{"success":true,"data":{"pressRelease":{"id":"178525","rtpr_id":"nGNX27QmWX-20261023","ticker":"MGNX","exchange":"NASDAQ","all_tickers":["MGNX"],"title":"MacroGenics Announces Positive Interim Phase 1 Results for MGC026 and Highlights Plans to Initiate Front-Line Combination Study in SCCHN","author":"Globe Newswire","published_at":"2026-10-23T13:15:00.209Z","article_body":"* Durable responses observed across multiple tumor types during dose\nescalation\n* MGC026 demonstrated 27% best overall response rate (6/22 patients; 4\nconfirmed and 2 unconfirmed PRs) in heavily pretreated SCCHN patients\n* MGC026 demonstrated manageable safety and tolerability profile with no\ntreatment-related discontinuations in SCCHN patients\n* Plan to initiate front-line SCCHN cohort evaluating MGC026 in combination\nwith pembrolizumab\nROCKVILLE, MD, Oct. 23, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:\nMGNX), a clinical-stage biopharmaceutical company focused on developing\ninnovative antibody-based therapeutics for the treatment of cancer, today\nannounced positive interim data from its Phase 1 study evaluating MGC026, a\nB7-H3-directed antibody-drug conjugate (ADC), in patients with advanced solid\ntumors. These Phase 1 data were presented today at the European Society for\nMedical Oncology (ESMO) 2026 Congress in Madrid, Spain. These results\ndemonstrated durable activity across a broad range of solid tumors, which the\nCompany believes supports expanded development of MGC026 in front-line\nmetastatic squamous cell carcinoma of the head and neck (SCCHN) in combination\nwith pembrolizumab.\n\n“The emerging profile of MGC026 reinforces our conviction that this molecule\nhas the potential to play an important and differentiated role in the\ntreatment of advanced solid tumors,” said Eric Risser, President and Chief\nExecutive Officer of MacroGenics. “We believe MGC026 is well positioned\nthrough the combination of a highly selective B7-H3-targeting antibody, a\nproprietary drug-linker technology and a potent TOP1 inhibitor payload.”\n\nOverall MGC026 Safety and Dose Selection\n\nAs of the September 1, 2026 data cutoff, 85 patients had been treated across\nthe dose-escalation and dose-expansion cohorts. Across this full safety\npopulation, treatment-related adverse events (TRAEs) led to discontinuation in\n5% of patients, and no Grade 5 TRAEs were reported. Grade ≥3 TRAEs occurred\nin 51% of patients. The most common Grade ≥3 TRAEs observed in ≥10% of\nparticipants were neutropenia (27%) and anemia (25%). No cases of interstitial\nlung disease (ILD), pneumonitis or ocular toxicity were observed.\n\nIn the 32-patient dose-escalation portion, patients with advanced and\nmetastatic solid tumors received MGC026 at doses ranging from 1 mg/kg to 9\nmg/kg administered every three weeks (Q3W) and had received a median of four\nprior lines of systemic therapy (range 1-8). Pharmacokinetic analyses\ndemonstrated dose-dependent exposure for the ADC and unconjugated payload,\nsupporting selection of the 7.5 mg/kg Q3W regimen for continued evaluation\nacross all tumor-specific expansion cohorts.\n\nDurable Antitumor Activity Across Solid Tumors in Dose Escalation\n\n\nAmong 17 response-evaluable patients representing 10 different tumor types who\nreceived MGC026 at doses of at least 6 mg/kg in dose escalation, the confirmed\nobjective response rate was 29% (5/17), and the disease control rate was 65%\n(11/17). Responses were durable, with a median duration of response (mDOR) of\n10.2 months. MacroGenics believes these findings highlight the potential of\nMGC026 to deliver meaningful and durable clinical benefit in a patient\npopulation with advanced solid tumors that were refractory to prior\ntreatments.\n\nEncouraging Activity in Heavily Pretreated SCCHN Patients\n\nAs part of the Phase 1 study, MacroGenics is evaluating MGC026 in an ongoing\nSimon's 2-stage tumor-specific expansion cohort in recurrent/metastatic SCCHN.