Aurigene's MALT1 Inhibitor AUR112 Shows 63.6% Response Rate in Phase 1 Lymphoma Trial
核心洞察
Aurigene Oncology reported encouraging Phase 1 results for AUR112, an oral MALT1 (搜索) inhibitor, achieving a 63.6% overall response rate in 11 efficacy-evaluable patients with relapsed/refractory lymphoid malignancies.
The drug demonstrated a favorable safety profile with only 14 treatment-related adverse events in 7 patients, and showed rapid IL-2 inhibition with sustained pharmacodynamic activity.
Objective responses were observed across multiple lymphoma subtypes including Mantle Cell Lymphoma (搜索), Marginal Zone Lymphoma (搜索), Hodgkin Lymphoma (搜索), and Diffuse Large B-Cell Lymphoma (搜索).
Aurigene Oncology Limited (搜索) announced promising initial clinical results from its Phase 1 dose-escalation study of AUR112, an oral small molecule MALT1 (搜索) inhibitor, in patients with relapsed or refractory lymphoid malignancies. The early data demonstrate meaningful clinical activity with an overall response rate of 63.6% in the efficacy-evaluable population and 58.3% in the intent-to-treat group.
Strong Efficacy Signal Across Multiple Lymphoma Subtypes
Among 11 efficacy-evaluable patients from the first two cohorts, AUR112 achieved six partial responses and one complete response. Objective responses were observed across multiple lymphoma subtypes, including Mantle Cell Lymphoma (搜索) (MCL), Marginal Zone Lymphoma (搜索) (MZL), Hodgkin Lymphoma (搜索) (HL), and Diffuse Large B-Cell Lymphoma (搜索) (DLBCL).
"We are very encouraged by the early results of the first two cohorts from our Phase 1 study of AUR112," said Dr. Murali Ramachandra, CEO of Aurigene Oncology. "AUR112 has shown a promising initial clinical profile, achieving an overall response rate of 63.6% in the efficacy-evaluable population and 58.3% in the intent-to-treat group. These strong early data, combined with its distinct preclinical and safety characteristics, reinforce our belief that AUR112 has the potential to become a best-in-class MALT1 (搜索) inhibitor."
Favorable Safety Profile with Manageable Toxicities
As of the November 21, 2025 cutoff, 13 patients were evaluable for safety across three dose cohorts (100 mg, 200 mg, and 400 mg). AUR112 was generally well tolerated, with 84.6% of patients experiencing Treatment Emergent Adverse Events (TEAEs), but only 14 events in 7 patients were treatment-related.
Notably, no Grade 3 or higher hyperbilirubinemia was observed, and bilirubin elevations resolved even with continued treatment. The study reported one dose-limiting toxicity (DLT) consisting of Grade 3 neutropenia and two DLT-equivalent events.
Pharmacodynamic Activity Demonstrates Target Engagement
Pharmacodynamic data revealed rapid and sustained IL-2 inhibition, with all evaluated patients showing IL-2 levels below the limit of quantification by Cycle 1 Day 15. Drug exposure at the 200 mg dose appears to be in the efficacious range, though further pharmacokinetic results are awaited.
Mechanism of Action and Development Strategy
AUR112 is designed to target a pivotal signaling node in the NF-κB (搜索) pathway through highly potent and selective inhibition of MALT1 (搜索). This mechanism aims to disrupt survival mechanisms that drive B-cell malignancies. In preclinical studies, AUR112 exhibited significant monotherapy activity and demonstrated a favorable safety profile.
Based on these encouraging results, Aurigene is planning to initiate dose-expansion cohorts in select lymphoid malignancies, including Chronic Lymphocytic Leukemia (搜索) (CLL), Waldenström's Macroglobulinemia (搜索), MCL, and MZL.
Company Pipeline and Background
Aurigene Oncology Limited (搜索), a wholly owned subsidiary of Dr. Reddy's Laboratories, is a clinical-stage biopharmaceutical company founded in 2001. The company has contributed to the discovery of 21 novel chemical entities for clinical development. Aurigene's clinical pipeline includes a first-in-class oral inhibitor of immune checkpoint protein CD47, a best-in-class inhibitor of DHODH, and a best-in-class inhibitor of acetyl transferases CBP and p300.
The Phase 1 study is evaluating AUR112 monotherapy in patients with relapsed/refractory lymphoid malignancies, with primary objectives including characterizing safety and identifying dose-limiting toxicities. Secondary objectives include pharmacokinetics, pharmacodynamics, objective response rate, duration of response, and disease control rate.