Delving into the Latest Updates on Granzer Regulatory Consulting & Services GmbH with Synapse

Overview

Tags

Neoplasms

Other Diseases

Urogenital Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

SIK3(SIK family kinase 3)	1

Background:OMX-0407 is an orally available spectrum-selective kinase inhibitor targeting a set of oncology-relevant tyrosine kinases (TK) as well as the salt-inducible kinase (SIK) family, demonstrating a dual mode of action (MoA) in cancer. This involves OMX-0407-induced cell cycle arrest in tumor cells by de-phosphorylation and inactivation of TKs such as Src family kinases (SFK) and the SIK family, and increased sensitivity of the tumor microenvironment to immune-mediated tumor cell killing. OMX-0407 is currently undergoing early clinical testing for the treatment of angiosarcoma (AS) and clear cell renal cell carcinoma (ccRCC) (NCT05826600).Methods:Kinase activity profiling using the PamChip® kinase array was used to quantify OMX-0407 treatment effects. Moreover, a flow-cytometry-based “phosFlow” assay was developed to assess the phosphorylation status of SFKs. Both assays revealed dose-dependent inhibition of SFK phosphorylation and activity in peripheral blood mononuclear cells (PBMCs). Hence, they were implemented as pharmacodynamic biomarkers in the ongoing first-in-human trial (NCT05826600) of OMX-0407 in patients with previously treated unresectable solid tumors.Results:As of 30th of October 2024, 24 patients have received continuous treatment with OMX-0407 administered orally in 28-day cycles in a dose escalation study at dose levels of 10, 30, 60, 90, 100, and 140 mg twice daily (BID). Treatment was well tolerated with the main safety finding being gastro-intestinal adverse reactions. One patient with secondary radiation-induced angiosarcoma achieved a complete response at doses of up to 60 mg BID, which remains ongoing at 14 months.PhosFlow analysis confirmed OMX-0407 effects on the phosphorylation of SFKs in PBMCs at doses of 60mg and above. This was associated with the inhibition of oncology-relevant TKs as determined by functional kinase activity profiling. Treatment effects were significantly correlated with PK exposure. This confirms that both phosFlow and kinase activity profiling successfully resolve dose-dependent OMX-0407 activity in peripheral patient blood as pharmacodynamic biomarkers.These findings, together with safety findings and PK profiling, contributed to the selection of 100mg BID as the recommended phase 2 dose (RP2D) for the dose expansion.Conclusions& Outlook: OMX-0407 is a promising therapeutic candidate for the treatment of angiosarcoma and RCC with a potential dual MoA combining direct anti-tumor effects with modulation of the immune cell compartment towards a pro-inflammatory state. In September 2024, Ph1b expansion cohorts of the first-in-human trial (NCT05826600) were initiated for patients with unresectable/metastatic AS or ccRCC who have received at least one prior line of therapy, evaluating OMX-0407 at a dose of 100mg BID.Citation Format:Marisa Stebegg-Wagner, Ilona Petra Maser, Bettina Bauer, Andreas Schirmer, Moritz Zulley, Carmen Amerhauser, Thorsten Meyer, Tiantom Jarutat, Hannes Loferer, Stefan Bissinger. Pharmacodynamic biomarker modulation by OMX-0407, a novel, spectrum-selective kinase inhibitor for the treatment of angiosarcoma and renal cell carcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4350.

100 Deals associated with Granzer Regulatory Consulting & Services GmbH

Login to view more data

100 Translational Medicine associated with Granzer Regulatory Consulting & Services GmbH

Login to view more data

Corporation Tree

Boost your research with our corporation tree data.

login

or

view full example data

Boost your research with our corporation tree data.

Pipeline

Pipeline Snapshot as of 18 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

1

Login to view more data