\nThe study is designed to enroll 40 patients treated at a dose of 7.5 mg/kg\nQ3W. The interim results reported here are based on a September 1, 2026 data\ncutoff and include 27 patients evaluable for safety and 22 patients evaluable\nfor response.\n\nPatients were heavily pretreated, with 46% of the response-evaluable\nparticipants having received three prior lines of systemic therapy and 41%\nhaving received four or more prior lines (median was 3 prior lines [range\n1-7]). MGC026 demonstrated encouraging antitumor activity in these SCCHN\npatients, achieving a best overall response rate of 27% (6/22), including four\nconfirmed and two unconfirmed partial responses (PRs), and a disease control\nrate of 64% (14/22). Activity appeared higher among patients with HPV-positive\ndisease, with five of the responses observed (5/16) in this population.\n\nMGC026 demonstrated a manageable safety profile in this heavily pretreated and\ndifficult-to-treat SCCHN population. No TRAEs led to treatment\ndiscontinuation, and no cases of ILD, pneumonitis or ocular toxicity were\nobserved. Grade ≥3 TRAEs occurred in 48% of patients. The only two Grade\n≥3 TRAEs observed in ≥10% of participants were anemia (30%) and\nneutropenia (26%). The TRAEs observed in Stage 1 were well managed and\nreversible. Many of the patients who experienced hematologic toxicities had\npreviously received platinum- and/or taxane-based chemotherapy. Based on these\nencouraging initial findings, enrollment continues in Stage 2 of the ongoing\nPhase 1 study, with updated data expected in mid-2027.\n\n“These preliminary Phase 1 data for MGC026 are encouraging and demonstrate a\nmanageable safety profile and promising antitumor activity in heavily\npretreated patients with advanced solid tumors,” said Apostolia M.\nTsimberidou, M.D., Ph.D., M.B.A., of The University of Texas MD Anderson\nCancer Center and the lead principal study investigator. “Importantly, of 22\nheavily pretreated patients with SCCHN (expansion cohort), six (27.3%) had a\npartial response. There was no drug-related treatment discontinuation, and no\npneumonitis, ocular toxicities, or unexpected toxicities were noted. Together,\nthese findings support the continued clinical development of MGC026 in SCCHN\nand across multiple tumor types, including evaluation in combination regimens\nand earlier lines of therapy.”\n\nNext Development Steps in SCCHN\n\nMacroGenics believes the emerging profile of MGC026 supports evaluation in\nearlier-line treatment settings, where the molecule’s orthogonal mechanism\nof action and non-overlapping toxicity profile may potentially complement\nimmune checkpoint inhibition. The Company plans to initiate an expansion\ncohort in early 2027 evaluating MGC026 in combination with pembrolizumab in\nfront-line patients with PD-L1 positive (CPS ≥1) recurrent or metastatic\nSCCHN.\n\nCommenting on the emerging SCCHN treatment landscape, Barbara Burtness, M.D.,\nAnthony N. Brady Professor of Medicine and Chief of Head and Neck Cancers,\nYale Cancer Center, commented: “As new therapies emerge in head and neck\ncancer, differentiation will increasingly depend not only on antitumor\nactivity, but also on durability, tolerability and the ability to be\nincorporated into combination regimens. I believe the developing clinical\nprofile of MGC026 positions this agent favorably among emerging therapies. The\nplanned pembrolizumab combination study represents an important next step in\ndetermining the potential role of MGC026 in earlier treatment settings.”\n\nPoster Presentation Details\n\nTitle: Phase 1, first-in-human study of MGC026, a B7-H3–targeted\nantibody-drug conjugate (ADC) in advanced solid tumors\nLead author: Rachel E. Sanborn, M.D.