Imugene (ASX:IMU) and ABL ink deal to fast-track VAXINIA manufacturing - Kalkine Media

Highlights

• Imugene Limited has announced its partnership with ABL to advance oncolytic virus candidates towards later-phase clinical trials.
• IMU selected ABL to ensure that its drug product supply needs for extended clinical trials are met.
• The newly built partnership will give Imugene access to ABL’s contract development and manufacturing organisation services.

ASX-listed immuno-oncology company, Imugene Limited (ASX:IMU), has entered into a partnership deal with ABL, a pureplay contract development and manufacturing organisation (CDMO). On the other hand, ABL will produce Imugene’s oncolytic virus for its Metastatic Advanced Solid Tumors (MAST) clinical trials testing the safety and efficacy of cancer-killing virus, CF33-hNIS (VAXINIA).

Building an association with ABL is a major milestone for Imugene to ensure the reliability of drug supply, which has been a significant barrier to the clinical development of many modern biological oncology drug candidates. IMU will be able to de-risk the vital element of clinical development now.

Importance of new partnership for IMU

Imugene has already commenced the clinical development of its oncolytic virus candidates, VAXINIA and CHECKVacc (CF33-hNIS-antiPDL1). These oncolytic virus candidates are based on the chimeric pox vaccinia platform, CF33, developed by Professor Yuman Fong, chairman of the Sangiacomo Family Chair in Surgical Oncology at the City of Hope Cancer Center in California (United States).

At the City of Hope, it has been demonstrated that the oncolytic virus can shrink ovarian, colon, pancreatic, lung, and breast cancer tumours in the preclinical laboratory and animal models.

Through a collaborative partnership with ABL, Imugene will secure access to ABL’s CDMO services. This will include a true end-toned solution with complete analytical support, the GMP production of vaccinia viruses, and drug product’s fill-finish with flexible development and manufacturing solutions.

Earlier, Imugene conducted its Phase I trial at the City of Hope’s Center for Biomedicine and Genetics. However, IMU has selected ABL, a CDMO that can provide added expertise and scale, to support its future drug product supply requirements, as IMU will require drug supply for extended later-phase clinical trials.

Key details of the agreement

• The five-year-long collaboration agreement stands effective immediately and will be executed following the contract terms.
• Funds for the collaboration will be sourced from existing resources.
• The first clinical batch of VAXINIA is likely to be delivered within the first year.
• Customary termination and intellectual property provisions for a contract manufacturing agreement are included in the agreement.

Imugene is eyeing a long-term association with ABL as a partner of choice. Imugene plans to keep the contract active throughout the life cycle of the CF33 platform. At present, Imugene is transferring the technology for the manufacturing and analytical processes to ABL so that ABL can deliver the first phase of the project with a cGMP batch of VAXINIA, which is anticipated to be produced and released in 2023.

An overview of ABL

ABL, a subsidiary of Institut Mérieux, is a pure play CDMO. The firm holds expertise in the development and production of solutions for biopharma. This includes viruses for gene therapies, oncolytic viruses, and vaccine candidates. However, ABL has a strong background in handling viruses, such as vaccinia, for which BSL-2 environments and aseptic conditions are essential.

ABL is driven by the mission to offer GMP viral vectors to the market from an early stage. Thus, helping its clients' immunotherapy and gene therapy innovations achieve success. Some CDMO services provided by ABL are: the manufacturing of the bulk drug substance, fill-finish of drug products, process and assay development, bioanalytical testing, and regulatory support.

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Imugene’s shares were trading at AU$0.182 each on 19 October 2022.