This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread to other parts of the body (localized). Currently, neoadjuvant therapy for rectal cancer includes chemotherapy and chemoradiation. Despite these aggressive treatments, only about half of patients achieve a complete clinical response. In fact, over half of rectal cancer patients go on to have surgery and often suffer post-surgery complications involving urine and bowel problems. Thus, there has been an increased focus on non-surgical treatments. Chemotherapy drugs, such as fluorouracil, oxaliplatin and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant FOLFOX with botensilimab and balstilimab may improve the rate of complete response and decrease the need for surgery and radiation therapy in patients with localized rectal adenocarcinoma.

开始日期2025-06-30

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06843551

/ Not yet recruiting临床2期IIT

A Phase 2 Single Arm Trial of Stereotactic Body Radiation Therapy Followed by Dual Immune Checkpoint Inhibition for Patients With Metastatic Pancreatic Ductal Adenocarcinoma - The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation

The purpose of this study is to assess if radiation therapy (which uses high-energy radiation to damage or destroy cancer cells) combined with immune checkpoint inhibitors (medications that helps the body recognize and attack cancer cells) will be beneficial for patients with metastatic pancreatic ductal adenocarcinoma.

开始日期2025-06-01

申办/合作机构

University of Miami

[+1]

NCT06782932

/ Not yet recruiting临床1/2期IIT

A Pilot Study Comparing Neoadjuvant and Adjuvant GVAX vs a Mutated KRAS Peptide Vaccine Given With Anti-PD-1 and Anti-CD137 for the Treatment of Surgically Resectable Pancreatic Adenocarcinoma

The purpose of this study is to determine the optimal dose of AGEN2373 that is safe when given in combination with balstilimab and Pancreatic GVAX Whole Cell Vaccine and evaluate the safety and clinical activity of balstilimab and AGEN2373 in combination with GVAX (Arm 1) or mKRASvax (Arm 2) in surgically resectable pancreatic adenocarcinoma.

开始日期2025-04-01

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+3]

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100 项与巴替利单抗相关的专利（医药）

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项与巴替利单抗相关的文献（医药）

2025-02-17·CLINICAL CANCER RESEARCH

The Prostaglandin EP4 Antagonist Vorbipiprant Combined with PD-1 Blockade for Refractory Microsatellite-Stable Metastatic Colorectal Cancer: A Phase Ib/IIa Trial

Article

作者: Niger, Monica ; Cristarella, Eleonora ; Vitalini, Cristina ; Rovati, Lucio C. ; Chiodoni, Claudia ; Morano, Federica ; Zaffaroni, Nadia ; Brambilla, Nadia ; Doldi, Valentina ; Girolami, Federica ; Ghelardi, Filippo ; Giacovelli, Giampaolo ; Pietrantonio, Filippo ; Benincasa, Elena ; Palazzo, Michele ; Nichetti, Federico ; Sabella, Giovanna ; Manca, Paolo

Abstract:

Purpose::

Novel combinations are required to overcome resistance to immune checkpoint inhibitors in proficient mismatch repair (pMMR) or microsatellite-stable (MSS) metastatic colorectal cancer (mCRC). We aimed to determine whether vorbipiprant, a prostaglandin E2 receptor EP4 subtype antagonist, can convert immune-resistant mCRC into a tumor responsive to anti–PD-1 inhibition.

Patients and Methods::

This phase Ib/IIa prospective, open-label, single-arm trial followed a 3 + 3 dose-escalation and dose-optimization design. A total of 28 patients with chemorefractory pMMR/MSS mCRC were given dose-escalated oral vorbipiprant (30, 90, or 180 mg twice daily), along with biweekly intravenous balstilimab (3 mg/kg), an anti–PD-1 antibody. The primary endpoints included safety and the disease control rate (DCR). Secondary endpoints were the overall response rate, duration of response, progression-free survival, and overall survival.

Results::

No dose-limiting toxicities were observed. Of the 28 patients, seven (25%) experienced serious adverse events, but only one was attributed to vorbipiprant and one to balstilimab. The trial achieved a DCR of 50% observed across the entire cohort. In the subgroup of patients with liver metastases (n = 12), the DCR was 25%. The overall response rate was 11%, with three patients showing a partial response (median duration of response, 7.4 months). The median progression-free survival was 2.6 months, and the median overall survival was 14.2 months. Translational exploratory analyses suggested that vorbipiprant may boost response to anti–PD-1 in patients with immunogenic tumors.

Conclusions::

The combination of vorbipiprant and a PD-1 inhibitor (balstilimab) yielded sufficient activity in refractory pMMR/MSS mCRC, which is worthy of confirmation in future clinical trials in biomarker-enriched populations.

