On October 18, 2022 ABL, a pure play Contract Development and Manufacturing Organization (CDMO) with specialized expertise in the development and manufacturing of solutions for biopharma, including viruses for gene therapies, oncolytic viruses and vaccine candidates, and Imugene (ASX: IMU), a clinical stage immuno-oncology company developing a range of new treatments that seek to activate the immune system of cancer patients to identify and eradicate tumors, today announce their partnership (Press release, Imugene, OCT 18, 2022, View Source [SID1234622189]). ABL will manufacture Imugene’s oncolytic virus for its MAST (Metastatic Advanced Solid Tumors) clinical studies evaluating the safety and efficacy of the novel cancer-killing virus CF33-hNIS (VAXINIA).
ABL has a strong background in handling a broad range of viruses, such as vaccinia, which require work under BSL-2 environments and aseptic conditions. Through this collaboration, Imugene will gain access to ABL’s top-of-the-line CDMO services, providing a true end-to-end solution with comprehensive analytical support, GMP manufacturing of vaccinia viruses and fill-finish of the drug product, with customizable and flexible development and manufacturing solutions.
Imugene has started the clinical development of its oncolytic virus candidates VAXINIA and CHECKVacc (CF33-hNIS-antiPDL1). These are based on the chimeric pox vaccinia platform CF33, invented by Professor Yuman Fong, chairman of the Sangiacomo Family Chair in Surgical Oncology at the City of Hope Cancer Center in California (US). The City of Hope has shown that the oncolytic virus it developed can shrink colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models.
"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," said Leslie Chong, managing director and CEO of Imugene.
"ABL is honored 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 Thierry Van Nieuwenhove, CEO of ABL.
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"We look forward to working with Imugene in this collaborative partnership based on openness and transparency. This deal strengthens ABL’s reputation as a leading service provider of GMP vaccinia-based oncolytic viruses," said Karim Pirani, strategic business development at ABL.
Access to clinical drug product supplies which match and pair the clinical trial development plans with the regulatory requirements of phase II/III and registrational trials is a critical component of drug development. Imugene first used the City of Hope’s Center for Biomedicine and Genetics (CBG) for its phase I trial. However, to support its future drug product supply needs, that require an ample drug supply for extended later phase clinical trials, it selected ABL, a CDMO that can provide added expertise and scale.
Imugene plans to work with ABL as a partner of choice over the long-term, remaining active throughout the entirety of the CF33 platform’s life cycle. Imugene is currently transferring to ABL its technology for the manufacturing and analytical processes. ABL will then deliver the first phase of the project with a cGMP batch of VAXINIA targeted to be manufactured and released in 2023.
Oncolytic viruses are designed to selectively kill tumor 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 R&D for effective therapies are driving the expansion of the oncolytic virus therapy market.
Effective immediately, under the terms of the agreement the collaboration is funded from existing budgets and resources. The agreement is for a five-year term, noting that the delivery of the first clinical batch of VAXINIA is anticipated within 12 months. It includes customary termination and intellectual property provisions for a contract manufacturing agreement.