An Open-label, Multicenter, Global Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Malignancies.

This study evaluates the efficacy, as measured by the objective response rate, of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected advanced lymphomas or biliary tract cancer.

开始日期2023-03-01

申办/合作机构

Sorrento Therapeutics, Inc.

NCT04809012

/ Withdrawn临床2期

An Open-label, Multicenter, Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Solid Tumors

This study evaluates the efficacy of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected solid tumors.

开始日期2021-06-01

申办/合作机构

Sorrento Therapeutics, Inc.

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100 项与 Danburstotug 相关的专利（医药）

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项与 Danburstotug 相关的文献（医药）

2025-11-01·MOLECULAR THERAPY

Preclinical development and a phase 1 trial of IMC001, an EpCAM-targeted CAR-T cell therapy, in patients with advanced gastric cancer

Article

作者: Zhang, Shuangshuang ; Ge, Jingyu ; Yin, Weiwei ; Sun, Minmin ; Hao, Ruidong ; Fang, Weijia ; Luo, Tianhang ; Zheng, Rui ; Lu, Zhengmao

Autologous EpCAM-targeted CAR-T cell therapy (IMC001) was developed for advanced gastric cancer (GC). This study evaluated the specificity, efficacy, and safety of IMC001 in preclinical models and a phase 1 dose-escalation/expansion trial in patients who had failed at least two lines of therapy. IMC001 specifically recognized EpCAM and exhibited potent anti-tumor activity in EpCAM⁺ tumor cells, xenograft models, and patient-derived organoids. From August 2021 to May 2023, 12 advanced GC patients received IMC001. All patients experienced grade 3 or 4 treatment-related adverse events, mainly lymphopenia related to lymphodepletion, with no treatment-related deaths. Five patients experienced cytokine release syndrome (n = 3, grade 3-4) and two patients experienced immune-related hepatitis (n = 1, grade 3 in middle-dose group; n = 1, grade 4 in high-dose group). Partial responses were observed in 33.3% (1/3) of low-dose patients and 40% (2/5) of middle-dose patients, achieving an objective response rate of 30% and a disease control rate of 70%. Median progression-free survival and overall survival were 4.5 and 8.4 months, respectively. One patient underwent conversion surgery at week 27 and remains alive 31.5 months post-infusion. These findings demonstrate an acceptable safety profile and promising efficacy of IMC001 in advanced GC, supporting further clinical development for refractory GC patients.

2021-12-01·Investigational new drugs3区 · 医学

A phase I study of IMC-001, a PD-L1 blocker, in patients with metastatic or locally advanced solid tumors

3区 · 医学

Article

作者: Oh, Do-Youn ; Kim, Tae Min ; Park, Young Suk ; Lee, Jeeyun ; Ahn, Yoen Hee ; Choi, Ji Yea ; Kim, Hyeon Ju ; Chang, Sook Kyung ; Kang, Won Ki ; Park, Jihyun ; Park, Yeon Hee ; Keam, Bhumsuk ; Lee, Ji Hye ; Ock, Chan-Young ; Song, Yun Jeong

Introduction IMC-001 is a fully human IgG1 monoclonal antibody that binds to human PD-L1 (programmed death-ligand 1). This study evaluated the safety, pharmacokinetics, and pharmacodynamics of IMC-001 in patients with advanced solid tumors. Materials and Methods This open-labeled phase I study used a standard 3 + 3 dose-escalation design, with doses ranging from 2 to 20 mg/kg. IMC-001 was administered intravenously every 2 weeks until disease progression or unacceptable toxicity. The dose-limiting toxicity window was defined as 21 days from the first dose. Results Fifteen subjects were included in 5 dose-escalation cohorts. No dose-limiting toxicity was observed, and the maximum tolerated dose was not reached. The most common adverse events (AEs) were general weakness, decreased appetite, fever, and cough. No grade 4 or 5 treatment emergent AEs were reported during the study. One subject in the 2 mg/kg cohort showed grade 2 immune-induced thyroiditis and diabetes mellitus suspected to be related to IMC-001. Over the dose range of 2-20 mg/kg IMC-001, the AUC_0-14d, AUC_0-∞, and C_max generally increased in a dose-proportional manner for each step of dose escalation. Of the 15 enrolled patients, 1 subject with rectal cancer showed a partial response, and the disease control rate was 33.3%. Conclusions IMC-001 demonstrated a favorable safety profile up to 20 mg/kg administered intravenously every 2 weeks and showed preliminary efficacy in patients with advanced solid tumors. Based on pharmacokinetic and pharmacodynamic data, 20 mg/kg was selected as the recommended phase II dose. Clinical trial identification NCT03644056 (date of registration: August 23, 2018).

Journal of pain research3区 · 医学

A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia

3区 · 医学

ArticleOA

作者: Gendreau, R Michael ; Pridgen, William L ; Duffy, Carol ; Gendreau, Judy F

OBJECTIVE:

Infections and other stressors have been implicated in the development of fibromyalgia. We hypothesized that these stressors could result in recurrent reactivations of latent herpes virus infections, which could lead to the development of fibromyalgia. This study evaluated a famciclovir + celecoxib drug combination (IMC-1), active against suspected herpes virus reactivation and infection, for the treatment of fibromyalgia.

METHODS:

A total of 143 fibromyalgia patients were enrolled at 12 sites in a 16-week, double-blinded, placebo-controlled proof-of-concept trial. Randomized patients received either IMC-1 or placebo in a 1:1 ratio. Outcome measures included a 24-hour recall pain Numerical Rating Scale, the Revised Fibromyalgia Impact Questionnaire (FIQ-R), the Patient's Global Impression of Change (PGIC) questionnaire, the Multidimensional Fatigue Inventory, the NIH Patient-Reported Outcomes Measurement Information System (PROMIS), and the Beck Depression Inventory-II conducted at baseline and weeks 6, 12, and 16 of the study.

RESULTS:

A significant decrease in fibromyalgia-related pain was observed for patients on IMC-1 treatment versus placebo. PGIC response rates were significantly improved with IMC-1 treatment. Overall, patient self-reported functioning, as measured by the FIQ-R, was significantly improved. Fatigue was also significantly improved as measured by the PROMIS fatigue inventory. The safety profile was encouraging. Despite the celecoxib component of IMC-1, gastrointestinal and nervous system treatment emergent adverse events were reported less frequently in the IMC-1 group, and study completion rates favored IMC-1 treatment.

CONCLUSION:

IMC-1 was efficacious and safe in treating symptoms of fibromyalgia, supporting the hypothesis that herpes virus infections may contribute to this syndrome. Improved retention rates, decreased adverse event rates, and evidence of efficacy on a broad spectrum of outcome measures are suggestive that IMC-1 may represent an effective, novel treatment for fibromyalgia.

