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更新于：2026-07-10
Nebokitug
更新于：2026-07-10
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟) |
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结构/序列
Sequence Code 929791904H
来源: *****
Sequence Code 929791906L
来源: *****
关联
6
项与 Nebokitug 相关的临床试验NCT06210945
A Phase 2, Multicenter, Randomized, Double-Blind, Proof of Biology Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis
This study is designed to assess the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with systemic sclerosis (SSc). Approximately 45 patients at approximately 40 sites will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo.
开始日期2026-09-01 |
申办/合作机构 |
NCT05824156
Phase 2A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of CM-101 in Patients With Non-Alcoholic Steatohepatitis (NASH)
This phase 2a study is a multi-center, double-blind randomized, placebo-controlled study. The study is designed to determine the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) patients with stage 1c, 2 or 3 fibrosis. The patients will be randomized to 1 of 2 treatment groups: 5 mg/kg CM-101 or placebo.
开始日期2021-02-24 |
申办/合作机构 |
NCT04595825
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects With Primary Sclerosing Cholangitis (The SPRING Study)
This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC). At least 68 subjects at approximately 50 sites will be randomized to receive either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo.
开始日期2020-10-01 |
申办/合作机构 |
100 项与 Nebokitug 相关的临床结果
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100 项与 Nebokitug 相关的转化医学
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100 项与 Nebokitug 相关的专利（医药）
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25
项与 Nebokitug 相关的文献（医药）2025-04-23·GLYCOBIOLOGY
Tumor Hemorrhage-inducing polysaccharides secreted by streptococci and Serratia proposed as the active principal ingredients (API’s) of Coley’s toxin: on PS1, the Serratia marcescens API
Article
作者: Lopez, Henry W ; Takematsu, Hiromu ; Laine, Roger A
Abstract:
Coley’s Toxin comprised a mixture of cell-free, heat-treated culture media from Streptococcus pyogenes (originally Streptococus erysipelatos) and Serratia marcescens (originally Bacillus prodigiosus). A 250 kDa tumor hemorrhage-inducing polysaccharide “PS1” is reported here secreted into culture medium by S. marcescens. Four h after PS1 is injected at 32 μg/kg (10pM) into the tail vein of Balb/C mice bearing C26 subcutaneous colon-derived tumors, tumor-specific capillary hemorrhage is exhibited in 90% of tumors. As a positive control, CM101, a similar tumor hemorrhagic polysaccharide from Streptococcus agalactica caused tumor hemorrhage in 75% of tumors in the Balb/C-C26 model at 7.5 μg/kg(2.5pM). CM101 has previously been safety tested in a Phase I clinical trial. These two polysaccharides have merit to be identified as the active principal ingredients (API’s) of Coley’sToxin. Additional approaches to cancer therapy are a global need. No matter the level of wealth of victims, some cancers are still incurable. Recall in recent years the tragic early cancer deaths of Steve Jobs and Paul Allen among other luminaries. Streptococcal and Serratia bacterial extracts have unique tumor specific capillary destructive activity, with observations originating with sarcomas cured by nosocomial erysipelas infections in the 1860’s. The active pharmaceutical ingredients (API’s) in these extracts and Coley’s Toxins are proposed to be polysaccharides.
2024-09-01·DRUG SAFETY
Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies
Article
作者: Friedman, Scott ; Safadi, Rifaat ; Mor, Adi ; Pinzani, Massimo ; Frankel, Matthew ; Hashmueli, Sharon ; Peled, Amnon
BACKGROUND:
Overexpression of C-C motif chemokine ligand 24 (CCL24) is associated with inflammatory and fibrotic diseases, including primary sclerosing cholangitis (PSC), systemic sclerosis, metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). CM-101 is a humanized monoclonal antibody that neutralizes CCL24 to attenuate inflammation and fibrosis in preclinical models. Here we report the results from two Phase 1a studies investigating the safety and tolerability of intravenous (IV) and subcutaneous (SC) CM-101 in healthy participants, and in one Phase 1b study of IV and SC CM-101 in patients with MASLD without evidence of MASH.