\nSession: Developmental therapeutics\nPoster number: 1020P\nDate and time: Friday, October 23, 2026, from 15:15 to 16:00 CEST\n\nA copy of the above ESMO poster presentation and a supplemental slide\npresentation are available on the Company's Investor Relations website or\nthrough the direct links below:\n* ESMO poster presentation\n(https://ir.macrogenics.com/static-files/1625bc77-7a32-45f8-9903-f9eaf68231e7)\n* Supplemental slide presentation\n(https://ir.macrogenics.com/static-files/c9162b93-c659-4b66-9be3-0348b416e252)\nAbout MGC026\n\nMGC026 is an investigational antibody-drug conjugate (ADC) targeting B7-H3, a\nprotein with expression across the tumor microenvironment, including on tumor\ncells, tumor-associated stroma, and tumor-associated vasculature. MGC026\nincorporates Synaffix’s proprietary ADC technology and the SYNtecan™\ntopoisomerase I inhibitor-based linker-payload, which consists of a cleavable,\nexatecan-based cytotoxic payload conjugated at a drug-to-antibody ratio (DAR)\nof 4. The ongoing Phase 1 study of MGC026 is an open-label clinical trial\nevaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and\npreliminary antitumor activity of MGC026 in patients with advanced solid\ntumors. The study is currently evaluating patients with SCCHN, endometrial\ncancer, melanoma, and soft tissue sarcoma. Additional information about the\nstudy is available at www.clinicaltrials.gov using the\nidentifier NCT06242470\n(https://www.globenewswire.com/Tracker?data=iUq6DhGDvnMOkMktFrQht9_hAHZClqLXR_gXetNJ2NC7YdkwhGwzE12JOpeh6o14I16Kqr14nDsBpqjXgkakr76XAFgYA63y5A60tCiJlbSg_NJVJrGggBFwgRgg70O4hFj5fUxMzMbCD3c15bjljh3-W2b8fvHJeOJ7VYIh6Ca6-adRjZP6XUARacFSqv_rROpMfoa-y0HSxZ7irn0xM0_FfIty1UbG-Ct6YVCozKbGhpVpmySBmMRQA_loRqf-IRsPF1bbXT5CfxCxIOMeguhFFyEgAPiD7BKu1uR2yVM=).\n\nAbout MacroGenics, Inc.\n\nMacroGenics (the Company) is a biopharmaceutical company focused on developing\ninnovative monoclonal antibody-based therapeutics for the treatment of cancer.\nThe Company generates its pipeline of product candidates primarily from its\nproprietary suite of next-generation antibody-based technology platforms,\nwhich have applicability across broad therapeutic domains. The combination of\nMacroGenics’ technology platforms and protein engineering expertise has\nallowed the Company to generate promising product candidates and enter into\nseveral strategic collaborations with global pharmaceutical and biotechnology\ncompanies. For more information, please see the Company’s website at\nwww.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks\nor registered trademarks of MacroGenics, Inc.\n\nCautionary Note on Forward-Looking Statements\n\nAny statements in this press release about future expectations, plans and\nprospects for MacroGenics (“Company”), including statements about the\nCompany’s strategy, future operations, clinical development of and\nregulatory plans for the Company’s therapeutic candidates, expected timing\nof the release of clinical updates and safety and efficacy data for the\nCompany’s ongoing clinical trials, anticipated cash runway and other\nstatements containing the words “subject to”, \"believe\", “anticipate”,\n“plan”, “expect”, “intend”, “estimate”, “potential”,\n“project”, “may”, “will”, “should”, “would”, “could”,\n“can”, the negatives thereof, variations thereon and similar expressions,\nor by discussions of strategy, including our ability to execute on our key\nstrategic priorities for 2026, constitute forward-looking statements within\nthe meaning of Section 27A of the Securities Act of 1933 and Section 21E of\nthe Securities Exchange Act of 1934. Actual results may differ materially from\nthose indicated by such forward-looking statements as a result of various\nimportant factors, including: risks related to the reproducibility of any\nresults initially seen in any product candidate including the results for\nMGC026 discussed herein; risks that any product candidate’s revenue,\nexpenses and costs may not be as expected; risks relating to any other product\ncandidate’s market acceptance, competition, reimbursement and regulatory\nactions; future data updates for MGC026 or any other product candidates,\nincluding timing and results of efficacy and safety data with respect to\nMGC026 