A Phase 2 Clinical Study of SKB264 With/Without KL-A167 in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-negative Breast Cancer Who Have Not Received Prior Systemic Therapy

The purpose of this study is to assess the safety and tolerability and preliminary antitumor activity of SKB264 with/without KL-A167 in patients with unresectable locally advanced, recurrent or metastatic TNBC and HR+/HER2- BC .The study is divided into three parts.Part 1（TNBC）: exploratory phase of the efficacy and safety of the combination treatment. Part 2（TNBC）: The subjects will be randomized to treatment group for SKB264 + KL-A167 or SKB264 . Part 3（HR+/HER2- BC）: The subjects will be randomized to treatment group for SKB264 + KL-A167 or SKB264 .

开始日期2022-08-17

申办/合作机构

四川科伦博泰生物医药股份有限公司

NCT05294172

/ Active, not recruiting临床3期

KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial

The study is to evaluate the efficacy of KL-A167 combined with cisplatin and gemcitabine vs placebo combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal carcinoma, as measured by progression-free survival (PFS) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

开始日期2022-06-16

申办/合作机构

四川科伦博泰生物医药股份有限公司

100 项与塔戈利单抗相关的临床结果

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100 项与塔戈利单抗相关的转化医学

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100 项与塔戈利单抗相关的专利（医药）

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项与塔戈利单抗相关的文献（医药）

2019-06-01·Plant disease2区 · 农林科学

Compatible Mixture of Bacterial Antagonists Developed to Protect Potato Tubers from Soft Rot Caused by Pectobacterium spp. and Dickeya spp.

2区 · 农林科学

Article

作者: Krychowiak, Marta ; Czajkowski, Robert ; Krzyzanowska, Dorota M. ; Maciag, Tomasz ; Siwinska, Joanna ; Jafra, Sylwia

Possibilities to protect potato tubers from rotting caused by Soft Rot Pectobacteriaceae (SRP) under disease favoring conditions were investigated using compatible mixtures of bacterial antagonists and tested with a newly developed stepwise efficacy-based screening protocol. Twenty-two bacterial antagonists were evaluated against a combination of five Pectobacterium and Dickeya strains representing species and subspecies most often associated with potato soft rot in Europe. To enable potential synergistic activity, the antagonists were initially tested against the combination of pathogens in 15 random mixtures containing up to 5 antagonists each. Three mixtures (M2, M4, and M14) out of 15 tested reduced tuber tissue maceration due to soft rot. The individual antagonists derived from M2, M4, and M14 mixtures were tested on potato slices and whole tuber injection assays. These five strains (S. plymuthica strain A294, E. amnigenus strain A167, R. aquatilis strain H145, S. rubidaea strain H440, and S. rubidaea strain H469) were combined to develop a tailored biological control mixture against potato soft rot. The new mixture, designated the Great Five (GF), was tested on seed potato tubers vacuum infiltrated with antagonists and subsequently with the combination of five SRP pathogens. In these experiments, the GF mixture provided stable protection of inoculated potato tubers, reducing soft rot by 46% (P = 0.0016) under high disease pressure conditions. The A294, A167, H145, H440, and H469 antagonists were characterized for features important for viable commercial applications including growth at different temperatures, resistance to antibiotics, and potential toxicity toward Caenorhabditis elegans. The implications for control of soft rot caused by SRP with the use of the GF mixture of antagonists are discussed.

2014-11-01·Bioorganic & medicinal chemistry letters4区 · 医学

From the covalent linkage of drugs to novel inhibitors of ribonucleotide reductase: Synthesis and biological evaluation of valproic esters of 3′-C-methyladenosine

4区 · 医学

Article

作者: Hofer, Anders ; Meli, Maria ; Vodnala, Munender ; Torquati, Ilaria ; Vita, Patrizia ; D'Alessandro, Natale ; Grifantini, Mario ; Ferro, Arianna ; Franchetti, Palmarisa ; Tolomeo, Manlio ; Jayaram, Hiremagalur N ; Kusumanchi, Praveen ; Petrelli, Riccardo ; Del Bello, Fabio ; Cappellacci, Loredana

