Etoposide

NetworkNewsWire Editorial Coverage NEW YORK, July 7, 2025 /PRNewswire/ -- An estimated 20 million people are diagnosed annually with cancer, while cancer kills almost 10 million people a year worldwide () with these numbers expected to grow. The American Cancer Society projects that by 2050, 35 million people will be diagnosed with cancer every year. Despite significant progress made in treating the disease, there is still a desperate need — and an enormous market potential — for new and more effective cancer drugs. Calidi Biotherapeutics Inc. (NYSE American: CLDI) (Profile) is committed to developing a novel approach to treating cancer through the precise delivery of genetic medicines to both primary tumors and metastatic sites of disease. This cutting-edge platform, which harnesses engineered viruses that can target sites of cancer in the body and deliver potent genetic medicines to attack tumors, has the potential to revolutionize the way cancer is treated. And while cancer is the initial focus for Calidi, the company has also begun to assess the potential of this technology in other areas of large unmet need such as autoimmune disease. Calidi is joining an elite group of high-quality companies focused on making a difference in the world of cancer and genetic medicines, including Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), CG Oncology Inc. (NASDAQ: CGON), Roche (OTCQX: RHHBY) and Merck & Co. Inc. (NYSE: MRK). Cancer remains one of the most devastating health challenges facing the globe today, responsible for about one in six deaths worldwide. Calidi's decade-long development journey has culminated in novel precision genetic medicine delivery platforms with real therapeutic promise. The company has taken a decisive step in the fight against advanced and hard-to-treat cancers with CLD-401, its first compound designed for systemic administration that delivers IL-15 superagonist directly to tumor sites, including metastatic cancers . Calidi Biotherapeutics has unveiled compelling preclinical data this year at two of the most influential oncology conferences. Click here to view the custom infographic of the Calidi Biotherapeutics Inc. editorial. Sustained Investment in Research, Development Cancer remains one of the most devastating health challenges facing the globe today, responsible for about one in six deaths worldwide (). The most common cancer types worldwide include lung cancer (accounting for around 2.2 million new cases and 1.8 million deaths in 2020), breast cancer (2.26 million new cases), colorectal cancer (1.93 million) and prostate cancer (1.41 million). In the United States, cancer claims more than 600,000 lives each year, with more than two million new cases expected in 2025 alone. These figures highlight both the scale of human suffering and the enormous burden cancer places on health systems around the world. These statistics underscore the importance of sustained investment in research and development. The global oncology drugs market was valued at approximately $190.1 billion in 2023 and is projected to grow to more than $564.5 billion by 2033, reflecting a compound annual growth rate (CAGR) of 11.5% over the forecast period (). This rapid expansion highlights the critical role of sustained investment in research and development, which drives advancements in early detection, targeted therapies, immunotherapies and personalized medicine — key tools in reducing the overwhelming global cancer burden Advancing Precision Delivery of Genetic Medicines Calidi Biotherapeutics Inc (NYSE American: CLDI) has spent more than a decade developing a breakthrough technology platform that enables the systemic delivery of genetic medicines to targeted tumor sites, including metastatic sites in cancer patients. At the core of this innovation is the company's proprietary engineered viral system, which cloaks therapeutic payloads in a protective human cell membrane (the "envelope") designed to evade the immune system and reach distant metastases with precision where genetic medicines that can drive tumor clearance are expressed. Calidi's decade-long development journey, from stem cell-based delivery systems to the enveloped systemic virotherapies, has culminated in novel precision genetic delivery platforms with real therapeutic promise. The company's preclinical breakthroughs have been detailed in peer-reviewed conferences and investor communications, leading to upcoming IND filing goals and potential partnerships on the horizon. Calidi appears to be well positioned to pioneer a new era of targeted cancer treatment, where genetic payloads reach disease sites directly, immune activation is localized, and patients benefit from safer, more effective therapies. Understanding the Platform Calidi Biotherapeutics is clinical stage biotechnology company that is developing genetic medicines and proprietary genetically engineered oncolytic viruses. Calidi's RedTail systemic antitumor virotherapy platform is a novel tumor-selective vaccinia virus strain designed to target all tumor sites (). The platform is capable of producing a high amount of enveloped vaccinia viruses resistant to humoral immunity. The technology allows the therapy to reach tumor sites and kill tumors by expressing genetic medicines in the tumor microenvironment. According to the company, the lead candidate from the RedTail platform, CLD-401, targets lung cancer and other tumor types with high unmet medical need. Pioneering Systemic Cancer Targeting Calidi Biotherapeutics has taken a decisive step in the fight against advanced and hard-to-treat cancers with CLD-401, its first compound designed for systemic administration. This lead candidate harnesses the company's decade-long innovation in enveloped viral delivery to simultaneously destroy cancer cells and deliver genetic medicine aimed at preventing disease recurrence at metastatic sites. By enabling intravenous administration, CLD–401 ushers in a new era of precision oncology where genetic payloads reach tumors throughout the body, rather than relying on localized injections. Central to CLD–401's mechanism is the company's proprietary RedTail platform. CLD–401 is an enveloped oncolytic vaccinia virus engineered to express a chimeric CD55 receptor, significantly enhancing its resistance to immune clearance and enabling systemic circulation to metastatic tumors. Loaded with an IL–15 superagonist payload, the virus not only lyses tumor cells but also delivers powerful genetic material directly into the tumor. This cytokine-based genetic medicine activates CD8+ T cells and natural killer cells, effectively transforming "cold" tumors into immunologically "hot" targets. Preclinical data has confirmed the platform's potential. "Of particular excitement is the rapid progress we have made with RedTail, the company's approach to systemically delivering genetic medicines to metastatic sites in patients with advanced cancer using our proprietarily engineered enveloped virus," reported Calidi CEO Dr. Eric Poma in a recent shareholder letter (). "RedTail represents the culmination of over a decade of meticulous research and innovation at Calidi to create what we believe is the most advanced systemic virotherapy platform. Advancing this novel platform is the company's main focus and priority." Sharing Compelling Preclinical Data Calidi Biotherapeutics has unveiled compelling preclinical data at two of the most influential oncology conferences — the American Association of Cancer Research (AACR) and the American Association of Clinical Oncology (ASCO) — highlighting the tumor-clearing and recurrence-blocking potential of CLD–401. At the AACR Annual Meeting, held in April 2025, Calidi presented key findings under the title "Development of a Systemic Enveloped Virotherapy for Targeting All Metastatic Sites" (). The data revealed that RedTail's enveloped vaccinia virus, coated with a human-like extracellular envelope, can survive immune defenses, access multiple tumor sites following intravenous administration and induce strong tumor killing even in traditionally hard-to-treat metastatic lung models, by delivering genetic medicines such as IL-15 superagonist directly to the tumor. The abstract emphasized the platform's ability to evade complement activation, substantially improving systemic circulation time and therapeutic impact. The momentum continued into the ASCO Annual Meeting in June 2025, where Calidi presented results demonstrating that CLD–401, enhanced with a chimeric CD55 receptor, further resists immune clearance and delivers its IL-15 superagonist payload directly into tumors (). This immune payload triggered robust expansion of CD8+ T cells and natural killer cells in the tumor microenvironment, key players in sustained anti-tumor immunity. Collectively, these data sets presented at AACR and ASCO illustrate the dual potency of CLD–401: it both breaks down tumor tissue and educates the immune system to prevent relapse. The systemic reach of RedTail, along with its tumor-targeted immune stimulation, positions Calidi's platform as a significant advancement in the field of immuno-oncology, especially for metastatic cancers with high unmet needs. "Looking ahead, our roadmap for the next 18 months includes multiple critical milestones," said Poma. "We are working to complete IND-enabling studies ahead of an IND filing by the end of 2026 for our lead RedTail candidate that delivers IL-15 superagonist to tumor sites, CLD-401. Our clinical strategy includes an optimized dose-escalation study designed to swiftly demonstrate efficacy and validate the systemic administration of RedTail in patients with metastatic disease." With promising results in hand and strategic plans in place, Calidi is positioning itself to enter human trials that may redefine how genetic medicines reach and treat cancer throughout the body. Leading Biotech Firms Share Promising Advances The global effort to transform cancer care continues to accelerate as leading biopharmaceutical companies report groundbreaking clinical data across multiple tumor types. Industry leaders are showcasing the progress of novel immunotherapies and targeted treatments aimed at some of the most challenging cancers. Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) shared new and updated data from its oncology and hematology portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (). According to the company, its 18 presentations will share the latest insights from ongoing research of approved and investigational treatment regimens across a range of difficult-to-treat cancers including non-melanoma and melanoma skin cancer, lung cancer, lymphoma and multiple myeloma. CG Oncology Inc . (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, presented key data at the 2025 American Urological Association (AUA) Annual Meeting (). The data was from the phase 3 BOND-003 Cohort C study of patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease. Roche (OTCQX: RHHBY) is reporting