or any other product candidates in ongoing clinical trials; the\nuncertainties inherent in the initiation and enrollment of future clinical\ntrials; the availability of financing to fund the internal development of our\nproduct candidates; expectations regarding the expansion of ongoing clinical\ntrials; expectations for the timing and steps required in the regulatory\nreview process; expectations for regulatory approvals; expectations of future\nmilestone payments; the impact of competitive products; our ability to enter\ninto agreements with strategic partners and other matters that could affect\nthe availability or commercial potential of the Company's product candidates;\nbusiness, economic or political disruptions due to catastrophes or other\nevents, including natural disasters, terrorist attacks, civil unrest and\nactual or threatened armed conflict, or public health crises; costs of\nlitigation and the failure to successfully defend lawsuits and other claims\nagainst us; risks related to the transition of the CDMO operations to the\npurchaser following the sale of our CDMO operations; and other risks described\nin the Company's filings with the Securities and Exchange Commission. In\naddition, the forward-looking statements included in this press release\nrepresent the Company's views only as of the date hereof. The Company\nanticipates that subsequent events and developments will cause the Company's\nviews to change. However, while the Company may elect to update these\nforward-looking statements at some point in the future, the Company\nspecifically disclaims any obligation to do so, except as may be required by\nlaw. These forward-looking statements should not be relied upon as\nrepresenting the Company's views as of any date subsequent to the date hereof.\n\nCONTACTS\nJim Karrels, Senior Vice President, CFO\n1-301-251-5172\ninfo@macrogenics.com\n\nArgot Partners\n1-212-600-1902\nmacrogenics@argotpartners.com\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/62d57970-4030-448d-b811-9e2eeef85b4d)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX27QmWX-20261023","title":"MacroGenics Announces Positive Interim Phase 1 Results for MGC026 and Highlights Plans to Initiate Front-Line Combination Study in SCCHN","author":"Globe Newswire","ticker":"MGNX","created":"2026-10-23T13:15:00.209Z","tickers":["MGNX"],"exchange":"NASDAQ","article_body":"* Durable responses observed across multiple tumor types during dose\nescalation\n* MGC026 demonstrated 27% best overall response rate (6/22 patients; 4\nconfirmed and 2 unconfirmed PRs) in heavily pretreated SCCHN patients\n* MGC026 demonstrated manageable safety and tolerability profile with no\ntreatment-related discontinuations in SCCHN patients\n* Plan to initiate front-line SCCHN cohort evaluating MGC026 in combination\nwith pembrolizumab\nROCKVILLE, MD, Oct. 23, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:\nMGNX), a clinical-stage biopharmaceutical company focused on developing\ninnovative antibody-based therapeutics for the treatment of cancer, today\nannounced positive interim data from its Phase 1 study evaluating MGC026, a\nB7-H3-directed antibody-drug conjugate (ADC), in patients with advanced solid\ntumors. These Phase 1 data were presented today at the European Society for\nMedical Oncology (ESMO) 2026 Congress in Madrid, Spain. These results\ndemonstrated durable activity across a broad range of solid tumors, which the\nCompany believes supports expanded development of MGC026 in front-line\nmetastatic squamous cell carcinoma of the head and neck (SCCHN) in combination\nwith pembrolizumab.\n\n“The emerging profile of MGC026 reinforces our conviction that this molecule\nhas the potential to play an important and differentiated role in the\ntreatment of advanced solid tumors,” said Eric Risser, President and Chief\nExecutive Officer of MacroGenics. “We believe MGC026 is well positioned\nthrough the combination of a highly selective B7-H3-targeting antibody, a\nproprietary drug-linker technology and a potent TOP1 inhibitor payload.”\n\nOverall MGC026 Safety and Dose Selection\n\nAs of the September 1, 2026 data cutoff, 85 patients had been treated across\nthe dose-escalation and dose-expansion cohorts. Across this full safety\npopulation, treatment-related adverse events (TRAEs) led to discontinuation in\n5% of patients, and no Grade 5 TRAEs were reported. Grade ≥3 TRAEs occurred\nin 51% of patients. The most common Grade ≥3 TRAEs observed in ≥10% of\nparticipants were neutropenia (27%) and anemia (25%). No cases of interstitial\nlung disease (ILD), pneumonitis or ocular toxicity were observed.\n\nIn the 32-patient dose-escalation portion, patients with advanced and\nmetastatic solid tumors received MGC026 at doses ranging from 1 mg/kg to 9\nmg/kg administered every three weeks (Q3W) and had received a median of four\nprior lines of systemic therapy (range 1-8). Pharmacokinetic analyses\ndemonstrated dose-dependent exposure for the ADC and unconjugated payload,\nsupporting selection of the 7.5 mg/kg Q3W regimen for continued evaluation\nacross all tumor-specific expansion cohorts.\n\nDurable Antitumor Activity Across Solid Tumors in Dose Escalation\n\n\nAmong 17 response-evaluable patients representing 10 different tumor types who\nreceived MGC026 at doses of at least 6 mg/kg in dose escalation, the confirmed\nobjective response rate was 29% (5/17), and the disease control rate was 65%\n(11/17). Responses were durable, with a median duration of response (mDOR) of\n10.2 months. MacroGenics believes these findings highlight the potential of\nMGC026 to deliver meaningful and durable clinical benefit in a patient\npopulation with advanced solid tumors that were refractory to prior\ntreatments.\n\nEncouraging Activity in Heavily Pretreated SCCHN Patients\n\nAs part of the Phase 1 study, MacroGenics is evaluating MGC026 in an ongoing\nSimon's 2-stage tumor-specific expansion cohort in recurrent/metastatic SCCHN.\nThe study is designed to enroll 40 patients treated at a dose of 7.5 mg/kg\nQ3W. The interim results reported here are based on a September 1, 2026 data\ncutoff and include 27 patients evaluable for safety and 22 patients evaluable\nfor response.\n\nPatients were heavily pretreated, with 46% of the response-evaluable\nparticipants having received three prior lines of systemic therapy and 41%\nhaving received four or more prior lines (median was 3 prior lines [range\n1-7]). MGC026 demonstrated encouraging antitumor activity in these SCCHN\npatients, achieving a best overall response rate of 27% (6/22), including four\nconfirmed and two unconfirmed partial responses (PRs), and a disease control\nrate of 64% (14/22). Activity appeared higher among patients with HPV-positive\ndisease, with five of the responses observed (5/16) in this population.\n\nMGC026 demonstrated a manageable safety profile in this heavily pretreated and\ndifficult-to-treat SCCHN population. No TRAEs led to treatment\ndiscontinuation, and no cases of ILD, pneumonitis or ocular toxicity were\nobserved. Grade ≥3 TRAEs occurred in 48% of patients. The only two Grade\n≥3 TRAEs observed in ≥10% of participants were anemia (30%) and\nneutropenia (26%). The TRAEs observed in Stage 1 were well managed and\nreversible. Many of the patients who experienced hematologic toxicities had\npreviously received platinum- and/or taxane-based chemotherapy. Based on these\nencouraging initial findings, enrollment continues in Stage 2 of the ongoing\nPhase 1 study, with updated data expected in mid-2027.\n\n“These preliminary Phase 1 data for MGC026 are encouraging and demonstrate a\nmanageable safety profile and promising antitumor activity in heavily\npretreated patients with advanced solid tumors,” said Apostolia M.