项与 Danburstotug 相关的新闻（医药）

2026-07-05

·灵枢探药

EpCAM靶点药物研发报告

报告日期：2026年7月5日聚焦领域：EpCAM（CD326 / 上皮细胞黏附分子）靶向双抗、ADC、CAR-T 数据截止：2026年7月 (Mol Ther 2025 / Drugs 2025 / Nature Sci Rep 2023 / ASCO 2026 / AACR 2025) 特别说明：EpCAM 是唯一同时拥有获批双抗 + 临床 CAR-T + 新代 ADC 的泛癌靶点目录靶点机制简介 TAA 表达谱分析全管线总览双特异性抗体管线 CAR-T 管线 ADC 管线核心要点 & 展望一、靶点机制简介 EpCAM（Epithelial Cell Adhesion Molecule，CD326）是最早通过单克隆抗体鉴定的人肿瘤抗原之一（发现于 1979 年），约 40 kDa 的 I 型跨膜糖蛋白，在上皮细胞间黏附、信号传导、干细胞维持中发挥核心作用 [1]。结构特征详情蛋白类型I 型跨膜糖蛋白，含胞外域（EpEX）+ 单次跨膜 + 胞内域（EpICD）分子量~40 kDa（去糖基化）；~35 kDa（EpEX 脱落形式）正常表达上皮组织基底侧膜（紧密连接内→大分子药物不易触及）肿瘤表达泛癌种高表达，远端转移灶保留CTC 标志物CellSearch® 系统 EpCAM 抗体捕获循环肿瘤细胞——FDA 获批核心信号机制 EpCAM 过表达 ↓受调节膜内蛋白水解 (RIP) ↓ EpICD 释放入胞 ↓ β-catenin/LEF-1 转录激活 ↓ c-Myc / Cyclin D1 / E-cadherin → 增殖+干性 EpCAM 是泛癌靶点的典范——几乎在所有上皮来源癌种中高表达，且在 CTC/DTC 和转移灶中保留，使靶向治疗覆盖原发灶和微小残留双场景。二、TAA 表达谱分析 2.1 正常组织正常组织EpCAM 蛋白可及性安全性含义结肠/小肠上皮+++（基底侧膜）⚠️ 紧密连接内→大分子药物不易触及GI 毒性低于预期胃上皮++（基底侧）同上—肝胆管上皮+—⚠️ 肝毒性风险肺/肾/心/皮肤−✅安全 ⚠️ EpCAM 正常组织表达虽广泛，但主要定位于上皮紧密连接内的基底侧膜——抗体/ADC/CAR-T 等大分子在未破坏上皮屏障时难以触及。这是 EpCAM 靶向治疗的核心安全逻辑。 2.2 各瘤种表达（11,053 例 TMA, Hamburg 大学 [2]）瘤种EpCAM 阳性率表达强度备注结直肠腺癌>99%强最经典的 EpCAM+ 癌种胃癌~90%强IMC001 CAR-T 适应症胰腺癌>95%强—卵巢癌>95%强—肺腺癌>95%强—乳腺癌>95%中-强—前列腺癌>90%强—食管腺癌>90%强—子宫内膜癌>95%强—膀胱尿路上皮癌>90%强—肝细胞癌<30%弱EPCAM 最低的上皮癌肾细胞癌<20%弱— 🔥 76 种上皮肿瘤中 60 种（79%）阳性率 ≥90%——EpCAM 是覆盖最广的泛癌靶点。仅 HCC、肾上腺皮质癌、肾细胞癌、间皮瘤为 EpCAM 低/阴性。三、全管线总览药物公司类型靶点阶段ORR / 关键终点状态Edrecolomab(Panorex®)GSK/Centocor鼠源 IgG2a 单抗EpCAMPhase IIIORR 有限 (CRC 辅助)❌ 未获批Adecatumumab(MT201)Micromet/Amgen全人源 IgG1 单抗EpCAMPhase I/II—❌ 终止Catumaxomab(Korjuny®)Lindis BiotechEpCAM×CD3 三功能双抗EpCAM×CD3✅ EU 获批(2025.02)腹水穿刺缓解 79%✅ 上市BA3182BioAtlaCAB EpCAM×CD3 TCE (pH 依赖)EpCAM×CD3Phase I (39例)🔥CRC PFS 11-14m✅ 活跃Solitomab (AMG 110)AmgenEpCAM×CD3 BiTEEpCAM×CD3Phase I (终止)—❌IMC001ImmunofocoEpCAM CAR-T(CD28ζ)EpCAMPhase I (12例)ORR 30%, mOS 8.4m✅ 活跃Dectin-1 EpCAM CAR-T学术EpCAM CAR-T (Dectin-1 共刺激)EpCAMIIT (4例)PR🔬 在研CX-2051(Varsetatug