2024-11-04·NEURO-ONCOLOGY

Fc-enhanced anti-CTLA-4, anti-PD-1, doxorubicin, and ultrasound-mediated blood–brain barrier opening: A novel combinatorial immunotherapy regimen for gliomas

Article

作者: Kim, Kwang-Soo ; Horbinski, Craig ; Najem, Hinda ; Chand, Dhan ; Habashy, Karl ; Billingham, Leah ; Zhao, Junfei ; Lee-Chang, Catalina ; Huber, Olivia ; Butowski, Nicholas ; Muzzio, Miguel ; Miska, Jason ; Padney, Surya ; Saganty, Ruth ; Chen, Li ; Zhang, Bin ; Levey, Daniel ; Morin, Benjamin M ; Savitsky, David A ; Arrieta, Víctor A ; Dmello, Crismita ; Zhang, Daniel Y ; Heimberger, Amy B ; Hu, Jian ; Rabadan, Raul ; Castro, Brandyn ; Zhang, Peng ; Canney, Michael ; Phillips, Joanna J ; Gould, Andrew ; Amidei, Christina ; Stupp, Roger ; Marques, Marilyn ; Sonabend, Adam M

Abstract:

Background:

Glioblastoma is a highly aggressive brain cancer that is resistant to conventional immunotherapy strategies. Botensilimab, an Fc-enhanced anti-CTLA-4 antibody (FcE-aCTLA-4), has shown durable activity in “cold” and immunotherapy-refractory cancers.

Methods:

We evaluated the efficacy and immune microenvironment phenotype of a mouse analogue of FcE-aCTLA-4 in treatment-refractory preclinical models of glioblastoma, both as a monotherapy and in combination with doxorubicin delivered via low-intensity pulsed ultrasound and microbubbles (LIPU/MB). Additionally, we studied 4 glioblastoma patients treated with doxorubicin, anti-PD-1 with concomitant LIPU/MB to investigate the novel effect of doxorubicin modulating FcγR expressions in tumor-associated macrophages/microglia (TAMs).

Results:

FcE-aCTLA-4 demonstrated high-affinity binding to FcγRIV, the mouse ortholog of human FcγRIIIA, which was highly expressed in TAMs in human glioblastoma, most robustly at diagnosis. Notably, FcE-aCTLA-4-mediated selective depletion of intratumoral regulatory T cells (Tregs) via TAM-mediated phagocytosis, while sparing peripheral Tregs. Doxorubicin, a chemotherapeutic drug with immunomodulatory functions, was found to upregulate FcγRIIIA on TAMs in glioblastoma patients who received doxorubicin and anti-PD-1 with concomitant LIPU/MB. In murine models of immunotherapy-resistant gliomas, a combinatorial regimen of FcE-aCTLA-4, anti-PD-1, and doxorubicin with LIPU/MB, achieved a 90% cure rate, that was associated robust infiltration of activated CD8+ T cells and establishment of immunological memory as evidenced by rejection upon tumor rechallenge.

Conclusions:

Our findings demonstrate that FcE-aCTLA-4 promotes robust immunomodulatory and anti-tumor effects in murine gliomas and is significantly enhanced when combined with anti-PD-1, doxorubicin, and LIPU/MB. We are currently investigating this combinatory strategy in a clinical trial (clinicaltrials.gov NCT05864534).

2024-09-01·NATURE MEDICINE

Botensilimab plus balstilimab in relapsed/refractory microsatellite stable metastatic colorectal cancer: a phase 1 trial

Article

作者: Curiel, Tyler J ; O'Day, Steven J ; Fakih, Marwan G ; Lenz, Heinz-Josef ; Sanborn, Rachel E ; Schwartz, Gary K ; Abou-Alfa, Ghassan K ; Grossman, Joseph E ; Delepine, Chloe ; Mednick, Gabriel ; El-Khoueiry, Anthony B ; Balmanoukian, Ani S ; Patel, Jaymin M ; Stebbing, Justin ; Wilky, Breelyn A ; Mahadevan, Daruka ; Tsimberidou, Apostolia M ; Gordon, Michael S ; Wu, Wei ; Sharma, Sunil ; Rosenthal, Katherine ; Chand, Dhan ; Segal, Neil H ; Pimentel, Agustin ; Moser, Justin C ; Bullock, Andrea J ; Schlechter, Benjamin L ; Bockorny, Bruno

Abstract:

Microsatellite stable metastatic colorectal cancer (MSS mCRC; mismatch repair proficient) has previously responded poorly to immune checkpoint blockade. Botensilimab (BOT) is an Fc-enhanced multifunctional anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody designed to expand therapy to cold/poorly immunogenic solid tumors, such as MSS mCRC. BOT with or without balstilimab (BAL; anti-PD-1 antibody) is being evaluated in an ongoing expanded phase 1 study. The primary endpoint is safety and tolerability, which was evaluated separately in the dose-escalation portion of the study and in patients with MSS mCRC (using combined dose-escalation/dose-expansion data). Secondary endpoints include investigator-assessed RECIST version 1.1–confirmed objective response rate (ORR), disease control rate (DCR), duration of response (DOR) and progression-free survival (PFS). Here we present outcomes in 148 heavily pre-treated patients with MSS mCRC (six from the dose-escalation cohort; 142 from the dose-expansion cohort) treated with BOT and BAL, 101 of whom were considered response evaluable with at least 6 months of follow-up. Treatment-related adverse events (TRAEs) occurred in 89% of patients with MSS mCRC (131/148), most commonly fatigue (35%, 52/148), diarrhea (32%, 47/148) and pyrexia (24%, 36/148), with no grade 5 TRAEs reported and a 12% discontinuation rate due to a TRAE (18/148; data fully mature). In the response-evaluable population (n = 101), ORR was 17% (17/101; 95% confidence interval (CI), 10–26%), and DCR was 61% (62/101; 95% CI, 51–71%). Median DOR was not reached (NR; 95% CI, 5.7 months–NR), and median PFS was 3.5 months (95% CI, 2.7–4.1 months), at a median follow-up of 10.3 months (range, 0.5–42.6 months; data continuing to mature). The combination of BOT plus BAL demonstrated a manageable safety profile with no new immune-mediated safety signals and encouraging clinical activity with durable responses. ClinicalTrials.gov identifier: NCT03860272.

