Vusolimogene oderparepvec

近日， 在美国犹他州盐湖城举行的2026年美国移植与细胞治疗协会（ASTCT）暨国际血液与骨髓移植研究中心（CIBMTR）联合会议上，一项关于晚期黑色素瘤的真实世界临床研究数据被公布。 Iovance Biotherapeutics公司发布的数据显示，其商业化产品Amtagvi在41名既往接受过治疗的晚期黑色素瘤患者中，经医生评估确认的客观缓解率（ORR）为44%，疾病控制率为73%。 更值得注意的是，研究显示较早使用Amtagvi治疗的患者应答率更高：在接受≤2线既往治疗后使用Amtagvi的患者中，ORR为52%；而在接受≥3线既往治疗后使用的患者中，ORR为33%。 H.Lee Moffitt癌症中心与研究中心的Lilit Karapetyan博士对此评价道：“真实世界应答率建立在现有临床数据基础之上，支持在免疫检查点抑制剂治疗后尽早考虑使用Amtagvi。” 近年来，随着免疫疗法和细胞疗法的进步，晚期黑色素瘤患者的生存希望显著增加。 肿瘤浸润淋巴细胞（TIL）疗法是一种创新的癌症治疗方法。该疗法通过提取患者肿瘤组织中的免疫细胞，在实验室中扩增后重新输回患者体内，增强其攻击癌细胞的能力。 此前，2025年美国临床肿瘤学会年会上公布的五年长期随访数据显示，Amtagvi在晚期黑色素瘤患者中表现出持久的疗效，客观缓解率为31.4%，中位缓解持续时间长达36.5个月，最长持续缓解时间达到了58.7个月。 北京南郊肿瘤医院国际部架设的生命之桥 尽管癌症治疗领域取得了显著进展，但对于晚期癌症患者而言，获取前沿的治疗方案仍然面临多重障碍。新药批准的时间差、治疗技术的可及性以及个体化医疗方案的制定，都是患者和家庭需要面对的现实挑战。 以Amtagvi为例，作为首款获FDA批准用于实体瘤的一次性T细胞疗法，它为经过前期治疗失败的晚期黑色素瘤患者提供了新的选择。然而，这类创新疗法的可及性在不同国家和地区存在显著差异。 这种治疗需要专门的医疗设施和专业团队进行操作，目前全球范围内能够提供此类治疗的医疗中心数量有限。对于大多数患者来说，了解并获取这类前沿治疗意味着需要跨越地域和信息的双重障碍。 对于国内治疗方案有限或副作用耐受不良的患者，通过北京南郊肿瘤医院国际部（400-880-3716）的国际会诊渠道，获取此类国际前沿的治疗策略与药物方案评估，可能意味着找到新的控制疾病、提升生活质量的路径。 对于许多面临诊断困境、治疗方案瓶颈或渴望获得国际前沿治疗理念的中国癌症患者而言，国际医疗协作不再是遥不可及的概念。通过北京南郊肿瘤医院国际部提供的专业服务，患者可以获得两大关键支持： 国际权威专家会诊：无需远渡重洋，患者即可将完整的病历资料（包括影像、病理切片等）经由专业医学翻译整理后，提交给如丹娜法伯癌症研究院、MD安德森癌症中心等全球顶级机构的权威专家团队进行深度评估。专家们将提供详细的第二诊疗意见，包括诊断复核、治疗方案建议、新药/临床试验评估等。整个过程，北京南郊肿瘤医院国际部（400-880-3716）的专业团队将提供全程协调、翻译与解读服务，确保沟通无碍，意见落地。 国际就医转诊与全程管理：当会诊后认为患者有必要或更适合前往海外接受特定治疗时，北京南郊肿瘤医院国际部（400-880-3716）可以提供从匹配医院专家、预约预约、办理医疗签证、安排住宿交通，到海外就医期间全程医疗协调与生活支持的一站式服务。确保患者能够心无旁骛地接受治疗，同时也能在陌生的国度感受到有序、温暖与高效的医疗体验。 结语 癌症治疗领域正迎来前所未有的创新浪潮。除了TIL疗法，其他新型疗法也在不断涌现。例如，Replimune公司开发的RP1是一种新型溶瘤免疫疗法，它使用经过基因改造的单纯疱疹病毒1型来增强肿瘤细胞裂解和全身抗肿瘤免疫力。 这种疗法旨在促进免疫原性肿瘤细胞死亡，释放肿瘤抗原并改变肿瘤微环境，从而增强全身抗肿瘤免疫反应。FDA已接受其生物制剂许可申请的重新提交，并设定了2026年4月10日的处方药用户费用法案日期。 同时，Scancell公司的DNA免疫体iSCIB1+在晚期黑色素瘤治疗中也显示出潜力，其二期研究数据显示，在选定的HLA人群中，16个月无进展生存率达到74%。 这些创新疗法的不断涌现，为癌症患者提供了更多治疗选择，同时也凸显了国际医疗服务和专家会诊在获取这些前沿治疗方面的重要作用。 国际医学前沿的发展日新月异，而生命的希望往往在前沿的医疗突破中孕育。 当北京南郊肿瘤医院国际部的电话400-880-3716响起时，另一端连接的可能是美国最新公布的临床数据，可能是欧洲顶尖癌症中心的专家预约，也可能是为特定患者量身定制的前沿治疗方案。 那些曾经遥不可及的国际医疗资源，如今通过专业机构的桥梁服务，变得触手可及。在这个全球医疗资源共享的时代，每一个癌症患者都应该知道，他们的治疗选择可能远比想象的更加广阔。 北京南郊肿瘤医院 ● 国际会诊中心  在线远程会诊 用文字或视频的形式，突破语言、地域限制，由国外医学专家根据患者提供的病历资料，实时在线对患者疾病及当前治疗情况进行评估，给出个性化的诊疗建议供患者及其主治医生参考。咨询电话：400-880-3716 海外就医 我们签约合作众多海外优质医疗资源，提供专业出国就医服务：提交病历，快速匹配医生医院，提供病历整理翻译，预约，医疗签证申请，医疗翻译，公寓住宿，交通接待等服务。 咨询电话：400-880-3716

April 10, 2026 Target Action Date for RP1 in Advanced Melanoma WOBURN, Mass., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2025 and provided a business update. The Company's Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in anti-PD-1 failed melanoma was accepted by the FDA in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026. Commercial readiness activities are well underway to support a potential launch, if approved. The Company has amended its existing loan agreement with Hercules Capital, Inc. The amendment included the draw down of $35 million upon closing and the potential to draw another $120 million at post approval milestones. The amendment also delays the repayment of debt from 2026 to 2027. The Company has extended its cash runway late into to the first quarter of 2027. "We have been engaged with the FDA in the review of the BLA resubmission for RP1,” said Sushil Patel, Ph.D., CEO of Replimune. "Advanced melanoma patients can progress quickly and are in urgent need of safe and effective treatment options. Our team remains ready to launch RP1 with commercial supply produced and the commercial organization prepared to engage with our target accounts rapidly, assuming FDA approval.” Program Highlights & Milestones RP1 (vusolimogene oderparepvec) IGNYTE-3 Confirmatory Study: The global Phase 3 trial will enroll approximately 400 patients and is assessing RP1 in combination with nivolumab versus physician's choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The primary endpoint of this trial is overall survival, and key secondary endpoints are progression free survival and overall response rate. Acral Melanoma: Recent data for RP1 plus nivolumab was recently presented at the ESMO Congress 2025. The analysis of acral melanoma data from the IGNYTE anti-PD-1 failed melanoma cohort showed treatment with RP1 combined with nivolumab resulted in an objective response rate (ORR) of 44% (8/18) with a median duration of response of 11.9 months. The safety pro favorable with generally transient grade 1 and 2 treatment related adverse events. Advanced Non-melanoma Skin Cancer (NMSC) Studies: Additionally, a poster from ESMO featuring data from the IGNYTE clinical trial showed that RP1 plus nivolumab provided responses across multiple advanced non-melanoma skin cancer (NMSC) tumor types, including anti–PD-1 naïve and failed disease, as well as both in locally advanced and metastatic disease. The ORR was 100.0%, 33.3%, 66.7%, and 56.3% in patients with anti–PD-1 naïve MCC, BCC, angiosarcoma, and CSCC, respectively. The ORR was 26.3%, 30.0%, 37.5%, and 15.2% in patients with anti–PD-1 failed MCC, BCC, angiosarcoma, and CSCC, respectively. The IGNYTE clinical trial cohort in NMSC is ongoing, however, enrollment was stopped in Q4 2025. ARTACUS Study: Data from the ongoing ARTACUS Phase 2 trial evaluating the potential of RP1 as monotherapy in cutaneous squamous cell carcinoma patients following organ transplant were recently presented during an oral session at the Society for Melanoma Research 22 nd International Congress. RP1 monotherapy showed robust anti-tumor activity in locally advanced CSCC with an ORR of 34.6% (CR rate was 23.1%) and 2-year duration of response of 61.0%. RP1 monotherapy was well tolerated, and the safety pro similar to that observed in non-immunocompromised patients with advanced skin cancers. RP2 REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027, with PFS analysis potentially supporting accelerated approval. Liver-focused Studies: The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD-1/PD-L1 progressed hepatocellular carcinoma is currently enrolling. The protocol was amended to include RP2 as monotherapy with data planned by the end of 2026. The trial is being conducted under a collaboration and supply agreement with Roche. The Company also has enrolled its first patients in a cohort evaluating RP2 in patients with biliary tract cancer. This cohort will evaluate RP2 combined with durvalumab. Financial Highlights Cash Position : As of December 31, 2025, cash, cash equivalents and short-term investments were $269.1 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans. Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments will enable us to fund operations late into the first quarter of calendar 2027. This includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue. R&D Expenses: Research and development expenses were $53.1 million for the fiscal third quarter and $48.0 million for the fiscal third quarter ended December 31, 2024. This increase was primarily due to an increase in RP1 direct research costs related to the IGNYTE-3 confirmatory study and other study costs including lab and operating supplies, as well as increased RP2 study costs. In addition, personnel-related costs increased as we continued to prepare for a potential commercial launch of RP1. Research and development expenses included $3.6 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025. S,G&A Expenses: Selling, general and administrative expenses were $18.7 million for the fiscal third quarter ended December 31, 2025, as compared to $18.0 million for the fiscal third quarter ended December 31, 2024. Selling, general and administrative expenses included $3.4 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025. Net Loss: Net loss was $70.9 million for the fiscal third quarter ended December 31, 2025 and $66.3 million for the fiscal third quarter ended December 31, 2024. About RP1 RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response. About RP2 RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity. About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit Forward Looking Statements This press release contains 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, including statements regarding our expectations about our cash runway, the status of the FDA review of our BLA for RP1 or potential approval of such BLA, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to the outcome of FDA’s review process, our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor Inquiries Chris Brinzey ICR Healthcare 339.970.2843 chris.brinzey@icrhealthcare.com Media Inquiries Arleen Goldenberg Replimune 917.548.1582 media@replimune.com Replimune Group, Inc. Condensed Consolidated Statements of Operations (Amounts in thousands, except share and per share amounts) (Unaudited) Three Months Ended December 31, Nine Months Ended December 31, 2025 2024 2025 2024 Operating expenses: Research and development $ 53,140 $ 48,004 $ 168,860 $ 135,472 Selling, general and administrative 18,728 18,015 77,721 46,827 Total operating expenses 71,868 66,019 246,581 182,299 Loss from operations (71,868 ) (66,019 ) (246,581 ) (182,299 ) Other income (expense): Research and development incentives 341 376 1,138 1,222 Investment income 2,846 5,137 11,256 15,243 Interest expense on finance lease liability (514 ) (528 ) (1,553 ) (1,594 ) Interest expense on debt obligations (1,466 ) (1,450 ) (4,429 ) (4,314 ) Other (expense) income, net (580 ) (3,281 ) (865 ) (850 ) Total other income (expense), net 627 254 5,547 9,707 Loss before income taxes $ (71,241 ) $ (65,765 ) $ (241,034 ) $ (172,592 ) Income tax (benefit) provision $ (311 ) $ 575 $ (311 ) $ 575 Net loss $ (70,930 ) $ (66,340 ) $ (240,723 ) $ (173,167 ) Net loss per common share, basic and diluted $ (0.77 ) $ (0.79 ) $ (2.62 ) $ (2.25 ) Weighted average common shares outstanding, basic and diluted 92,187,581 83,498,892 91,874,481 77,113,695 Replimune Group, Inc. Condensed Consolidated Balance Sheets (Amounts In thousands, except share and per share amounts) (Unaudited) December 31, 2025 March 31, 2025 (in thousands) Consolidated Balance Sheet Data: Cash, cash equivalents and short-term investments $ 269,137 $ 483,804 Working capital 230,267 433,518 Total assets 333,590 551,328 Total stockholders' equity 210,539 415,843