masetecan)CytomXProbody ADC 🔥EpCAM + TOPO1iPhase I (25例)ORR 28-43%, DCR 94%✅ 活跃Oportuzumab monatoxSesen BioEpCAM ADC (假单胞菌外毒素)EpCAMPhase I/II—❌EpCAM×CLDN3 BsADC学术双靶 ADCEpCAM×CLDN3临床前—🔬 在研Anti-EpCAM sdAbs学术单域抗体 (纳米抗体)EpCAM临床前—🔬 在研IGN101Igeneon抗 EpCAM 疫苗EpCAMPhase I/II—❌四、双特异性抗体管线 4.1 Catumaxomab（Korjuny®）— 全球首个获批双抗，2025 年重新上市 🔥🔥 EpCAM×CD3 三功能抗体（Trifunctional Antibody） | Lindis Biotech | EU 批准：2025.02.11 [3,4] 药物设计参数数据类型鼠-大鼠杂交 IgG2 三功能双抗靶点EpCAM（肿瘤）× CD3（T 细胞）Fc 功能完整 FcγR 结合→同时招募巨噬细胞/NK 细胞（第三功能）作用机制T 细胞重定向 + FcγR 介导 ADCC/ADCP → 三模式免疫突触给药腹腔灌注（IP）——恶性腹水专属审批历程时间事件2009EU 首次批准 (Removab®)，Fresenius/TRION 开发2017商业原因退市2025.02.11EU 再次批准 (Korjuny®)，Lindis Biotech 🔥 临床数据终点数据适应症EpCAM+ 恶性腹水（不适合进一步全身治疗的成人）恶性腹水穿刺缓解率79% (vs 对照组)给药方式4 次腹腔灌注（第 0/3/7/10 天）核心安全性CRS（可控）、一过性肝酶升高、腹痛 ⭐ Catumaxomab 的历史地位：全球首个获批的双特异性抗体——比 blinatumomab（2014）早 5 年。2025 年再次获批证明 EpCAM 靶点的临床价值经得起时间考验。 4.2 BA3182（BioAtla）— CAB 条件性活化 EpCAM×CD3 TCE，Phase I 🔥 ESMO GI 2025 | BioAtla | 首个临床验证的 CAB EpCAM TCE [7]参数数据公司BioAtla (BCAB)技术CAB（Conditionally Active Biologic）双条件结合靶点2× EpCAM + 2× CD3ε（四价双抗）机制pH 依赖性——仅在酸性 TME（pH 6.0-6.5）中结合 EpCAM 和 CD3ε；中性 pH 下掩蔽设计目标消除 normal tissue on-target 毒性→解决 solitomab 失败的根本原因 Phase I 数据 (n=39, ESMO GI 2025)终点数据入组39 例（中位 3 线经治）；56% CRC剂量IV 0.0026-0.032 mg → SC 0.032-1.2 mg（继续爬坡中）疗效信号：终点数据肿瘤缩小5 例客观缩小：CRC −8%/−10%、乳腺 −11%、胆管 −13%、NSCLC −25%延长 PFS (CRC)11 个月 + 14 个月 🔥（2 例）安全性：终点数据CRSG1-2 仅 3 例（仅 IV 给药，tocilizumab 预防后消失）；SC 给药 0% CRS ⭐肝转氨酶↑8 例（G1-3，一过性，无症状，不影响治疗）GI 毒性未报告——CAB 设计成功规避 on-target GI 毒性 ⭐ 🔥 BA3182 的核心价值：CAB 平台验证了"pH 条件性活化"可以从根本上解决 EpCAM 正常组织毒性。CRC 中 11-14 月 PFS 在 3 线经治人群中极为突出。SC 给药途径消除了 CRS。EpCAM TCE 的"第二次机会"正在书写。 4.3 Solitomab（AMG 110 / MT110）— EpCAM×CD3 BiTE 先驱，已终止参数数据公司Amgen（BiTE 平台）类型EpCAM×CD3 双特异性 T 细胞衔接器试验Phase I（实体瘤）核心问题系统性 T 细胞激活→严重 CRS + GI 毒性（EpCAM 在正常肠上皮表达）状态❌ 终止 💡 Solitomab 的终止教训：EpCAM 在正常上皮的广泛表达→系统性 TCE 的"on-target/off-tumor" GI 毒性严重限制了给药剂量。腹腔灌注（Catumaxomab）和 CAR-T（IMC001）成功规避了这一限制。 