XL114 / Dr. Reddy’s, Aurigene - LARVOL DELTA

A Study of AUR104 in Patients With Relapsed/Refractory Lymphoid Malignancies (VIJAY-1) (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: Aurigene Discovery Technologies Limited | N=42 ➔ 9 | Trial completion date: Jan 2027 ➔ Feb 2026 | Recruiting ➔ Terminated | Trial primary completion date: Nov 2026 ➔ Feb 2026; Patient recruitment problems

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hematological Malignancies • Hodgkin Lymphoma • Multiple Myeloma • Oncology

A Study of AUR104 in Patients with Relapsed/Refractory Lymphoid Malignancies (VIJAY-1) (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Aurigene Discovery Technologies Limited

New P1 trial • Hematological Malignancies • Oncology

Study of XL114 in Subjects With Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=2 | Terminated | Sponsor: Exelixis | N=144 ➔ 2 | Trial completion date: Dec 2025 ➔ Nov 2022 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2025 ➔ Nov 2022; Due to Sponsor reasons.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

A First-in-Human Phase 1 Dose Escalation and Expansion Study of the Oral CARD11-BCL10-MALT1 Signaling Pathway Inhibitor XL114 in Patients with Non-Hodgkin's Lymphoma (ASH 2022) - P1 | "Exploratory endpoints include the relationship between pharmacokinetics, pharmacodynamics, tumor and blood biomarkers, efficacy, and safety. The study has started screening patients, with total enrollment estimated to be up to 144 patients."

Clinical • P1 data • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CARD11 • MALT1

Study of XL114 in Subjects With Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: Exelixis | Not yet recruiting ➔ Recruiting

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

Exelixis Announces Initiation of First-In-Human Phase 1 Trial Evaluating XL114 Monotherapy in Patients with Non-Hodgkin’s Lymphoma (Businesswire) - "Exelixis, Inc...announced initiation of the dose-escalation stage of the first-in-human phase 1 trial of XL114, a novel anti-cancer compound that inhibits the CARD11-BCL10-MALT1 complex, as a monotherapy in patients with non-Hodgkin’s lymphoma (NHL) who have received prior standard therapies. The objectives of the study are to determine the recommended dose and/or the maximum tolerated dose of XL114 and to evaluate the safety and preliminary efficacy of XL114 in patients with NHL."

Trial status • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Exelixis Announces Preliminary Fourth Quarter and Full Year 2021 Financial Results, Provides 2022 Financial Guidance, and Outlines Key Priorities and Milestones for 2022 (Businesswire) - "Anticipated Pipeline Milestones: (i) Expansion of the XL102 clinical program:...Exelixis expects to provide clinical updates and present initial data from the ongoing phase 1 study of XL102 in 2022; (ii) Initiation of phase 1 trial for XL114: Exelixis expects to initiate dosing in the phase 1 trial of XL114 in patients with non-Hodgkin’s lymphoma during the first half of 2022."

P1 data • Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Study of XL114 in Subjects With Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1; N=144; Not yet recruiting; Sponsor: Exelixis

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

Exelixis In-Licenses Second Anti-Cancer Compound from Aurigene Following FDA Acceptance of Investigational New Drug Application for Phase 1 Clinical Trial in Non-Hodgkin’s Lymphoma (Businesswire) - "Exelixis, Inc...and Aurigene Discovery Technologies Limited (Aurigene) today announced that Exelixis has exercised its exclusive option under the companies’ July 2019 agreement to in-license XL114 (formerly AUR104)...Exelixis has now assumed responsibility for the future clinical development, commercialization and global manufacturing of XL114. Following the U.S. Food and Drug Administration’s (FDA) recent acceptance of its Investigational New Drug (IND) application, Exelixis will soon initiate a phase 1 clinical trial evaluating XL114 monotherapy in patients with Non-Hodgkin’s lymphoma (NHL)...Exelixis made an upfront payment of $10 million for exclusive options to obtain an exclusive license from Aurigene to three preexisting programs, including the compounds now known as XL102 and XL114. In addition, Exelixis and Aurigene initiated three Aurigene-led drug discovery programs on mutually agreed upon targets, in exchange for an additional upfront payment of $2.5 million per program."

IND • Licensing / partnership • New P1 trial • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology