MGD024 / MacroGenics, Gilead - LARVOL DELTA

CP-MGD024-01: A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: MacroGenics | Trial completion date: Jan 2026 ➔ May 2027 | Trial primary completion date: Jan 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Classical Hodgkin Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Myelodysplastic Syndrome • Oncology • IL3RA

CP-MGD024-01: A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: MacroGenics | Trial completion date: Oct 2025 ➔ Jan 2026 | Trial primary completion date: Oct 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Classical Hodgkin Lymphoma • Hairy Cell Leukemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Myelodysplastic Syndrome • Oncology • IL3RA

CP-MGD024-01: A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: MacroGenics | N=90 ➔ 130 | Trial completion date: Mar 2025 ➔ Oct 2025 | Trial primary completion date: Mar 2025 ➔ Oct 2025

Enrollment change • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hairy Cell Leukemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Myelodysplastic Syndrome • Oncology • IL3RA

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) - "MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing. 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. "

Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

MacroGenics Announces Achievement of $15 Million Milestone Related to Gilead’s Nomination of a Bispecific Research Program (GlobeNewswire) - "MacroGenics, Inc...announced that its partner, Gilead Sciences, Inc...nominated the first of two research programs, leveraging MacroGenics’ DART^® and TRIDENT^® platforms for generating bispecific antibodies. This nomination grants Gilead an exclusive option, upon achievement of a pre-defined preclinical milestone, to license worldwide rights to the research program. Under the October 2022 agreement, MacroGenics will receive $15 million related to the nomination of a bispecific research program to be conducted by MacroGenics and funded by Gilead. Pursuant to this agreement, which covers MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART platform, and up to two additional bispecific research programs, MacroGenics remains eligible to receive up to $1.7 billion in target nomination, option fees, and development, regulatory and commercial milestones."

Financing • Oncology

MacroGenics Provides Corporate Update and 2022 Financial Results (GlobeNewswire) - "R&D Expenses: Research and development expenses were $207.0 million for the year ended December 31, 2022, compared to $214.6 million for the year ended December 31, 2021. The decrease was primarily related to decreased retifanlimab manufacturing costs for Incyte, and decreased costs related to discontinued studies. These decreases were partially offset by increased development, manufacturing and clinical trial costs related to vobramitamab duocarmazine, increased expenses related to discovery projects and preclinical molecules, and increased clinical expenses related to lorigerlimab and MGD024."

Commercial • Acute Myelogenous Leukemia • Genito-urinary Cancer • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Prostate Cancer • Solid Tumor

A Phase 1, First-in-Human, Dose-Escalation Study of MGD024, a CD123 x CD3 Bispecific Dart® Molecule, in Patients with Relapsed or Refractory CD123-Positive (+) Hematologic Malignancies (ASH 2022) - P1 | "Of note, the CD123-directed therapy tagraxofusp has now become the standard of care (SoC) for blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Pemmaraju NEJM 2019)...This new construct permits intermittent intravenous (IV) dosing due to a longer half-life (Alderson ASH 2021) compared with the first-generation DART molecule flotetuzumab, a continuous-infusion molecule that showed preliminary single-agent activity in refractory acute myeloid leukemia (AML) (Uy Blood 2021)...Secondary objectives include pharmacokinetics, immunogenicity, preliminary assessment of MGD024 clinical activity, and preliminary evaluation of safety/efficacy of tocilizumab in the management of MGD024-induced CRS...Response evaluation is determined using modified European LeukemiaNet (ELN) 2017 criteria for ALM and ALL; International Working Group (IWG) 2006 criteria for MDS; Lugano 2014 criteria for cHL; ELN 2020 criteria for CML; 2017 consensus criteria for HCL; IWG-Myeloproliferative..."

