AUR-101 / Dr. Reddy’s - LARVOL DELTA

Property based optimization of heterobifunctional degraders of KAT2A and KAT2B for the treatment of cancer (ACS-Fall 2024) - "In vivo, AUR1545 significantly inhibited tumor growth in an NCI-H1048 xenograft model when administered via IP at substantially lower doses than AUR101. Building on the success of AUR1545, we subsequently focused on further property refinement of our heterobifunctional degraders and successfully developed orally bioavailable degraders of KAT2A/ B."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3) (clinicaltrials.gov) - P2 | N=141 | Completed | Sponsor: Aurigene Discovery Technologies Limited | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3) (clinicaltrials.gov) - P2 | N=141 | Active, not recruiting | Sponsor: Aurigene Discovery Technologies Limited | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2022 ➔ Jan 2023

Enrollment closed • Trial completion date • Dermatology • Immunology • Psoriasis

A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3) (clinicaltrials.gov) - P2 | N=128 | Recruiting | Sponsor: Aurigene Discovery Technologies Limited | Trial completion date: Jun 2022 ➔ Oct 2022 | Trial primary completion date: Jun 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

[VIRTUAL] A phase I dose escalation study evaluating the safety and tolerability of a novel anti-HER2 antibody-drug conjugate (PF‑06804103) in patients with HER2-positive solid tumors. (ASCO 2020) - P1 | "Background: PF-06804103 is an anti-HER2 immunoglobulin G1 antibody-drug conjugate (ADC), comprising an anti-HER2 monoclonal antibody conjugated with a cleavable linker to the cytotoxic agent Aur0101. The PF-06804103 ADC demonstrated manageable toxicity and promising anti-tumor activity in this small, heavily pretreated study population. Research Funding: Pfizer"

Clinical • P1 data • Alopecia • Breast Cancer • Dermatopathology • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Gene Therapies • HER2 Breast Cancer • Oncology • Pain • Solid Tumor

A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3) (clinicaltrials.gov) - P2; N=128; Recruiting; Sponsor: Aurigene Discovery Technologies Limited; Trial primary completion date: Dec 2021 ➔ Jun 2022

Clinical • Trial primary completion date • Dermatology • Immunology • Psoriasis

A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3) (clinicaltrials.gov) - P2; N=108; Recruiting; Sponsor: Aurigene Discovery Technologies Limited; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dermatology • Immunology • Psoriasis

A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3) (clinicaltrials.gov) - P2; N=108; Not yet recruiting; Sponsor: Aurigene Discovery Technologies Limited

New P2 trial • Dermatology • Immunology • Psoriasis

INDUS-2: A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2; N=90; Completed; Sponsor: Aurigene Discovery Technologies Limited; Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

INDUS-2: A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2; N=90; Active, not recruiting; Sponsor: Aurigene Discovery Technologies Limited; Recruiting ➔ Active, not recruiting; Trial primary completion date: Nov 2020 ➔ Mar 2021

Clinical • Enrollment closed • Trial primary completion date • Dermatology • Immunology • Psoriasis

INDUS-2: A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Aurigene Discovery Technologies Limited; Not yet recruiting ➔ Recruiting

Enrollment open

INDUS-2: A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2; N=90; Not yet recruiting; Sponsor: Aurigene Discovery Technologies Limited

Clinical • New P2 trial

Safety, tolerability, pharmacokinetics and pharmacodynamics of AUR101, An ROR?t inhibitor, in normal healthy volunteers (EAACI 2019) - "Clinical validation of this pathway comes from the therapeutic efficacy of IL-17 antibodies, such as secukinumab, in several autoimmune disorders. Additional MAD cohorts are being planned.Conclusion At exposures that are multiple folds lower than pre-clinical NOAEL dose exposures in rats and dogs, AUR101 is showing excellent and promising PD (RORγt dependent IL-17) modulation in healthy volunteers without any clinical concerns. Updated safety and PK / PD data will be presented at the meeting."

Clinical • PK/PD data

A phase 1, dose-escalation study of PF-06664178, an anti-Trop-2/Aur0101 antibody-drug conjugate in patients with advanced or metastatic solid tumors. (PubMed, Invest New Drugs) - "Neutropenia, skin rash and mucosal inflammation were dose limiting toxicities. Findings from this study may potentially aid in future antibody drug conjugate design and trials."

Clinical • Journal • P1 data