This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

开始日期2022-09-15

申办/合作机构

Janux Therapeutics, Inc.

100 项与 Prostate specific membrane antigen tumour activated T-cell engager therapy (Janux Therapeutics/Merck & Co) 相关的临床结果

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100 项与 Prostate specific membrane antigen tumour activated T-cell engager therapy (Janux Therapeutics/Merck & Co) 相关的转化医学

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100 项与 Prostate specific membrane antigen tumour activated T-cell engager therapy (Janux Therapeutics/Merck & Co) 相关的专利（医药）

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项与 Prostate specific membrane antigen tumour activated T-cell engager therapy (Janux Therapeutics/Merck & Co) 相关的新闻（医药）

2025-05-11

·药明康德

使“癌症之王”患者总生存期优于历史对照的小分子疗法；使多名患者肿瘤完全消失的组合疗法…… | 一周盘点

本期看点1. 在一项早期临床试验中，tuspabetinib（TUS）联用标准剂量的venetoclax和azacitidine的三联疗法使多名急性髓系白血病（AML）患者的肿瘤细胞完全消失。2. 放射增敏剂JNJ-1900用于局部晚期或临界可切除胰腺癌患者的1期临床试验结果亮眼，患者的中位总生存期（OS）优于历史对照组，并有两名患者成功实现R0根治性手术切除。3. 大环MEK抑制剂PAS-004的药效学（PD）数据积极，对评估MEK抑制剂活性的金标准PD生物标志物的抑制率高达91%。药明康德内容团队整理Tuspetinib：公布1/2期联合治疗试验的新数据Aptose Biosciences公司公布了其针对新确诊的AML患者开展的1/2期TUSCANY试验的新数据。这些患者分别接受了40毫克或80毫克剂量的tuspabetinib联用标准剂量的venetoclax和azacitidine（TUS+VEN+AZA三联疗法）。该三联疗法正在被开作发为一种安全且不依赖于特定突变的一线治疗方案，用于治疗那些无法接受诱导化疗的新诊断AML患者，这些患者具有多样的突变。在两种剂量下，均有多名携带不同突变（包括TP53突变/复杂核型、FLT3野生型）的患者达到了完全缓解（CR）或伴有血液学不完全恢复的完全缓解（CRi），40毫克剂量组中达到CR/CRi的3名患者的最小残留病（MRD）状态均为阴性。安全性方面，该三联疗法的安全性良好，在两个剂量水平下均未观察到剂量限制性毒性。JNJ-1900（NBTXR3）：公布1期临床试验数据Nanobiotix公司公布了其潜在“first-in-class”的新型放射增敏剂JNJ-1900（NBTXR3）用于局部晚期或临界可切除胰腺癌患者的1期临床试验数据。NBTXR3由功能化二氧化铪（HfO2）纳米颗粒组成，经由一次性瘤内注射给药并通过放射疗法激活。它的物理作用机制为：通过放疗激活，诱导被注射肿瘤内大量的肿瘤细胞死亡，随后触发适应性免疫反应和长期的抗癌记忆。得益于该物理作用机制，Nanobiotix公司认为NBTXR3可扩展到任何可以通过放疗治疗的实体肿瘤和任何联合治疗方案中，特别是与免疫检查点抑制剂联合。2023年，Nanobiotix宣布与强生旗下杨森公司（现名为强生创新制药）达成全球共同开发和商业化NBTXR3的许可协议。此次公布的研究结果显示，22名接受JNJ-1900治疗的患者的中位OS达到23个月（从诊断日期开始计算），优于历史对照组（19.2个月）；中位局部无进展生存期（PFS）为13.3个月（从放疗结束时开始计算）；两名患者成功实现R0根治性手术切除。探索性生物标志物分析显示，循环肿瘤突变负荷（cTMB）升高与更长的局部PFS和OS相关；CA19-9肿瘤标志物在59%的患者中恢复正常，同样与更长的OS相关。这些结果支持在随机对照试验中进一步评估JNJ-1900。PAS-004：公布1期临床试验数据Pasithea Therapeutics公司公布了其大环MEK抑制剂PAS-004治疗MAPK通路驱动的晚期实体肿瘤患者的1期临床研究的PD数据。与目前FDA批准的MEK抑制剂不同，PAS-004是大环化合物，环化可增强药物与靶受体的结合，被认为有望改善药代动力学和安全性。ERK磷酸化（pERK）的抑制被广泛认为是评估MEK抑制剂活性的金标准PD生物标志物。为了评估PAS-004的靶点作用，研究人员在基线和第22天稳态时检测了患者外周血单核细胞（PBMCs）中的pERK水平。结果显示，PAS-004对pERK的抑制率高达91%，证实其具有强大的靶点作用。该结果得到了初步临床观察的支持，表现为多名患者实现了疾病稳定（SD）和肿瘤缩小。其中，一名IV期携带KRAS G12R突变的胰腺癌患者已获得超过5个月的SD，肿瘤体积缩小了9.8%。REC-4881：公布1b/2期临床试验数据Recursion公司公布了其正在进行的1b/2期TUPELO试验中REC-4881的初步安全性和疗效结果。REC-4881是一种正在被开发用于治疗家族性腺瘤性息肉病（FAP）的选择性变构MEK1/2抑制剂。FAP是一种由APC基因突变引起的罕见遗传性疾病，患者若不治疗，几乎100%会发展为结直肠癌。