METHODS:
In each dose group (0.75 mg/kg, 2.5 mg/kg, 5.0 mg/kg, and 10.0 mg/kg) of the single-center, double-blind, placebo-controlled Phase 1a IV study, healthy volunteers were randomized 3:1 to receive a single IV infusion of CM-101 or placebo. In another Phase 1a, single-center, double-blind placebo-controlled study, healthy volunteers were randomized 3:1 to receive a single SC injection of CM-101 5.0 mg/kg or placebo. In the multicenter, double-blind, placebo-controlled Phase 1b MASLD study, patients with MASLD without evidence of MASH were randomized 3:1 to receive the following: cohort 1, IV CM-101 2.5 mg/kg or placebo, and cohort 2, SC CM-101 5.0 mg/kg or placebo every three weeks for 12 weeks. The primary endpoints (for all these studies) were safety, tolerability, and serum pharmacokinetic parameters of CM-101.
RESULTS:
In each study, adverse events were rare and mild to moderate. The CM-101 pharmacokinetics profile was typical of a monoclonal antibody, with a terminal half-life of approximately 19 days when given IV and approximately 17 days when given as SC injection. In patients with MASLD without evidence of MASH, CM-101 was associated with decreased serum levels of inflammatory, fibrotic, and collagen turnover biomarkers.
CONCLUSIONS:
In healthy volunteers and patients with MASLD without evidence of MASH, IV and SC CM-101 was well tolerated at doses ranging from 0.75 mg/kg to10.0 mg/kg and engaged its target (i.e., CCL24), indicating therapeutic potential in treating inflammatory and fibrotic diseases.
CLINICAL TRIAL RETROSPECTIVELY REGISTRATION:
NCT06025851, NCT06037577, and NCT06044467. Date of registration: September 2023.
2023-06-22·JCI insight
CCL24 regulates biliary inflammation and fibrosis in primary sclerosing cholangitis
Article
作者: Maor, Yaakov ; Trivedi, Palak ; Peled, Amnon ; Saffioti, Francesca ; Aricha, Revital ; Weston, Christopher J. ; Salhab, Ahmad ; Mishalian, Inbal ; Segal-Salto, Michal ; Hall, Andrew ; Olam, Devorah ; Barashi, Neta ; Vaknin, Ilan ; Snir, Tom ; Aharoni, Sarit ; Levi, Omer ; Pinzani, Massimo ; Katav, Avi ; Safadi, Rifaat ; Hay, Ophir ; Amer, Johnny ; Greenman, Raanan ; Thorburn, Douglas ; Mor, Adi
ˆCCL24 is a pro-fibrotic, pro-inflammatory chemokine expressed in several chronic fibrotic diseases. In the liver, CCL24 plays a role in fibrosis and inflammation, and blocking CCL24 led to reduced liver injury in experimental models. We studied the role of CCL24 in primary sclerosing cholangitis (PSC) and evaluated the potential therapeutic effect of blocking CCL24 in this disease. Multidrug resistance gene 2–knockout (Mdr2
–/–
) mice demonstrated CCL24 expression in liver macrophages and were used as a relevant experimental PSC model. CCL24-neutralizing monoclonal antibody, CM-101, significantly improved inflammation, fibrosis, and cholestasis-related markers in the biliary area. Moreover, using spatial transcriptomics, we observed reduced proliferation and senescence of cholangiocytes following CCL24 neutralization. Next, we demonstrated that CCL24 expression was elevated under pro-fibrotic conditions in primary human cholangiocytes and macrophages, and it induced proliferation of primary human hepatic stellate cells and cholangiocytes, which was attenuated following CCL24 inhibition. Correspondingly, CCL24 was found to be highly expressed in liver biopsies of patients with PSC. CCL24 serum levels correlated with Enhanced Liver Fibrosis score, most notably in patients with high alkaline phosphatase levels. These results suggest that blocking CCL24 may have a therapeutic effect in patients with PSC by reducing liver inflammation, fibrosis, and cholestasis.
117
项与 Nebokitug 相关的新闻（医药）2026-07-08
COMPREHENSIVE PHARMA R&D DAILY综合医药研发日报2026年7月9日 星期四 | 研究突破T0ctDNA MRD预测可切除CRLM辅助化疗OS获益——CIRCULATE-Japan GALAXY研究同步发表于JAMA Oncology
CIRCULATE-Japan GALAXY研究（UMIN000039205）在2026 ESMO GI大会口头报告并同步发表于JAMA Oncology。298例可切除结直肠癌肝转移（CRLM）患者中，术后2-10周ctDNA MRD阳性是最强独立不良预后因素（OS HR 9.13, P<.001）。在直接手术队列MRD+患者中，辅助化疗显著改善OS（调整HR 0.27; 48月OS 65.3% vs 32.9%）和DFS（HR 0.07）；而MRD-患者48月OS约91%，辅助化疗未见明确获益，支持降阶梯治疗。该研究为ctDNA指导CRLM辅助治疗决策提供了迄今最强证据。摘要号：ESMO GI Oral | 试验：CIRCULATE-Japan GALAXY | 药物/技术：Signatera (Natera) | 靶点：ctDNA MRD | 适应症：可切除CRLM来源1 | 来源2BD与并购T0阿斯利康 × 中国生物制药 | TQC3721 License-out | $19亿
正大天晴授予AZ在中国以外地区开发、生产及商业化TQC3721（吸入式PDE3/4双重抑制剂，COPD及慢性呼吸系统疾病）的独家许可；AZ同时获得特定开发方案的全球独家许可。首付款$2亿 + 最高$17亿里程碑 + 最高双位数分级特许权使用费。II期PACER-II研究显示3mg/6mg剂量组FEV1峰值分别提升194mL/241mL，具同类最佳潜力。雾化吸入混悬液中国已进入III期（首个III期顶线数据预计2026年底），干粉吸入粉雾剂推进至II期。公司：正大天晴/阿斯利康 | 类型：License-out | 适应症：COPD | 金额：$19亿来源1 | 来源2T0Merck KGaA收购Bio-Techne | $113亿
德国默克以$113亿全现金收购生命科学工具公司Bio-Techne，较1个月均价溢价36%，预计2026年底或2027年初完成。核心资产：细胞因子/生长因子/抗体目录、ProteinSimple蛋白分析设备、RNAscope空间生物学技术、细胞治疗工具。战略意义：补齐CGT产业链短板，FY2025净销售额>$12亿，交割第三年预计释放€1.4亿成本协同。类型：M&A | 金额：$113亿 | 预计完成：2026年底-2027年初来源1 | 来源2T1GSK × 正大天晴 | 呼吸药中国商业化合作
GSK扩大与正大天晴战略合作，新增全再乐(Trelegy, 2025年全球销售£30亿)和欧乐欣(Anoro, £5.42亿)中国内地商业化运营。正大天晴负责进口、分销、医院准入及推广；GSK保留MAH身份及监管注册/质控/药物警戒。继2026年5月bepirovirsen乙肝合作后再次扩展，覆盖>9000家医院及基层医疗机构。类型：商业化合作 | 产品：Trelegy/Anoro来源T1百奥赛图 × Whitehawk Therapeutics | BsADC全球战略合作
百奥赛图输出RenLite®平台至多5款全人双特异性抗体；Whitehawk贡献CPT113连接子-载荷及CBCR偶联技术。12-24个月内新ADC项目IND申报。百奥赛图获首付款+里程碑款+低个位数销售提成。类型：平台合作 | 技术：RenLite双抗+CPT113 ADC来源T2OTR Therapeutics × LG Chem | 肿瘤资产战略合作
OTR利用中国科学生态系统识别和初步评估肿瘤资产；LG Chem主导中国以外临床开发和商业化。类型：Co-dev | 领域：肿瘤来源T2Scipher Medicine合并Chemomab Therapeutics | 全股票合并
全股票合并，Chemomob股东占32%+里程碑，Scipher占68%。核心资产：Nebokitug (anti-CCL24抗体) + PrismRA精准医学血检筛选RA患者，新II期预计2028 H1读出。合并后估值~$1.5亿，Nasdaq上市(SCIP)。类型：M&A(合并) | 领域：自身免疫/精准医学来源交易进展：云顶新耀-Travere civorebrutinib授权协议完成交割
2026年7月7日完成交割，云顶新耀收到$1.125亿首付款。civorebrutinib(EVER001)下一代共价可逆BTK抑制剂全球权益授权Travere，最高$10.3亿里程碑+高单至双位数分级版税。来源神经退行领域：AAIC 2026会前预告AAIC 2026将于7/12-15在伦敦召开，3天后开幕。以下为最新会前预告汇总。T1Biogen：diranersen（tau ASO）CELIA II期 + LEQEMBI真实世界LEADER研究
Biogen将在AAIC 2026 Develop Topics Session（7/14, 2:00-3:30 PM BST）公布CELIA研究临床/生物标志物/安全性数据。Diranersen（BIIB080）靶向MAPT RNA的反义寡核苷酸，旨在从源头减少tau蛋白产生，已获FDA Fast Track认定。CELIA为18个月II期研究，入组416例早期AD患者。此外，LEQEMBI（仑卡奈单抗）将展示皮下制剂新证据（7/12）及LEADER研究3年真实世界数据（7/14）。药物：diranersen / lecanemab | 靶点：tau (MAPT RNA) / Aβ | 适应症：早期AD来源T1AriBio：AR1001 III期POLARIS-AD进展 + AR1005路易体痴呆IIa期
韩国AriBio将在AAIC进行1场口头报告+3场壁报：口服多机制AD药AR1001（POLARIS-AD III期进展、pTau-217生物标志物分析）及路易体痴呆药AR1005 IIa期中期数据。Topline结果预计2026下半年。药物：AR1001 / AR1005 | 适应症：AD / 路易体痴呆来源T1Acumen Pharmaceuticals：EBD脑递送技术 + ALTITUDE-AD患者视角
Acumen将在AAIC进行1场口头报告（7/15）+2场壁报。口头报告展示Aβ寡聚体/转铁蛋白受体双特异性抗体在食蟹猴中实现增强脑递送，EBD技术源自与JCR Pharma合作（J-Brain Cargo®穿越BBB）。Sabirnetug (ACU193) II期ALTITUDE-AD（n=542）topline预计2026下半年。药物：sabirnetug (ACU193) | 靶点：Aβ寡聚体 | 适应症：早期AD | 状态：FDA Fast Track来源T1AC Immune：TDP-43 PET示踪剂首个人体数据 + NLRP3抑制剂 + α-突触核蛋白Morphomer
AC Immune (NASDAQ: ACIU) 将在AAIC进行1场口头报告+2场壁报：①首创TDP-43 PET示踪剂[18F]ACI-19626在FTD/ALS中的早期人体成像数据（7/15口头）；②脑渗透NLRP3抑制剂ACI-19764在神经炎症模型中的疗效（7/12壁报）；③α-突触核蛋白Morphomer聚集抑制剂的体内神经保护效应（7/14壁报）。药物：ACI-19626 / ACI-19764 | 靶点：TDP-43 / NLRP3 / α-syn | 适应症：FTD/ALS / 神经炎症 / PD来源T1Cognito Therapeutics Spectris：非侵入性脑刺激设备新生物标志物
Cognito将在AAIC展示Spectris（同步光声脑刺激家庭用设备）新生物标志物数据，显示疗法增加了脑内胆固醇样脂质运输蛋白水平，提示可能增强大脑应对AD相关损伤的韧性。结果仍属探索性。技术：Spectris | 类型：非侵入性神经技术设备 | 适应症：AD来源T2Longeveron laromestrocel：CLEAR MIND IIa期额外分析
Longeveron将在AAIC壁报展示laromestrocel（骨髓来源MSC干细胞疗法）在轻度AD中的Phase 2a CLEAR MIND研究额外分析。此前发表于Nature Medicine的早期结果支持继续开发。已获FDA RMAT认定。药物：laromestrocel (Lomecel-B) | 类型：MSC干细胞疗法 | 适应症：轻度AD来源T2Linus Health + BrainCheck：数字认知评估工具验证
Linus Health展示3场壁报：DCR数字认知评估在识别DMT适用患者和超越MoCA方面的表现、ePSOM个体化结局量表的日本可行性。BrainCheck展示3场壁报：与MoCA的精神测量学等价性、Care Plan真实世界效果、PREDICTOM欧洲多语言适应（98.3%完成率）。来源1 | 来源2肿瘤领域ESMO GI 2026消化期T1Agenus BOT+BAL：3年OS数据在难治性MSS mCRC中显示持久生存获益
Agenus在ESMO GI 2026（7/2壁报，摘要号91P）公布botensilimab+balstilimab在无活性肝转移的难治性MSS mCRC中3年OS数据：中位OS 21.2个月，3年OS率33%，K-M曲线在2年后出现平台期。123例Phase 1b队列，中位3线既往治疗，确认ORR 21%（含3例CR），中位DOR未达到，17%患者存活且脱离系统治疗。安全性：无治疗相关死亡，98%免疫性腹泻/结肠炎可缓解。数据支撑III期BATTMAN研究进行中。摘要号：91P | 靶点：CTLA-4 + PD-1 | 适应症：难治性MSS mCRC来源T1Transworld Health ESMO GI 2026亮点综述：KRAS G12D / GLEAM阴性 / FGFR2抑制剂
Transworld Health发布ESMO GI 2026会后深度解读播客：①zoldonrasib+化疗1L KRAS G12D mPDAC高ORR/DCR，支撑III期RASolute-305；②zoldonrasib+daraxonrasib 2L/3L promising ORR/PFS，支撑III期RASolute-309；③GLEAM研究（zolbetuximab+Gem+nab-P在CLDN18.2+胰腺癌）未改善PFS/OS；④FGFR2抑制剂fanregratinib/futibatinib+化疗+免疫在BTC中显示有意义活性；⑤P-32瘤内近距离放疗在局部晚期PDAC有OS信号。来源T2胃/GEJ腺癌新辅助后手术完成率与生存：86.5%完成手术，OS 43.5 vs 34.8月
ESMO GI 2026壁报展示96例局限性胃/GEJ腺癌新辅助化疗后回顾性分析：86.5%患者完成手术，R0切除率74.7%。手术组中位OS 43.5个月 vs 非手术组34.8个月。来源ASCO Breakthrough 2026消化期T1Gene Solutions SPOT-MAS 10：亚洲最大规模多癌早检真实世界数据
