优的“去化疗”选择。目前依沃西有15项注册性/III期临床已开展/启动，包括5项国际多中心注册性III期临床研究。 2024年12月，卡度尼利和依沃西均通过医保谈判被纳入国家新版医保目录。2025年12月，除派安普利新获批的一线肝细胞癌适应症，康方生物5个自主商业化自研新药的其余全部获批适应症均已纳入国家医保目录。 此外，基于公司在肿瘤免疫双抗领域取得的全球领先优势，公司正全力推进IO2.0+ADC2.0全球战略，构建“跨代”式国际竞争优势。目前，公司自主研发的首个双抗ADC药物Trop2/Nectin4 ADC（AK146D1）、新一代Her3 ADC（AK138D1） 已经获得中国NMPA和美国FDA批准，正在中国和澳洲等开展临床研究。后续一系列自研新一代ADC/双抗ADC/双毒素ADC也将相继进入临床开发阶段。这将助力公司产品组合在全球范围内建立“跨代”式的竞争战略优势。 国际市场开发是康方生物核心发展战略，继2015年开中国先河将自主研发的CTLA-4单抗权益许可给默沙东公司之后，2022年12月，公司再次创造中国纪录，以50亿美金+2位数百分比销售提成的方案，将依沃西部分海外权益许可给美国Summit公司，该合作创下了彼时中国新药对外许可的最高交易金额纪录。此外，派安普利单抗治疗鼻咽癌的两项适应症于2025年4月获得美国食品药品监督管理局（FDA）批准上市。 公司非肿瘤板块也已全面进入商业化发展阶段：伊努西单抗（PCSK9）治疗高胆固醇血症两项适应症获批销售；依若奇单抗（IL-12/IL-23）治疗中重度斑块状银屑病成人患者适应症获批上市销售；此外，古莫奇单抗（IL-17）和曼多奇单抗（IL-4R）多项III期临床研究成功，正处于上市审评阶段。公司非肿瘤领域的产品协同效应和战略组合力进一步提升。 康方生物期望通过高效及突破性的研发创新，开发国际首创及同类药物最佳疗法的新药，为全球患者提供更优疾病解决方案，成为全球领先的生物制药企业。 关于 INOVIO及其DNA 药物平台 INOVIO是一家专注于开发和商业化DNA药物，以帮助治疗和预防HPV相关疾病、癌症及传染病的生物技术公司。INOVIO的技术旨在优化创新DNA药物的设计与递送，这些药物能“教导”人体制造其自身的疾病对抗工具。公司官网：www.inovio.com。 INOVIO的DNA药物平台包含两大创新组成部分：精确设计的DNA质粒，以及由INOVIO专有的在研医疗器械CELLECTRA进行递送。INOVIO利用专有技术设计其DNA质粒，这些小型环状DNA分子如同可被人体细胞“下载”的软件，能指导细胞产生特定的蛋白质以靶向和对抗疾病。INOVIO专有的CELLECTRA递送设备旨在将其DNA药物最优地递送至人体细胞，无需化学佐剂或脂质纳米颗粒，且避免了病毒载体平台历史上常见的抗载体反应风险。 往期推荐 产品动态 康方5个新药所有适应症全部谈判成功，纳入国家医保：2个首创双抗新增一线适应症及3个新药首次进医保 临床 进展 HARMONi-A OS最终分析显示：依沃西达到OS临床终点，取得具有临床意义和统计学显著的OS获益 产品动态 依沃西联合化疗1L治疗sq-NSCLC的上市申请获NMPA受理 数据发布 HARMONi研究发布：PFS HR=0.52，OS HR=0.79  依沃西2L+ EGFRm NSCLC国际多中心III期 产品动态 卡度尼利获批第三项适应症：一线宫颈癌全人群 产品动态 依沃西一线治疗NSCLC获批上市（全球首个对比帕博利珠单抗获显著阳性结果的III期研究） 产品动态 派安普利2个适应症美国重磅上市！获FDA批准用于晚期鼻咽癌治疗 临床 进展 康方首个双抗ADC（Trop2/Nectin4 ADC）临床入组，“IO+ADC”2.0 迭代战略加速推进 临床 进展 康方非肿瘤领域首个双抗IL-4Rα/ST2（AK139）IND获受理，剑指呼吸系统及皮肤疾病领域 临床 进展 头对头度伐利尤单抗方案，依沃西方案一线治疗胆道肿瘤III期临床完成首例患者入组 临床 进展 全球首个CD47单抗实体瘤III期临床首例入组：依沃西联合莱法利一线治疗HNSCC（对比帕博利珠单抗） 数据发布 IGCS 2024 LBA & 《柳叶刀》主刊，卡度尼利1L宫颈癌III期研究PFS和OS双阳性结果重磅发布 产品动态 卡度尼利第二个适应症获批：一线胃癌全人群 数据发布 全球首个对比帕博利珠单抗取得显著阳性结果的随机对照大III期研究——依沃西HARMONi-2重磅研究成果在WCLC发表 临床 进展 卡度尼利联合方案治疗uHCC的III期临床研究完成首例患者入组 临床 进展 针对PD-1/L1治疗进展晚期胃癌，卡度尼利+普络西（VEGFR-2）联合疗法Ⅲ期临床完成首例入组 数据发布 ASCO Oral & JAMA主刊丨Ⅲ期HARMONi-A研究重磅公布，依沃西疗法有望改变EGFR-TKI进展肺癌全球治疗标准 临床 进展 国际多中心注册性III期研究HARMONi-3中国启动：依沃西单抗联合化疗对比帕博利珠单抗联合化疗1L治疗sq-NSCLC 产品动态 高达50亿美金！康方生物与Summit就PD-1/VEGF双抗依沃西达成合作和许可协议 产品动态 全球首个肿瘤免疫治疗双抗——开坦尼®（PD-1/CTLA-4双抗，卡度尼利）获批上市