161

项与巴替利单抗相关的新闻（医药）

2025-03-18

·GlobeNewswire-Health Care

MiNK Therapeutics Reports Fourth Quarter & Full Year 2024 Results and Highlights Business Progress

NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the development of allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced its financial results for the fourth quarter and full year 2024, highlighting significant business progress and clinical advancements. The company will host a conference call and webcast at 8:30 a.m. ET. “Throughout 2024, MiNK advanced its mission to bring off-the-shelf iNKT cell therapies to patients fighting hard-to-treat cancers and severe immune-related disorders,” said Dr. Jennifer Buell, President and Chief Executive Officer of MiNK Therapeutics. “We made significant clinical strides, strengthened our manufacturing foundation, and forged strategic alliances. Through disciplined capital management, we are positioned to scale efficiently and seize new collaboration opportunities for value creation. With our rapid AI-driven drug discovery platform generating a world-class library of phosphorylated neoantigens and proprietary TCRs, MiNK is uniquely poised to progress a new standard in oncology and beyond.” Operational Highlights Clinical Advancements Expanding Benefit in Cancer Where Standards Fail: Presentations at leading oncology conferences—including AACR IO, ASCO GI, and SITC—demonstrated that AgenT-797 enhanced immune activation, improved checkpoint inhibitor efficacy, and augmented bispecific engagers in heavily pretreated patients and preclinical models. A Phase 2 Investigator-Sponsored Trial (Memorial Sloan Kettering Cancer Center) in second-line advanced gastric cancer (NCT06251973) is actively enrolling. Early data suggest promising activity when combining AgenT-797 with botensilimab/balstilimab (BOT/BAL) and chemotherapy.Immunologic Activity in Inflammatory Lung Conditions (ARDS): Published results in Nature Communications and presented at the American Thoracic Society (ATS) showed AgenT-797’s potential in acute respiratory distress, with an approximately 80% survival rate among VV ECMO patients versus 10% in hospital controls. Late-stage trials are designed and planned for upcoming discussion with the regulatory agencies. Next-Generation iNKT Programs PRAME-TCR iNKTs: Demonstrated high specificity and potent tumor-killing against intracellular cancer targets resistant to conventional therapies. MiNK’s expertise in accessing a proprietary library of phosphorylated peptides and personalized neoantigens supports the generation of high-quality TCRs.MiNK-215 (IL-15 Armored CAR-iNKT): Robust anti-tumor activity in models of metastatic colorectal cancer, reshaping the immunosuppressive tumor microenvironment. These data, including exciting findings from AACR IO on the importance of neoantigen targeting, underscore MiNK’s commitment to evolving next-generation iNKT treatments that could potentially tackle the most challenging cancer types. Strategic Growth and Manufacturing Optimization MiNK’s state-of-the-art manufacturing process enables the production of billions of donor-derived iNKT cells per run, scalable to support rapid global distribution, aimed at reducing logistical hurdles, cost, and enhancing patient access.In October 2024, MiNK entered into a research collaboration with Autonomous Therapeutics to develop precision RNA-iNKT therapies for metastatic tumors. This collaboration is actively underway.In 2024, MiNK raised $5.8M in private financing and is prioritizing externally funded clinical trials to effectively sustain and advance its iNKT cell programs. “We believe MiNK Therapeutics is on solid footing to pioneer the next generation of cell therapies,” added Dr. Buell. “We will continue to pair scientific discipline with operational rigor, a strategy designed to enable value-inflection in 2025 and beyond.” Financial Highlights We ended the year with a cash balance of $4.6 million. Cash used in operations for the three and twelve months ended December 31, 2024, was $1.7 million, and $9.6 million, respectively, compared to $3.0 million and $15.8 million for the same periods in 2023. Net loss for the year ended December 31, 2024 was $10.8 million, or $2.86 per share, compared to net loss for the same period in 2023 of $22.5 million or $6.54 per share. Summary Consolidated Financial Information Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) December 31, 2024 2023 Cash and cash equivalents$4,577 $3,367 Total assets 5,721 4,552 Other Financial Information(in thousands)(unaudited) Three months ended December 31, Year ended December 31, 2024 2023 2024 2023 Cash used in operations$1,728 $3,036 $9,555 $15,763 Non-cash expenses 757 1,155 770 3,798 Condensed Consolidated Statements of Operations Data(in thousands, except per share data)(unaudited) Three months ended December 31, Year ended December 31, 2024 2023 2024 2023 Operating expenses: Research and development$1,406 $3,311 $6,336 $15,490 General and administrative 809 2,189 4,314 7,431 Change in fair value of related party note 288 - 638 - Operating loss 2,503 5,500 11,288 22,921 Other income, net (39) (41) (503) (463) Net loss$2,464 $5,459 $10,785 $22,458 Per common share data, basic and diluted: Net loss$0.62 $1.58 $2.86 $6.54 Weighted average number of common shares outstanding, basic and diluted 3,957 3,456 3,773 3,436 Conference Call Dial-in numbers: 646-307-1963 (New York), 800-715-9871 (USA & Canada) Conference ID: 8023784 Webcast A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at https://investor.minktherapeutics.com/events-and-presentations and via https://edge.media-server.com/mmc/p/s9hd6k7m/. About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit https://minktherapeutics.com or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels. About AgenT-797 AgenT-797 is an allogeneic invariant natural killer T (iNKT) cell therapy that harnesses the dual power of innate and adaptive immunity. iNKTs function as “master regulators,” combining the cytotoxic capabilities of NK cells with T-cell–like antigen recognition and memory. This unique biology enables a robust, pathogen-agnostic immune response that can be directed against hard-to-treat tumors. Manufactured by MiNK Therapeutics in Lexington, MA, agenT-797 is a scalable, off-the-shelf product designed to provide accessible, transformative treatment options. In clinical trials, agenT-797 can bolster peripheral memory T-cell activation, enhance tumor infiltration, and potentially improve outcomes for patients with solid cancers (Cytryn et al. AACR IO 2024, Oncogene. 2024) and to combat inflammation in critically ill patients with severe respiratory pathology (Nature Communications. 2024). Forward Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential, anticipated benefit, plans and timelines of iNKT cells, as well as the collaboration between MiNK and Agenus. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K, Form 10-Q and the S-1 Registration Statement filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK and Agenus with no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Investor Contact 917-362-1370 investor@minktherapeutics.com Media Contact 781-674-4428 communications@minktherapeutics.com