Clinical • P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hairy Cell Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Inflammation • Lymphoma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • CD123

Gilead and MacroGenics Announce Oncology Collaboration to Develop Bispecific Antibodies (Businesswire) - "Gilead Sciences...announced an exclusive option and collaboration agreement to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART platform, and two additional bispecific research programs. The collaboration agreement grants Gilead the option to license MGD024, a potential treatment for certain blood cancers, including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS)."

Licensing / partnership • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: MacroGenics | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hairy Cell Leukemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Myelodysplastic Syndrome • Oncology • CRP

MacroGenics Provides Update on Corporate Progress and First Quarter 2022 Financial Results (GlobeNewswire) - "MacroGenics continues to recruit patients into its Phase 2 study of enoblituzumab in front-line patients with SCCHN...The Company expects to complete enrollment of the PD-L1 positive patient cohort during the first half of this year and provide an update on this cohort during the second half of the year....MacroGenics is also conducting a Phase 1/2 dose expansion study with lorigerlimab as monotherapy in cohorts of patients with microsatellite stable colorectal cancer (MSS CRC), mCRPC, melanoma and checkpoint-naïve NSCLC. MacroGenics anticipates sharing data from this ongoing study in the second half of 2022....The Company expects to begin enrollment in a Phase 1 study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia (AML) in mid-2022."

Enrollment status • P1/2 data • Acute Myelogenous Leukemia • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

A Phase 1 Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: MacroGenics

New P1 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hairy Cell Leukemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Myelodysplastic Syndrome • Oncology • CRP

Combinatorial Anti-Tumor Activity in Animal Models of a Novel CD123 x CD3 Bispecific Dart® Molecule (MGD024) with Cytarabine, Venetoclax or Azacitidine Supports Combination Therapy in Acute Myeloid Leukemia (ASH 2021) - "Introduction: Notwithstanding recent progress, acute myeloid leukemia (AML) remains an incurable disease, particularly in patients (pts) with relapsing/refractory disorder or ineligible for intensive induction therapy (unfit pts). Consistent with its decreased affinity for CD3, MGD024 demonstrated reduced in vitro potency in killing CD123-positive target cells compared to flotetuzumab or RES234M1.1, but proportionally greater reduction in cytokine release. MGD024, however, achieved maximal cytolytic activity as flotetuzumab or RES234M1.1, albeit at increased concentrations. Similarly, MGD024 showed reduced potency in vivo against CD123-positive tumors compared to RES234M1.1; nevertheless, tumor growth reduction of the same magnitude as that observed with RES234M1.1 was attained at higher doses of MGD024 (0.5-1 mg/kg IV 2QW MGD024 vs."

Combination therapy • IO biomarker • Preclinical • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • CD123 • IL2RA

MacroGenics Provides Update on Corporate Progress and Third Quarter 2021 Financial Results (GlobeNewswire) - "MGC018: The Company expects to present additional data from the ongoing Phase 1 study of MGC018 in the first half of next year. In addition, MacroGenics intends to provide details regarding further development plans in mCRPC in the first quarter of 2022. The Company also intends to initiate a study combining MGC018 with one of its proprietary checkpoint inhibitor molecules in the first half of next year....The Company intends to present preclinical MGD024 data at the American Society of Hematology (ASH) Annual Meeting in December."

P1 data • Preclinical • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor

MacroGenics Provides Update on Corporate Progress and First Quarter 2021 Financial Results (GlobeNewswire) - "MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule in preclinical development...The Company anticipates submitting an Investigational New Drug (IND) application to the FDA by the end of 2021."

IND • Oncology

MacroGenics Provides Update on Corporate Progress and 2020 Financial Results (GlobeNewswire) - "MGD019...The Company is enrolling Phase 1 dose expansion cohorts, initially in patients with microsatellite stable colorectal cancer (MSS CRC) and checkpoint-naïve NSCLC at the recommended Phase 2 dose. The Company expects to provide a clinical update on this study in mid-2021...MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule in preclinical development...The Company anticipates submitting an Investigational New Drug (IND) application to the FDA by the end of 2021."

IND • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology