Sirexatamab

USA News Group News Commentary Issued on behalf of GT Biopharma, Inc. VANCOUVER, BC, Oct. 7, 2025 /PRNewswire/ -- USA News Group News Commentary – Major pharmaceutical companies are unveiling breakthrough cancer data at the European Society for Medical Oncology Congress taking place October 17-21 in Berlin[1], while the global cancer immunotherapy market reached $137.70 billion in 2024 and analysts project explosive growth toward $261.74 billion by 2033[2]. The timing reflects a critical inflection point as HHS doubled federal funding for its Childhood Cancer Data Initiative from $50 million to $100 million, while researchers discovered how cancer uses a hidden hormone to shield itself from immune attack[3]. Against this backdrop of scientific momentum and institutional capital deployment, clinical-stage immunotherapy developers including GT Biopharma, Inc. (NASDAQ: GTBP), Leap Therapeutics, Inc. (NASDAQ: LPTX), IO Biotech (NASDAQ: IOBT), Celcuity Inc. (NASDAQ: CELC), and MAIA Biotechnology, Inc. (NYSE-American: MAIA). With eight new oncology approvals issued from July through September[4] and regulatory agencies accelerating approval pathways through breakthrough therapy designations, institutional forecasters at Precedence Research project the market will expand at a 10.65% CAGR through 2034[5] as long-term survival data validates immunotherapy durability. The convergence of rising disease burden, proven efficacy across cancer types, and expanded federal research support creates favorable conditions for early-positioned companies with differentiated mechanisms advancing through clinical milestones before broader institutional recognition materializes. GT Biopharma, Inc. (NASDAQ: GTBP) is a clinical-stage immunotherapy company making significant progress in its fight against difficult-to-treat cancers. The San Francisco-based biotech has been advancing its lead drug candidate, GTB-3650, through a Phase 1 clinical trial targeting blood cancers that have stopped responding to other treatments. In August, the company successfully moved into Cohort 3 after formal safety reviews of the first two patient groups showed no safety or tolerability problems. The trial had treated five patients by mid-August, with encouraging early signals of immune system activation. "We are pleased with the enrollment momentum in our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which continues to advance on schedule," said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma. "Moving into the third dose cohort after a successful safety review and encouraging early evidence of immunological activity, mark important steps forward in the development of GTB-3650. We look forward to sharing more data later this year to reinforce the ability of our TriKE constructs to activate endogenous NK cells, and the potential for broader utility with other targets to treat solid tumors (GTB-5550) and autoimmune indications (GTB-7550)." The Phase 1 trial is testing GTB-3650 in patients with relapsed or refractory CD33-expressing blood cancers, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These are patients whose cancers have come back or never responded to standard therapies. The drug works by activating the body's own natural killer cells to attack cancer cells. Patients receive the treatment through continuous infusions in two-week cycles, alternating two weeks on and two weeks off, for up to four months based on how well they're responding. What makes