Gene Solutions在ASCO Breakthrough 2026报告SPOT-MAS 10（AI驱动多组学血液多癌早检）在84,145名亚洲无症状人群中的真实世界数据。中期分析22,597人≥12月随访，性能与前瞻性验证K-DETEK一致。获FDA Breakthrough Device Designation。技术：AI多癌早检 | 人群：亚洲6国84,145人来源管线进展daraxonrasib深度解读：pan-RAS抑制剂2L mPDAC中OS翻倍
OncLive深度解读RASolute 302：daraxonrasib（pan-RAS抑制剂）在2L mPDAC中OS翻倍（13.2 vs 6.6月, HR 0.40），已获FDA突破性疗法认定+安全进入信函，NDA拟提交。来源中国药企动态T1石药集团+康宁杰瑞：安尼妥单抗（KN026, HER2双抗）拟纳入突破性疗法——一线HER2+乳腺癌
安尼妥单抗（KN026）是全球首款获批国产HER2双抗（2026年5月获批胃癌），此次拟纳入突破性疗法用于一线HER2+乳腺癌。联合HB1801 III期研究已达PFS主要终点并呈OS获益趋势。双方已布局一线/新辅助/辅助3项III期临床。公司：石药集团/康宁杰瑞 | 药物：安尼妥单抗 (KN026) | 靶点：HER2双特异性 | 适应症：一线HER2+乳腺癌来源T1百利天恒：BL-M07D1启动II期临床 对标DS-8201
百利天恒登记一项BL-M07D1 vs DS-8201随机对照II期临床，在HR+/HER2低表达复发/转移性乳腺癌中开展。公司：百利天恒 | 药物：BL-M07D1 | 靶点：HER2 ADC | 适应症：HR+/HER2低表达乳腺癌来源T1恒瑞口服GLP-1 HRS-7535：中国III期达主要终点，减重最高10.9%
Kailera Therapeutics公告恒瑞HRS-7535（口服小分子GLP-1）两项中国III期结果：HARBOR-1肥胖试验180mg组44周减重10.9%（efficacy estimand），50周达11.1%；OUTSTAND-2 T2D试验降HbA1c 1.50-1.68%。无肝安全性信号。Kailera全球II期2026年4月启动。公司：恒瑞医药/Kailera | 药物：HRS-7535 (KAI-7535) | 类型：口服GLP-1 | 适应症：肥胖/T2D来源T2恒瑞医药：SHR-4685注射液获临床批文
恒瑞SHR-4685注射液（抗肿瘤新药，全球无同类获批）获临床批文。公司：恒瑞医药 | 药物：SHR-4685 | 状态：临床批文来源2026上半年中国创新药BD出海总金额达997亿美元
据医药魔方统计，2026上半年中国创新药License-out交易总金额997亿美元，约为2024年2倍。全球Top 10交易中国独占8席：石药-AZ 185亿、恒瑞-BMS 152亿、信达-辉瑞 105亿。Co-Co模式兴起，中国药企从"配角"走向"核心供给方"。来源简讯科伦博泰：拟配售583.8万股新股净筹27.23亿港元，为ADC管线研发补充资金。来源来源索引编号来源域名1OncLiveonclive.com2JAMA Oncology (via pracamedyka.pl)jamanetwork.com3GlobeNewswire (Biogen/Acumen)globenewswire.com4Business Wire (Agenus/Cognito/BrainCheck)businesswire.com5PR Newswire (Linus Health/OTR)prnewswire.com6Wall Street Online (AC Immune)wallstreet-online.de7Transworld Health Podcastpodcasts.apple.com8OncNursingNewsoncnursingnews.com9Kyodo News PR Wire (Gene Solutions)kyodonewsprwire.jp10Kailera/GlobeNewswire (恒瑞GLP-1)ceo.ca11财联社/BioPharma Dive (BD交易)cls.cn / biopharmadive.com12中国经济网/ChemExWorld (Merck/Bio-Techne)ce.cn / chemexworld.com13医药魔方 (百奥赛图/BD出海)emedclub.com / biospace.com14pharmnews.com (AriBio)pharmnews.com15Morningstar (BrainCheck)morningstar.com16FierceBiotech (Scipher/Chemomab)fiercebiotech.com17Minichart (云顶新耀)minichart.com.sg
2026-07-08
Precision immunology company Scipher Medicine will absorb Chemomab Therapeutics after having identified the Israeli biotech’s liver disease drug as the ideal fit for its own expertise.
