Avelumab

Mr. Vat-Ho's appointment adds more than 20 years of oncology, biopharma and capital markets experience, including senior roles in transactions totaling more than $25 billion in aggregate value Mr. Vat-Ho brings highly relevant ADC payload partnering experience, including recently executed collaborations with Exelixis and BioNTech TAMPA, Fla. and LONDON, Oct. 13, 2026 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with a novel RNA splicing disrupting payload, today announced the appointment of Vatnak Vat-Ho as Chief Business Officer, strengthening the Company’s leadership team with an accomplished oncology business development executive whose experience spans major biopharmaceutical transactions, ADC payload collaborations, capital markets and commercial strategy. Mr. Vat-Ho brings more than 20 years of experience across oncology business development, biopharmaceutical strategy, equity research and healthcare investing. Throughout his career, he has led or held senior transaction roles in deals totaling more than $25 billion in aggregate value, including transactions and collaborations involving Pfizer, Exelixis, BioNTech, Merck KGaA, Roivant and Roche/Genentech. Importantly for Akari, Mr. Vat-Ho brings direct and recent experience creating strategic collaborations in oncology, including novel ADC payload technology. Most recently, as Chief Business Officer of Ryvu Therapeutics, he originated and closed a collaboration with Exelixis involving a novel ADC payload, as well as a multi-target immuno-oncology research collaboration with BioNTech. At Akari, Mr. Vat-Ho will lead corporate and business development, including corporate strategy, partnering and licensing, and investor engagement, as the Company advances its lead TROP2-targeted ADC, AKTX-101, toward the clinic and continues to develop the broader potential of its proprietary PH1 spliceosome-modulating payload platform. “Vatnak is joining Akari at an important point in our evolution, and the relevance of his experience to our strategy is exceptional,” said Abizer Gaslightwala, Chief Executive Officer of Akari Therapeutics. “He has spent his career at the intersection of oncology innovation, strategic transactions and capital markets, and, importantly, he has recent direct experience structuring collaborations around novel ADC payload technology with leading oncology companies. As we advance AKTX-101 toward the clinic and continue to demonstrate the potential breadth of PH1, we believe there is a significant opportunity to create value not only through our wholly owned pipeline, but also through strategic partnerships that can expand the reach and application of our technology. Vatnak gives us additional leadership, relationships and transaction experience to pursue that opportunity with focus and discipline.” “The ADC field is increasingly recognizing that the payload can be one of the most important drivers of differentiation and value, and I believe Akari has built something particularly compelling with PH1,” said Mr. Vat-Ho. “The combination of a differentiated mechanism of action, encouraging preclinical activity, potential immune activation and applicability across multiple tumor targets creates several potential avenues for value creation. I am excited to join Akari at this stage and work with Abizer and the team to advance AKTX-101, expand the strategic reach of the PH1 platform and pursue partnerships that can accelerate and broaden the development of this technology.” About Vatnak Vat-Ho Mr. Vat-Ho brings more than 20 years of experience spanning oncology business development, biopharmaceutical strategy, equity research and healthcare investing. Over his career, he has led or held senior transaction roles in deals totaling more than $25 billion in aggregate value, combining leadership of collaborations with major biopharmaceutical companies with an understanding of the clinical, commercial and financial factors that shape partnering and investment decisions. Most recently, Mr. Vat-Ho served as Chief Business Officer and a member of the Management Board of Ryvu Therapeutics, where he originated and closed the company's collaboration with Exelixis on a novel ADC payload, as well as its multi-target immuno-oncology research collaboration with BioNTech. At Ryvu, he also oversaw partnering/BD, U.S. investor relations, commercial development and alliance management. Previously, as Vice President, Business Development at Affimed, he originated and closed a multi-target license and discovery collaboration with Roivant and served as alliance manager for the company's partnerships including Roche/Genentech. Prior to that, Mr. Vat-Ho spent eight years at Pfizer Oncology in business development and commercial development, rising to Senior Director and Team Lead, Strategy, Business Development & Alliances. He worked on transactions including the $14 billion acquisition of Medivation, the $850 million upfront avelumab collaboration with Merck KGaA, Darmstadt, Germany, and several strategic financing and out-licensing transactions. He began his career in equity research and healthcare investing at firms including BMO Capital Markets and Broadfin Capital, building a foundation in valuation, capital markets and investor engagement. Mr. Vat-Ho holds an A.B. in Biology from Harvard University and an M.B.A. from New York University's Leonard N. Stern School of Business. About Akari Therapeutics Akari Therapeutics is an oncology biotechnology company developing next-generation antibody drug conjugates (ADCs) with a unique payload, PH1, which targets RNA splicing. Utilizing its innovative ADC discovery platform, the Company has the ability to generate ADC candidates and optimize them based on the desired application to any antigen target of interest. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells with a proprietary linker, enabling it to deliver its novel PH1 payload directly into the tumor with minimal off-target effects. Unlike current ADCs that use microtubule inhibitors and DNA-damaging agents as their payloads, PH1 is a novel payload that is a spliceosome modulator designed to disrupt RNA splicing within cancer cells. This splicing modulation has been shown in preclinical animal models to induce cancer cell death while activating both the innate and adaptive immune systems to drive robust and durable activity. In preclinical studies, AKTX-101 has been shown to have significant activity and prolonged survival relative to ADCs with traditional payloads. Additionally, AKTX-101 has the potential to be synergistic with checkpoint inhibitors and has demonstrated prolonged survival as both a single agent and in combination with checkpoint inhibitors. The PH1 payload