ABBV-319 / AbbVie - LARVOL DELTA

A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants With Systemic Lupus Erythematosus (SLE) and Sjogren's Disease (SjD) (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P1 trial • Dry Eye Disease • Immunology • Inflammatory Arthritis • Lupus • Ophthalmology • Sjogren's Syndrome • Systemic Lupus Erythematosus

A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=154 | Recruiting | Sponsor: AbbVie | N=114 ➔ 154

Adverse events • Enrollment change • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ABBV-319: A CD19-targeting glucocorticoid receptor modulator antibody-drug conjugate therapy for B-cell malignancies. (PubMed, Blood) - P1 | "ABBV-319 also showed durable anti-tumor activity across multiple B-cell lymphoma PDX models, including non-germinal center B-cell (GCB) DLBCL and relapsed lymphoma post R-CHOP treatment. Collectively, these data support the ongoing evaluation of ABBV-319 in Phase I clinical trial (NCT05512390)."

Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD34 • IL15

A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: AbbVie | Trial completion date: Feb 2026 ➔ Feb 2027 | Trial primary completion date: Feb 2026 ➔ Feb 2027

Adverse events • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ABBV-319: A First-In-Class Glucocorticoid Receptor Modulator (GRM) Agonist ADC for the Treatment of B-cell Malignancies (ADC-USA 2023) - "ABBV-319 is a first-in-class oncology multi-modal ADC with a potent GRM steroid payload; The ADC targets CD19 a clinically validated target with high expression across B-cell malignancies; ABBV-319 has three mechanisms-of-action (MOA): 1) GRM payload delivery, 2) enhanced ADCC and 3) CD19 / BCR signaling inhibition; ABBV-319 demonstrated sustained anti-tumor activity in cell-line xenografts, PDXs and humanized models with superiority to benchmarks; ABBV-319 was well tolerated in GLP toxicities studies and has progressed into Phase 1 clinical testing"

Hematological Malignancies • Oncology

A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2026 ➔ Feb 2026 | Initiation date: Aug 2022 ➔ Apr 2023 | Trial primary completion date: Sep 2026 ➔ Feb 2026

Adverse events • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ABBV-319: A first-in-class Glucocorticoid Receptor Modulator (GRM) agonist ADC for the treatment of B-cell malignancies (AACR 2023) - P1 | "Given ADCC/ADCP is a highly effective mechanism in B-cell malignancies (e.g., rituximab, tafasitamab) the CD19 antibody was engineered to have increased FcγR binding via afucosylation, that retains its enhanced ADCC activity as a GRM drug conjugate. ABBV-319 was well tolerated in cynomolgus monkey studies with favorable drug-like properties and antibody-like pharmacokinetics, enabling a high mg/kg clinical starting dose. A first in-human Phase 1 clinical trial evaluating ABBV-319 in B-cell malignancies (DLBCL, FL, CLL) was recently initiated in late 2022 (clinicaltrials.gov, NCT05512390)."

Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Oncology

Preclinical development of ABBV-319: a CD19-targeting glucocorticoid receptor modulator (GRM) agonist antibody-drug conjugate (ADC) for the treatment of B-cell malignancies (AACR 2023) - "Introduction: Glucocorticoids are key components of standard-of-care treatment regimens (e.g., R-CHOP, Hyper-CVAD) for several B-cell malignancies. ABBV-319 has potent anti-tumor activity from three distinct MoA and exhibits safety improvements compared to systemic glucocorticoids, supporting its recent progression into Phase I clinical trial."

Preclinical • Hematological Malignancies • Oncology • CD34 • IL15

A First-in-Human Phase 1 Study of Abbv-319, an Antibody-Drug Conjugate Composed of a CD19 Antibody Linked to a Potent Proprietary Glucocorticoid Receptor Modulator, in Patients with Relapsed or Refractory B-Cell Malignancies (ASH 2022) - "Duration of response, time to response, progression-free survival, and overall survival will be evaluated per Kaplan-Meier analysis. QT prolongation, PD, and biomarker data will be assessed as changes from baseline and may be summarized for each scheduled postbaseline visit."

Clinical • P1 data • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia

A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - P1 | N=114 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P1 trial • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology