Aurigene Oncology Limited Announces Encouraging Initial Data From 1st Two Cohorts of Phase 1 Study of AUR112, an Oral Small Molecule Inhibitor of MALT1, in Relapsed/Refractory Lymphoid Malignancies
Aurigene Oncology Limited Announces Encouraging Initial Data From 1st Two Cohorts of Phase 1 Study of AUR112, an Oral Small Molecule Inhibitor of MALT1, in Relapsed/Refractory Lymphoid Malignancies
Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.
dose-escalationmedical
Dose-escalation is the part of an early-stage clinical trial where researchers gradually increase a drug’s dose in small groups of participants to find the safest and most effective amount. Think of it like turning up the volume slowly to find the sweet spot: investors watch these results closely because they reveal safety risks, potential effectiveness, and how quickly a drug can move to later trials or approval, all of which affect the development timeline and commercial prospects.
dose-limiting toxicitiesmedical
Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.
pharmacokineticsmedical
Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.
pharmacodynamicsmedical
Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.
objective response ratemedical
The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.
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Treatment emergent adverse events are any new or worsened medical problems that appear after a patient starts a drug or medical intervention during a clinical trial. Investors care because the number, severity, and frequency of these events influence safety profiles, regulatory approval chances, and market acceptance; think of them like unexpected problems that crop up after installing a software update—minor ones may be manageable, but serious or common issues can stall or derail the product.
intent-to-treatmedical
A method for analyzing clinical trial results that counts every participant in the group they were originally assigned to, regardless of whether they completed the treatment or followed instructions. Like grading a class by the seats students were assigned rather than who finished the exam, it preserves the trial’s original comparisons and gives a realistic, often more conservative, estimate of how a drug or device performs in real-world use — information investors use to judge reliability and regulatory risk.
BANGALORE, India--(BUSINESS WIRE)--
Aurigene Oncology Limited, a clinical-stage biopharmaceutical company developing novel therapies in oncology,today announced initial clinical results from 1st two cohorts of its ongoing Phase 1 clinical trial evaluating AUR112 in patients with relapsed or refractory lymphoid malignancies. Early findings show that AUR112 is safe, well tolerated, demonstrating meaningful clinical activity, with objective responses observed across multiple lymphoma subtypes, including Mantle Cell Lymphoma (MCL) and Marginal Zone Lymphoma (MZL).
“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. “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 inhibitor.”
Study Design and Key Findings
The company is currently conducting a Phase 1 dose-escalation study evaluating AUR112 monotherapy in patients with relapsed/refractory lymphoid malignancies. Primary objectives include characterizing safety and identifying dose-limiting toxicities and secondary objectives include pharmacokinetics, pharmacodynamics, objective response rate, duration of response, and disease control rate.
As of the November 21, 2025 cutoff, 13 patients were evaluable for safety and 11 patients were evaluable for efficacy across three dose cohorts (100 mg, 200 mg, and 400 mg).
Safety: AUR112 was generally well tolerated. While 84.6% of patients experienced Treatment Emergent Adverse Events (TEAEs), only 14 events in 7 patients were treatment-related. No Grade 3 or higher hyperbilirubinemia was observed, and bilirubin elevations resolved even with continued treatment. One dose-limiting toxicity (DLT) (Grade 3 neutropenia) and two DLT-equivalent events were reported.
Pharmacokinetics/Pharmacodynamics: Drug exposure at 200 mg appears to be in the efficacious range, however further results are awaited. Pharmacodynamic data demonstrated rapid and sustained IL-2 inhibition, with all evaluated patients showing IL-2 levels below the limit of quantification by Cycle 1 Day 15.
Efficacy: Among 11 efficacy-evaluable patients (all in 1st two cohorts), the overall response rate was 63.6%, including six partial responses and one complete response. Responses were observed in MCL, MZL, Hodgkin Lymphoma (HL), and Diffuse Large B-Cell Lymphoma (DLBCL).
Based on these encouraging results, the initiation of dose-expansion cohorts in select lymphoid malignancies, including Chronic Lymphocytic Leukemia (CLL), Waldenström’s Macroglobulinemia, MCL, and MZL are being planned.
About AUR112
AUR112 is an oral investigational MALT1 inhibitor designed to target a pivotal signaling node in the NF-κB pathway. Through highly potent and selective inhibition of MALT1, AUR112 aims to disrupt survival mechanisms that drive B-cell malignancies. In preclinical studies, AUR112 exhibited significant monotherapy activity and demonstrated a favorable safety profile.
About Aurigene Oncology Limited
Aurigene Oncology Limited, a wholly owned subsidiary of Dr. Reddy’s Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY), is a clinical stage biotech committed to bringing in novel and effective therapeutics for the treatment of cancer. Founded in 2001, Aurigene has contributed to the discovery of 21 novel chemical entities for clinical development. Some of these molecules were in collaboration with global Pharma and biotech companies while remaining were developed on its own. Aurigene’s clinical pipeline with encouraging early clinical activity also includes first- in-class oral inhibitor of immune checkpoint protein CD47, best-in-class inhibitor of DHODH, an enzyme in the pyrimidine biosynthesis pathway and best-in-class inhibitor of acetyl transferases CBP and p300. Aurigene also has a strong pre-clinical pipeline, including advanced programs based on selective degradation of SMRACA2 (IND accepted by US-FDA), pan-KRAS, SMARCA4 and p300 discovered using its proprietary Proximity Inducer Platform (A-PROX).
