In a recent ASX update, Australian headquartered Imugene Limited (ASX: IMU) has notified that CF33 oncolytic virus CheckVacc and Vaxinia constructs have completed clinical grade GMP batches at the manufacturing facility, City of Hope Center for Biomedicine & Genetics (CBG).
The CBG is a 20,000 square foot, California-licensed, multi-product biologics manufacturing facility within the US-headquartered City of Hope.
The CBG holds the ability to produce virtually any kind of biologic at scales fit for Phase I through Phase II clinical trials, backed by its dedicated aseptic fill suite and a staff with extensive biopharmaceutical experience and twelve ISO 7 production rooms in three product type âzonesâ.
Significant Development in Commencement of CF33âs OV Phase 1 Clinical Trials
As per Imugeneâs M.D. & CEO, Ms Leslie Chong, the completion of clinical grade GMP batches by CheckVacc and Vaxinia constructs marks a significant milestone for the company in its preparation for the commencement of Phase 1 clinical trials for CF33 oncolytic virus in 2020.
The oncolytic virus (OV) CF33 is a chimeric vaccinia (pox) virus developed by the world-renowned Professor Yuman Fong, that carries a strong track record of safe use in a large number of humans as it was an active constituent of the vaccine that wiped out smallpox.
The company has recently completed the acquisition of City of Hope licence of CF33.
The CF33 has been developed in the following two constructs:
CheckVacc construct is armed with an immune checkpoint inhibitor inserted in the virus, and combines CF33 with PD-L1 inhibition, and also hNIS (a reporter gene for Human Sodium Iodide Symporter, to enable imaging).
Pre-clinical studies performed at US-based City of Hope by Dr. Fong have demonstrated encouraging results in TNBC (triple negative breast cancer) when an immune checkpoint inhibitor, particularly a PD-L1 inhibitor, is combined with CF33 to yield CheckVacc.
Following the March approval of the checkpoint inhibitor from Roche, Tecentriq, for the treatment of TNBC, the company is likely to start the Phase I trial in TNBC patients in 2020.
Vaxinia is an unarmed construct, whose Phase 1 MAST (Mixed Advanced Solid Tumours) trial will seek to recruit patients with different solid tumours. The virus will be delivered through IV (Intravenous therapy) or directly into the tumour.
The company intends to undertake two separate clinical trials for CF33 in Phase 1 to test both these constructs in 2020.
A World-Renowned Thoracic Surgeon Joined Imugeneâs OV SAB
Progressing with the development of CF33, IMU has appointed Professor Prasad S. Adusumilli to its recently formed OV Scientific Advisory Board (SAB). Dr. Adusimilli is a Head, Solid Tumors Cell Therapy, Cellular Therapeutics Center; Co-Director, Mesothelioma Program; and Deputy Chief, Thoracic Service at the Memorial Sloan Kettering Cancer Center in New York.
Moreover, he is an internationally recognized thoracic surgeon with expertise in the diagnosis and treatment of cancers in the chest - mesothelioma, lung cancer, thymoma, esophageal cancer, mediastinal and chest wall tumours, and cancers metastatic to pleura and lung. He has devoted his scientific discoveries and career for the benefit of cancer sufferers.
Recently, the company appointed Dr. Fong to chair its OV Scientific Advisory Board. Dr. Fong is a world-known cancer researcher, physician and surgeon whose clinical work has focused on oncolytic virotherapy for more than 30 years.
Amidst the scenario where OVs are attracting the significant attention of big pharma companies, Imugene is progressing rapidly with the development of CF33 that has demonstrated compelling tumour inhibition in multiple cancers.
Stock Performance: IMU traded at $0.053 on 25th November 2019. The stock has delivered a massive return of ~235.3per cent in the last six months.
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