We synthesized a series of serum-stable covalently linked drugs derived from 3'-C-methyladenosine (3'-Me-Ado) and valproic acid (VPA), which are ribonucleotide reductase (RR) and histone deacetylase (HDAC) inhibitors, respectively. While the combination of free VPA and 3'-Me-Ado resulted in a clear synergistic apoptotic effect, the conjugates had lost their HDAC inhibitory effect as well as the corresponding apoptotic activity. Two of the analogs, 2',5'-bis-O-valproyl-3'-C-methyladenosine (A160) and 5'-O-valproyl-3'-C-methyladenosine (A167), showed promising cytotoxic activities against human hematological and solid cancer cell lines. A167 was less potent than A160 but had interesting features as an RR inhibitor. It inhibited RR activity by competing with ATP as an allosteric effector and concomitantly reduced the intracellular deoxyribonucleoside triphosphate (dNTP) pools. A167 represents a novel lead compound, which in contrast to previously used RR nucleoside analogs does not require intracellular kinases for its activity and therefore holds promise against drug resistant tumors with downregulated nucleoside kinases.

1993-01-01·Biological & pharmaceutical bulletin4区 · 医学

Mitogenic Activity and Lethal Toxicity of Lipid A Analogs, Glucosamine-phosphate Carrying Aromatic Alkyl Groups, in Mice.

4区 · 医学

Article

作者: Iwamoto, Yoshihisa ; Yanagihara, Yasutake ; Nakamoto, Shinichi ; Achiwa, Kazuo ; Shimizu, Tadayori ; Itoh, Hajime

The mitogenicity and lethal toxicity of four synthetic lipid A analogs, glucosamine-4-phosphate with a 7-hydroxy-heptanoyl group (A-166), with a 7-phenyl-heptanoyl group (A-167), or with a 8-(1-phenyl-hexanoyl)-nonanoyl group (A-168), at the C-2 and C-3 positions, and glucosamine-6-phosphate with the same substituents as A-168 at C-2 and C-3 (A-169), were compared. The compound A-166 exhibited no mitogenic activity at various concentrations ranging from 3.13 to 50 micrograms/ml in the splenocytes of BALB/c mice, but A-167 exhibited weak mitogenic activity at concentrations of 12.5 and 25 micrograms/ml. A-168 and A-169, as well as A-103, glucosamine-4-phosphate carrying (R)-3-tetradecanoyl-oxytetradecanoyl groups, have remarkable mitogenic activity at concentrations ranging from 12.5 to 100 micrograms/ml; the activity of A-169 (6-phosphate) was stronger than that of A-168 (4-phosphate). Compound A-167 failed to cause death at doses of 25 and 50 micrograms/mouse in galactosamine-loaded C57BL/6 mice while A-166 and A-169 were toxic to 2 out of 6 mice at 50 micrograms/mouse; no deaths were observed at 25 micrograms/mouse. A-168 showed the highest toxicity of any of the compounds tested at 25 and 50 micrograms/mouse. The lethal effect of A-103 appeared to be somewhere between that of A-168 and A-169. These findings indicate that lipid A analogs, carrying an aromatic alkyl group as well as a hydroxyacyl group, are mitogenic and lethal when given to mice.

172

项与塔戈利单抗相关的新闻（医药）

2025-01-23

·PRNewswire

Kelun-Biotech's Product Tagitanlimab Approved for Marketing in Second Indication in Combination with Cisplatin and Gemcitabine For the First-line Treatment of Patients with recurrent or metastatic NPC

CHENGDU, China, Jan. 23, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the " Company") announced that the Company received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand 1(PD-L1)-directed innovative humanized monoclonal antibody (" mAb") tagitanlimab (formerly KL-A167) used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC). The approval is based on a randomized, double-blinded, placebo controlled, multi-center, phase III clinical study evaluates the efficacy and safety results of tagitanlimab in combination with cisplatin and gemcitabine versus placebo in combination with cisplatin and gemcitabine for the treatment of recurrent or metastatic NPC, which was led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator. According to the study results, tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment for recurrent or metastatic NPC could have better progression-free survival (PFS), higher objective response rate (ORR) and extended duration of response (DoR) compared with chemotherapy, where all the patients could benefit regardless of the PD-L1 expression. The median PFS for tagitanlimab in combination with chemotherapy is not reached compared to 7.9 months for placebo in combination with chemotherapy (HR=0.47, 95% CI: 0.33-0.66, p<0.0001), and the risk of disease progression and death is reduced by 53%; ORR is 81.7% vs 74.5%; median DoR is 11.7 vs 5.8 months (HR=0.48, 95% CI: 0.32-0.70), which has nearly doubled compared to placebo arm; currently the median overall survival (OS) is still not mature, however the beneficial trend for OS of tagitanlimab in combination with chemotherapy has already been observed (HR=0.62, 95％CI: 0.32-1.22), and its risk of death is reduced by 38%[1]. Tagitanlimab also showed a manageable safety profile. This is the second indication approved for tagitanlimab. Previously, NMPA has approved the marketing in China of tagitanlimab monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy. Dr. Micheal Ge, CEO of Kelun-Biotech said, "We are pleased that the second indication of our self-developed PD-L1 monoclonal antibody was successfully approved for marketing and demonstrated statistically significant and clinically meaningful improvements in PFS. For domestic NPC patients, Tagitanlimab has realized a breakthrough in therapeutic coverage and innovation from the backline to the frontline, which once again strongly validates the excellent strength of Kelun-Biotech's new drug research and development. In the future, the company will always be based on unmet clinical needs, source innovation, and explore more and more excellent clinical therapeutic solutions to benefit more patients." About Kelun-Biotech Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 2 projects have been approved for marketing, 2 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit . SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床3期申请上市临床结果