\nTsimberidou, M.D., Ph.D., M.B.A., of The University of Texas MD Anderson\nCancer Center and the lead principal study investigator. “Importantly, of 22\nheavily pretreated patients with SCCHN (expansion cohort), six (27.3%) had a\npartial response. There was no drug-related treatment discontinuation, and no\npneumonitis, ocular toxicities, or unexpected toxicities were noted. Together,\nthese findings support the continued clinical development of MGC026 in SCCHN\nand across multiple tumor types, including evaluation in combination regimens\nand earlier lines of therapy.”\n\nNext Development Steps in SCCHN\n\nMacroGenics believes the emerging profile of MGC026 supports evaluation in\nearlier-line treatment settings, where the molecule’s orthogonal mechanism\nof action and non-overlapping toxicity profile may potentially complement\nimmune checkpoint inhibition. The Company plans to initiate an expansion\ncohort in early 2027 evaluating MGC026 in combination with pembrolizumab in\nfront-line patients with PD-L1 positive (CPS ≥1) recurrent or metastatic\nSCCHN.\n\nCommenting on the emerging SCCHN treatment landscape, Barbara Burtness, M.D.,\nAnthony N. Brady Professor of Medicine and Chief of Head and Neck Cancers,\nYale Cancer Center, commented: “As new therapies emerge in head and neck\ncancer, differentiation will increasingly depend not only on antitumor\nactivity, but also on durability, tolerability and the ability to be\nincorporated into combination regimens. I believe the developing clinical\nprofile of MGC026 positions this agent favorably among emerging therapies. The\nplanned pembrolizumab combination study represents an important next step in\ndetermining the potential role of MGC026 in earlier treatment settings.”\n\nPoster Presentation Details\n\nTitle: Phase 1, first-in-human study of MGC026, a B7-H3–targeted\nantibody-drug conjugate (ADC) in advanced solid tumors\nLead author: Rachel E. Sanborn, M.D.\nSession: Developmental therapeutics\nPoster number: 1020P\nDate and time: Friday, October 23, 2026, from 15:15 to 16:00 CEST\n\nA copy of the above ESMO poster presentation and a supplemental slide\npresentation are available on the Company's Investor Relations website or\nthrough the direct links below:\n* ESMO poster presentation\n(https://ir.macrogenics.com/static-files/1625bc77-7a32-45f8-9903-f9eaf68231e7)\n* Supplemental slide presentation\n(https://ir.macrogenics.com/static-files/c9162b93-c659-4b66-9be3-0348b416e252)\nAbout MGC026\n\nMGC026 is an investigational antibody-drug conjugate (ADC) targeting B7-H3, a\nprotein with expression across the tumor microenvironment, including on tumor\ncells, tumor-associated stroma, and tumor-associated vasculature. MGC026\nincorporates Synaffix’s proprietary ADC technology and the SYNtecan™\ntopoisomerase I inhibitor-based linker-payload, which consists of a cleavable,\nexatecan-based cytotoxic payload conjugated at a drug-to-antibody ratio (DAR)\nof 4. The ongoing Phase 1 study of MGC026 is an open-label clinical trial\nevaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and\npreliminary antitumor activity of MGC026 in patients with advanced solid\ntumors. The study is currently evaluating patients with SCCHN, endometrial\ncancer, melanoma, and soft tissue sarcoma. Additional information about the\nstudy is available at www.clinicaltrials.gov using the\nidentifier NCT06242470\n(https://www.globenewswire.com/Tracker?data=iUq6DhGDvnMOkMktFrQht9_hAHZClqLXR_gXetNJ2NC7YdkwhGwzE12JOpeh6o14I16Kqr14nDsBpqjXgkakr76XAFgYA63y5A60tCiJlbSg_NJVJrGggBFwgRgg70O4hFj5fUxMzMbCD3c15bjljh3-W2b8fvHJeOJ7VYIh6Ca6-adRjZP6XUARacFSqv_rROpMfoa-y0HSxZ7irn0xM0_FfIty1UbG-Ct6YVCozKbGhpVpmySBmMRQA_loRqf-IRsPF1bbXT5CfxCxIOMeguhFFyEgAPiD7BKu1uR2yVM=).\n\nAbout MacroGenics, Inc.\n\nMacroGenics (the Company) is a biopharmaceutical company focused on developing\ninnovative monoclonal antibody-based therapeutics for the treatment of cancer.\nThe Company generates its pipeline of product candidates primarily from its\nproprietary suite of next-generation antibody-based technology platforms,\nwhich have applicability across broad therapeutic domains. The combination of\nMacroGenics’ technology platforms and protein engineering expertise has\nallowed the Company to generate promising product candidates and enter into\nseveral strategic collaborations with global pharmaceutical and biotechnology\ncompanies. For more information, please see the Company’s website at\nwww.