Exatecan mesilate

TOKYO, Japan & BASKING RIDGE, NJ, USAI March 03, 2025 I Positive topline results from the DESTINY-Gastric04 phase 3 trial showed ENHERTU ® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to ramucirumab and paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. At a planned interim analysis, the Independent Data Monitoring Committee recommended unblinding the trial based on the superior efficacy of ENHERTU. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). Gastric cancer is associated with a poor prognosis, particularly in advanced stages of the disease where the five-year survival rate is 5% to 10%. 1,2 Following disease progression in the first-line metastatic setting of HER2 positive gastric cancer, there historically have been no HER2 directed medicines that have demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial. 3 ENHERTU is currently approved in more than 65 countries based on DESTINY-Gastric01 , a randomized phase 2 trial, and DESTINY-Gastric02 and DESTINY-Gastric06 , two single-arm phase 2 trials. DESTINY-Gastric04 is the first phase 3 trial of ENHERTU in HER2 positive advanced gastric cancer. “ENHERTU is the first HER2 directed medicine to demonstrate an improvement in overall survival in a randomized phase 3 trial in the second-line metastatic setting of patients with HER2 positive gastric cancer, reinforcing previous findings seen in our other earlier phase gastric cancer trials,” said Ken Takeshita, MD, Global Head, Oncology R&D, Daiichi Sankyo. “With these DESTINY-Gastric04 results, we will work with global regulatory authorities to seek approval in regions where ENHERTU is not currently indicated as a second-line option, as well as work to secure full approval in regions where ENHERTU is conditionally approved.” “We are committed to advancing the care of patients with metastatic gastric cancer and continuing to understand the role of ENHERTU in earlier lines of treatment,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. “The results of DESTINY-Gastric04 show that second-line treatment with ENHERTU can extend survival compared with a chemotherapy-based regimen and should be considered for all eligible patients with HER2 positive metastatic gastric cancer.” The safety profile seen in DESTINY-Gastric04 is consistent with the established safety profile of ENHERTU. Data from DESTINY-Gastric04 will be presented at an upcoming medical meeting and shared with global regulatory authorities. About DESTINY-Gastric04 DESTINY-Gastric04 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (6.4 mg/kg) versus ramucirumab and paclitaxel in patients with HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen. The primary endpoint is OS. Secondary endpoints include investigator-assessed progression-free survival, objective response rate, duration of response, disease control rate and safety. DESTINY-Gastric04 enrolled 494 patients in Asia, Europe and South America. For more information about the trial, visit ClinicalTrials.gov . About HER2 Positive Gastric Cancer Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth leading cause of cancer-related death. 