“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
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 profile in 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 www.clinicaltrials.gov 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 www.macrogenics.com. 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.
CONTACTS: Jim Karrels, Senior Vice President, CFO 1-301-251-5172 info@macrogenics.com Argot Partners 1-212-600-1902 macrogenics@argotpartners.com