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks\nor registered trademarks of MacroGenics, Inc.\n\nCautionary Note on Forward-Looking Statements\n\nAny statements in this press release about future expectations, plans and\nprospects for MacroGenics (“Company”), including statements about the\nCompany’s strategy, future operations, clinical development of and\nregulatory plans for the Company’s therapeutic candidates, expected timing\nof the release of clinical updates and safety and efficacy data for the\nCompany’s ongoing clinical trials, anticipated cash runway and other\nstatements containing the words “subject to”, \"believe\", “anticipate”,\n“plan”, “expect”, “intend”, “estimate”, “potential”,\n“project”, “may”, “will”, “should”, “would”, “could”,\n“can”, the negatives thereof, variations thereon and similar expressions,\nor by discussions of strategy, including our ability to execute on our key\nstrategic priorities for 2026, constitute forward-looking statements within\nthe meaning of Section 27A of the Securities Act of 1933 and Section 21E of\nthe Securities Exchange Act of 1934. Actual results may differ materially from\nthose indicated by such forward-looking statements as a result of various\nimportant factors, including: risks related to the reproducibility of any\nresults initially seen in any product candidate including the results for\nMGC026 discussed herein; risks that any product candidate’s revenue,\nexpenses and costs may not be as expected; risks relating to any other product\ncandidate’s market acceptance, competition, reimbursement and regulatory\nactions; future data updates for MGC026 or any other product candidates,\nincluding timing and results of efficacy and safety data with respect to\nMGC026 or any other product candidates in ongoing clinical trials; the\nuncertainties inherent in the initiation and enrollment of future clinical\ntrials; the availability of financing to fund the internal development of our\nproduct candidates; expectations regarding the expansion of ongoing clinical\ntrials; expectations for the timing and steps required in the regulatory\nreview process; expectations for regulatory approvals; expectations of future\nmilestone payments; the impact of competitive products; our ability to enter\ninto agreements with strategic partners and other matters that could affect\nthe availability or commercial potential of the Company's product candidates;\nbusiness, economic or political disruptions due to catastrophes or other\nevents, including natural disasters, terrorist attacks, civil unrest and\nactual or threatened armed conflict, or public health crises; costs of\nlitigation and the failure to successfully defend lawsuits and other claims\nagainst us; risks related to the transition of the CDMO operations to the\npurchaser following the sale of our CDMO operations; and other risks described\nin the Company's filings with the Securities and Exchange Commission. In\naddition, the forward-looking statements included in this press release\nrepresent the Company's views only as of the date hereof. The Company\nanticipates that subsequent events and developments will cause the Company's\nviews to change. However, while the Company may elect to update these\nforward-looking statements at some point in the future, the Company\nspecifically disclaims any obligation to do so, except as may be required by\nlaw. These forward-looking statements should not be relied upon as\nrepresenting the Company's views as of any date subsequent to the date hereof.