1,2 Approximately one million cases of gastric cancer were diagnosed in 2022. 2 Gastric cancer is associated with a poor prognosis, particularly in advanced stages of the disease where the five-year survival rate is 5% to 10%. 1,2 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including gastric cancer. 4 Approximately one in five gastric cancers are considered HER2 positive. 4,5 Following disease progression in the first-line metastatic setting of HER2 positive gastric cancer, there historically have been no HER2 directed medicines that have demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial. 3 About ENHERTU ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. ENHERTU (5.4 mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. ENHERTU (5.4 mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. ENHERTU (5.4 mg/kg) is approved in the U.S. for the treatment of adult patients with unresectable or metastatic HR positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. ENHERTU (5.4 mg/kg) is approved in more than 50 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (6.4 mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 , DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (5.4 mg/kg) is approved in Brazil, Israel, Russia and the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02 , DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the ENHERTU Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY ® in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. ENHERTU U.S. Important Safety Information Indications ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:Unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either: Please see accompanying full Prescribing Information , including Boxed WARNINGS, and Medication Guide . About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . References 1 Casamayor M, et al. Ecancermedicalscience. 2018;12:883. 2 Globocan 2022. Stomach Cancer. Accessed December 2024. 3 Mitani S, et al. Cancers. 2020;12(2):400. 4 Abrahao-Machado LF, et al. World J Gastroenterol. 2016;22(19):4619-25. 5 Iqbal N, et al. Mol Biol Int. 2014:852748. SOURCE: Daiichi Sankyo

▎药明康德内容团队编辑 本期看点 1. 个体化新抗原疫苗autogene cevumeran的1期临床试验最新结果积极，在接受手术切除肿瘤的胰腺导管腺癌（PDAC）患者中，中位随访时间为3.2年时，对该疫苗产生应答患者的疾病复发风险与未产生应答的患者相比降低86%。 2. 用于治疗遗传性耳聋的在研基因疗法DB-OTO的1/2期临床试验数据亮眼，在11名接受治疗后疗效可评估的患儿中，10人表现出显著的听力改善。 3. 在研基因疗法rAAV8.hRKp.AIPL1用于治疗AIPL1相关严重视网膜营养不良（LCA4），在首个人体试验中使所有11名先天失明儿童的治疗眼均获得了视力改善。 药明康德内容团队整理 Autogene cevumeran（BNT122）：公布1期临床试验的新数据 纪念斯隆凯特琳癌症中心（MSKCC）科学家领衔的研究团队，在《自然》期刊上发表了由BioNTech和罗氏（Roche）联合开发的个体化新抗原疫苗autogene cevumeran（BNT122）的1期临床试验最新结果。Autogene cevumeran是基于BioNTech的iNeST癌症疫苗技术平台生成的个体化新抗原疫苗。该公司的mRNA新抗原疫苗可在一个mRNA分子里编码数十种新抗原，从而激发人体针对肿瘤细胞产生更为全面的免疫反应，防止肿瘤细胞逃避免疫系统的攻击。 在这项1期临床试验中，研究人员给19名接受过手术治疗的PDAC患者使用了抗PD-L1抗体atezolizumab的治疗，其中16人接受了随后的autogene cevumeran治疗。在这16名患者中，有15人此后还接受了化疗。在2023年发表的研究显示，16名接受癌症疫苗治疗的患者中有8人（50%）产生了T细胞反应，被认为是这种癌症疫苗治疗的应答患者。近日发布的论文公布了这些患者的3年随访数据，结果表明，autogene cevumeran能够持续降低患者的疾病复发风险。在中位随访时间为3.2年时，对该疫苗产生应答的PDAC患者的疾病复发风险与未产生应答的患者相比，降低了86%。两组患者的中位总生存期（OS）均尚未达到。 ▲接受mRNA癌症疫苗治疗患者的无复发生存期（RFS）和OS数据（图片来源：参考资料[2]） DB-OTO：公布1/2期临床试验的新数据 再生元（Regeneron Pharmaceuticals）公布了其用于治疗遗传性耳聋的在研基因疗法DB-OTO的1/2期临床试验的新数据。DB-OTO是一种在研细胞选择性腺相关病毒（AAV）基因疗法，旨在通过AAV载体将OTOF基因的健康拷贝传递至耳蜗毛细胞，为因OTOF基因突变导致的先天性深度听力损失患者提供持久的生理性听力。此前，DB-OTO已获得了FDA的孤儿药资格、罕见儿科疾病认定、快速通道资格和再生医学先进疗法认定，以及欧洲药品管理局授予的孤儿药资格。 截至目前，该试验中已有12名10个月至16岁的患儿接受了DB-OTO治疗，其中9人单耳接受了耳蜗内注射，3人双耳接受了注射。在11名接受治疗后疗效可评估的患儿中，10人表现出显著的听力改善。在接受24周评估的5名患儿中，3人的平均听力阈值改善至接近正常或正常水平。首例在10个月大时就接受治疗的患儿在治疗后48周时，听力改善已接近正常水平，尤其是关键的语音相关频率范围内的听力水平。该患儿的语言感知测试结果从第48周到第72周表现出进一步的改善，孩子已能够在对话中正确识别出“妈妈”、“饼干”和“飞机”等词语，且无需任何视觉提示。 安全性方面，在所有12名受试者中，手术和DB-OTO均表现出良好的耐受性，未发生与DB-OTO相关的不良事件或严重不良事件。5名患者经历了短暂的手术后前庭不良事件（如眼球震颤、恶心、头晕、呕吐），这些症状在给药后6天内消失。 rAAV8.hRKp.AIPL1：公布首个人体临床试验结果 MeiraGTx公司宣布，其在研基因疗法rAAV8.hRKp.AIPL1用于治疗AIPL1相关严重视网膜营养不良的首个人体临床试验结果在《柳叶刀》期刊上发表。由AIPL1基因缺陷导致的视网膜营养不良会从出生起严重影响视力。rAAV8.hRKp.AIPL1利用重组腺相关病毒载体，递送由人类视紫红质激酶启动子调控的人类AIPL1转基因。 该论文报告了首批单眼接受rAAV8.hRKp.AIPL1治疗的4名儿童的相关数据。接受治疗前，他们的双眼视力仅限于对光的感知。接受治疗平均3.5年后，其治疗眼的视力平均改善至LogMAR评分0.9，而未治疗眼在最终随访时的视力无法测量。LogMAR是检测视力的评分系统，数值变小说明视力改善。正常视力的LogMAR评分为0，而干预前患者的LogMAR为2.7。另外，还有7名患有LCA4的儿童双眼接受了治疗。所有11名先天失明儿童的治疗眼均获得了视力改善。 ▲接受rAAV8.hRKp.AIPL1治疗的四名儿童的视力检测结果（图片来源：参考资料[4]） Versamune HPV、PDS01ADC：公布1/2期联合治疗试验数据 PDS Biotechnology公司宣布，其HPV16靶向免疫疗法Versamune HPV、IL-2融合抗体偶联药物（ADC）PDS01ADC联用PD-L1免疫检查点抑制剂（ICI）的临床研究结果已发表在JAMA Oncology上。这项由美国国家癌症研究所（NCI）领导的临床试验评估了该三联疗法在复发性/转移性HPV相关癌症（包括肛门癌、宫颈癌、头颈癌等）患者中的疗效。 此次公布的试验结果显示，该三联疗法在HPV16阳性患者中表现出显著的临床效益。在14名未接受过ICI治疗的患者中，中位OS达到42.4个月，高于历史结果的7-12个月。在8名未接受过ICI治疗的HPV16阳性患者中，中位OS尚未达到。在ICI耐药的患者中，中位OS为17个月，优于历史结果的3-4个月。此外，未接受过ICI治疗的HPV16阳性患者的客观缓解率（ORR）达75%，历史上发表的结果为11-24%。 LTZ-301：IND申请获得FDA许可 LTZ Therapeutics公司宣布美国FDA已批准其LTZ-301的IND申请，初步研究将在无标准疗法可用或标准治疗失败的复发/难治性非霍奇金淋巴瘤（r/r NHL）患者中进行。LTZ-301是一种新型的髓系细胞接合双特异性抗体，通过增强Fcγ受体（FcγR）非依赖性抗体依赖性细胞吞噬作用（ADCP）来清除CD79b阳性B细胞。CD79b是一种独特的肿瘤抗原受体，在B细胞恶性肿瘤中高度表达，包括接受现有CD19或CD20靶向疗法治疗后复发或耐药的肿瘤细胞。LTZ-301通过将单核细胞和巨噬细胞重新定向至CD79b阳性B细胞，从而增强这些免疫细胞的吞噬作用并清除癌细胞。临床前研究表明，LTZ-301在体外和体内实验中均表现出强效的药理活性，并具有良好的安全性。 ADCE-T02：IND申请获得FDA许可 Adcendo公司宣布，美国FDA已批准ADCE-T02的IND申请，可在晚期实体瘤患者中开展1期临床试验。组织因子（TF）在膀胱癌、非小细胞肺癌、结直肠癌、宫颈癌、食管癌、头颈癌和胃肠道癌等过度表达，但在正常组织中表达受限，因此是表现优异的ADC靶点。ADCE-T02是一种新型、高度差异化的TF靶向ADC，其独特的抗体设计能够减弱对凝血通路的影响。同时，T1000-exatecan连接子-有效载荷技术平台经研究证明，能够放大“旁观者效应”、提高连接子稳定性，并具备克服耐药性机制的潜力。这些差异化的特性有望转化为更高的临床治疗应答率、更长的疗效持续时间以及更好的安全性，拥有更优异的治疗窗口。2024年8月，Adcendo与普众发现达成超10亿美元的许可协议，获得在大中华区以外ADCE-T02的全球独家开发和商业化权利。 ▲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] In Early-Phase Pancreatic Cancer Clinical Trial, Investigational mRNA Vaccine Induces Sustained Immune Activity in Small Patient Group. Retrieved February 21, 2025, from https://www.mskcc.org/news/can-mrna-vaccines-fight-pancreatic-cancer-msk-clinical-researchers-are-trying-find-out [2] Sethna et al., (2025). RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer. Nature, https://doi-org.libproxy1.nus.edu.sg/10.1038/s41586-024-08508-4 [3] MeiraGTx Announces The Lancet Publication of Data Demonstrating the Efficacy of rAAV8.hRKp.AIPL1 for the Treatment of Leber Congenital Amaurosis 4 (LCA4) Retinal Dystrophy. Retrieved February 21, 2025, from https://www.globenewswire.com/news-release/2025/02/21/3030330/0/en/MeiraGTx-Announces-The-Lancet-Publication-of-Data-Demonstrating-the-Efficacy-of-rAAV8-hRKp-AIPL1-for-the-Treatment-of-Leber-Congenital-Amaurosis-4-LCA4-Retinal-Dystrophy.html [4] Michaelides et al., (2025). Gene therapy in children with AIPL1-associated severe retinal dystrophy: an open-label, first-in-human interventional study. The Lancet, DOI: 10.1016/S0140-6736(24)02812-5 [5] Latest DB-OTO Results Demonstrate Clinically Meaningful Hearing Improvements in Nearly All Children with Profound Genetic Hearing Loss in CHORD Trial. Retrieved February 28, 2025, from https://investor.regeneron.com/news-releases/news-release-details/latest-db-oto-results-demonstrate-clinically-meaningful-hearing [6] PDS Biotech Announces Positive Clinical Data Demonstrating Compelling Survival and Clinical Responses in Recurrent/Metastatic HPV-Associated Cancers Published in JAMA Oncology. Retrieved February 28, 2025, from https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/132-2025-news/971-iotechnnouncesositivelinicalataemonstrating20250226 [7] LTZ Therapeutics Announces FDA Clearance of IND Application to Initiate Trial of First-in-Class Myeloid Engager Immunotherapy, LTZ-301. 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Retrieved February 28, 2025, from https://www.globenewswire.com/news-release/2025/02/20/3030046/0/en/Inventiva-and-Hepalys-Pharma-Inc-announce-the-initiation-of-the-clinical-development-program-of-lanifibranor-in-Japan-with-the-dosing-of-the-first-participant-in-Phase-1-trial.html [10] Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital. Retrieved February 28, 2025, from https://www.globenewswire.com/news-release/2025/02/24/3031073/0/en/Calidi-Biotherapeutics-Announces-Commencement-of-Recruitment-for-Multiple-Dose-CLD-101-Trial-in-Patients-with-Newly-Diagnosed-High-Grade-Glioma-at-Northwestern-University-Hospital.html [11] Synnovation Therapeutics Announces Second Program to Enter the Clinic: First Patient Dosed in Phase I Trial with SNV4818, a Potential Best-In-Class Pan-Mutant-Selective PI3Kα Inhibitor for the Treatment of Solid Tumors. Retrieved February 28, 2025, from https://www.synnovationtx.com/pi3ka-fip-pressrelease [12] Halda Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial Evaluating HLD-0915 in Metastatic Castration-Resistant Prostate Cancer. Retrieved February 28, 2025, from https://haldatx.com/halda-therapeutics-announces-first-patient-dosed-in-phase-1-2-clinical-trial-evaluating-hld-0915-in-metastatic-castration-resistant-prostate-cancer/ [13] Inceptor Bio Announces First Patient Dosed in Clinical Trial of IB-T101 for Clear Cell Renal Cell Carcinoma (ccRCC) and $21M Series A2 Financing. Retrieved February 28, 2025, from https://www.prnewswire.com/news-releases/inceptor-bio-announces-first-patient-dosed-in-clinical-trial-of-ib-t101-for-clear-cell-renal-cell-carcinoma-ccrcc-and-21m-series-a2-financing-302383539.html [14] Assembly Biosciences Doses First Participant in Phase 1a Clinical Study of Oral Entry Inhibitor Candidate ABI-6250 for Hepatitis Delta Virus. Retrieved February 28, 2025, from https://investor.assemblybio.com/news-releases/news-release-details/assembly-biosciences-doses-first-participant-phase-1a-clinical [15] ProMIS Neurosciences Doses First Patients in Phase 1b PRECISE-AD Trial of PMN310 for Alzheimer’s Disease. Retrieved February 28, 2025, from https://www.promisneurosciences.com/news-media/press-releases/detail/239/promis-neurosciences-doses-first-patients-in-phase-1b [16] TIXiMED Inc. Announces Successful Dosing of First Cohort in the Phase 1 Clinical Trial of TIX100, its Investigational Disease-Modifying Treatment for Type 1 Diabetes. Retrieved February 28, 2025, from https://www.businesswire.com/news/home/20250227506831/en/TIXiMED-Inc.-Announces-Successful-Dosing-of-First-Cohort-in-the-Phase-1-Clinical-Trial-of-TIX100-its-Investigational-Disease-Modifying-Treatment-for-Type-1-Diabetes [17] Significant milestone reached for EG 427 with first patient treated with EG110A, first non-replicative herpes vector based genetic medicine for the treatment of neurogenic bladder. Retrieved February 28, 2025, from https://www.globenewswire.com/news-release/2025/02/27/3033525/0/en/Significant-milestone-reached-for-EG-427-with-first-patient-treated-with-EG110A-first-non-replicative-herpes-vector-based-genetic-medicine-for-the-treatment-of-neurogenic-bladder.html [18] Hemab Therapeutics Announces Start of Velora Pioneer, a Phase 1/2 Clinical Trial Investigating HMB-002 for the Treatment of Von Willebrand Disease. Retrieved February 28, 2025, from https://www.prnewswire.com/news-releases/hemab-therapeutics-announces-start-of-velora-pioneer-a-phase-12-clinical-trial-investigating-hmb-002-for-the-treatment-of-von-willebrand-disease-302387425.html [19] Ensho Therapeutics Announces Presentation of Data Highlighting NSHO-101 as a Once-Daily Oral Agent for the Potential Treatment of Inflammatory Bowel Disease at ECCO 2025. Retrieved February 28, 2025, from https://www.globenewswire.com/news-release/2025/02/21/3030459/0/en/Ensho-Therapeutics-Announces-Presentation-of-Data-Highlighting-NSHO-101-as-a-Once-Daily-Oral-Agent-for-the-Potential-Treatment-of-Inflammatory-Bowel-Disease-at-ECCO-2025.html [20] Immunic's Oral IMU-856 Demonstrated Dose-Dependent Increase of GLP-1 in Celiac Disease Patients and Corresponding Effects in Preclinical Testing. Retrieved February 28, 2025, from https://www.prnewswire.com/news-releases/immunics-oral-imu-856-demonstrated-dose-dependent-increase-of-glp-1-in-celiac-disease-patients-and-corresponding-effects-in-preclinical-testing-302381158.html [21] Arialys Therapeutics Initiates MAD Cohorts Having Completed All Planned SAD Cohorts in a Phase 1 Study of ART5803 for the Treatment of Autoimmune Neuropsychiatric Disease. Retrieved February 28, 2025, from https://www.arialysrx.com/news/arialys-therapeutics-initiates-mad-cohorts-having-completed-all-planned-sad-cohorts-in-a-phase-1-study-of-art5803-for-the-treatment-of-autoimmune-neuropsychiatric-disease [22] Adcendo ApS Announces U.S. FDA Clearance of IND Application for Phase I Tiffany-01 Trial of ADCE-T02. Retrieved February 28, 2025, from https://www.prnewswire.com/news-releases/adcendo-aps-announces-us-fda-clearance-of-ind-application-for-phase-i-tiffany-01-trial-of-adce-t02-302384298.html 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