ABBV-525 / AbbVie, Lupin - LARVOL DELTA

A First-in-Human Phase 1 Study of ABBV-525, a Small-Molecule MALT1 Inhibitor, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (ASH 2023) - P1 | "ABBV-MALT1 has also shown activity in a range of preclinical lymphoma models as both monotherapy and in combination with venetoclax, including robust antitumor activity in malignant B-cell models that are resistant to BTK inhibitors. Pts are being enrolled in 25 sites across the USA, Australia, Belgium, France, Germany, Israel, Spain, and UK. As of August 1, 2023, 2 pts had been treated."

Clinical • P1 data • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia • MALT1 • PLCG2

Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

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

Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: AbbVie | Initiation date: Dec 2022 ➔ Mar 2023

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

Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: AbbVie

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

Schrödinger Reports Financial Results for the Fourth Quarter and Full Year 2021 (Businesswire) - "IND submission for the MALT1 program in first half of 2022, IND submission for the CDC7 program in early 2023 and IND submission for the Wee1 program in 2023; Initiate a Phase 1 clinical study for the MALT1 program in the second half of 2022, and initiate Phase 1 clinical studies for the CDC7 and Wee1 programs in 2023; Publication of data from internal programs in peer-reviewed forums, including presentation of preclinical data from the Wee1 program in the first half of 2022."

IND • New P1 trial • Preclinical • Oncology

Schrödinger to Present New Preclinical Data From Its MALT1 Inhibitor Program at ASH 2021 Annual Meeting (Businesswire) - "Schrödinger...today announced that new preclinical data on its small-molecule MALT1 inhibitors will be presented during a poster session at the American Society of Hematology (ASH) 63rd Annual Meeting taking place virtually and in Atlanta, Georgia, December 11-14, 2021."

Preclinical • Hematological Malignancies • Oncology