Imugene Ltd (ASX:IMU) is advancing its preliminary clinical development plan (CDP) for the proposed exclusive license of the patents covering the CF33 oncolytic virus technology, which is subject to shareholders’ approval at an Extraordinary Meeting of Shareholders to be held on November 18, 2019.
The CF33 oncolytic virus (OV) was developed in the lab of Professor Yuman Fong, an internationally recognised surgeon and scientist at City of Hope, a world-renowned independent research and treatment centre for cancer, diabetes and other life-threatening diseases based in California.
CF33 has been developed in two different constructs: one version of the OV is armed with an immune checkpoint inhibitor inserted in the virus, which is known as CheckVacc; and the other an unarmed construct, known as Vaxinia.
It is planned by Imugene that two separate Phase 1 clinical trials will be conducted in 2020 to test a CheckVacc construct and a Vaxinia construct of the OV.
Pre-clinical studies conducted at City of Hope by Professor Fong have shown encouraging results in triple negative breast cancer (TNBC) when CF33 is combined with an immune checkpoint inhibitor (ICI), specifically a PD-L1 inhibitor to yield CheckVacc.
TNBC is an aggressive subtype of breast cancer affecting 20% of breast cancer patients with poor prognosis upon diagnosis of metastases, largely due to lack of effective targeted therapy.
Immune check point inhibitors have shown efficacy in TNBC’s.
The Phase 1 trial commencing in 2020 will be an open-label, dose-escalating, non-randomised, single-centre phase 1 study of CheckVacc administered intratumorally in patients with metastatic TNBC with injectable metastatic lesions.
The purpose of the study will be to evaluate the safety and initial evidence of efficacy of the CF33-antiPDL1 combination oncolytic virus against TNBC.
The impressive activity of the CF33 oncolytic virus Vaxinia has been demonstrated in multiple solid tumour types in validated in-vivo models of pancreatic, colorectal, lung, TNBC and colon cancers.
Importantly, Vaxinia outperforms the industry leading OV’s from Amgen and Genelux.
Vaxinia is more potent than its competitors and a strong advantage is the level of dosing required, at least in preclinical animal models, is much lower.
The Phase 1 MAST (Mixed Advanced Solid Tumours) trial commencing in 2020 will be an FDA IND Imugene sponsored open-label, dose-escalating, non-randomised, multi-centre (including Australian hospitals) phase 1 study of Vaxinia administered intratumorally or intravenously in patients with solid tumours (lung, TNBC, melanoma, bladder, GI).
The purpose of the study will be to evaluate the safety and initial evidence of efficacy of the CF33 Vaxinia oncolytic virus against solid tumours.