the early data particularly interesting is the biomarker evidence. Multiple blood tests from the first four patients showed measurable increases in natural killer cell activity and expansion. This suggests the drug is doing exactly what it was designed to do—wake up the immune system and direct it against cancer. GT Biopharma expects to release more detailed Phase 1 results later this year after completing additional dose cohorts. Beyond blood cancers, GT Biopharma has a second drug candidate moving toward the clinic. GTB-5550 targets a protein called B7H3 that appears in many different types of solid tumors, including breast, lung, ovarian, head and neck, pancreatic, bladder, and prostate cancers. The company expects to submit its application to start human testing of GTB-5550 during the fourth quarter of this year. Unlike many cancer immunotherapies that require lengthy hospital infusions, GTB-5550 is being developed as a simple injection that patients could potentially give themselves at home, similar to insulin shots. Both drug candidates are built on GT Biopharma's proprietary TriKE platform, which uses specialized antibody fragments originally discovered in camels and llamas. These molecules are smaller and more stable than traditional antibodies, allowing them to work more effectively. GT Biopharma holds an exclusive worldwide license from the University of Minnesota to develop and commercialize therapies using this technology. As of June 30, 2025, GT Biopharmareported cash and cash equivalents of approximately $5.3 million, which management expected would fund operations into the first quarter of 2026. CONTINUED… Read this and more news for GT Biopharma, Inc. at: Leap Therapeutics, Inc. (NASDAQ: LPTX) are set to present final clinical results from Part B of the DeFianCe study at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17-21 in Berlin, Germany. The Phase 2 study evaluated sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy compared to bevacizumab and chemotherapy alone in patients with advanced microsatellite stable colorectal cancer who received one prior systemic therapy for advanced disease. The final results will be presented in a Mini Oral Session on October 19, 2025 at 4:05 p.m. CEST, with the presentation providing detailed efficacy and safety data from the second-line treatment cohort. Leap Therapeutics' pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 protein, as the company continues developing targeted and immuno-oncology therapeutics for solid tumor indications. IO Biotech (NASDAQ: IOBT) announced that the U.S. Food and Drug Administration has recommended against submitting a Biologics License Application based on data from the IOB-013 clinical trial, in which Cylembio plus pembrolizumab improved progression free survival but narrowly missed statistical significance. The company is implementing a restructuring that includes an approximate 50 percent reduction in full-time employees and expects to incur a non-recurring charge of between $1.0 million and $1.5 million in the third quarter of 2025. "We had a productive meeting with FDA; while this is not the outcome we had hoped for, we respect FDA's feedback and remain confident in the therapeutic potential of Cylembio," said Mai-Britt Zocca, PhD, CEO of IO Biotech. "We look forward to continuing the dialogue with FDA to align on the design for a potential new registrational study. Additionally, we plan to discuss the data from our IOB-013 study with