Exatecan mesilate

▎Armstrong 2026年10月19日，ESMO年会摘要公布，信达生物首款双抗ADC新药IBI3001报告初步临床数据。 IBI3001为一款EGFR/B7H3 ADC，采用Exatecan为payload，DAR值为4，目前处于一期临床阶段。 的此次披露的数据，50例患者可评估疗效，ORR为28.0%，其中6mg/kg的ORR为26.9%，8mg/kg的ORR为38.9%，DCR为88%，其中6mg/kg的DCR为80.8%，8mg/kg的DCR为100%。16例EGFR突变NSCLC，ORR为31.3%，mPFS 为7.0个月，6例SCLC患者，ORR为66.7%,PFS还不成熟。13例胰腺癌患者，mPFS为7.0个月。安全性方面，3级及以上副作用为47.4%，最常见的副作用为贫血、白细胞计数下降、中性粒细胞计数下降等。 总结 恒瑞医药的EGFR/B7H3 ADC新药FH-006前不久启动了食管癌三期临床，采用恒瑞9256毒素，DAR值为6。拓济医药的EGFR/B7H3 ADC新药TJ101采用TOP1i（PY-4car2）为payload，DAR值为8，目前处于一期临床阶段。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理； 补体靶向药物技术全梳理； 补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理； 靶点冷暖，行业自知； 中国大分子新药研发格局； 被炮轰的“me too”； 佐剂百年史； 胰岛素百年传奇； CUSBEA：风雨四十载； 中国新药研发的焦虑； 中国生物医药企业的研发竞争； 中国双抗竞争格局； 中国ADC竞争格局； 中国双抗技术全梳理； 中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理； 亘喜生物技术全梳理； 康哲药业技术全梳理； 科济药业技术全梳理； 恺佧生物技术全梳理； 同宜医药技术全梳理； 百奥赛图技术全梳理； 腾盛博药技术全梳理； 创胜集团技术全梳理； 永泰生物技术全梳理； 中国抗体技术全梳理； 德琪医药技术全梳理； 德琪医药技术全梳理2.0； 和铂医药技术全梳理； 荣昌生物技术全梳理； 再鼎医药技术全梳理； 药明生物技术全梳理； 恒瑞医药技术全梳理； 豪森药业技术全梳理； 正大天晴技术全梳理； 吉凯基因技术全梳理； 基石药业技术全梳理； 百济神州技术全梳理； 百济神州技术全梳理第2版； 信达生物技术全梳理； 信达生物技术全梳理第2版； 中山康方技术全梳理； 复宏汉霖技术全梳理； 先声药业技术全梳理； 君实生物技术全梳理； 嘉和生物技术全梳理； 志道生物技术全梳理； 道尔生物技术全梳理； 尚健生物技术全梳理； 康宁杰瑞技术全梳理； 科望医药技术全梳理； 岸迈生物技术全梳理； 礼进生物技术全梳理； 康桥资本技术全梳理； 余国良的抗体药布局； 荃信生物技术全梳理； 安源医药技术全梳理； 三生国健技术全梳理； 仁会生物技术全梳理； 乐普生物技术全梳理； 同润生物技术全梳理； 宜明昂科技术全梳理； 派格生物技术全梳理； 迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理； 普米斯生物技术全梳理； 普米斯生物技术全梳理2.0； 三叶草生物技术全梳理； 贝达药业抗体药全梳理； 泽璟制药抗体药全梳理； 恒瑞医药抗体药全梳理； 齐鲁制药抗体药全梳理； 石药集团抗体药全梳理； 豪森药业抗体药全梳理； 华海药业抗体药全梳理； 科伦药业抗体药全梳理； 百奥泰技术全梳理； 凡恩世技术全梳理。

ROCKVILLE, MD, Oct. 15, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today announced that the first patient has been dosed in the Phase 1 study of MGC030, a first-in-class antibody-drug conjugate (ADC) directed against an undisclosed target, in patients with advanced solid tumors. “MGC030 demonstrated encouraging antitumor activity in multiple preclinical models, and we look forward to advancing this product candidate through the Phase 1 study. We expect that this trial will deepen our understanding of how the molecule may help address the unmet needs of patients with selected advanced solid tumors,” said Ezio Bonvini, M.D., Senior Vice President and Chief Scientific Officer of MacroGenics. “The dosing of a first patient with MGC030 builds upon the strong early-stage clinical momentum we have sustained across our innovative ADC pipeline, as this molecule is now our third ADC in active clinical development.” The Phase 1, open-label, multi-center, dose-escalation, dose-optimization and cohort-expansion study of MGC030 is designed to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary antitumor activity of MGC030, as well as explore biomarkers that may be associated with these endpoints. Participants with relapsed or refractory solid tumors that are unresectable, locally advanced, or metastatic, including urothelial, colorectal, gastric or gastroesophageal junction, esophageal, and pancreatic cancers, will be enrolled. The dose escalation portion of the study will enroll up to 54 participants with the potential to further expand enrollment at selected dose levels. About MGC030 MGC030 is a clinical-stage ADC that targets an undisclosed antigen expressed across several solid tumors. There are currently no approved therapeutics directed against this target. MGC030 incorporates Synaffix’s proprietary ADC technology and the SYNtecan E™ topoisomerase I inhibitor-based linker-payload, which consists of a cleavable, exatecan-based cytotoxic payload conjugated at a drug-to-antibody ratio (DAR) of 4. MGC030 has demonstrated potent antitumor activity in multiple in vivo models and an encouraging safety and tolerability pro cyno tox studies. The ongoing Phase 1 study of MGC030 is an open-label clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC030 in patients with advanced solid tumors. Additional information about the study is available at using the identifier NCT07822399. About MacroGenics, Inc. MacroGenics (the Company) is a biopharmaceutical company focused on developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, expected timing of the release of clinical updates and safety and efficacy data for the Company’s ongoing clinical trials, anticipated cash runway and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy, including our ability to execute on our key strategic priorities for 2026, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks related to the reproducibility of any results initially seen in any product candidate including the preclinical results for MGC030 discussed herein; risks that any product candidate’s revenue, expenses and costs may not be as expected; risks relating to any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates for MGC030 or any other product candidates, including timing and results of efficacy and safety data with respect to MGC030 or any other product candidates in ongoing clinical trials; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations regarding the expansion of ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; risks related to the transition of the CDMO operations to the purchaser following the sale of our CDMO operations; and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. CONTACT: CONTACTS: Jim Karrels, Senior Vice President, CFO 1-301-251-5172 info@macrogenics.com Argot Partners 1-212-600-1902 macrogenics@argotpartners.com