目前，该病尚无获得美国FDA批准的治疗方法。REC-4881已获得FDA和欧洲药品管理局授予的孤儿药资格及FDA的快速通道资格。截至2025年3月17日的数据，在接受4 mg每日一次治疗的6例可评估患者中，第13周时息肉负荷的中位降幅为43%，其中83%的患者（5人）的降幅范围为31%至82%，1例患者的息肉负荷较基线大幅增加。50%的患者实现了Spigelman分期（衡量上消化道疾病严重程度的指标）改善≥1分。REC-4881的早期安全性特征与以往的MEK1/2抑制剂相似。在1b期和2期研究里的19名患者中，大多数治疗相关不良事件为1/2级，16%的患者发生了3级不良事件，目前未报告任何4级及以上的治疗相关不良事件。JANX007：启动1b期扩展研究Janux Therapeutics公司宣布在未接受过紫杉烷类药物的转移性去势抵抗性前列腺癌（mCRPC）患者中启动1b期扩展研究，该研究的启动得到了此前公布的1a期剂量递增研究数据的支持。JANX007是一款靶向前列腺特异性膜抗原（PSMA）的肿瘤激活T细胞接合器，分别靶向PSMA和T细胞表面表达的CD3受体。它的设计让JANX007在肿瘤微环境中经过蛋白酶切割而被激活，从而在降低了其潜在毒性的同时，最大化抗肿瘤免疫反应。截至2025年4月21日的数据，16名mCRPC患者的中位影像学PFS为7.5个月，6个月时的影像学无进展生存率为65%；接受6 mg和9 mg治疗剂量的9名患者的中位影像学PFS为7.9个月，6个月时的影像学无进展生存率为78%。安全性数据与2024年12月披露的数据保持一致。SPY001：公布1期临床试验的新数据Spyre Therapeutics公司公布了其抗体疗法SPY001的1期临床试验的新数据。SPY001是一种高效、具有选择性的抗α4β7单克隆抗体，采用工程化改造延长半衰期，正在被开发用于治疗炎症性肠病（IBD）。长达8个月的随访结果显示，SPY001具有良好的耐受性，药代动力学（PK）数据显示，其半衰期长达约80天，是现有标准治疗之一的vedolizumab的三倍以上。PD数据显示，在预期的2期谷浓度，单次给药SPY001仍能维持对靶点的持续作用，导致α4β7受体快速、持续饱和。该数据进一步支持SPY001在更高暴露量下可能实现更优的诱导治疗反应，以及具有每季度或每半年给药一次的潜力。参考资料：[1] Perfuse Therapeutics Announces Positive Results from the Completed Phase 1/2a Clinical Trial of PER-001 Intravitreal Implant in Patients with Glaucoma. Retrieved May 9, 2025, from https://www.prnewswire.com/news-releases/perfuse-therapeutics-announces-positive-results-from-the-completed-phase-12a-clinical-trial-of-per-001-intravitreal-implant-in-patients-with-glaucoma-302446082.html[2] IDEAYA Biosciences Announces US FDA IND-Clearance for IDE849, a Potential First-in-Class DLL3 TOP1 ADC, for a Phase 1 Study in Solid Tumors. Retrieved May 9, 2025, from https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-us-fda-ind-clearance-for-ide849-a-potential-first-in-class-dll3-top1-adc-for-a-phase-1-study-in-solid-tumors-302446498.html[3] Cohen, R.B., Jimeno, A., Hreno, J. et al. Safety, tolerability, and preliminary efficacy of nadunolimab, an anti-IL- 1 receptor accessory protein monoclonal antibody, in combination with pembrolizumab in patients with solid tumors. Invest New Drugs (2025). https://doi.org/10.1007/s10637-025-01538-3[4] Opus Genetics Announces Presentation of OPGX-LCA5 Gene Therapy Data at ARVO; 12 Month Phase 1/2 Results Support Potential to Restore to Meaningful Vision. Retrieved May 9, 2025, from https://ir.opusgtx.com/press-releases/detail/484/opus-genetics-announces-presentation-of-opgx-lca5-gene-therapy-data-at-arvo-12-month-phase-12-results-support-potential-to-restore-to-meaningful-vision[5] Janux Therapeutics Initiates Phase 1b Expansion Studies with JANX007 in Patients with Prostate Cancer and Provides Program Updates. Retrieved May 9, 2025, from