MGC028 / MacroGenics - LARVOL DELTA

Preclinical development of MGC028, an ADAM9-targeted, glycan-linked, exatecan-based antibody-drug conjugate for the treatment of solid cancers. (PubMed, Mol Cancer Ther) - P1 | "MGC028 exhibited specific, dose-dependent in vivo antitumor activity toward ADAM9-positive cell line-derived and patient-derived xenograft models and was well tolerated in a repeat-dose non-human primate toxicology study, with no evidence of the ocular toxicities observed with IMGC936. A first-in-human study of MGC028 in patients with advanced solid tumors has been initiated (NCT06723236)."

Journal • Preclinical • Oncology • Ophthalmology • Solid Tumor • ADAM9

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

A Study of MGC028 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: MacroGenics | Trial completion date: Aug 2026 ➔ Apr 2027 | Trial primary completion date: Aug 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

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

A Study of MGC028 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: MacroGenics | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Cholangiocarcinoma • Hepatology • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

MGC028: Initiation of P1 trial (NCT06723236) for solid tumors in Q1 2025 (Madrigal Pharmaceuticals) - Corporate Presentation

Trial initiation date • Oncology • Solid Tumor

A Study of MGC028 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=124 | Not yet recruiting | Sponsor: MacroGenics

Metastases • New P1 trial • Biliary Cancer • Cholangiocarcinoma • Hepatology • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

MacroGenics Provides Update on Corporate Progress, Third Quarter 2024 Financial Results (GlobeNewswire) - "Emerging ADC Pipeline: MGC028:...The Company submitted an IND application for MGC028 to the U.S. Food and Drug Administration (FDA) in October; Lorigerlimab: This bispecific checkpoint molecule is being evaluated in the ongoing LORIKEET trial, a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve mCRPC patients....The Company anticipates completing enrollment of the study in late 2024 or early 2025 and providing a clinical update on the study in the first half of 2025."

Enrollment status • IND • P2 data • Castration-Resistant Prostate Cancer • Solid Tumor

MacroGenics Provides Update on Corporate Progress, Second Quarter 2024 Financial Results (GlobeNewswire) - "The Company anticipates completing enrollment of the study in 2024 or early 2025 and providing a clinical update in the first half of 2025....The Company continues to anticipate submitting an investigational new drug (IND) application for MGC028 by the end of 2024 and initiating a Phase 1 clinical study in 2025....MacroGenics continues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes."

Enrollment status • IND • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Metastatic Castration-Resistant Prostate Cancer • Myelodysplastic Syndrome • Oncology • Prostate Cancer • Solid Tumor

MacroGenics Provides Update on Corporate Progress, First Quarter 2024 Financial Results and Interim TAMARACK Phase 2 Study Data (GlobeNewswire) - "MGC028 preclinical data was presented recently at the AACR Annual Meeting. In preclinical studies, MGC028 demonstrated specific antitumor activity in in vivo models representing gastric, lung, pancreatic, colorectal cancer, SCCHN and cholangiocarcinoma. In addition, in a non-human primate study, MGC028 was well tolerated at high dose levels, with mild, reversible side effects and no ocular toxicity, which is often a concern with tubulin-inhibitor-based ADCs. These promising preclinical results support the continued investigation of MGC028 as a therapeutic option for treating ADAM9-expressing solid cancers."

P2 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Preclinical development of MGC028, an ADAM9-targeted, glycan-linked, exatecan-based antibody-drug conjugate for the treatment of solid cancers (AACR 2024) - "MGC028 exhibited potent antitumor activity in in vivo models representing various solid cancer indications and was well tolerated in non-human primates at exposure levels exceeding those required for antitumor activity. Our findings support continued investigation of MGC028 as an ADC therapeutic for the treatment of ADAM9-expressing solid cancers."

Preclinical • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ADAM9

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