4.3 CAB EpCAM×CD3（条件性活化双抗）参数数据公司BioAtla / 学术机制pH 依赖性活化——酸性肿瘤微环境（pH 6.0-6.5）中构象变化→暴露 CD3 结合位点；中性 pH 下掩蔽设计逻辑仅肿瘤微环境激活 T 细胞→避免系统性 CRS + 正常上皮毒性阶段临床前五、CAR-T 管线 5.1 IMC001（Immunofoco）— 首个 EpCAM CAR-T 临床数据 🔥 *Molecular Therapy* 2025 | Phase I 剂量递增/扩展 | 12 例晚期胃癌 [5]参数数据CAR 设计二代 CAR：HuC215 scFv + CD28 共刺激域 + CD3ζ特异性膜蛋白组阵列验证→仅结合 EpCAM体外MKN-45/KATO-III/NCI-N87（胃癌）+ HCT116（CRC）+ MIA PaCa-2（胰腺）均强效杀伤体内CDX 模型肿瘤消退；PDO 验证安全性入组12 例 ≥2 线治疗失败晚期胃癌（2021.08-2023.05）剂量低/中/高三组临床疗效终点低剂量 (n=3)中剂量 (n=5)全人群 (n=10*)ORR33.3% (1/3)40% (2/5)30% (3/10)DCR——70% (7/10)mPFS——4.5mmOS——8.4m *2 例不可评估标志性案例：1 例患者在治疗第 27 周接受转化手术，截至报告时已存活 31.5 个月 🔥安全性数据≥G3 TRAE100%（主要淋巴清除相关淋巴细胞↓）CRS（G3-4）3/12（25%）免疫相关肝炎2/12（G3-4，中/高剂量组）治疗相关死亡0 🔥 IMC001 的核心突破：作为首个 EpCAM CAR-T 临床试验,在 ≥2 线失败胃癌中 ORR 30%（中剂量 40%），对比三线标准治疗（ORR 2.8-11.2%, mOS 4.8-6.5m），mOS 8.4m 是现有标准的 1.3-1.8 倍。1 例转化手术 + 31.5 月长期生存提示 EpCAM CAR-T 可能为部分患者带来根治性机会。 5.2 Dectin-1 共刺激 EpCAM CAR-T参数数据设计EpCAM CAR + Dectin-1 共刺激（替代 CD28/4-1BB）临床4 例 IV 期胃癌，1×10⁷-1.5×10⁷/kg结果PR + 轻微副作用阶段研究者发起六、ADC 管线 6.1 CX-2051（Varsetatug Masetecan）— CytomX Probody® 掩蔽 ADC，EpCAM ADC 重生 🔥 Phase I (25例 CRC) | NCT06265688 | 2025.05 中期数据 [8]参数数据公司CytomX Therapeutics (CTMX)技术Probody® 掩蔽技术——正常组织中蛋白酶可裂解肽掩蔽抗体 Fab, 仅在 TME 中被 MMP 切割激活抗体抗 EpCAM（掩蔽状态下不结合正常上皮 EpCAM）载荷TOPO1i（exatecan 类），DAR4给药Q3W Phase I 疗效（n=18 可评估, 7.2/8.6/10 mg/kg Q3W）终点全人群 (3 剂量)10 mg/kg (n=7) 🔥确认 ORR28%43%DCR94%—mPFS5.8m—仍治疗中10/18 (56%)— 基线特征：中位 4 线经治, 100% 伊立替康暴露, 64% 肝转移, 64% KRAS 突变, 96% MSS, 不筛选 EpCAM 表达（全人群入组）安全性数据DLT0 ⭐G4-5 TRAE0 ⭐G3 TRAE腹泻 5/25, 贫血 3/25, 中性粒细胞↓ 2/25任意 TRAE腹泻 18, 恶心 11, 呕吐 8, 乏力 8胰腺炎/ILD/粒缺发热0% 🔥 CX-2051 的战略意义：CytomX Probody 掩蔽技术完美解决了 EpCAM ADC 的历史性难题——正常上皮毒性。通过掩蔽肽在血液循环和组织中"遮蔽"ADC 的 Fab, 仅在肿瘤微环境 MMP 酶切后暴露活性位点。10 mg/kg ORR 43% + DCR 94% + 零 DLT + 零 G4-5 TRAE——这是 EpCAM ADC 的历史性突破。 