https://investors.januxrx.com/investor-media/news/news-details/2025/Janux-Therapeutics-Initiates-Phase-1b-Expansion-Studies-with-JANX007-in-Patients-with-Prostate-Cancer-and-Provides-Program-Updates/default.aspx[6] Lantern Advances Drug Candidate LP-184 with IND Clearance for Phase 1b/2 Clinical Trial in Triple Negative Breast Cancer (TNBC). Retrieved May 9, 2025, from https://ir.lanternpharma.com/news-events/press-releases/detail/177/lantern-advances-drug-candidate-lp-184-with-ind-clearance[7] Spyre Therapeutics Announces Poster Presentations at Digestive Disease Week (DDW) 2025 Including Up to Eight months of Follow-up from an Ongoing Phase 1 Trial of SPY001. Retrieved May 9, 2025, from https://www.prnewswire.com/news-releases/spyre-therapeutics-announces-poster-presentations-at-digestive-disease-week-ddw-2025-including-up-to-eight-months-of-follow-up-from-an-ongoing-phase-1-trial-of-spy001-302445258.html[8] Aptose Provides Clinical Update for the Tuspetinib-based Triple Drug Frontline Therapy in Newly Diagnosed AML Patients from the Phase 1/2 TUSCANY Trial. Retrieved May 9, 2025, from https://www.aptose.com/news-media/press-releases/detail/317/aptose-provides-clinical-update-for-the-tuspetinib-based[9] Regeneration Biomedical to Present Updated Phase 1 Trial Data on Autologous Stem Cell Therapy Injected Directly into the Brain for Alzheimer’s Disease in Podium Presentation at the ISCT 2025 Scientific Annual Meeting. Retrieved May 9, 2025, from https://www.globenewswire.com/news-release/2025/5/5/3073944/0/en/Regeneration-Biomedical-to-Present-Updated-Phase-1-Trial-Data-on-Autologous-Stem-Cell-Therapy-Injected-Directly-into-the-Brain-for-Alzheimer-s-Disease-in-Podium-Presentation-at-the.html[10] Nanobiotix Announces Full Results From Completed Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Pancreatic Cancer. Retrieved May 9, 2025, from https://ir.nanobiotix.com/news-releases/news-release-details/nanobiotix-announces-full-results-completed-phase-1-study[11] Preliminary Phase 1b/2 Data for REC-4881 in Familial Adenomatous Polyposis (FAP) Demonstrates Reduced Polyp Burden. Retrieved May 9, 2025, from https://ir.recursion.com/news-releases/news-release-details/preliminary-phase-1b2-data-rec-4881-familial-adenomatous[12] TransCode Therapeutics Reports Further Progress on Phase 1a Clinical Trial with No Dose Limiting Toxicities Reported in Patients with Metastatic Cancer. Retrieved May 9, 2025, from https://www.prnewswire.com/news-releases/transcode-therapeutics-reports-further-progress-on-phase-1a-clinical-trial-with-no-dose-limiting-toxicities-reported-in-patients-with-metastatic-cancer-302443677.html[13] Design