The merged entity will retain the Scipher brand and take advantage of Chemomab’s Nasdaq listing, although the ticker will switch to “SCIP.” The new company’s primary focus will be Chemomab’s anti-CCL24 antibody asset nebokitug, which will initially be launched into a phase 2 study for rheumatoid arthritis.
The plan is to take the anti-CCL24 antibody into a fresh phase 2 study that will also leverage Scipher’s multi-omic PrismRA blood test to help identify the most suitable patients. A topline readout from that study is penciled in for the first half of 2028, according to a July 8 release .
Chemomab has already taken nebokitug into a separate mid-stage trial for primary sclerosing cholangitis, where the drug “demonstrated a favorable safety and tolerability profile and improvement in both inflammatory and fibrotic-related biomarkers,” the companies said in this morning’s release.
Schipher CEO Reginald Seeto—who will lead the merged business—said that CCL24 had been identified by the Massachusetts company’s AI precision medicine platform as “the highest-ranked clinical stage RA target for efficacy.”
“We believe this combination will enable us to advance nebokitug as the first precision medicine for the millions of RA patients whose disease is not well treated by current medications,” Seeto added in the release. “Notably, there have been no new novel mechanisms approved in RA by the FDA since 2012, and no new branded FDA approvals in RA since 2019.”
Meanwhile, Chemomab CEO Adi Mor, Ph.D.—who will join the board of the merged company—said she believed the merger “provides our shareholders a compelling potential opportunity to realize value through the clinical advancement of nebokitug in a large indication with substantial unmet need and well-established clinical endpoints as well as through Scipher’s revenue-generating precision medicine business and its strong biopharma partnerships.”
“Additionally, the opportunity remains to secure a potential partner for a phase 3 trial in primary sclerosing cholangitis, an indication with no FDA-approved therapies,” Mor pointed out.
Under the deal, which has been signed off by the boards of both companies, Chemomab’s shareholders will own 32% of the merged company and will also be in line for potential milestone payouts related to nebokitug’s progress. Scipher’s current equity holders will own 68% of the new company.
The combined company is expected to have a value of $150 million, ahead of an incoming $30 million from a private placement. This article was amended on July 8 at 9.20 pm ET to clarify that the previous phase 2 study of nebokitug was in primary sclerosing cholangitis, not rheumatoid arthritis.
