First Patients Dosed in Combination Trial as Imugene Advances Development of Novel Cancer-Killing Virus

Imugene, an Australian immuno-oncology company, has begun dosing patients in a combination study evaluating its novel cancer-killing virus, CF33 oncolytic virotherapy, in metastatic advanced solid tumours (MAST). Imugene is developing a range of therapies designed to activate a cancer patient’s immune system to help it fight malignant cells. It is investigating treatments as sole therapies (monotherapies) and in combination with other marketed drugs. The company’s portfolio includes multiple immunotherapy B-cell vaccine candidates, an oncolytic virotherapy (VAXINIA or CF33), and emerging technologies, including onCARlytics (CF33 CD19) in combination with CAR-Ts or bispecific antibody targeting CD19 for solid tumours.

Imugene is evaluating VAXINIA as a monotherapy and in combination with pembrolizumab in patients with MAST. In early March, the first patients in the IV and IT cohorts received VAXINIA in combination with pembrolizumab. Last month, Imugene reported it was on its third cohort of three-to-six patients evaluating VAXINIA as a monotherapy at escalating doses. Patients treated to-date have received the lowest doses of VAXINIA and have shown what Imugene describes as “acceptable safety,” which allowed for escalating monotherapy doses and evaluation of the virus in combination with immunotherapy pembrolizumab.

Imugene licensed the CF33 oncolytic virus platform in 2019 from Prof Yuman Fong, who is the chair of the Department of Surgery at City of Hope in the United States. In pre-clinical laboratory research and mouse models, CF33 was able to shrink malignant colon, lung, breast, ovarian and pancreatic tumours. Imugene’s managing director and CEO Leslie Chong said the company was “incredibly eager” to unlock the potential of CF33 and the oncolytic virotherapy platform for cancer patients.

In addition, Imugene is developing CHECKvacc and onCARlytics therapeutics. CHECKvacc, also known as CF33-hNIS-antiPD-L1, is an armed chimeric vaccinia poxvirus, which is designed to selectively kill tumour cells while also activating the immune system. The immunotherapy is undergoing a phase 1 trial in patients with metastatic triple negative breast cancer – targeting the PD-L1 protein and activating the local tumour microenvironment. OnCARlytics combines CF33 and CD19 with CD19 directed therapeutics to include CAR-T (chimeric antigen receptor) therapies.

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