MGC026 / MacroGenics, Lonza - LARVOL DELTA

MGC026, a glycan-linked, exatecan-based antibody-drug conjugate (ADC) targeting B7-H3, is efficacious toward prostate cancer patient-derived xenografts (AACR-NCI-EORTC 2025) - "MGC026 demonstrated strong efficacy in CRPC LuCaP PDX models, supporting its clinical development for the treatment of B7-H3-expressing advanced PC. With their extensive characterization, these models also provide future opportunities to assess potential biomarkers of response in this indication."

Clinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Key Strategic Priorities for 2025 and 2026 (Macrogenics Press Release) - "Determine development path for lorigerlimab based on data from the ongoing LORIKEET and LINNET studies. Advance MGC026 and MGC028 programs to assess clinical proof-of-concept. Submit Investigational New Drug (IND) application for MGC030. Initiate IND-enabling studies for two new product candidates. Forge partnerships and collaborations to accelerate development of the Company’s proprietary product candidates and technology platforms."

IND • M&A • Preclinical • Oncology

MacroGenics Provides Update on Corporate Progress and First Quarter 2025 Financial Results (Macrogenics Press Release) - "First patient dosed in LINNET Phase 2 study of lorigerlimab in ovarian and other gynecologic cancers; Clinical update on LORIKEET, a randomized 150-patient Phase 2 study of lorigerlimab in combination with docetaxel in patients with mCRPC, expected in second half of 2025...MGC026 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors, with dose expansion in selected indications expected to initiate in 2025; An Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for 2026."

IND • P2 data • Trial status • Castration-Resistant Prostate Cancer • Ovarian Cancer

MacroGenics Provides Update on Corporate Progress and 2024 Financial Results (GlobeNewswire) - "Emerging ADC Pipeline:...(i) MGC026:...MGC026 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors, with dose expansion in selected indications expected to initiate in 2025; (ii) MGC028:...The first patient was recently dosed in a Phase 1 study of MGC028 in patients with advanced solid tumors; (iii) MGC030:...An Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for 2026."

IND • Trial status • Solid Tumor

MGC026: Data from P1 trial (NCT06242470) for solid tumors in 2025 (Macrogenics) - Corporate Presentation

P1 data • Oncology • Solid Tumor

MacroGenics Provides Update on Corporate Progress, First Quarter 2024 Financial Results and Interim TAMARACK Phase 2 Study Data (GlobeNewswire) - "A Phase 1 dose escalation study of MGC026 in patients with advanced solid tumors is ongoing...MGC026 preclinical data was presented recently at the American Association for Cancer Research (AACR) Annual Meeting. In preclinical studies, MGC026 was shown to have greater potency than B7-H3-directed antibodies conjugated to deruxtecan, or DXd, a topoisomerase-based payload utilized in other ADCs. In addition, the MGC026 payload has been shown to be less susceptible to multi-drug resistance (MDR) mechanisms than DXd and SN-38."

Preclinical • Trial status • Solid Tumor

Preclinical development of MGC026, a glycan-linked, exatecan-based antibody-drug conjugate (ADC) targeting B7-H3 for solid cancer (AACR 2024) - "A duocarmycin-based B7-H3-targeted DNA-alkylating ADC, vobramitamab duocarmazine (vobra duo), has shown encouraging clinical activity in the treatment of metastatic castration-resistant prostate cancer. MGC026 exhibited a favorable preclinical profile, with potent in vivo activity toward B7-H3-expressing tumor xenografts representing a range of cancer indications. MGC026 was tolerated in cynomolgus monkeys, a relevant toxicology model, at exposure levels exceeding those required for antitumor activity. These data support clinical development of MGC026 for the treatment of B7-H3-expressing solid cancers."

Preclinical • Genito-urinary Cancer • Head and Neck Cancer • Melanoma • Metastatic Castration-Resistant Prostate Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

MacroGenics Provides Update on Corporate Progress and 2023 Financial Results (GlobeNewswire) - "The Company plans to present MGC026 preclinical data at the upcoming American Association for Cancer Research (AACR) Annual Meeting in April 2024....MacroGenics plans to present preclinical data for MGC028 at the upcoming AACR Annual Meeting in April and currently anticipates submitting an investigational new drug (IND) application for MGC028 by the end of 2024."

IND • Preclinical • Oncology

A Study of MGC026 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=230 | Recruiting | Sponsor: MacroGenics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Bladder Cancer • Castration-Resistant Prostate Cancer • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of MGC026 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=230 | Not yet recruiting | Sponsor: MacroGenics

New P1 trial • Bladder Cancer • Castration-Resistant Prostate Cancer • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

MacroGenics Provides Update on Corporate Progress and Third Quarter 2023 Financial Results (GlobeNewswire) - "MGC026 is an ADC with a topoisomerase inhibitor-based cytotoxic mechanism directed against an undisclosed solid tumor target. The Company recently submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration and, assuming acceptance, anticipates commencing a Phase 1 dose escalation study beginning in the first quarter of 2024. More details on this program will be provided in early 2024."

IND • New P1 trial • Solid Tumor