Therapeutics Announces Favorable Phase 1 Data for DT-168 Supporting Advancement into Phase 2 Biomarker Trial for Patients with Fuchs Endothelial Corneal Dystrophy. Retrieved May 9, 2025, from https://investors.designtx.com/news-releases/news-release-details/design-therapeutics-announces-favorable-phase-1-data-dt-168[14] Pasithea Therapeutics Reports Positive Pharmacodynamic Results Demonstrating Robust Target Engagement from its Ongoing Phase 1 Clinical Trial of PAS-004. Retrieved May 9, 2025, from https://www.globenewswire.com/news-release/2025/05/06/3074902/0/en/Pasithea-Therapeutics-Reports-Positive-Pharmacodynamic-Results-Demonstrating-Robust-Target-Engagement-from-its-Ongoing-Phase-1-Clinical-Trial-of-PAS-004.html[15] Aspen Neuroscience Announces 6-Month ASPIRO Phase 1/2a Clinical Trial Results of Personalized Cell Therapy for Parkinson's Disease. Retrieved May 9, 2025, from https://www.prnewswire.com/news-releases/aspen-neuroscience-announces-6-month-aspiro-phase-12a-clinical-trial-results-of-personalized-cell-therapy-for-parkinsons-disease-302448009.html[16] Arbutus Presents Clinical Trial Data from its Two HBV Assets, Imdusiran and AB-101, at the European Association for the Study of the Liver (EASL) Congress 2025. Retrieved May 9, 2025, from https://investor.arbutusbio.com/news-releases/news-release-details/arbutus-presents-clinical-trial-data-its-two-hbv-assets[17] CRISPR Therapeutics Provides First Quarter 2025 Financial Results and Announces Positive Top-Line Data from Phase 1 Clinical Trial of CTX310™ Targeting ANGPTL3. Retrieved May 7, 2025 from https://ir.crisprtx.com/news-releases/news-release-details/crispr-therapeutics-provides-first-quarter-2025-financial[18] Marengo Doses First Patient in STARt-002 Clinical Trial Evaluating First-in-Class Dual T Cell Agonist, Invikafusp Alfa in Combination with TROP2-directed ADC Trodelvy® in Metastatic Breast Cancer. Retrieved May 7, 2025 from https://www.prnewswire.com/news-releases/marengo-doses-first-patient-in-start-002-clinical-trial-evaluating-first-in-class-dual-t-cell-agonist-invikafusp-alfa-in-combination-with-trop2-directed-adc-trodelvy-in-metastatic-breast-cancer-302449274.html[19] Phio Pharmaceuticals Announces Positive Pathology Results in Third Cohort in INTASYL PH-762 Skin Cancer Clinical Trial. Retrieved May 9, 2025, from https://phiopharma.com/phio-pharmaceuticals-announces-positive-pathology-results-in-third-cohort-in-intasyl-ph-762-skin-cancer-clinical-trial/免责声明：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：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2

