DO-1 / Octimet, Allist, DeuterOncology - LARVOL DELTA

A Phase I Trial of the Dual MET Kinase/OCT-2 Inhibitor OMO-1 in Metastatic Solid Malignancies Including MET Exon 14 Mutated Lung Cancer. (PubMed, Oncologist) - "OMO-1 was tolerated at the dose of 250 mg BID and shows initial signs of MET inhibition and anti-tumor activity in METex14 mutated NSCLC patients."

Clinical • Journal • Metastases • P1 data • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor • MET

Modular phase I/II clinical trial evaluating the selective MET-kinase inhibitor OMO-1 in patients with advanced malignancies: Safety and proof of mechanism. (ASCO 2019) - P1/2; "OMO-1 has a favourable safety profile at a RP2D of 250mg BD. Expansion cohorts for MET mutated/amplified tumour types are enrolling. Clinical trial information: NCT03138083"

Clinical • P1/2 data

Differentiated pharmacokinetic and pharmacodynamic properties of a highly selective MET kinase inhibitor, OMO-1: Implications for efficacy and safety. (ASCO 2019) - P1, P1/2; "OMO-1 is an oral, potent MET TKI with a novel dosing regime, identified during preclinical optimization (BD 4hr apart), that demonstrates encouraging signs of clinical activity without certain ‘class-specific’ adverse events. Further evaluation of this differentiated and efficacious agent is warranted and ongoing."

Clinical • PK/PD data

OMO-1 reduces progression and enhances cisplatin efficacy in a 4T1-based non-c-MET addicted intraductal mouse model for triple-negative breast cancer. (PubMed, NPJ Breast Cancer) - "Corroborating this finding, cisplatin delivery to the 4T1 primary tumor was enhanced upon OMO-1 treatment, increasing cisplatin DNA-adduct levels and tumor cell death. Although verification in additional cell lines is warranted, our findings provide initial evidence that TNBC patients may benefit from OMO-1 treatment, even in cases of non-c-MET addicted tumors."

Journal • Preclinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • MET

OCTIMET partners OMO-1 and OMO-2 with Shanghai Allist Pharmaceuticals Co., Ltd. for Greater China (PRNewswire) - "OCTIMET Oncology...is pleased to announce the licensing of the Greater China rights for its lead clinical compound OMO-1 and a second preclinical asset exclusively to Shanghai Allist Pharmaceuticals Co., Ltd....'Development in China is strategically important for OMO-1 and we look forward to seeing the results of the combination studies with Allist's EGFR TKI compound, thereby making a difference for cancer patients in need of efficacious targeted therapies.'"

Licensing / partnership • Oncology • Solid Tumor

"#OCTIMET partners #OMO1 and #OMO2 with Shanghai #AllistPharmaceuticals Co., Ltd. for Greater China https://t.co/nksRStPtkl" (@1stOncology)

OMO-1 in Solid Malignancies (clinicaltrials.gov) - P1/2; N=40; Terminated; Sponsor: Octimet Oncology N.V.; N=220 ➔ 40; Active, not recruiting ➔ Terminated; strategic reasons (not due to lack of efficacy or safety issues)

Clinical • Combination therapy • Enrollment change • Trial termination • Oncology • Solid Tumor

OMO-1 in Solid Malignancies (clinicaltrials.gov) - P1/2; N=220; Active, not recruiting; Sponsor: Octimet Oncology N.V.; Recruiting ➔ Active, not recruiting; Trial completion date: Oct 2021 ➔ Jun 2020; Trial primary completion date: Aug 2021 ➔ May 2020

Clinical • Combination therapy • Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

OCTIMET expands ongoing proof of concept study to evaluate the combination of highly selective MET kinase inhibitor OMO-1 with EGFR TKIs (PRNewswire) - "OCTIMET Oncology NV...is pleased to announce the recruitment of the first patient into the second module of its phase I/II clinical study in patients with advanced solid malignancies....Preliminary top-line results of the combination of OMO-1 with EGFR TKIs are expected in 2020."

Enrollment open • P1/2 data

OMO-1 in Solid Malignancies (clinicaltrials.gov) - P1/2; N=220; Recruiting; Sponsor: Octimet Oncology N.V.; N=80 ➔ 220; Trial completion date: Dec 2020 ➔ Oct 2021; Trial primary completion date: Sep 2019 ➔ Aug 2021

Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date