AUR109 / Orion Corp, Dr. Reddy’s, Aurigene - LARVOL DELTA

TEJAS-2: A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients With Colorectal, Ovarian, and Renal Cancers (clinicaltrials.gov) - P2 | N=29 | Terminated | Sponsor: Aurigene Discovery Technologies Limited | N=90 ➔ 29 | Trial completion date: May 2027 ➔ Feb 2026 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2026 ➔ Feb 2026; Patient recruitment problems.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Colorectal Cancer • Kidney Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • BRCA • EGFR • FOLR1 • KRAS • MSI

TEJAS-2: A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients with Colorectal, Ovarian, and Renal Cancers (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Aurigene Discovery Technologies Limited

New P2 trial • Colorectal Cancer • Kidney Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor

Generation of profound anti-tumor immunity by AUR-109, a spectrum-selective tyrosine kinase inhibitor, either as a single agent or in combination with immune checkpoint inhibitors (AACR 2023) - "In the TILs, there was decrease in the expression of PD-1 and PD-L1 with a concomitant increase in IFN-γ expression on CD8 T cells and NK cells indicating a profound immune activation caused by AUR-109 within the tumor. These results demonstrate the therapeutic potential of AUR-109 in combination with PD-1 blockade in preclinical models and the results from the ongoing combination studies will be presented."

Checkpoint inhibition • Combination therapy • IO biomarker • Oncology • CD4 • CD8 • DDR1 • FGFR • IFNG

Phase 1/2 study of ODM-203, a selective dual FGFR/VEGFR inhibitor, in patients with advanced solid tumours (ESMO 2018) - P1; "Patients treated with ODM-203, especially those with FGFR-aberrant or VEGFR sensitive tumours, had preliminary promising anti-tumour response and on-target effects."

Clinical • P1/2 data • Ovarian Cancer • Thyroid Gland Carcinoma

How to stop disproportionation of a hydrochloride salt of a very weakly basic compound in a non-clinical suspension formulation. (PubMed, Int J Pharm) - "The compound under research was a hydrochloride salt of a practically insoluble discovery compound ODM-203...This procedure enabled us to proceed to the toxicological studies in rats. The in vivo study results obtained for the practically insoluble compound showed adequate exposures with acceptable variation at each dose level."

Clinical • Journal

Phase I/IIa, open-label, multicentre study to evaluate the optimal dosing and safety of ODM-203 in patients with advanced or metastatic solid tumours. (PubMed, ESMO Open) - P1 | "This study suggests ODM-203 400 mg/day results in sufficient plasma concentrations and acceptable tolerability in most patients. Preliminary signs of therapeutic activity of ODM-203 in patients with solid tumours was observed."

Clinical • Journal • P1/2 data • Oncology • Solid Tumor

Orion Group financial statement release for 2019 (GlobeNewswire) - "With regard to other earlier phase development projects, we are looking for partners for possible next development phases of the ODM-203 and ODM-207 molecules...We estimate that Nubeqa® will start to generate more substantial net sales growth starting from 2021-2022 and ODM-109, if successful, to have a significant impact on net sales growth from around 2022-2023."

Clinical • Sales

ODM-203 a selective inhibitor of FGFR and VEGFR, shows strong anti-tumor activity, and induces anti-tumor immunity. (PubMed, Mol Cancer Ther) - "Interestingly, potent anti-tumor activity in the subcutaneous syngenic model correlated well with immune modulation in the tumor microenvironment as indicated by marked decrease in the expression of immune check points PD-1 and PD-L1 on CD8 T cells and NK cells, and increased activation of CD8 T cells. In summary, ODM-203 shows equipotent activity for both FGFR and VEGFR kinase families and antitumor activity in both FGFR- and angigogenesis- models."

IO Biomarker • Journal

KIDES-203: Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1; N=84; Completed; Sponsor: Orion Corporation, Orion Pharma; Active, not recruiting ➔ Completed

Clinical • Trial completion

KIDES-203: Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours (clinicaltrials.gov) - P1; N=117; Active, not recruiting; Sponsor: Orion Corporation, Orion Pharma; Trial completion date: Jan 2019 ➔ Jul 2019; Trial primary completion date: Jan 2019 ➔ Jul 2019

Clinical • Trial completion date • Trial primary completion date