has also been demonstrated to be very active against cancer cells with key oncogenic drivers such as KRAS, BRAF, AR-V7, FGFR3 fusions, and others. The Company has initiated IND enabling studies for AKTX-101 with a goal of starting its First-In-Human trial by mid-2027. Akari is also developing AKTX-102, an ADC candidate targeting CEACAM5 (Carcinoembryonic Antigen-related Cell Adhesion Molecule-5), a well-validated tumor antigen broadly expressed across multiple solid tumors. AKTX-102 is designed to leverage Akari’s proprietary PH1 spliceosome-modulating payload and a novel antibody construct to enable differentiated tumor cell killing and immune activation. For more information about the Company, please visit and connect on X and LinkedIn . Cautionary Note Regarding Forward-Looking Statements This press release includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding the ability of the Company to advance its product candidates for the treatment of cancer and the timing of a filing of an IND and commencement of a Phase I clinical trial. These statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the Company’s need for additional capital; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the business; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company’s programs or product candidates; risks related to any loss of the Company’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company’s product candidates, including as a result of potential tariffs; the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company’s product candidates; risks related to competition for the Company’s product candidates; and the Company’s ability to successfully develop or commercialize its product candidates. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the SEC, copies of which may be obtained from the SEC’s website at The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release except as required by law. Investor Relations Contact JTC Team, LLC Jenene Thomas 908-824-0775 AKTX@jtcir.com

确诊局部晚期或转移性尿路上皮癌后，大多数患者和家属第一反应是：接下来只能选铂类化疗了。这个根深蒂固的认知，正在被改写。新的治疗选择正在进入一线，它们不是传统化疗，而是一类精准靶向的生物药物。这些变化意味着什么？你能从中获得什么？这篇文章会给你答案。  一  ADC药物是什么，为什么能治疗尿路上皮癌ADC药物，全称抗体药物偶联物，是一类由抗体、连接头和细胞毒性药物组成的靶向生物药剂。它通过特定的连接头，将靶标特异性的单克隆抗体与高杀伤性的细胞毒性药物偶联起来，用单克隆抗体作载体，把小分子细胞毒性药物精准运输到肿瘤细胞中[1]。简单说，ADC药物结合了抗体的靶向性和化疗药的杀伤力，既能精准打击肿瘤，又能降低传统化疗的脱靶副作用。图片来源：AI生成针对尿路上皮癌，目前临床研究最多的ADC药物是Enfortumab Vedotin（EV）。它的靶点是Nectin-4，一种在细胞黏附中发挥作用的黏附分子。研究发现，超过50%的尿路上皮样本中Nectin-4蛋白表达呈阳性，且膀胱癌样本中的Nectin-4蛋白免疫组化检测水平最高。因此，Nectin-4是尿路上皮癌理想的ADC药物靶点[1]。EV最初获批时，是用于后线治疗。在EV201研究中，针对既往接受过含铂化疗和免疫治疗后病情进展的患者，EV治疗的客观缓解率（ORR）达44%，完全缓解率（CR）达12%，中位无进展生存期（PFS）达5.8个月，中位总生存期（OS）达11.7个月[1]。这些数据确认了EV的基础疗效。但问题来了：能不能把它用到一线？  二  新方案放到一线，效果真的更好吗能。而且不只是“能用”，是“更优”。1长期生存数据已经出来了EV-103研究是一项针对未经治疗的局部晚期或转移性尿路上皮癌患者的临床试验，评估了EV联合帕博利珠单抗（一种免疫检查点抑制剂）的疗效。5年随访数据显示，这一联合方案能带来长期的生存获益[2]。5年，这个时间跨度意味着什么？意味着部分患者可能实现长期带瘤生存，甚至临床治愈。2与传统方案对比，新方案更有优势一项调整对比研究直接比较了一线EV联合帕博利珠单抗与传统铂类化疗联合免疫维持治疗（阿维鲁单抗维持）的疗效。结果显示，新方案在局部晚期或转移性尿路上皮癌中的获益更优[3]。这不是理论推测，是数据对比的结果。3真实世界验证，效果一致临床试验的结果能在真实世界复制吗？两项多中心真实世界研究给出了答案：能。一项来自德国等多国的真实世界队列研究（GUARDIANS）验证了EV联合帕博利珠单抗在尿路上皮癌患者中的有效性和安全性，与临床试验结果一致[4]。另一项土耳其多中心研究再次确认了这一结论[5]。真实世界研究的价值在于，它纳入的患者更接近临床实际情况，包括那些年龄更大、合并疾病更多的患者。这些研究的结果说明，新方案不是“只在临床试验里有效”，而是真的能让更多患者受益。图片来源：AI生成4生存获益的同时，还能改善生活质量治疗不只是为了延长生存时间，还要让患者活得更好。EV-302研究的生活质量数据分析显示，一线联合治疗在带来生存获益的同时，还能改善患者的生活质量[6]。这一点尤其重要。晚期肿瘤患者最担心的，就是治疗带来的副作用让生活质量下降，甚至“活着只是为了治疗”。新方案在这方面表现更好。  