Imugene Limited (ASX:IMU) shareholders have agreed to the purchase of Vaxinia Pty Ltd and City of Hope licence which results in the company completing the acquisition of the CF33 oncolytic virus technology.
Approval was granted at an Extraordinary Meeting of Shareholders held in Melbourne today.
All resolutions relating to the acquisition were carried unanimously on a show of hands.
Shares surged on the vote, up as much as 40% to an intra-day high of A6.3 cents, which is a new 12-month high.
Imugene’s MD and CEO Leslie Chong said, “We are delighted to be able to complete the acquisition of Vaxinia Pty Ltd and City of Hope licence of such a promising next-generation oncolytic virus in a competitive marketplace where big pharma companies are actively seeking OV technologies.
“CF33 comes with robust intellectual property and long patent life, compelling pre-clinical efficacy and safety, and is anticipated to enter two Phase 1 clinical trials in 2020,” she said.
Developed at City of Hope
The CF33 oncolytic virus 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 in California for cancer, diabetes and other life-threatening diseases.
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 these constructs.
Pre-clinical studies conducted 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.
Phase 1 trial
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 will be to evaluate the safety and initial evidence of efficacy of the CF33-antiPDL1 combination oncolytic virus against TNBC.
Impressive Vaxinia activity
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 OVs 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).
US Defense grant
Professor Fong and fellow City of Hope researcher Yanghee Woo recently received a $564,173 US Department of Defense grant for CF33 in gastric cancer.
This focuses on the area of stomach (gastric) cancer (GC), a disease that disproportionately affects US military service members, veterans and their beneficiaries who have increased exposure to hazardous environmental risk factors.
Peritoneal carcinomatosis (PC) is a fatal evolution of GC for which there is no effective treatment.
Across military families and the general population, over 60% of all patients with GC will develop peritoneal disease as the most common manifestation of recurrence or metastatic presentation.
The progression of primary GC to PC is facilitated by the unique peritoneal tumour microenvironment, where metastatic peritoneal seeding requires evasion of anti-tumour immunity and maintenance of a highly immunosuppressive microenvironment.
The researchers rationalise that a combined approach using Imugene’s proposed licence for novel oncolytic virus CF33 armed to express an anti-PD-L1 antibody as immune modulator could specifically kill cancer cells, convert the immunologically ‘cold’ environment of PC into a ‘hot’ environment, and enhance the overall efficacy of GC therapy.