重大事件
即時報告
8-K
2026-07-23
MacroGenics公佈MGC026 Phase 1正面數據 SCCHN隊列進入第二階段 將於ESMO 2026展示
AI 繁中摘要
📄 **申報類型**:8-K(重大事件公告)
**公司**:MacroGenics, Inc.(納斯達克代碼:MGNX)
**日期**:2026年7月23日
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### 重點摘要
MacroGenics 公佈其 B7-H3 靶向抗體藥物偶聯物(ADC)MGC026 的 Phase 1 臨床試驗最新進展。該藥物採用拓撲異構酶 I 抑制劑連接子-載荷技術,用於治療晚期實體腫瘤。
#### 臨床關鍵數據
- **劑量遞增階段**已完成(1–9 mg/kg,每三週一次),第四季2025年完結。
- **選定劑量**:7.5 mg/kg q3W,正於四個腫瘤特定隊列中評估:復發/轉移性頭頸鱗狀細胞癌(SCCHN)、子宮內膜癌、黑色素瘤及軟組織肉瘤。
- **SCCHN 隊列**:採用 Simon 兩階段設計。已達到第一階段預設反應閾值,現正招募第二階段患者(目標總數40人)。
- **截至2026年7月8日**,共 74 名患者入組(包括劑量遞增及擴展階段)。**無間質性肺病或眼部毒性報告**,並在多個適應症中觀察到抗腫瘤活性。
#### 學術會議展示
MacroGenics 將於 **ESMO 2026 大會**(10月23–27日,馬德里)以海報形式展示:
1. **MGC026**:Phase 1 首次人體試驗數據(海報編號1020P,10月23日)。
2. **Lorigerlimab**(雙特異性 DART® 分子,靶向 PD-1/CTLA-4):LINNET Phase 2 研究(海報編號1278P,10月26日)。
#### 管理層觀點
總裁兼 CEO Eric Risser 表示:「期待在 ESMO 分享數據,相信這是展示 MGC026 潛力的重要機會,我們將繼續推進臨床開發。」
#### 對投資者的潛在影響
- **正面信號**:MGC026 在 SCCHN 隊列達到預設療效閾值,安全性良好,顯示 ADC 平台潛力。
- **催化劑**:ESMO 2026 數據公佈可能影響股價。後續 Stage 2 及額外隊列結果將決定註冊策略。
- **風險提示**:仍為早期階段,需關注後續療效持久性、競爭格局及融資狀況。公司維持前瞻性陳述免責聲明。
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🔬 **一句總結**:MGC026 Phase 1 數據正面,SCCHN 隊列進入第二階段,ESMO 2026 將是關鍵事件,投資者需密切留意安全性與療效細節。
展開英文正文
EX-99.1 2 exhibit991_clinicalupdatem.htm EX-99.1 Document Exhibit 99.1 MacroGenics Provides Clinical Update on Ongoing Phase 1 Study for MGC026 •Interim Phase 1 results accepted for poster presentation at ESMO Congress 2026 •Achieved pre-specified Stage 1 response threshold in squamous cell carcinoma of the head and neck (SCCHN) cohort and enrolling Stage 2 per Simon’s two-stage design •Ongoing enrollment in other tumor-specific cohorts, including endometrial cancer, melanoma and soft tissue sarcoma ROCKVILLE, Md., July 23, 2026 — MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on the ongoing Phase 1 study evaluating MGC026, a novel B7-H3-directed antibody-drug conjugate (ADC), incorporating a topoisomerase I inhibitor-based linker-payload, in patients with advanced solid tumors. MacroGenics plans to present dose escalation and preliminary tumor-specific cohort results at the European Society for Medical Oncology (ESMO) 2026 Congress, taking place October 23-27, 2026, in Madrid, Spain. The dose escalation portion of the study evaluated MGC026 at doses ranging from 1 mg/kg to 9 mg/kg administered every three weeks (q3W) and was completed in the fourth quarter of 2025. A dose of 7.5 mg/kg q3W is being further evaluated in four tumor-specific cohorts: recurrent or metastatic SCCHN, endometrial cancer, melanoma, and soft tissue sarcoma. The study is active at clinical sites in the United States, Australia and the United Kingdom. The SCCHN cohort employs a Simon’s two-stage design, with a planned enrollment target of 40 patients. MacroGenics is currently enrolling SCCHN patients in Stage 2 after meeting the pre-specified response threshold in Stage 1. Enrollment in the other three cohorts continues as planned. As of July 8, 2026, a total of 74 patients had been enrolled across the dose escalation and ongoing cohort expansion portions of the study. As of this date, there were no cases of interstitial lung disease or ocular toxicity reported, and evidence of anti-tumor activity was observed across several indications. “We look forward to sharing the data at ESMO and believe this presentation represents an important opportunity to demonstrate the potential of MGC026 as we continue its clinical development,” said Eric Risser, President and Chief Executive Officer of MacroGenics. ESMO 2026 Poster Presentations •Title: Phase 1, first-in-human study of MGC026, a B7-H3–targeted antibody-drug conjugate (ADC) in advanced solid tumors Exhibit 99.1 •Presentation Number: 1020P •Lead Author: Rachel E. Sanborn, M.D. •Date: Friday, October 23, 2026 •Time: 15:15 – 16:00 CEST The Company also plans to present the following poster on lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4: •Title: LINNET: A phase 2 study to evaluate lorigerlimab in participants (pts) with advanced gynecologic cancers •Presentation Number: 1278P •Lead Author: Amir Jazaeri, M.D. •Date: Monday, October 26, 2026 •Time: 12:00 – 12:45 CEST About MGC026 MGC026 is an investigational antibody-drug conjugate (ADC) targeting B7-H3, a protein with expression across the tumor microenvironment, including on tumor cells, tumor-associated stroma, and tumor-associated vasculature. MGC026 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. MGC026 is designed to deliver this potent payload selectively to B7-H3-expressing tumors and is being developed for patients with advanced solid tumors. The ongoing Phase 1 study of MGC026 is an open-label clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of MGC026 in patients with advanced solid tumors. Additional information about the study is available at www.clinicaltrials.gov using the identifier NCT0624270. 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 www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc. Exhibit 99.1 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 the interim MGC026 clinical data reported herein; risks that TZIELD, lorigerlimab, ZYNYZ, MGC026 or any other product or product candidate’s revenue, expenses and costs may not be as expected; risks relating to TZIELD, lorigerlimab, ZYNYZ, MGC026 or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, including timing and results of efficacy and safety data with respect to 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 of expanding 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 in the Transaction, including the diversion of management's attention from the Company's ongoing business operations; risks related to the Company's post-closing manufacturing arrangements with Bora the purchaser in the Transaction, including under the manufacturing and supply agreement and the transition services agreement; the possibility that the anticipated benefits of the sale of the Company’s CDMO operations (the “Transaction”), including that the additional post-closing cash payments may not be earned or received, in whole or in part; the costs and expenses associated with the Transaction; potential litigation relating to the Transaction; 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 Exhibit 99.1 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. CONTACTS Jim Karrels, Senior Vice President, CFO 1-301-251-5172 [email protected] Argot Partners 1-212-600-1902 [email protected]