细胞疗法临床2期财报AACR会议免疫疗法

2025-03-17

·FierceBiotech

Agenus CMO touts immunotherapy advances on The Top Line

None\n Agenus Chief Medical Officer Dr. Steven O\'Day joined Fierce\'s Chris Hayden on a recent sponsored episode of The Top Line podcast to discuss the evolving landscape of cancer immunotherapy.O\'Day, a medical oncologist with 30 years of experience, explained the fundamental differences between immunotherapy and traditional cancer treatments like chemotherapy, surgery, and radiation. He emphasized immunotherapy\'s potential for durable responses and even cures by activating the body\'s own T-cells to fight cancer.The conversation addressed the challenges of treating \"cold\" tumors, such as colorectal cancer, which are less visible to the immune system. O\'Day highlighted Agenus\'s pipeline of antibodies, botensilimab (BOT) and balstilimab (BAL), designed to trigger T-cell recognition of these colder cancers.O\'Day expressed his excitement about a potential \"2.0 revolution\" of immuno-oncology, expanding the benefits of immunotherapy to a wider range of cancers. He described BOT and BAL as a \"one-two punch,\" with BOT priming T-cells and BAL preventing their exhaustion.Listen to the full conversation on the latest episode of The Top Line.

免疫疗法

2025-03-09

·药明康德

快速持久降解目标蛋白超80%的小分子疗法；有望使患者停止激素替代治疗的创新生物器官疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 小分子蛋白降解剂BHV-1300的1期临床试验结果积极，目标IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。 2. 创新生物混合器官Cell Pouch获批一项新的IND申请，它与自体甲状腺细胞疗法相结合，旨在恢复自然的甲状腺功能，使患者无需使用甲状腺激素替代药物或免疫抑制疗法。 3. 巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎，在一项1/2期临床试验中使患者报告的疼痛平均减少47.0%，关节功能改善46%。药明康德内容团队整理 BHV-1300：公布1期临床试验的新数据 Biohaven公司公布了其皮下给药的在研小分子蛋白降解剂BHV-1300的1期临床试验的新结果。BHV-1300在选择性清除目标IgG（IgG1、IgG2和IgG4）方面具有独特优势，同时保留IgG3水平。IgG3在对抗细菌、寄生虫和病毒中发挥关键作用。BHV-1300的设计目标是避免与其他IgG降低方法相关的广泛免疫抑制，同时在治疗自身免疫性疾病的过程中允许免疫系统对潜在感染做出反应。在为期四周的1期研究中，每周皮下注射1000 mg剂量的BHV-1300可使总IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。在每次给药后的数小时内，患者的IgG就会逐渐降低，并且与基线值相比，在四周内持续降低。BHV-1300在高达2000 mg的皮下给药剂量下安全性和耐受性良好。大多数不良事件轻微，可自行消退，没有因与研究药物相关的不良事件而停药，也没有严重的不良事件。 ▲BHV-1300的作用方式和1期临床试验结果（图片来源：参考资料[7]） Cell Pouch：IND申请获得FDA许可 Sernova Biotherapeutics公司宣布，美国FDA已批准其IND申请，允许在因结节性甲状腺疾病接受甲状腺手术的患者中评估Cell Pouch与自体移植甲状腺细胞的联合疗法。Sernova公司的Cell Pouch是一种创新的生物混合器官，由非生物材料与活体组织结合而成，旨在恢复或增强受损器官的功能。Cell Pouch与自体甲状腺细胞疗法相结合，旨在通过提供一种稳定、长期的生理解决方案，恢复自然甲状腺功能，而无需使用甲状腺激素替代药物或免疫抑制疗法。临床前研究表明，在没有免疫抑制的情况下，将甲状腺组织重新植入预先血管化的Cell Pouch中，成功地将两种主要的甲状腺激素——甲状腺素（T4）和三碘甲状腺原氨酸（T3）恢复到甲状腺切除术前水平，而无需激素补充。放射性同位素成像和组织学分析证实，植入后5个月内Cell Pouch内存在健康、功能性的甲状腺组织。 Allocetra：公布1/2期临床试验的中期数据 Enlivex Therapeutics公司公布了其巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎的1/2期临床试验的中期数据。败血症、骨关节炎、银屑病关节炎等疾病会使巨噬细胞失去平衡状态。这些非稳态巨噬细胞在很大程度上导致了相应疾病的严重性。Allocetra是一种通用、现货型细胞疗法，通过对巨噬细胞进行重编程，旨在恢复其稳态（homeostasis），进而治疗疾病。Allocetra提供创新的免疫调节机制，具潜力作为单药或组合疗法治疗这些具未竟医疗需求的疾病。此次公布的结果显示，治疗后第6个月，患者报告的疼痛平均显著减少了47.0%（P=0.0001），关节功能改善了46%。此外，83%接受治疗的患者在6个月时仍被认为对治疗有应答。这表明Allocetra作为骨关节炎的潜在突破性治疗方法，具有良好的持久性和持续疗效。安全性方面，没有报告严重的不良事件。 PER-001：公布1/2a期临床试验数据 Perfuse Therapeutics公司公布了其玻璃体内植入疗法PER-001在青光眼患者中的首次人体1/2a期试验的24周数据。PER-001是一种新型的小分子长效内皮素受体拮抗剂。内皮素是人体内最强的血管收缩剂，在青光眼中上调，并通过其在视网膜血管和神经视网膜细胞中的受体参与炎症和细胞死亡。PER-001是一种生物可降解的植入疗法，通过一次性25号注射器注入眼球玻璃体腔中。该疗法被设计为每6个月给药一次，能够持续释放药物。 24周的数据表明，PER-001具有良好的耐受性，仅有一例药物相关不良事件（轻微且短暂的玻璃体飞蚊症），没有严重药物相关不良事件或眼内炎症报告。接受PER-001治疗的患者从第1周开始，视神经头血流量较基线平均增加了至少10%，并持续至第24周。第24周时，光学相干断层扫描（OCT）显示，PER-001治疗组患者的视野平均偏差改善了1 dB/年，视网膜神经纤维层厚度平均增加了3微米。相比之下，假手术对照组患者的视野平均偏差下降了0.63 dB/年，OCT视网膜神经纤维层厚度减少了1.3微米。这些结果表明，PER-001在青光眼患者中不仅安全性良好，还显示出显著的功能和结构改善，为其作为青光眼治疗的潜在疗法提供了概念验证。 RPESC-RPE-4W：公布1/2a期临床试验数据 Luxa Biotechnology公司公布了一项1/2a期临床试验的数据，该试验评估了其专有的视网膜色素上皮（RPE）细胞疗法RPESC-RPE-4W在干性年龄相关性黄斑变性（AMD）患者中的应用。RPESC-RPE-4W是一种基于成人RPE干细胞的疗法，旨在通过替换受损的RPE细胞来恢复视力功能。干性AMD是一种导致中心视力模糊或丧失的退行性眼病，目前尚无有效治疗方法。