放射疗法临床1期临床结果临床2期

2025-05-08

·investors.januxrx.com

Janux Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights

SAN DIEGO--(BUSINESS WIRE)-- Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today reported financial results for the first quarter ended March 31, 2025, and provided a business update. “We are proud to advance into the next phase of our clinical journey for JANX007 and begin treating patients in our Phase 1b expansion studies,” said David Campbell, Ph.D., President and CEO of Janux. “We also look forward to our first R&D Day where we will unveil previously undisclosed preclinical programs that utilize our expertise and platform technologies to address significant unmet medical needs.” RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES: *8/16 patients were noted as in-progress in the December 2024 reported results. **rPFS results based upon Kaplan-Meier estimate. Janux selected 0.3/2/6mg and 0.3/2/9mg with dosing administered once weekly or once every two weeks as the two dose regimens for the Phase 1b expansion studies. In addition, Janux has selected a CRS-mitigation strategy to support the initiation of the Phase 1b expansion studies that is designed to reduce the risk of overuse of steroids while maintaining the early cycle grades 1 and 2 CRS profile reported in December. Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025. Separately, Janux will host an R&D Day in mid-2025 highlighting product candidates identified from its preclinical pipeline to move into clinical trials. FIRST QUARTER 2025 FINANCIAL RESULTS: Janux’s TRACTr and TRACIr Pipeline Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline. About Janux Therapeutics Janux is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies for cancer. Janux’s proprietary technology enabled the development of two distinct bispecific platforms: TRACTr and TRACIr. The goal of both platforms is to provide cancer patients with safe and effective therapeutics that direct and guide their immune system to eradicate tumors while minimizing safety concerns. Janux is currently developing a broad pipeline of TRACTr and TRACIr therapeutics directed at several targets to treat solid tumors. Janux has two TRACTr therapeutic candidates in clinical trials, the first targeting PSMA is in development for prostate cancer, and the second targeting EGFR is being developed for colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. For more information, please visit www.januxrx.com and follow us on LinkedIn. Forward-Looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Janux’s ability to bring new treatments to cancer patients in need, expectations regarding the timing, scope and results of Janux’s development activities, including its ongoing and planned preclinical studies and clinical trials, the timing of and plans for regulatory filings, the potential benefits of Janux’s product candidates and platform technologies, expectations regarding the use of Janux’s platform technologies to generate novel product candidates and the strength of Janux’s balance sheet and the adequacy of cash on hand. Factors that may cause actual results to differ materially include the risk that compounds that appear promising in early research do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Janux may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Janux faces, please refer to Janux’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Janux assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Janux Therapeutics, Inc. Condensed Balance Sheets (in thousands) March 31, 2025 December 31, 2024 Assets (unaudited) Current assets: Cash and cash equivalents $ 73,743 $ 430,605 Short-term investments 940,403 594,568 Prepaid expenses and other current assets 9,193 8,493 Total current assets 1,023,339 1,033,666 Restricted cash 816 816 Property and equipment, net 4,947 4,864 Operating lease right-of-use assets 18,878 19,286 Other long-term assets 2,792 2,884 Total assets $ 1,050,772 $ 1,061,516 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 2,351 $ 4,026 Accrued expenses 13,340 11,684 Current portion of operating lease liabilities 1,811 1,749 Total current liabilities 17,502 17,459 Operating lease liabilities, net of current portion 20,801 21,276 Total liabilities 38,303 38,735 Total stockholders’ equity 1,012,469 1,022,781 Total liabilities and stockholders’ equity $ 1,050,772 $ 1,061,516 Janux Therapeutics, Inc. Unaudited Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) Three Months Ended March 31, 2025 2024 Collaboration revenue $ — $ 1,252 Operating expenses: Research and development 25,055 14,070 General and administrative 9,842 7,343 Total operating expenses 34,897 21,413 Loss from operations (34,897 ) (20,161 ) Total other income 11,389 5,401 Net loss $ (23,508 ) $ (14,760 ) Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities, net 1,593 (1,189 ) Comprehensive loss $ (21,915 ) $ (15,949 ) Net loss per common share, basic and diluted $ (0.38 ) $ (0.30 ) Weighted-average shares of common stock outstanding, basic and diluted 61,791,721 49,049,741 Investors: Andy Meyer Janux Therapeutics ameyer@januxrx.com (202) 215-2579 Media: Jessica Yingling, Ph.D. Little Dog Communications Inc. jessica@litldog.com (858) 344-8091

