“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).
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).
For more information, please visit: www.aurigene.com and follow us on LinkedIn and X.
Media Contact:
Email: [email protected]
]]>Aurigene’s A-PROX platform integrates library screening, direct-to-biology chemistries, proprietary ternary complex assays, modelling algorithms, and structure-based design to accelerate the discovery and optimization of both protein degraders, molecular glues and proximity inducers.
Through this integrated approach, Aurigene has advanced a strong pre-clinical portfolio of next-generation degraders, including a SMARCA2-selective degrader, which recently received Investigational New Drug (IND) approval from the United States Food and Drug Administration (FDA); a pan-KRAS degrader; a SMARCA4-selective degrader; and a p300 degrader.
“Our A-PROX platform represents a significant step forward in the rational discovery of targeted protein degraders and molecular glues,” said Dr. Murali Ramachandra, CEO of Aurigene Oncology Ltd. “We are excited to share our progress at the AACR-NCI-EORTC conference and continue advancing differentiated therapies that have the potential to transform cancer treatment.”
These programmes underscore Aurigene’s capability to deliver potent, paralogue-selective, and mutant-agnostic degraders, enabling the targeting of previously undruggable oncology pathways. Aurigene’s proprietary long-acting injectable (LAI) formulation has enabled infrequent intravenous dosing, just once every three weeks for most molecules, while maintaining excellent efficacy.
Poster Presentations
Title: Identification of an orally bio-available SMARCA2 selective degrader for treatment of SMARCA4 mutant cancers
Presenting Author: Susanta Samajdar
Presentation Date/Time: Oct 25 12:30-4PM ET
Abstract Number: C025
This presentation describes the identification and characterization of an orally bioavailable SMARCA2 degrader with good potency and selectivity over SMARCA4. SMARCA2 and SMARCA4 regulate chromatin architecture by mobilizing and repositioning nucleosomes on DNA, which is critical for various genomic functions, including transcriptional regulation, DNA recombination and repair, and mitotic chromosome segregation. Loss-of-function mutations or silencing of SMARCA4 are frequently observed in multiple cancer types, where tumorigenesis becomes dependent on the residual SMARCA2 degrader with good potency and selectivity over SMARCA4. In this study, the lead SMARCA2 degrader demonstrated potent antitumor activity, driven by efficient SMARCA2 degradation, in multiple SMARCA4-deficient cell line-derived xenograft (CDX) models at well-tolerated dose levels. Additionally, with the use of Aurigene’s proprietary long-acting injectable (LAI) formulation, AUR110, a candidate with US-FDA clearance for first-in-human studies, has shown potent and comparable anti-tumor activity following once every three week intravenous dosing.
Aurigene will also be showcasing other pipeline programmes in poster presentations at the conference, including:
Title: Discovery and development of a highly differentiated, efficacious, first-in-class anti-SIRPα/β dual antibody with single agent phagocytosis activity
Presenting Author: Subhra Chakrabarty
Presentation Date/Time: Oct 24 12:30-4PM ET
Abstract Number: B077
Title: Discovery and preclinical characterization of novel macrocyclic KIF18A inhibitors for treatment of chromosomally instable tumors
Presenting Author: Susanta Samajdar
Presentation Date/Time: Oct 23 12:30-4PM ET
Abstract Number: A030
Title: Development of a Differentiated, Best-in-Class oral Cbl-b inhibitor with Robust Immune Activation and Favourable Safety for Cancer Immunotherapy
Presenting Author: Susanta Samajdar
Presentation Date/Time: Oct 25 12:30-4PM ET
Abstract Number: C059
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 includes first- in-class oral inhibitor of immune checkpoint protein CD47, best-in-class inhibitor DHODH, an enzyme in the pyrimidine biosynthesis pathway, best-in-class inhibitor of acetyl transferases CBP and p300 and a best-in-class inhibitor of MALT1 protease impacting B-cell receptor signalling. Aurigene also has a strong pre-clinical pipeline, including advanced programs based on selective degradation of SMRACA2, pan-KRAS, SMARCA4 and p300.
For more information, please visit: www.aurigene.com and follow us on LinkedIn and X.
Contact:
Email: [email protected]
2)Identification of first-in-class paralog selective SMARCA4 degraders for treatment of hematological and prostate malignancies.
3)Discovery of highly selective, potent and orally bio-available SMARCA2 degraders.
]]>2)Discovery and development of a highly differentiated, efficacious, first-in-class anti-SIRPα/β dual antibody with single agent phagocytosis activity.
3)Discovery and preclinical characterization of novel macrocyclic KIF18A inhibitors for treatment of chromosomally instable tumors.
4)Development of a Differentiated, Best-in-Class oral Cbl-b inhibitor with Robust Immune Activation and Favourable Safety for Cancer Immunotherapy.
]]>The study reported initial results from the first 8 patients. All patients were heavily pre-treated with median of 5.5 previous lines of treatment. Most patients had also received transplant in the past and had disease progression post-transplant. All 8 patients (100%) achieved clinical response, with 5/8 (62.5%) having achieved stringent complete response. With respect to safety, there were no high-grade events of Cytokine Release Syndrome (CRS) or neurotoxicity, in any of the patients.
After reviewing the Phase 1 data, the Indian Regulatory Agency i.e., Drugs Controller General of India (DCGI), has given the nod to commence Phase 2 part of the trial. These results of Phase 1 were presented at the 21st annual meeting of the International Myeloma Society at Rio De Janeiro, Brazil, held recently.
“The results from the trial in heavily pre-treated relapsed refractory myeloma patients are very exciting for us in India. We are thrilled with the data, as the drug could be transformative for Indian patients with myeloma” commented Dr. Murali Ramachandra, CEO, Aurigene Oncology Limited.
Ribrecabtagene autoleucel is an autologous anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. DRL-1801 for the clinical trials is manufactured at the CAR-T GMP manufacturing facility at Aurigene Oncology Limited, Bangalore.
About Aurigene Oncology Limited:
Aurigene Oncology Limited, a wholly owned subsidiary of Dr. Reddy’s Laboratories, is a clinical stage biotech committed to bringing in novel and effective therapeutics for the treatment of cancer. Founded in 2002, Aurigene has contributed to the discovery of 20 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 has out-licensed several assets and is now engaged in clinical development of 10 assets. Aurigene’s clinical pipeline includes first- in-class oral inhibitor of immune checkpoint protein CD47, first-in-class inhibitor fatty-acid binding protein FABP5 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, first-in class CBP, p300 and pan-KRAS degraders.
Source: https://www.bseindia.com/xml-data/corpfiling/AttachLive/0a8f8bc1-7d0f-4e7d-b98f-31dd6a6bdad8.pdf
]]>1) Discovery and Development of pan-KRAS Degraders for Cancer Therapy\n
2) Efficacy of a First-in-Class Polymerase Theta Degrader in Preclinical Cancer Models
Posted On: 14 SEP 2024 12:05PM by PIB Delhi
In a significant stride towards strengthening India’s clinical research ecosystem, the Indian Council of Medical Research (ICMR) has formalized Memorandum of Agreements (MoAs) with multiple sponsors under its Network of Phase 1 Clinical Trials. The agreements mark a ground-breaking entry into First-in-Human Clinical Trials for four promising molecules. These include collaborative research over a small molecule for multiple myeloma with Aurigene Oncology Limited, partnering for Zika vaccine development with Indian Immunologicals Limited, coordinating seasonal Influenza virus vaccine trial with Mynvax Private Limited, and CAR-T cell therapy advancement study for a new indication of chronic lymphocytic leukemia with ImmunoACT. This initiative is a crucial step towards establishing India as a leader in the clinical development of pharmaceutical agents.
Union Health and Family Welfare Minister, Shri J P Nadda, commended the strategic collaboration between ICMR and prominent industry and academic partners, emphasizing it as a key milestone in the pursuit of affordable and accessible cutting-edge treatments for all citizens. He noted that this initiative positions India to emerge as a global leader in healthcare innovation.
Dr. Rajiv Bahl, Secretary, Department of Health Research & Director General, ICMR, emphasized the transformative potential of the project, stating, “This collaboration reflects our commitment to advancing clinical research in India through strategic public-private partnerships. Establishing Phase 1 clinical trial infrastructure is a key component in fostering the development of indigenous molecules and cutting-edge treatments. Our vision is to expand this network further, ensuring that India continues to lead in the development of innovative and affordable healthcare solutions.”
Dr. Bahl also highlighted the broader impact of ICMR’s initiatives, such as the Network for Phase 1 Clinical Trials, INTENT Network, and MedTech Mitra, aligning with the government’s vision of a “Viksit Bharat” (Developed India). He cited ICMR’s pivotal role in development of Covaxin in collaboration with Bharat Biotech as a testament to the organization’s commitment to affordable and accessible healthcare for all.
The ICMR Network for Phase 1 Clinical Trials comprises four strategically located institutions across India—KEMH & GSMC, Mumbai; ACTREC, Navi Mumbai; SRM MCH&RC, Kattankulathur; and PGIMER, Chandigarh—supported by a Central Coordinating Unit at ICMR Headquarters, New Delhi. This network is designed to build and enhance India’s capacity to conduct early-phase clinical trials, supported by robust infrastructure and dedicated manpower at each trial site, ensuring smooth and effective operations.
The signing of these agreements reinforces the strong partnerships ICMR has cultivated with key industry players. It underscores the institute’s dedication to building a robust clinical trial ecosystem in India, fostering capacity to develop new drugs from early-phase trials through to marketing, thereby reducing dependency on international resources, and ultimately driving the mission of affordable, high-quality healthcare for all.
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HFW/ICMR Release/14September2024/1
Source: https://pib.gov.in/PressReleasePage.aspx?PRID=2054864
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