在1/2a期试验的最低剂量组中，6名干性AMD患者被分为视力较差组和视力较好组。视力较差组的3名患者在12个月的随访中，平均在ETDRS视力表上获得了21.67个字母的改善，视力较好组的3名患者在3个月时，平均改善了3.3个字母。 VXA-G1.1-NN：公布1b期临床试验数据 Vaxart公司宣布，其第一代口服诺如病毒候选疫苗VXA-G1.1-NN在老年人群（55-80岁）中的1b期临床试验完整数据已发表在学术期刊Science Translational Medicine上。VXA-G1.1-NN是一种口服疫苗片剂，将表达诺如病毒GI.1主要衣壳蛋白VP1的非复制性腺病毒载体递送到小肠，旨在预防由诺如病毒引起的急性胃肠炎。该试验评估了VXA-G1.1-NN在55-65岁和66-80岁两个健康老年人群中的安全性和免疫原性。受试者以2：1的比例随机接受疫苗或安慰剂，并在第28天进行加强接种。63名志愿者完成了研究，安全性及免疫原性评估持续至第390天。免疫原性结果显示，与安慰剂相比，疫苗在所有三个剂量组中均诱导了强效且持久的血清抗体反应，第29天和第57天的血清抗VP1 IgA水平显著增加，且抗VP1 IgG水平也显著高于接种前水平，呈剂量依赖性增加。口服疫苗还刺激了唾液和鼻腔中强烈且持久的IgA反应。安全性方面，疫苗在老年人群中表现出良好的安全性和耐受性，未发生与疫苗相关的3级不良事件。最常见的不良反应为头痛（14%）和不适/疲劳（16%），与安慰剂组的发生率相似。 APG990：公布1期临床试验的中期数据 Apogee Therapeutics公司公布了其新型半衰期延长的OX40L单克隆抗体APG990的首个人体试验的积极中期结果。APG990是一种皮下注射疗法，靶向炎症通路中位于IL-13上游的OX40L，从而对1型、2型和3型炎症通路产生广泛影响。此次公布的结果显示，APG990的半衰期约为60天，可支持每3个月或6个月一次的维持给药方案。在所有5个剂量组（最高剂量为1200 mg）中，APG990均表现出良好的耐受性。Apogee公司还开发了APG279，即APG777（一种深度抑制2型炎症的药物）与APG990的联合制剂，旨在实现单次注射2 mL联合制剂，每年仅需给药2-4次的治疗方案，为患者提供更有效的治疗选择，同时最大限度地减少其他可用疗法的副作用。 BL-001：公布1期临床试验数据 Bloom Science公司公布了其在研口服疗法BL-001在一项涉及32名健康成年人（体重从正常到超重）的1期试验中的疗效和安全性结果。BL-001是一种潜在“first-in-class”、口服给药的活生物治疗产品（LBP），旨在模拟生酮饮食的治疗效果。临床前数据表明，BL-001在癫痫模型中复制了生酮饮食的治疗效果，并进一步展示了其对γ-氨基丁酸（GABA）和其他关键生物能途径的调节作用，以抑制癫痫发作的关键驱动因素——过度兴奋性。 BL-001在28天的治疗期内在体重减轻方面的整体治疗效果具有统计学显著性（p=0.0424）。超重组（BMI≥25）中接受BL-001治疗的受试者与所有接受安慰剂的受试者相比，体重的百分比变化具有统计学意义（p=0.0007）。此外，BL-001治疗的超重和正常体重个体之间的体重百分比变化也具有统计学意义（p=0.0003），体重减轻最高为4.9%。80%在BL-001治疗期间体重减轻的受试者在最后一次给药两周后仍保持体重减轻，其中接受最高剂量的所有超重受试者的体重继续下降，在两周随访期结束时体重减少了3.4%。此外，BL-001治疗组观察到了剂量依赖性的变化，包括尿酮、食欲降低和体重减轻，而安慰剂组未观察到这些变化。靶向生物标志物分析显示，与食欲控制、代谢调节和消化相关的关键代谢激素发生了具有统计学意义的变化。更大规模的代谢组学分析还揭示了循环酮体的统计学显著变化，这些发现进一步支持了BL-001的潜在生酮和减肥效果。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Perfuse Therapeutics Announces Positive Visual, Structural and Safety Data from a Ph1/2a Trial of PER-001 in Glaucoma Patients at the American Glaucoma Society Meeting. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/perfuse-therapeutics-announces-positive-visual-structural-and-safety-data-from-a-ph12a-trial-of-per-001-in-glaucoma-patients-at-the-american-glaucoma-society-meeting-302387598.html [2] Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035709/0/en/Sernova-Biotherapeutics-Receives-FDA-Clearance-for-IND-Application-for-its-Cell-Pouch-Bio-hybrid-Organ-with-Autograft-Thyroid-Cells-in-Patients-with-Hypothyroidism.html [3] Enlivex Therapeutics Announces Investor Webinar to Discuss Positive Interim Data from Phase I/II Allocetra™ Trial in Knee Osteoarthritis. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/04/3036995/0/en/Enlivex-Therapeutics-Announces-Investor-Webinar-to-Discuss-Positive-Interim-Data-from-Phase-I-II-Allocetra-Trial-in-Knee-Osteoarthritis.html [4] Bloom Science Reports Positive Data from Phase 1 Trial of BL-001 Demonstrating Statistically Significant, Durable Weight Loss in Overweight Individuals. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bloom-science-reports-positive-data-from-phase-1-trial-of-bl-001-demonstrating-statistically-significant-durable-weight-loss-in-overweight-individuals-302391446.html [5] Bioheng Therapeutics Announces FDA Clearance of IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bioheng-therapeutics-announces-fda-clearance-of-ind-application-for-cd7-ucar-t-cell-therapy-in-t-alllbl-302392846.html [6] Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBI-1140675, a Second-Generation VMAT2 Inhibitor, in Healthy Adults. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-initiation-of-phase-1-clinical-study-evaluating-nbi-1140675-a-second-generation-vmat2-inhibitor-in-healthy-adults-302392294.html [7] Biohaven Reports Positive Degrader Data Achieving > 80% Sustained Reductions in Total IgG with Potential First-in-Class BHV-1300. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/biohaven-reports-positive-degrader-data-achieving--80-sustained-reductions-in-total-igg-with-potential-first-in-class-bhv-1300-302389515.html [8] Adiso Therapeutics Announces Data Publication of Two Phase 1 Studies of First-in-Class Neutrophil Modulator ADS051 in the American Journal of Gastroenterology. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/adiso-therapeutics-announces-data-publication-of-two-phase-1-studies-of-first-in-class-neutrophil-modulator-ads051-in-the-american-journal-of-gastroenterology-302393958.html [9] Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990). Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035377/0/en/Apogee-Therapeutics-Announces-Positive-Interim-Phase-1-Results-from-the-APG990-Healthy-Volunteer-Trial-Unlocking-Potential-Maintenance-Dosing-Every-Three-and-Six-Months-for-APG279-.html [10] Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 (formerly SAN711) Phase 1 Study. Retrieved March 7, 2025, from https://acadia.com/en-us/media/news-releases/acadia-pharmaceuticals-and-saniona-announce-initial-positive [11] Actio Biosciences Announces First Participant Dosed in Phase 1 Clinical Trial of ABS-0871, a Novel TRPV4 Inhibitor, for the Treatment of Charcot Marie Tooth Disease 2C. Retrieved March 7, 2025, from https://actiobiosciences.com/actio-biosciences-announces-first-participant-dosed-in-phase-1-clinical-trial-of-abs-0871-a-novel-trpv4-inhibitor-for-the-treatment-of-charcot-marie-tooth-disease-2c/ [12] Contineum Therapeutics Initiates Patient Dosing in Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20241216396391/en/Contineum-Therapeutics-Initiates-Patient-Dosing-in-Phase-1b-Positron-Emission-Tomography-PET-Trial-of-PIPE-791 [13] Phio Pharmaceuticals Announces Completion of Enrollment in Third Safety Cohort in PH-762 Phase 1b Dose-Escalation Study. Retrieved March 7, 2025, from https://phiopharma.com/phio-pharmaceuticals-announces-completion-of-enrollment-in-third-safety-cohort-in-ph-762-phase-1b-dose-escalation-study/ [14] Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT001, a Novel Multi-Targeting, Half-Life Extended Bispecific Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Skin Diseases. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-announces-first-subject-dosed-in-phase-1-clinical-trial-of-bbt001-a-novel-multi-targeting-half-life-extended-bispecific-antibody-for-the-treatment-of-atopic-dermatitis-and-other-inflammatory-skin-diseases-302388661.html [15] Luxa Biotechnology Presents Clinical Data from First-in-Human Retinal Pigment Epithelium Cell Therapy Trial for Dry Age-Related Macular Degeneration at the 77th Annual Wills Eye Conference. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20250306998366/en/Luxa-Biotechnology-Presents-Clinical-Data-from-First-in-Human-Retinal-Pigment-Epithelium-Cell-Therapy-Trial-for-Dry-Age-Related-Macular-Degeneration-at-the-77th-Annual-Wills-Eye-Conference [16] ImmunoGenesis Doses First Patient in Phase 1/2 Clinical Trial of IMGS-101 in Combination With Balstilimab (anti-PD-1) and Zalifrelimab (anti-CTLA-4) in Relapsed or Refractory Advanced Prostate, Pancreatic, and HPV(-) Head & Neck Tumors. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/immunogenesis-doses-first-patient-in-phase-12-clinical-trial-of-imgs-101-in-combination-with-balstilimab-anti-pd-1-and-zalifrelimab-anti-ctla-4-in-relapsed-or-refractory-advanced-prostate-pancreatic-and-hpv--head--neck-t-302393719.html [17] Vaxart Announces Publication Demonstrating the Immunogenicity and Safety of its First-Generation Oral Pill Norovirus Vaccine Candidate in Elderly Adults. Retrieved March 7, 2025, from https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-publication-demonstrating-immunogenicity-and 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床申请临床1期细胞疗法免疫疗法临床结果

100 项与巴替利单抗相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11820	-	-	DB15676

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
宫颈癌	申请上市	美国	Recepta Biopharma SA	2022-01-30
胃腺癌	临床3期	法国	Agenus, Inc.	2024-10-15
MMRD实体瘤	临床3期	荷兰	Agenus, Inc.	2024-01-29
实体瘤	临床3期	荷兰	Agenus, Inc.	2024-01-29
晚期癌症	临床3期	美国	Agenus, Inc.	2021-08-02
晚期癌症	临床3期	亚美尼亚	Agenus, Inc.	2021-08-02
转移性宫颈癌	临床3期	美国	Agenus, Inc.	2021-08-02
转移性宫颈癌	临床3期	亚美尼亚	Agenus, Inc.	2021-08-02
复发性宫颈癌	临床3期	美国	Agenus, Inc.	2021-08-02
复发性宫颈癌	临床3期	亚美尼亚	Agenus, Inc.	2021-08-02

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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


NCT03860272 (Pubmed \| J Clin Oncol) 人工标引	临床1期	肉瘤	64	Botensilimab + Balstilimab	選鹹遞醖壓願艱衊餘窪(夢鑰遞鹽積淵糧醖顧壓) = The most common treatment-related adverse event (TRAE) was diarrhea/colitis occurring in 35.9% of patients, with grade 3 in 6.3% of patients. 觸鬱築繭簾襯鏇廠鹽鹹 (鏇淵築鏇鑰鏇艱簾齋壓 )	积极	2025-01-27
				Botensilimab + Balstilimab (angiosarcoma)
NCT05608044 (ASCO_GI2025)	临床2期	转移性微卫星稳定结直肠癌 MSS \| pMMR \| KRAS mutant ... 更多	234	Botensilimab 75 mg Q6W	醖簾鏇積網齋蓋夢齋顧(積築廠艱衊選夢鏇構襯) = 壓膚廠壓簾鑰遞網廠鏇醖憲顧廠築夢夢鏇繭窪 (壓繭鹽範製憲鏇願簾鑰 ) 更多	积极	2025-01-23
				Botensilimab 150 mg Q6W	醖簾鏇積網齋蓋夢齋顧(積築廠艱衊選夢鏇構襯) = 窪願網築餘構鹹鬱鹹繭醖憲顧廠築夢夢鏇繭窪 (壓繭鹽範製憲鏇願簾鑰 ) 更多
UNICORN (ASCO_GI2025)	临床2期	错配修复缺陷或微高卫星不稳定性结肠癌新辅助 pMMR \| dMMR	56	Botensilimab 1 mg/kg	願糧製範壓鹽廠鹹鹽簾(窪築顧遞糧顧繭鹹鹽遞) = 餘衊衊憲淵鏇艱蓋艱窪壓淵積窪製顧鏇鬱淵憲 (構廠鹹鏇夢窪積鑰網餘 ) 更多	积极	2025-01-23
				Botensilimab 1 mg/kg + Balstilimab 3 mg/kg	顧鬱壓鬱淵獵糧憲鏇鬱(構製餘觸餘範窪餘餘遞) = 顧膚繭顧繭膚糧構艱夢顧簾壓積衊製膚艱壓廠 (糧願積鬱鑰醖顧築餘襯 ) 更多
NCT05627635 (ASCO_GI2025)	临床1期	微卫星稳定型结直肠癌 MSS	14	Folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B)	鏇顧窪選齋鏇糧積艱鏇(齋獵鑰鏇築窪獵蓋艱築) = one pt at DL1 with transient G3 AST/ALT elevation and transient G2 colitis (resolved with steroids and infliximab), one pt at DL1 with G2 hypothyroidism and one patient at DL2 with G2 hyperthyroidism 艱夢糧願糧窪襯繭鏇獵 (齋網襯醖鹽餘壓蓋鹽製 ) 更多	积极	2025-01-23