2025-01-22

·GBIHealth

逾12亿美元！乐普生物授予ArriVent MRG007全球独家许可

药械追踪 No.1 / 强生艾司氯胺酮抑郁症适应证在美国获批上市 2025年1月21日，强生（NYSE：JNJ）宣布，旗下抗抑郁药物速开朗（艾司氯胺酮）CIII鼻喷雾剂获美国FDA批准上市，成为首个且唯一单药治疗重度抑郁症（MDD）成人患者的疗法，这些成年人对至少两种口服抗抑郁药的反应不足。 SPRAVATO是一种非选择性、非竞争性N-甲基-D-天冬氨酸（NMDA）受体拮抗剂，被认为通过作用于大脑中影响谷氨酸的途径发挥不同的作用机制。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 乘典生物完成肿瘤候选药CD-001首例患者给药 2025年1月20日，乘典生物宣布，其创新型抗肿瘤候选药物CD-001针对晚期实体瘤患者的Ⅰ期临床研究已顺利完成首例受试者入组给药。该受试者在接受首剂量CD-001注射液治疗之后，情况平稳，各项指标正常。 CD-001是乘典生物针对目前临床PD-1抑制剂肿瘤治疗有效率不高的问题，自主研发的一种靶向肿瘤反应性CD8+T细胞的IL-21融合蛋白药物，在阻断PD-1免疫抑制信号的同时，体内选择性扩增肿瘤反应性CD8+T细胞，可显著提高免疫治疗的疗效。 ->点击文末阅读原文，解锁完整双语新闻企业动态 No.1 / 逾12亿美元！乐普生物授予ArriVent MRG007全球独家许可 2025年1月22日，乐普生物（2157.HK）发布公告称，与ArriVent BioPharma, Inc.（Nasdaq：AVBP）就针对消化道癌的潜在同类最佳抗体偶联药物MRG007达成全球独家许可协议。根据协议，乐普生物授予ArriVent在大中华区（包括中国大陆和港澳台）以外地区开发、制造和商业化MRG007的全球独家许可。乐普生物将获得总计4700万美元的一次性首付款和近期里程碑付款，和最高达11.6亿美元的开发、注册和销售等里程碑付款，以及基于大中华区以外地区净销售额的分级特许权使用费。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 康方生物收到科伦药业关于塔戈利单抗合作开发付款 2025年1月22日，康方生物（9926.HK）宣布，因靶向程序性细胞死亡配体1（PD-L1）的创新人源化单克隆抗体塔戈利单抗近日获得中国国家药品监督管理局批准上市，公司已于近日收到四川科伦药物研究院有限公司支付的相应新药合作开发付款。 2014年，康方生物就塔戈利单抗与四川科伦药物研究院有限公司达成相关合作合同，按该合同约定，公司除了因新药开发应取得的付款外，在塔戈利单抗获批上市后，康方生物未来还将持续收到塔戈利单抗商业化销售相应比例的提成。 ->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

引进/卖出临床1期上市批准医药出海

2025-01-22

·PRNewswire

Akeso Received Payment for the Development Collaboration on Tagitanlimab

HONG KONG, Jan. 22, 2025 /PRNewswire/ -- On January 22, 2025, Akeso Inc. (9926.HK) announced that it had received payment from Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. ("Sichuan Kelun") for their collaboration on the development of tagitanlimab, an innovative humanized monoclonal antibody targeting PD-L1, following its recent marketing approval by China's National Medical Products Administration. In 2014, Akeso signed a cooperation agreement with Sichuan Kelun for the development of tagitanlimab. Under the terms of the agreement, Akeso will receive royalties from the commercial sales of tagitanlimab in addition to the development payment. Tagitanlimab marks Akeso's second oncology product to yield commercial royalties, following pucotenlimab, a PD-1 monoclonal antibody developed in collaboration with Lepu Biopharma in 2016. Dr. Yu Xia, founder, chairwoman, president, and CEO of Akeso, said: "Congratulations to our partners. We are thrilled about continuously successful approval of our innovative products, and truly anticipate their outstanding commercialization performance. This achievement highlights Akeso's strong R&D capabilities and our commitment to innovation. Since its inception, Akeso has established multiple external collaborations, including ivonescimab with Summit Therapeutics, quavonlimab with Merck and pucotenlimab with Lepu Biopharma. These partnerships not only benefit patients but also deliver significant returns for both Akeso and our collaborators. Looking ahead, Akeso will continue to pursue a diversified strategy for new drug development, leveraging global resources to drive the high-quality commercialization of our independently developed innovative therapeutics." SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出上市批准

100 项与塔戈利单抗相关的药物交易

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研发状态

批准上市

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适应症	国家/地区	公司	日期
鼻咽癌	中国	四川科伦博泰生物医药股份有限公司	2024-12-25

未上市

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适应症	最高研发状态	国家/地区	公司	日期
转移性HER2阴性乳腺癌	临床2期	中国	四川科伦博泰生物医药股份有限公司	2022-08-17
难治性经典霍奇金淋巴瘤	临床2期	中国	四川科伦博泰生物医药股份有限公司	2018-07-17
复发性经典霍奇金淋巴瘤	临床2期	中国	四川科伦博泰生物医药股份有限公司	2018-07-17
B细胞淋巴瘤	临床1期	中国	四川科伦博泰生物医药股份有限公司	2018-09-19
结外NK-T细胞淋巴瘤	临床1期	中国	四川科伦博泰生物医药股份有限公司	2018-09-19
晚期恶性实体瘤	临床1期	中国	四川科伦博泰生物医药股份有限公司	2017-12-28
非鳞状非小细胞肺癌	临床申请批准	中国	四川科伦博泰生物医药股份有限公司	2024-09-11
HR阳性/HER2阴性乳腺癌	临床申请批准	中国	四川科伦博泰生物医药股份有限公司	2023-09-27
三阴性乳腺癌	临床申请批准	中国	四川科伦博泰生物医药股份有限公司	2022-04-11

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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


CTR20220691 (NEWS) 人工标引	临床3期	鼻咽癌	-	塔戈利单抗+顺铂+吉西他滨	鹹襯餘選窪鏇醖鏇夢蓋(蓋齋選簾壓廠顧築獵觸) = 繭鏇廠壓齋膚構憲齋願範餘襯醖遞蓋壓壓餘醖 (築築膚餘鏇窪鑰憲淵壓 ) 更多	积极	2025-01-21
				安慰剂+顺铂+吉西他滨	鹹襯餘選窪鏇醖鏇夢蓋(蓋齋選簾壓廠顧築獵觸) = 簾觸廠網願餘窪鹹獵繭範餘襯醖遞蓋壓壓餘醖 (築築膚餘鏇窪鑰憲淵壓 ) 更多
NCT05351788 (OptiTROP-Lung01, ASCO2024) 人工标引	临床2期	非小细胞肺癌一线	103	SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W	衊夢廠壓廠簾構簾衊衊(鏇獵觸膚鹽選廠艱憲餘) = 選糧壓膚衊範積簾夢夢淵獵襯鹽鑰遞憲鏇襯齋 (壓繭鏇鹽製壓窪襯襯簾 ) 更多	积极	2024-05-24
				SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W	衊夢廠壓廠簾構簾衊衊(鏇獵觸膚鹽選廠艱憲餘) = 憲齋鬱廠製窪構憲選艱淵獵襯鹽鑰遞憲鏇襯齋 (壓繭鏇鹽製壓窪襯襯簾 ) 更多
NCT03848286 (KL167-2-05-CTP, Pubmed \| NEWS) 人工标引	临床2期	鼻咽癌	153	KL-A167 900mg	顧範觸憲遞製遞願簾壓(鏇築蓋顧淵繭鑰鹽廠構) = 顧憲廠範網築顧遞鹽觸願淵夢齋構選艱簾壓鹽 (壓鹽鏇齋衊鬱壓窪鑰蓋, 19.2 ~ 34.9) 更多	积极	2022-10-10