6.2 Oportuzumab Monatox（VB4-845）— 已终止的前代 EpCAM ADC参数数据公司Sesen Bio / Viventia Bio类型EpCAM ADC——人源化 scFv + 假单胞菌外毒素 A（ETA）适应症非肌层浸润性膀胱癌（NMIBC）——膀胱灌注给药局部灌注→规避系统性 EpCAM 毒性状态❌ Phase I/II 后终止 6.2 EpCAM×CLDN3 BsADC参数数据设计双靶 ADC（EpCAM + CLDN3）创新通过 CLDN3 作为第二靶点→在正常 EpCAM+ 组织中不结合（正常 CLDN3 隐秘）→降低 GI 毒性来源*J Hematol Oncol* 2025 [6]阶段临床前 ⭐ 双靶策略是解决 EpCAM 正常组织毒性的最有前景方向。七、核心要点 & 展望 7.1 全景疗效对比药物类型阶段适应症ORR / 关键终点核心安全状态CatumaxomabEpCAM×CD3 三功能双抗✅ EU 获批恶性腹水穿刺缓解 79%CRS + 肝酶↑✅ 上市BA3182CAB EpCAM×CD3 TCEPhase I (39例)泛腺癌CRC PFS 11-14mCRS 0% (SC)✅ 活跃CX-2051Probody ADCPhase I (25例)CRC ≥4LORR 43% (10mg/kg), DCR 94%腹泻 G3 20%, 零 DLT✅ 🔥IMC001EpCAM CAR-TPhase I (12例)胃癌 ≥2LORR 30%, mOS 8.4mCRS 25%✅ 活跃SolitomabEpCAM×CD3 BiTEPhase I实体瘤—GI 毒性❌Edrecolomab鼠源 IgG2a 单抗Phase IIICRC辅助 OS 未优效低❌ 7.2 EpCAM 靶点的核心矛盾与解决方案矛盾EpCAM 特性解决方案（已验证）正常上皮广泛表达结肠/胃/肝胆管→系统性靶向药物 GI/肝毒性✅ 腹腔灌注（Catumaxomab） ✅ 局部灌注（Oportuzumab 膀胱） ✅ CAR-T（IMC001 无治疗相关死亡）正常上皮基底侧定位紧密连接内→大分子不易触及✅ 天然安全屏障→CAR-T 可行抗原脱落EpEX 可脱落→可能中和抗体⚠️ 需 sEpCAM 监测泛癌表达→定向性差几乎所有上皮癌阳性✅ 无需筛选→全人群策略 7.3 核心要点 EpCAM 是历史最悠久的肿瘤靶点之一（1979 年发现）——至今仍是唯一同时拥有重新上市双抗 + 活跃临床 CAR-T 的泛癌靶点 Catumaxomab 是全球首个获批双抗（2009），2025 年再次获 EU 批准（Korjuny®）——证明 EpCAM 靶点的持久价值 IMC001 是首个 EpCAM CAR-T 临床试验——胃癌 ORR 30%, mOS 8.4m, 1 例转化手术 + 31.5 月长期生存 EpCAM 正常组织毒性可通过给药方式规避——腹腔灌注/局部灌注/CAR-T 均可实现"系统性安全+局部疗效" EpCAM CAR-T 的疗效信号可与 GUCY2C CAR-T 媲美——均证明消化道肿瘤 CAR-T 的临床可行性 ADC 路径在 EpCAM 上受限于正常组织毒性——EpCAM×CLDN3 双靶 ADC 是潜在的突破方向 CAB 条件性活化双抗值得关注——pH 依赖性仅在肿瘤微环境激活，理论上可复现 catumaxomab 疗效 + 系统性安全性 EpCAM 最适配的临床定位：腹腔内肿瘤（胃癌腹膜/卵巢癌/恶性腹水）+ 局部灌注 CAR-T/双抗参考文献 Expression and function of EpCAM. *Cancer Metastasis Rev*. 2020;39:741-756. EpCAM expression in 11,053 human tumours. *Pathology*. 2023;55(S1):S91. Catumaxomab: First Approval (Re-approval). *Drugs*. 2025;85:1101-1107. (Springer) Catumaxomab EU re-approval press release. Lindis Biotech. 2025.02.11. IMC001 EpCAM CAR-T Phase 1 in advanced gastric cancer. *Mol Ther*. 2025;33(11):5516-5529. Development of EpCAM×CLDN3 bispecific ADC. *J Hematol Oncol*. 2025;18:32. 声明：本报告基于公开发表学术文献和会议摘要编制，仅供研究参考，不构成投资或临床建议。

2026-04-01

·生物药园

龙沙（Lonza）签署两项肿瘤候选药物的临床生产协议

这些协议涵盖了两种药物的后期临床供应：一种是针对淋巴瘤的单克隆抗体，另一种是正在开发用于治疗光化性角化病的小分子抑制剂。透过树木远眺位于瑞士的龙沙公司总部大楼龙沙（Lonza）是一家总部位于瑞士巴塞尔的全球合同开发与制造组织（CDMO），该公司已分别与 ImmuneOncia Therapeutics 和 Torqur AG 签署了制造协议，旨在支持两种肿瘤候选药物的后期临床供应。根据与 ImmuneOncia（一家总部位于韩国的临床阶段生物制药公司）达成的协议，龙沙将为 Danburstotug 提供开发和临床生产服务。Danburstotug 是一种针对 PD-L1 的全人源单克隆抗体，目前正处于针对复发/难治性 NK/T 细胞淋巴瘤的临床研究阶段。据公告显示，该药物的原料药（Drug Substance）将在龙沙位于英国斯劳（Slough）的工厂进行生产，而药物制剂（Drug Product）的开发及临床生产工作则将在其位于瑞士巴塞尔和施泰因（Stein）的工厂完成。在与 Torqur（一家临床阶段生物技术公司）达成的协议中，龙沙将为 Bimiralisib 提供技术转移、工艺优化及 cGMP 生产服务。Bimiralisib 是一种口服 PI3K 和 mTOR 抑制剂，目前已完成针对光化性角化病的 II 期临床评估，并正筹备进入下一阶段的临床开发。该药物的生产工作将在龙沙位于中国南沙和瑞士维斯普（Visp）的高活性原料药（HPAPI）生产设施内进行。 ImmuneOncia 首席执行官 Heung-Tae Kim 在一份声明中表示，公司计划针对 NK/T 细胞淋巴瘤这一罕见癌症适应症寻求加速审批；他同时指出，与龙沙的合作有望为公司未来的全球授权交易及进军海外市场提供有力支持。 Torqur 的母公司 Swiss Rockets 的首席执行官 Vladimir Cmiljanovic 在另一份声明中补充道，龙沙所具备的专业技术能力及协作式工作模式，将进一步夯实基础，助力 Bimiralisib 顺利迈入后期临床开发阶段。上述协议的签署，是龙沙近期一系列业务动态的延续。上周，该公司在其新加坡基地设立了一家培养基开发实验室，旨在协助生物工艺客户优化细胞培养基配方，并降低在进入 GMP 生产阶段前的规模放大风险。作者提示：本文来源www.pharmamanufacturing.com/网站，小编只做了翻译和校对，对原文未进行编辑，如有涉及侵权，请联系删除。

2026-03-31

·Pharma Manufacturing

Lonza signs clinical manufacturing deals for two oncology drug candidates

Lonza, a global contract development and manufacturing organization (CDMO) headquartered in Basel, Switzerland, has signed separate manufacturing agreements with ImmuneOncia Therapeutics and Torqur AG s to support late-stage clinical supply of two oncology drug candidates. Under the agreement with ImmuneOncia, a clinical-stage biopharmaceutical company based in South Korea, Lonza will provide development and clinical manufacturing services for danburstotug, a fully human monoclonal antibody targeting PD-L1 under clinical investigation for relapsed/refractory NK/T-cell lymphoma. Drug substance will be manufactured at Lonza’s Slough, UK site, with drug product development and clinical manufacturing carried out at its Basel and Stein, Switzerland sites, according to the announcement. In the deal with Torqur, a clinical-stage biotechnology company, Lonza will provide technology transfer, process optimization, and cGMP manufacturing services for bimiralisib, an oral PI3K and mTOR inhibitor that has completed Phase II clinical evaluation for actinic keratosis and is preparing for the next stage of clinical development. Manufacturing will be carried out across Lonza’s highly potent active pharmaceutical ingredient (API) facilities in Nansha, China and Visp, Switzerland. Heung-Tae Kim, CEO of ImmuneOncia, said in a statement that the company plans to target the rare cancer indication of NK/T-cell lymphoma for early approval, and that the Lonza collaboration is expected to support future global licensing and overseas market entry. Vladimir Cmiljanovic, CEO of Swiss Rockets, Torqur’s parent company, added in a separate statement that Lonza’s technical expertise and collaborative approach strengthen the foundation needed to advance bimiralisib into late-stage clinical development. The agreements follow other recent activity at Lonza. Last week, the company launched a media development lab at its Singapore site to help bioprocessing customers optimize cell culture media formulations and reduce scale-up risk ahead of GMP manufacturing.

临床2期引进/卖出免疫疗法

100 项与 Danburstotug 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
高肿瘤突变负荷肿瘤	临床2期	韩国	Immuneoncia Therapeutics, Inc.	2025-01-13
局部晚期恶性实体瘤	临床2期	韩国	Immuneoncia Therapeutics, Inc.	2025-01-13
胆管癌	临床2期	-	Sorrento Therapeutics, Inc.	2023-03-01
弥漫性大B细胞淋巴瘤	临床2期	-	Sorrento Therapeutics, Inc.	2023-03-01
胆囊肿瘤	临床2期	-	Sorrento Therapeutics, Inc.	2023-03-01
肝内胆管癌	临床2期	-	Sorrento Therapeutics, Inc.	2023-03-01
外周T细胞淋巴瘤	临床2期	-	Sorrento Therapeutics, Inc.	2023-03-01
难治恶性实体肿瘤	临床2期	-	Sorrento Therapeutics, Inc.	2021-06-01
复发性实体肿瘤	临床2期	-	Sorrento Therapeutics, Inc.	2021-06-01
结外NK-T细胞淋巴瘤	临床2期	韩国	Immuneoncia Therapeutics, Inc.	2020-10-27

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04196465 (NeoChance, ESMO2025)	临床2期	肝细胞癌 \| 食管鳞状细胞癌 \| 胃癌新辅助	50	IMC-001 (20 mg/kg)	遞築憲獵淵鬱鏇簾淵廠(顧製糧淵選鏇齋憲淵憲) = 築膚選網築築醖齋製願鹹積繭鹹壓艱淵繭築窪 (窪壓壓壓築顧艱遞憲壓 ) 更多	积极	2025-10-17
NCT04414163 (DISTINKT Study, ICML2023)	临床2期	结外NK-T细胞淋巴瘤	15	IMC-001 20 mg/kg	齋鑰鹽衊壓廠鑰鏇蓋憲(獵餘壓選廠網鏇範夢蓋) = 獵築夢鹽衊構遞襯製積鹽壓鑰築築鹽觸襯夢選 (夢壓網鹹網鏇鏇窪鹹鬱 )	积极	2023-06-09
NCT04196465 (Neo-Chance, AACR2023) 人工标引	临床2期	胃肠道肿瘤辅助 Microsatellite Stable (MSS) \| PD-L1 Expression	50	IMC-001 20 mg/kg	製淵繭選齋顧遞襯膚艱(網鹹餘鏇選鹽蓋淵餘觸) = Although there was no major pathologic response, 51% of pts showed various degree of tumor necrosis or fibrosis and 7 pts (15%) had residual viable tumor cells less than 50%. 簾遞壓糧獵鑰積膚鑰願 (選窪襯艱糧憲獵餘觸獵 ) 更多	积极	2023-04-14
NCT04196465 (Neo-Chance, AACR2023) 人工标引	临床2期	胃肠道肿瘤辅助 Microsatellite Stable (MSS) \| PD-L1 Expression	50	IMC-001 20 mg/kg (metabolic response-evaluable pts)		积极	2023-04-14
NCT04414163 (ESMO_ASIA2022) 人工标引	临床2期	结外NK-T细胞淋巴瘤	13	IMC-001 20 mg/kg	廠遞獵夢艱顧醖襯夢構(選願糧顧淵艱鑰艱艱鹽) = 淵鬱製範膚夢積網鑰艱製顧鹽衊遞餘簾廠願鑰 (蓋窪艱蓋鹽醖衊構簾鏇 ) 更多	积极	2022-12-04
NCT03644056 (Pubmed \| Invest New Drugs) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	15	IMC-001	壓鑰蓋襯憲糧齋壓憲製(獵製蓋蓋獵獵構選壓鬱) = 範積網範艱選餘製窪衊夢鹹糧蓋願蓋製獵繭顧 (製獵憲糧壓淵憲艱網範 ) 更多	积极	2021-12-01
NCT04196465 (NeoChance, ASCO2020)	临床2期	胃肠道肿瘤新辅助	14	IMC-001	廠顧窪襯構遞獵築構蓋(繭膚醖糧糧鑰選築夢膚) = 醖襯範積餘鑰鏇觸築壓壓窪鹹淵窪鬱選衊積襯 (憲簾獵積構選襯糧淵範 )	-	2020-05-25