NCT05864534 (Pubmed \| Neuro Oncol)	临床2期	胶质瘤	-	FcE-aCTLA-4	鹽衊膚鬱齋鏇廠餘觸夢(淵鑰簾齋簾膚鹽願鹽醖) = 築憲憲廠襯醖壓夢鏇廠糧網窪廠製壓鬱齋窪構 (鹽襯襯築網選餘觸壓廠 )	-	2024-11-04
NCT03860272 (ESMO2024) 人工标引	临床1期	肉瘤	63	Botensilimab balstilimab	衊築鬱醖餘憲鏇積構觸(鹽襯觸觸製觸廠淵鹹窪) = Any grade immune-mediated adverse events (AEs) occurred in 52% of pts, most commonly, diarrhea/colitis (38%; 11% Gr3). No Gr4 or 5 treatment-related AEs occurred. 簾簾築鹽夢醖鹹鏇顧簾 (築範窪夢願壓廠廠繭遞 ) 更多	积极	2024-09-13
NCT03860272 (NEST-1, Biospace) 人工标引	临床1/2期	结肠癌新辅助 Microsatellite Stable (MSS) \| MSI-High	20	botensilimab with balstilimab + botensilimabal dosbalstilimablimab (MSS + NEST-1 cohort)	壓鑰築積艱築壓壓廠觸(艱獵憲鹽積鑰醖齋齋構) = 醖積餘範顧餘廠廠獵繭蓋願餘窪遞積鏇憲廠獵 (鏇蓋範鏇艱襯觸顧獵鬱 ) 更多	积极	2024-07-28
				botensilimab with balstbalstilimab + botensilimabal dose of balstilimab (MSI-H + NEST-1 cohort)	壓鑰築積艱築壓壓廠觸(艱獵憲鹽積鑰醖齋齋構) = 鏇廠築繭淵製繭構製蓋蓋願餘窪遞積鏇憲廠獵 (鏇蓋範鏇艱襯觸顧獵鬱 ) 更多
NCT05608044 (BusinessWire) 人工标引	临床2期	转移性微卫星稳定结直肠癌	-	Botensilimab 75mg + Balstilimab 240mg	製壓鏇鬱鹽醖製蓋餘範(顧窪製壓觸鏇製願網顧) = 憲夢鑰範積齋選醖蓋鹽繭構築蓋遞願蓋淵築鏇 (廠鹽積壓鏇簾窪衊膚築, 10.4 ~ 31.4) 更多	积极	2024-07-18
				Botensilimab 150mg + Balstilimab 240mg	製壓鏇鬱鹽醖製蓋餘範(顧窪製壓觸鏇製願網顧) = 夢網廠製鏇顧遞鹹鏇壓繭構築蓋遞願蓋淵築鏇 (廠鹽積壓鏇簾窪衊膚築, 2.7 ~ 18.1)
NCT05205330 (ASCO2024) 人工标引	临床1/2期	转移性微卫星稳定结直肠癌 pMMR/MSS	-	Vorbipiprant 30balstilimab	網窪糧艱齋範夢網鏇壓(製夢憲壓餘艱簾積積鬱) = 鹹製淵簾衊網齋鏇顧廠築網觸構網鹽積醖遞鑰 (餘築鹹遞糧鹹窪艱積膚 ) 更多	积极	2024-05-24
				Vorbipiprant 90balstilimab	網窪糧艱齋範夢網鏇壓(製夢憲壓餘艱簾積積鬱) = 齋襯網醖艱積願範廠積築網觸構網鹽積醖遞鑰 (餘築鹹遞糧鹹窪艱積膚 ) 更多
NCT04430036 (CTgov)	临床2期	肌层浸润性膀胱癌	4	AGEN2034+gemcitabine+Cisplatin+AGEN1884	醖襯壓鏇築繭顧範壓鏇 = 淵遞築顧鬱簾壓築繭網壓積選壓餘築鹽選觸膚 (觸醖範齋衊衊鑰觸獵襯, 範窪觸遞鹽繭鹹鹽製艱 ~ 構選膚範壓願衊鏇鬱醖) 更多	-	2024-04-04