2026-07-08
Scipher Medicine has found a way to go public — and gain a clinical rheumatoid arthritis (RA) candidate — by merging with Israeli drug developer Chemomab Therapeutics.The Massachusetts-based biotech, which is deploying AI to improve the likelihood that a therapeutic will succeed at every step in the drug development process, also markets the PrismRA blood-based RA assay. The test evaluates a patient's molecular and clinical signature to determine whether or not they're likely to respond to a TNF inhibitor.While Chemomab was not working in the RA space before the merger, its lead antibody asset, nebokitug, caught Scipher's eye because of its target: CCL24. According to Scipher CEO Reginald Seeto, its AI Network Medicine Platform identified CCL24 as the "highest-ranked clinical stage RA target for efficacy." Chemomab had been advancing nebokitug for primary sclerosing cholangitis (PSC). In the Phase II SPRING trial, the anti-CCL24 antibody demonstrated numerical improvements in a range of biomarkers for inflammation and fibrosis, suggesting nebokitug may have an effect in other inflammatory diseases in addition to PSC. "There have been no new novel mechanisms approved in RA by the FDA since 2012, and no new branded FDA approvals in RA since 2019," said Seeto, who will lead the combined company. "Nebokitug, which blocks the chemokine CCL24, represents a unique dual acting mechanism in RA as it targets both inflammation and fibrosis."After the merger closes, expected in the fourth quarter, the company will move nebokitug into a Phase II trial for RA. The study will use standard 12-week, FDA-accepted RA endpoints, and Scipher will use its PrismRA test to guide enrollment.Under the deal terms, Chemomab shareholders will own 32% of the combined company and receive contingent value rights tied to milestones related to nebokitug. While PSC will no longer be a priority, Chemomab CEO Adi Mor said there will still be an opportunity for the combined company to pursue Phase III development of the antibody in PSC with a partner. Scipher equity holders will own about 68% of the combined company, which will operate as Scipher Medicine and trade on NASDAQ under the ticker "SCIP."Alongside the merger, Scipher is raising $30 million in a private placement from Khosla Ventures, Blue Owl Healthcare Opportunities and funds managed by Neuberger. Combined with each party's cash at closing, the company will have sufficient funds to operate through the second half of 2028; topline data from the Phase II RA trial are expected in the first half of 2028.
临床2期并购临床结果临床3期
100 项与 Nebokitug 相关的药物交易
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 系统性硬皮病 | 临床2期 | 美国 | 2023-02-21 | |
| 代谢功能障碍相关脂肪性肝炎 | 临床2期 | 以色列 | 2021-02-24 | |
| 原发性硬化性胆管炎 | 临床2期 | 德国 | 2020-10-01 | |
| 原发性硬化性胆管炎 | 临床2期 | 以色列 | 2020-10-01 | |
| 原发性硬化性胆管炎 | 临床2期 | 西班牙 | 2020-10-01 | |
| 原发性硬化性胆管炎 | 临床2期 | 英国 | 2020-10-01 |
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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 |
|---|
临床2期 | 76 | (all doses) | 蓋醖鏇淵範製窪憲蓋蓋(膚艱網齋製廠鏇鏇繭齋) = Frequency and severity were similar between the groups. 襯鏇獵衊獵憲網餘憲網 (艱餘鏇齋選壓網繭選淵 ) 更多 | 积极 | 2025-11-19 | ||
Placebo | |||||||
临床2期 | 29 | (10 mg/kg / 20 mg/kg) | 廠膚願窪獵顧艱膚積蓋(艱壓艱顧築窪淵襯衊構) = 觸鏇衊積糧顧顧壓餘網 蓋襯淵糧醖艱積衊繭壓 (艱衊獵齋顧艱鹹襯餘鹹 ) | 积极 | 2025-03-27 | ||
Historical control | 廠膚願窪獵顧艱膚積蓋(艱壓艱顧築窪淵襯衊構) = 鏇遞鹽衊遞顧鹽憲鹹膚 蓋襯淵糧醖艱積衊繭壓 (艱衊獵齋顧艱鹹襯餘鹹 ) | ||||||
临床1期 | C-C motif chemokine ligand 24 (CCL24) | - | 齋鏇淵獵築齋膚鹽淵夢(鬱鹹遞餘夢艱齋鹽繭憲) = adverse events were rare and mild to moderate 網遞艱鏇遞廠觸糧遞襯 (膚願鏇範膚製獵鬱網鑰 ) 更多 | - | 2024-09-01 | ||
临床2期 | 76 | 憲鑰蓋遞遞醖艱獵壓糧(醖襯糧鏇壓糧蓋淵鏇願) = Adverse events, which most commonly included fatigue, headache, and pruritis, were generally mild/moderate and distributed similarly between the placebo and CM-101-treated dosing arms. 觸糧觸範繭構鑰積鬱繭 (醖壓鏇觸衊艱繭製遞窪 ) 达到 更多 | 积极 | 2024-07-25 | |||
临床2期 | 23 | 淵廠製積艱範網鹽膚淵(淵夢糧選築顧鑰糧淵窪) = significant reduction 顧鹹餘積觸艱鑰鏇襯繭 (鏇積遞鹽窪糧遞積蓋餘 ) 更多 | 积极 | 2023-11-13 | |||
placebo |
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