positive results from its phase 3 IMforte study of Tecentriq(R) (atezolizumab) in combination with lurbinectedin (Zepzelca(R)) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and Tecentriq (). The company noted that the data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Merck & Co. Inc. (NYSE: MRK) announced that its phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers (). The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1. The study is evaluating KEYTRUDA(R) (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for these patients. Together, these data presentations and reports underscore the power of innovation in oncology, where immunotherapy combinations, genetic medicine therapies and personalized treatment approaches are driving new standards of care. With each development, the cancer research community moves one step closer to achieving more durable responses, longer survival and, ultimately, potential cures. For more information, visit Calidi Biotherapeutics Inc. 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点击蓝字关注我们本期看点肺癌的分类，按照组织学，可以分为小细胞肺癌（13.9%）；非小细胞肺癌：鳞状细胞癌（24.4%）、腺癌（45.4%）、大细胞癌（1.5%）、其他（如腺鳞癌、肉瘤样癌等）。小细胞肺癌，相较于靶向治疗、免疫治疗进展迅速的非小细胞肺癌，小细胞肺癌一直都是临床难治性瘤种，但SCLC近年来逐步成为创新药物竞逐的热点。小细胞肺癌的治疗正在经历着变革，迎来了前所未有的快速发展时期，中国研究者做出了突出的贡献，掀起了小细胞肺癌诊疗研究领域的新浪潮。创新型抗肿瘤药物的研发和新的联合策略的探索将带给SCLC治疗格局日新月异的改变，随着分子机制的不断揭示，治疗脆弱点和预测标志物的络绎涌现，SCLC在迈向精准治疗的道路上更进一步，未来有望实现更大的突破。对于在此过程中做出突出贡献的学者给予赞许。愿时光倒流，只专注学术为好。本期内容012025CSCO小细胞肺癌指南更新02小细胞肺癌治疗现状和流行病学03全球小细胞肺癌在研态势04总结与展望【01 2025CSCO小细胞肺癌指南更新】针对2025CSCO小细胞肺癌的指南药物更新制图如下：简要整理如下：广泛期 SCLC 初始治疗新增 I 级推荐：替雷利珠单抗 + 卡铂或顺铂 + 依托泊苷 4 周期后替雷利珠单抗维持治疗由 III 级推荐修订为 I 级推荐（优选，1A 类）特瑞普利单抗 + 卡铂或顺铂 + 依托泊苷 4-6 周期后特瑞普利单抗维持治疗由 III 级推荐修订为 I 级推荐（优选，1A 类）。新增“贝莫苏拜单抗+安罗替尼+卡铂+依托泊苷4周期后贝莫苏拜单抗和安罗替尼维持治疗”为I级推荐。复发SCLC二线治疗上调“芦比替丁”为I级推荐。“贝莫苏拜单抗+安罗替尼”的更新要点更加凸显出中国生物制药的创新产品获得更多指南推荐的实力验证。根据中国国家药监局药品审评中心（CDE）公示信息及企业公告，贝莫苏拜单抗联合安罗替尼注射液已申报上市的适应症包括以下5项：广泛期小细胞肺癌（ES-SCLC）一线治疗2024年5月获批，成为该联合疗法首个上市适应症，用于联合化疗（卡铂+依托泊苷）治疗广泛期小细胞肺癌。复发性或转移性子宫内膜癌2024年11月获批，适用于既往系统性抗肿瘤失败且不适合根治性手术/放疗的非MSI-H/dMMR患者，客观缓解率（ORR）达34.1%，中位总生存期（OS）为21.8个月。晚期鳞状非小细胞肺癌（sq-NSCLC）一线治疗2025年4月23日新申报，联合化疗后序贯安罗替尼，对比传统方案显著延长无进展生存期（PFS）。Ⅲ期非小细胞肺癌（NSCLC）巩固治疗2025年4月23日新申报，针对同步/序贯放化疗后未进展的局部晚期不可切除患者，降低疾病进展风险。晚期或不可切除腺泡状软组织肉瘤已于2024年纳入优先审评，临床前研究显示其对JAK抑制剂耐药模型仍有效，预计2025年获批。02 小细胞肺癌治疗现状和流行病学03 全球小细胞肺癌在研态势【安进丨DLL3/CD3双抗】2025年4月11日，安进宣布DLL3/CD3双特异性抗体Tarlatamab（商品名Imdelltra）在III期DeLLphi-304研究中达到主要终点。该研究纳入前线铂类化疗后进展的广泛期小细胞肺癌（ES-SCLC）患者，对比标准治疗（SOC）化疗显示，Tarlatamab显著延长总生存期（OS），且具有统计学和临床意义。安全性数据与既往研究一致，未出现新的安全性信号。详细数据计划于近期国际学术会议披露。Tarlatamab于2024年5月获FDA加速批准上市，用于铂类化疗后进展的ES-SCLC治疗，成为全球首个靶向DLL3的双抗药物。此次III期数据为其从加速批准转为完全批准提供关键支持。国内研发进展百济神州拥有Tarlatamab中国区商业化权益，同步推进多项临床：DeLLphi-305：比较Tarlatamab+度伐利尤单抗 vs 度伐利尤单抗维持治疗的III期研究联合放疗探索：DeLLphi-306研究局限期SCLC放化疗后辅助治疗（NCT05740566）随着Tarlatamab等创新疗法的涌现，ES-SCLC治疗进入精准免疫时代。DLL3靶点的突破不仅为患者提供新选择，更验证了双抗技术在实体瘤治疗中的潜力。普米斯丨PD-L1/VEGF双抗此外，其他国产双抗也纷纷布局小细胞肺癌，如普米斯的PD-L1/VEGF双抗PM8002。针对占肺癌病例14%的小细胞肺癌（SCLC），这款中国二期临床试验中展现突破性疗效的药物，已迈入全球三期临床阶段。数据显示，BNT327联合化疗为患者带来16.8个月的中位总生存期（OS），较当前罗氏Tecentriq（12.3个月）和阿斯利康Imfinzi（13个月）的标准疗法显著延长，有望重塑SCLC一线治疗格局。  尽管跨试验对比存在局限性——BioNTech的48例单臂研究与跨国多中心数千人试验的样本差异引发讨论，但其二线治疗数据同样亮眼：65例患者中位OS达14.3个月，未接受免疫治疗人群的缓解持续时间（DOR）更长达11.5个月，超越安进同类药物Imdelltra（9.7个月）。目前，BNT327联合化疗的二线三期试验已在华启动，而全球布局则聚焦一线治疗，覆盖SCLC、非小细胞肺癌及三阴性乳腺癌三大癌种。正大天晴广泛期小细胞肺癌（ES-SCLC）一线治疗：2024年5月，贝莫苏拜单抗注射液联合安罗替尼、依托泊苷及卡铂一线治疗ES-SCLC获国家药监局批准。在ETER701Ⅲ期研究中，接受该四药联合疗法的患者中位总生存期（OS）达19.3个月，较单纯化疗延长7.4个月，疗效数据亮眼。这是国内首个PD-L1抗体与安罗替尼联合用于ES-SCLC的一线疗法，为该类型患者提供了新的治疗选择。齐鲁制药丨PD-1/CTLA-4组合抗体2025年2 月 11 日，药物临床试验登记与信息公示平台官网显示，齐鲁制药登记了一项 QL1706 注射液（艾帕洛利单抗/托沃瑞利单抗，PD-1/CTLA4 混合抗体）单药巩固治疗局限期小细胞肺癌的 III 期临床研究（CTR20250450）。在齐鲁艾托组合抗体肺癌、宫颈癌、结直肠癌、肝癌、食管癌数据汇总 一文中就QL1706在各个实体瘤领域的研究进展进行过梳理。04 总结与展望本次更新可以看出，国产创新药物逐步获得更多认可，也期望后续有更多创新产品重塑小细胞肺癌的治疗格局。★