三  我能不能用这个方案，有哪些注意事项1适用人群和治疗地位目前，ADC药物在尿路上皮癌治疗中的地位正在提升。一项综述总结了膀胱癌治疗领域的最新进展，明确指出ADC类药物在尿路上皮癌治疗中的地位提升，以及一线治疗格局的变化[7]。简单说，如果你是未经治疗的局部晚期或转移性尿路上皮癌患者，EV联合帕博利珠单抗已经成为一线可选的治疗方案。2常见不良反应和管理要点一项系统综述详细分析了EV在晚期或转移性尿路上皮癌中的疗效、安全性和临床应用，明确了常见不良反应的管理要点[8]。EV常见的≥3级严重不良反应包括：贫血（8%）、低钠血症（7%）、尿路感染（7%）和高血糖（6%）[1]。这些不良反应大多可以通过对症处理控制。关键是：① 治疗前明确告知医生自己的基础疾病，尤其是糖尿病、肾功能不全等。② 治疗过程中定期复查血常规、电解质、血糖等指标。③ 出现异常症状（如乏力加重、口渴多尿、发热等）及时就诊，不要拖。中国抗癌协会发布的《抗体药物偶联物治疗恶性肿瘤临床应用专家共识（2020版）》特别强调，ADC药物的不良反应管理需要多学科协作，必要时应邀请相关学科专家会诊，降低不良反应对患者预后和生活质量的影响[1]。图片来源：AI生成3治疗顺序的新思考ADC药物进入一线后，带来了一个新问题：如果一线用了EV联合免疫治疗，后续治疗怎么选？目前这个问题还在探讨中。有综述讨论了晚期尿路上皮癌系统治疗顺序中尚未解决的问题，包括不同ADC类药物的线序安排等临床热点[9][10]。但有一点是明确的：一线治疗的选择，会影响后续治疗的空间。这也是为什么要在最开始就和医生充分讨论，制定完整的治疗规划。结语晚期尿路上皮癌的治疗，不再只有铂类化疗这一条路。以ADC为基础的一线联合方案，已经成为更优的新选择。治疗格局的更新，意味着更多的机会。如果你或家人正面临治疗选择，不妨主动和主管医生沟通，评估自身情况，了解是否适合新方案。信息不对等是治疗中最大的障碍。你有权利知道所有可能的选择，也有权利为自己争取更好的治疗机会。本文仅作科普知识分享，所有治疗方案需在专业医师指导下选择，具体请咨询您的主治医师。内容制作温馨提示：本文中所涉及的信息旨在科普，部分内容为AI生成，不涉及诊疗方案推荐，临床上请遵从医生或专业人士建议。封面图片：AIGC责任编辑：觅健科普君参考文献温馨提示：本文中所涉及的信息旨在传递医药前沿信息和研究进展，不涉及诊疗方案推荐，临床上请遵从医生或其他医疗卫生专业人士的意见与指导。[1] 《抗体药物偶联物治疗恶性肿瘤临床应用专家共识（2020版）》（中国抗癌协会肿瘤药物临床研究专业委员会，2020）。[2] Rosenberg JE， O'Donnell PH， Petrylak DP， et al. EV-103 dose escalation/cohort A： 5-year follow-up of enfortumab vedotin plus pembrolizumab in previously untreated locally advanced/metastatic urothelial carcinoma[J]. ESMO open， 2026. DOI： 10.1016/j.esmoop.2026.107700。[3] Dillon R， Jones R， Fléchon A， et al. Adjusted Comparison of First-line Enfortumab Vedotin Plus Pembrolizumab Versus Platinum-based Chemotherapy ± Avelumab Maintenance for the Treatment of Locally Advanced/Metastatic Urothelial Carcinoma[J]. European urology oncology， 2026. DOI： 10.1016/j.euo.2026.06.004。[4] Zschäbitz S， Bhatti I， Casuscelli J， et al. Effectiveness and safety of enfortumab vedotin and pembrolizumab in a real-world patient population with urothelial carcinoma： results from a multi-institutional cohort (GUARDIANS)[J]. Cancer immunology， immunotherapy ： CII， 2026. DOI： 10.1007/s00262-026-04448-2。[5] Kıkılı Cİ， Araz M， Ürün Y， et al. Real-World Efficacy and Safety of Frontline Enfortumab Vedotin Plus Pembrolizumab in Metastatic Urothelial Carcinoma： A Multicenter Study and Review of the Literature[J]. Clinical genitourinary cancer， 2026. DOI： 10.1016/j.clgc.2026.102594。[6] Benjamin DJ， Rezazadeh Kalebasty A. Quality of life with EV-302 in advanced urothelial carcinoma： lessons and implications[J]. Translational cancer research， 2026. DOI： 10.21037/tcr-2026-1-0069。[7] Xu X， Hao HY， Chen HY. The clinical landscape of bladder cancer treatment： a brief report on new developments and future perspectives in pharmaceutical interventions[J]. Frontiers in oncology， 2026. DOI： 10.3389/fonc.2026.1747070。[8] Piekarz J， Picheta N， Pobideł J， et al. Enfortumab Vedotin in Advanced or Metastatic Urothelial Carcinoma： A Systematic Review of Efficacy， Safety， and Clinical Perspectives[J]. Cancers， 2026. DOI： 10.3390/cancers18142324。[9] Petrelli F， Ghidini A， Vavassori I， et al. Early versus deferred immunotherapy in urothelial carcinoma： a review of evidence and post-progression survival[J]. International urology and nephrology， 2026. DOI： 10.1007/s11255-026-05151-y。[10] Ram P， Merseburger AS， Huabkong M， et al. Unresolved questions in the sequencing of systemic therapy for advanced urothelial carcinoma[J]. World journal of urology， 2026. DOI： 10.1007/s00345-026-06408-y。