European regulators and determine a path to submission in the EU." The company plans to design a new registrational study for Cylembio for the treatment of first-line patients with advanced melanoma and currently has capital to run its operations into the first quarter of 2026. IO Biotech is pursuing a pathway to regulatory approval while working to complete ongoing studies of its immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate. Celcuity Inc. (NASDAQ: CELC) will present detailed efficacy and safety data from the PIK3CA wild-type cohort of the pivotal Phase 3 VIKTORIA-1 trial at the European Society of Medical Oncology Congress 2025 in Berlin, Germany. The late breaking abstract has been selected for an oral presentation on October 18, 2025 at 10:15 a.m. CEST in a Proffered Paper Session, with the presentation covering results from gedatolisib plus fulvestrant with or without palbociclib versus fulvestrant in patients with HR+/HER2-/PIK3CA wildtype advanced breast cancer. The VIKTORIA-1 trial has completed enrollment and reported topline data for the PIK3CA wild-type cohort, while the company continues enrolling patients for the PIK3CA mutant cohort. Celcuity is also conducting its VIKTORIA-2 Phase 3 trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer, along with a Phase 1/2 trial combining gedatolisib with darolutamide in metastatic castration resistant prostate cancer patients. MAIA Biotechnology, Inc. (NYSE American: MAIA) has been awarded a $2.3 million grant by the National Institutes of Health for the expansion of its THIO-101 Phase 2 clinical trial evaluating ateganosine as a third-line treatment for patients with advanced non-small cell lung cancer. The grant, to be distributed over three years from 2025-2027, will support expenses related to enrollment of U.S. patients who are resistant to chemotherapy and immunotherapy, with Parts A and B of THIO-101 demonstrating median overall survival of 17.8 months for 22 patients in third-line treatment compared to 5 to 6 months for standard-of-care chemotherapy treatments. "We are thrilled to receive this prestigious NIH grant for the expansion of our Phase 2 trial," said Vlad Vitoc, M.D., CEO of MAIA Biotechnology. "It's a great honor to have the support of the National Institutes of Health as we seek to further validate the efficacy of our lead agent ateganosine and its potential to be a breakthrough treatment within the vastly underserved NSCLC market. With the clearance of FDA Investigational New Drug (IND) for THIO-101 in 2023, we can begin enrolling U.S. patients in the expansion phase of the trial immediately." The first patient in the expansion of the trial was dosed in July 2025 in Taiwan, with the NIH grant enabling MAIA to access a substantially larger patient pool across multiple continents. Ateganosine is a first-in-class investigational telomere-targeting agent that induces telomerase-dependent telomeric DNA modification and activates both innate and adaptive immune responses, currently being developed as a second or later line of treatment for NSCLC patients who have progressed beyond standard-of-care checkpoint inhibitor regimens. 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点击蓝字 关注我们 本 期 看 点 2025年欧洲肿瘤内科学会（ESMO 2025）将于10月17-21日在德国柏林举行。作为全球肿瘤学领域的顶尖盛会，多项即将改变临床实践的重磅研究将在本届大会发布。目前，大会“突破性摘要”（LBA）的标题已经公布。 结直肠癌（CRC）长期是固态肿瘤治疗中最复杂的系统之-其分子异质性、免疫景观差异及治疗路径多层交错。然而，2025 年的 ESMO 大会，让我们看到 CRC 领域迎来一场真正意义上的“多维突破”： ctDNA 指导的辅助与再挑战策略、免疫治疗新布局、以及 VEGF/多靶点联合方案的临床深化，正在系统性地重塑 CRC 的治疗逻辑。