Imugene Ltd (ASX:IMU, OTC:IUGNF) has partnered with contract development and manufacturing organisation ABL to advance IMU’s oncolytic virus candidate towards later-phase clinical trials.
Under the partnership, ABL will manufacture Imugene’s oncolytic virus for its Metastatic Advanced Solid Tumors (MAST) clinical studies, evaluating the safety and efficacy of novel cancer-killing virus CF33-hNIS (also known as VAXINIA).
Throughout the collaboration, Imugene will gain access to ABL’s top-of-the-line contract development and manufacturing services and a true end-to-end solution.
ABL will provide everything from analytical support and GMP manufacturing to vial filling and packaging for distribution.
The fine print
Although this partnership covers a five-year term, Imugene plans to work with ABL as a partner of choice in the long run, remaining active throughout the entirety of the CF33 platform’s life cycle.
To kick off the collaboration, Imugene is transferring the technology for the manufacturing and analytical processes to ABL.
From here, ABL will deliver the first phase of the project with a cGMP batch of VAXINIA, targeted for manufacture and release in 2023.
Clinical pipeline
Imugene has kicked off clinical development on its oncolytic virus candidates, known as VAXINIA and CHECKVacc.
These are based on the chimeric pox vaccinia platform CF33, invented by Professor Yuman Fong, chairman of Sangiacomo Family Chair in Surgical Oncology at the City of Hope Cancer Center in California.
Crucially, City of Hope has shown that the oncolytic virus it developed can shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.
Down the line, Imugene hopes its own oncolytic virus candidate will treat a variety of cancers in combination with standard-of-care drugs and emerging immunotherapies, such as CAR T for solid tumours.
Oncolytic viruses are designed to selectively kill tumour cells while activating the immune system against cancer cells with the potential to improve clinical response and survival.
The rise in cancer around the globe and increased investment in research and development for effective therapies are driving the expansion of the oncolytic virus therapy market.
Long-term partnership
Speaking to the partnership with ABL, Imugene managing director and CEO Leslie Chong said: “Reliability of drug supply is a major hurdle for the clinical development of many modern biological oncology drug candidates.
“De-risking this critical component of clinical development by working with ABL is a significant milestone for Imugene.”
“ABL is honoured to have Imugene’s trust and to enter into a long-term partnership for the development and manufacturing of CF33, a new generation of oncolytic virus, for its later phase clinical trial plans, said ABL chief executive Thierry Van Nieuwenhove.
“We look forward to working with Imugene in this collaborative partnership based on openness and transparency.
“The deal strengthens ABL’s reputation as a leading service provider of GMP vaccinia-based oncolytic viruses” explained Karim Pirani, ABL’s strategic business development representative.