\n\nCONTACTS\nJim Karrels, Senior Vice President, CFO\n1-301-251-5172\ninfo@macrogenics.com\n\nArgot Partners\n1-212-600-1902\nmacrogenics@argotpartners.com\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/62d57970-4030-448d-b811-9e2eeef85b4d)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-23T13:15:00.255699491Z","server_sent_at_ms":1792761300255},"received_at":"2026-10-23T13:15:00.454Z","source_url":null},"analysis":{"id":"166438","press_release_id":"178525","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["early Phase 1 data with small response-evaluable cohorts (n=17 and n=22); two unconfirmed partial responses","Grade ≥3 TRAEs in ~half of all patients (neutropenia 27%, anemia 25%)"],"eventType":"clinical_trial","narrative":"MacroGenics reported positive interim Phase 1 data for MGC026, a B7-H3-directed ADC, presented at the ESMO 2026 Congress.\n\nIn heavily pretreated SCCHN patients, MGC026 achieved a 27% best overall response rate (6/22) with a 64% disease control rate, and no treatment-related discontinuations, ILD, pneumonitis or ocular toxicity were observed.\n\nAcross the dose-escalation population, confirmed ORR was 29% with durable responses (median DOR 10.2 months), supporting selection of 7.5 mg/kg Q3W for expansion cohorts.\n\nMacroGenics plans to initiate a front-line SCCHN cohort combining MGC026 with pembrolizumab in early 2027, with Stage 2 data expected mid-2027.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"MGNX's B7-H3 ADC shows durable 27% ORR in heavily pretreated SCCHN with clean discontinuation profile -- front-line pembrolizumab combo in 2027 is the next value inflection."},"keyFigures":{"drugName":"MGC026","phaseOfTrial":"Phase 1","customDimensions":{"orr_scchn":"27% (6/22, 4 confirmed + 2 unconfirmed PRs)","selected_dose":"7.5 mg/kg Q3W","safety_population":85,"stage2_data_timing":"mid-2027","grade3plus_trae_all":"51%","orr_dose_escalation":"29% confirmed (5/17)","grade3plus_trae_scchn":"48%","front_line_combo_start":"early 2027","disease_control_rate_scchn":"64% (14/22)","median_duration_of_response":"10.2 months","disease_control_rate_escalation":"65% (11/17)"}},"quotedText":"The emerging profile of MGC026 reinforces our conviction that this molecule has the potential to play an important and differentiated role in the treatment of advanced solid tumors","namedEntities":{"people":[{"name":"Eric Risser","role":"President and CEO of MacroGenics"},{"name":"Apostolia M. Tsimberidou, M.D., Ph.D., M.B.A.","role":"lead principal study investigator, MD Anderson Cancer Center"},{"name":"Barbara Burtness, M.D.","role":"Chief of Head and Neck Cancers, Yale Cancer Center"},{"name":"Rachel E. Sanborn, M.D.","role":"lead poster author"},{"name":"Jim Karrels","role":"SVP, CFO of MacroGenics"}],"products":["MGC026","pembrolizumab","SYNtecan™ linker-payload"],"companies":[{"name":"MacroGenics, Inc.","ticker":"MGNX","relationship":"filer"},{"name":"Synaffix","relationship":"technology licensor (ADC platform)"},{"name":"European Society for Medical Oncology (ESMO)","relationship":"conference venue"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Positive interim Phase 1 data for lead pipeline ADC MGC026 with 27% ORR in heavily pretreated SCCHN and a plan to move into front-line pembrolizumab combination in 2027. 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Sanborn, M.D.","role":"lead poster author"},{"name":"Jim Karrels","role":"SVP, CFO of MacroGenics"}],"products":["MGC026","pembrolizumab","SYNtecan™ linker-payload"],"companies":[{"name":"MacroGenics, Inc.","ticker":"MGNX","relationship":"filer"},{"name":"Synaffix","relationship":"technology licensor (ADC platform)"},{"name":"European Society for Medical Oncology (ESMO)","relationship":"conference venue"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-23T13:15:07.574Z","global_importance":42,"audience_relevance":30,"importance_components":{"tickerTier":"mid-cap clinical-stage biotech","eventGravity":"positive interim Phase 1 data at major congress (ESMO)","pipelineDeRisking":"lead/near-lead ADC advancing to front-line combo","retailFavoriteBoost":false}},"durationMs":7073,"modelName":"glm-5.3-flashx"}}