本文详细梳理2025ESMO大会的重磅七项研究。 本期内容 01 七大重磅研究全景速览 02 ctDNA在结直肠癌领域的应用 03 免疫从MSI-H到MMR-p的前移探索 04 MSS人群的系统突破 【01 七大重磅研究全景速览】 LBA9：DYNAMIC-III 研究 标题： ctDNA-Guided Adjuvant Chemotherapy De-Escalation in Stage III Colon Cancer: Primary Analysis of the ctDNA-Negative Cohort from the Randomized AGITG DYNAMIC-III Trial (Intergroup Study of AGITG and CCTG) ctDNA指导下III期结肠癌辅助化疗降阶治疗：AGITG DYNAMIC-III随机试验（AGITG与CCTG多中心研究）中ctDNA阴性队列的初步分析 讲者： Jeanne Tie（彼得·麦卡勒姆癌症中心） LBA33：CITRIC 研究 标题： Circulating Tumor (ct) DNA-Guided Anti-EGFR Rechallenge Strategy in Metastatic Colorectal Cancer (mCRC): Final results of the phase II randomized CITRIC trial ctDNA指导下的抗EGFR药物再挑战策略用于转移性结直肠癌：II期随机CITRIC试验的最终结果 讲者： Clara Montagut（Hospital del Mar） LBA32：PARERE 研究 标题： Panitumumab retreatment followed by regorafenib versus the reverse sequence in chemorefractory metastatic colorectal cancer patients with RAS and BRAF wild-type circulating tumor DNA (ctDNA): Final results of the randomized PARERE trial by GONO 帕尼单抗再治疗后接受瑞戈非尼对比反向治疗顺序用于经ctDNA检测为RAS和BRAF野生型化疗难治性转移性结直肠癌患者：GONO随机PARERE研究的最终结果 讲者： Marco Maria M. Germani（比萨大学） LBA29：CheckMate 8HW 研究 标题： Nivolumab plus ipilimumab vs nivolumab monotherapy for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): new results from CheckMate 8HW 纳武利尤单抗联合伊匹木单抗对比纳武利尤单抗单药治疗MSI-H/dMMR转移性结直肠癌：CheckMate 8HW研究最新结果 讲者： Sara Lonardi（Veneto Institute of Oncology） LBA30：STELLAR-303 研究 标题： Zanzalintinib plus atezolizumab (zanza + atezo) vs regorafenib (rego) in patients (pts) with previously treated metastatic colorectal cancer (mCRC): Primary overall survival (OS) analysis from the randomized, open-label, phase 3 STELLAR-303 study Zanzalintinib +阿替利珠单抗（zanza + atezo） vs 瑞戈非尼（rego）用于既往接受过治疗的转移性结直肠癌患者：随机、开放标签、III期STELLAR-303研究的主要总生存期分析 讲 者： Anwaar Saeed（UPMC 希尔曼癌症中心） LBA31 标题： Neoadjuvant immunotherapy induces immune activation and responses in MMR-proficient colon cancers 新辅助免疫疗法在MMR功能正常的结肠癌中诱导免疫激活和应答 讲者： Yara L. Verschoor（荷兰癌症研究中心） LBA34：DeFianCe研究 标题： DeFianCe Trial: A randomized phase 2 trial of sirexatamab (DKN-01) plus bevacizumab and chemotherapy versus bevacizumab and chemotherapy as second-line therapy in advanced microsatellite stable (MSS) colorectal cancer (CRC) DeFianCe研究：一项比较sirexatamab（DKN-01）+贝伐珠单抗+化疗 vs 贝伐珠单抗+化疗作为晚期MSS型结直肠癌的二线治疗的随机II期试验 讲者： Zev A. A. Wainberg（加州大学洛杉矶分校） 【02 ctDNA在结直肠癌领域的应用】 本届 ESMO 汇总的结直肠癌领域的重磅研究中，其中三项研究聚焦 ctDNA。 LBA9（DYNAMIC-III）在Ⅲ期结肠癌术后人群中，首次以随机对照的方式验证 ctDNA 阴性患者可实施辅助化疗降阶的可行性：在维持无病生存（DFS）不受影响的前提下，降低治疗强度与毒性负担，为“以分子残留状态（MRD）而非单一病理分期定强度”的新范式奠基。 面向转移性结直肠癌（mCRC），LBA33（CITRIC）通过ctDNA 动态确认 RAS/BRAF 野生型后实施抗 EGFR 再挑战，为“分子转阴→再用药”的闭环提供临床证据。 LBA32（PARERE，GONO）进一步比较帕尼单抗再治疗→瑞戈非尼与反向顺序：结果支持“先分子精准、后多靶点抗血管”的顺序优化思路。三项研究共同指向：ctDNA 不只是“测”，更要“用”；从辅助到再治疗，动态分层 + 精准时机将成为下一代标准路径的核心。 03 免疫从MSI-H到MMR-p的前移探索 免疫治疗板块两项 LBA 形成“巩固一线标准 + 前移新证据”的互补格局。LBA29（CheckMate 8HW）在MSI-H/dMMR mCRC中，纳武利尤单抗 + 伊匹木单抗相较单药纳武利尤单抗，持续在PFS、缓解持续时间（DOR）乃至 OS上展示优势，进一步稳固双免作为一线标准的地位，并以可管理的安全性支持长期用药。更具前瞻性的是 LBA31：在传统意义上的“免疫冷肿瘤”——MMR 功能正常（MMR-p）结肠癌中，新辅助免疫亦可诱导显著的免疫活化与病理应答，提示通过术前窗口期“预热”肿瘤微环境，或有望拓宽免疫获益人群。由此，CRC 免疫策略正从“静态分层（MSI 与否）”走向“时空重塑（围手术期免疫激活）”，边界被重新定义。 04 MSS人群的系统突破 面对占比最大的 MSS/mCRC，2025 年的两项Ⅲ/Ⅱ期研究带来可操作的联合思路。LBA30（STELLAR-303）显示，多靶点 TKI（Zanzalintinib）+ PD-L1 抑制剂（阿替利珠单抗）在既往治疗后的 mCRC 中对比瑞戈非尼实现总生存期（OS）层面的提升，为“抗血管 + 免疫”在 MSS 人群的应用提供了分层证据与安全性参考。LBA34（DeFianCe）则以DKK1 抑制剂 sirexatamab（DKN-01）+ 贝伐珠单抗 + 化疗对比“贝伐珠单抗 + 化疗”作为 MSS 型 CRC 的二线方案，在客观缓解率（ORR）与无进展生存（PFS）上取得优势，提示“WNT 通路调节 + 抗血管”有望成为免疫冷型肿瘤的可复用模板。配合前述 ctDNA 与免疫窗口策略，MSS 人群的组合—顺序—时机三维优化正加速成形：先以分子与微环境“做减法”，再以多通路“做加法”，把更多患者推向可获益的治疗轨道。 ★