免疫疗法临床1期财报临床结果

2025-05-07

·抗体密码

不服输的再生元！

再生元作为最具有创新能力的制药公司，在双特异性抗体的开发方面，开创性的推出了靶向CD28的双抗，并且在临床中探索了与CD3双抗或者PD-1进行联用，在2022年的ESMO会议上，其PSMA/CD28联合PD-1展现了惊人的疗效，让整个制药界一度看到了CD28成药性的希望，但是2023年，再生元披露，该联合疗法因为两起免疫介导的患者死亡事件，暂停了该研究联合治疗组的患者招募。在今年的AACR会议上，其公布了该临床的详细数据。该1/2临床主要考察双特异抗体单药或者与Cemiplimab联用的安全性，有效性及PK等，前三周为安全导入期，患者接受REGN5678单独静脉给药，后续将联合PD-1抗体Cemiplimab进行联合治疗，其中REGN5678的给药方式不变，每周静脉给药，而Cemiplimab给药按照标准治疗进行，每三周静脉给药，每次给药350mg。其中，PSMA/CD28双抗给药剂量设置了8个组，从0.1mg~300mg，同时其将0.1~10mg设置为低剂量A组，而30~300mg为高剂量B组。疗效方面，在较低剂量的17位患者中，PSMA/CD28联合PD-1治疗仅展现较弱的抗肿瘤活性，但是患者的PSA响应不明显，同时在这些患者中也没有出现3级及以上的irAE；但是在高剂量组中，PSMA/CD28联合PD-1治疗展现了良好的疗效，其中15位患者达到PSA50，并且9位患者达到PSA90，截止到2024年7月19日，高剂量组的mOS为17.3个月（11.0-not estimable），而低剂量组为10.3个月（3.7-12.6）安全性方面，77%的患者出现治疗相关的副作用，其中28%的为3级及以上副作用。在高剂量组中，14%的患者出现3级及以上的imARs(免疫相关副作用)，包括神经学，皮肤，肝脏，肺等相关副作用。而在CRS方面，仅有13%的患者出现相关副作用，且绝大多数为1级。进一步的分析发现，发生3级及以上的imARs所有11位患者，在临床中都对该疗法具有响应，这表明imARs与治疗疗效具有较强的相关性。总体上，PSMA/CD28联合PD-1治疗在高剂量组展现了强劲的疗效，但是随之而来的是较高的毒性，并且免疫相关毒性与疗效也有较强的正相关。再生元在分析两起免疫介导的患者死亡原因后，认为其与PD-1的相关剂量相关，目前其并没有停止相关临床的开发，而且在探索PSMA/CD28双抗和其它药物联用，并尝试如何在维持疗效的同时降低相关毒性。而作为对比，Janux JANX007治疗的患者在治疗前平均接受过4线以上的治疗，目前临床爬坡还没有完成，初步的临床数据表明，在剂量≥ 0.2mg (n=6)的患者中，所有患者的PSA都降低了30%的PSA，其中83%的患者PSA降低超过50%，17%的患者PSA降低超过90%，而在低剂量组中≥ 0.1mg (n=18)也观察到PSA的降低，其中6%的患者PSA降低超过90%，而在安全性方面，没有患者发生大于2级的CRS反应。总结CD3作为激活T细胞的第一信号，相关疗法在血液瘤中已经获得成功，并且在实体瘤领域也获得突破，而CD28作为第二信号，自从TGN1412失败后一蹶不振，再生元作为后CD28时代第一人，开发的CD28双抗在临床前展现了良好的疗效，在临床中也展现了治疗实体瘤的潜力，但是，其安全性也是无法逃避的难题。虽然暂时遭遇了挫折，但是再生元并没有放弃CD28双抗，目前也在探索相关解决方案。我们已经建立抗体密码读者交流群，有兴趣的可以扫描下方二维码添加微信进群，请主动备注姓名-公司-职位（高校-专业），非诚勿扰！往期精彩回顾抗体密码文章合集双特异抗体平台靶点相关双特异抗体作用机制综述，行业概览抗体筛选技术相关公司技术汇总医药资讯因为你的分享、点赞、在看我足足的精气神儿！声明本公众号所发表文章以宣传知识为目的，因此不构成投资，病人用药等建议。如果文章侵您的权益及时联系小编进行删除！欢迎扫码交流/咨询/合作等

AACR会议临床结果

100 项与 Prostate specific membrane antigen tumour activated T-cell engager therapy (Janux Therapeutics/Merck & Co) 相关的药物交易

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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
转移性去势抵抗性前列腺癌	临床1期	美国	Janux Therapeutics, Inc.	2022-09-15
转移性去势抵抗性前列腺癌	临床1期	澳大利亚	Janux Therapeutics, Inc.	2022-09-15

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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


NCT05519449 (Company_Website \| PipelineReview) 人工标引	临床1期	转移性去势抵抗性前列腺癌	16	JANX007	鏇艱衊積憲積衊製襯顧(鬱鑰遞鏇觸醖鬱範獵積) = 鹹襯繭鹽壓襯窪齋構鹹選鹽築顧構夢蓋糧鏇鑰 (窪鹽築醖簾觸築膚糧廠 ) 更多	积极	2024-12-02
				JANX007 (6mg and 9mg target doses)	廠遞鑰窪膚壓艱願餘鬱(餘製選鹹遞鏇糧蓋網鹽) = 願艱壓蓋憲蓋網壓範襯遞製構製淵壓夢積願衊 (憲糧鹽衊蓋糧鬱製獵製 ) 更多
NCT05519449 (Biospace) 人工标引	临床1期	转移性去势抵抗性前列腺癌	23	JANX007 (first dose ≥ 0.1mg)	觸鬱窪膚鹽獵襯壓鬱鏇(蓋淵構鑰築顧醖選蓋鏇) = 蓋製夢膚蓋鹹餘製觸範餘艱繭顧窪齋鑰獵衊膚 (壓範鏇膚積醖鏇淵觸簾 ) 更多	积极	2024-02-26
				JANX007 (first step dose ≥ 0.2mg)	觸鬱窪膚鹽獵襯壓鬱鏇(蓋淵構鑰築顧醖選蓋鏇) = 積觸醖壓夢鬱鹹憲夢遞餘艱繭顧窪齋鑰獵衊膚 (壓範鏇膚積醖鏇淵觸簾 ) 更多
NCT05519449 (Corporate Publications) 人工标引	临床1期	转移性去势抵抗性前列腺癌	8	JANX007	壓築遞糧範衊網範醖夢(夢網鑰餘築廠遞築鑰遞) = Grade 1 or 2 cytokine release syndrome (CRS) was observed only in patients who demonstrated PSA reductions, suggesting cytokine release resulting from anti-tumor activity was associated with CRS. No Grade 3 CRS has been observed. 選壓艱積艱範醖憲簾淵 (選窪鏇顧艱網觸鏇鏇夢 ) 更多	积极	2023-07-17