Imugene Ltd (ASX:IMU, OTC:IUGNF) and Kincell Bio, LLC are joining forces in a manufacturing and process development deal, which includes Kincell acquiring Imugene’s Current Good Manufacturing Practice (CGMP)-compliant cell therapy manufacturing facility in North Carolina.
The transaction will allow Imugene to realise US$32 million in staff cost reductions – Imugene’s staff overheads will shrink by around 50% - and to make manufacturing efficiencies and overhead savings over the next three years.
Extended cash runway
The sale of the facility and its staff, and the outsourcing of Azer-cel process development will also extend the immuno-oncology innovator’s cash runway to 2026.
Additionally, both parties have inked a manufacturing supply agreement whereby Kincell will manufacture Imugene’s Azer-cel to support ongoing clinical trials.
Imugene will also transfer process and analytical development of Azer-cel to Kincell in order to support process and method optimisation for commercial readiness.
This will allow Kincell to expand its capacity and commitment to provide high-quality development and manufacturing support for the immunocellular therapy market, while the collaboration will support Imugene’s Azer-cel clinical study supply in Sydney and Gainesville, Florida.
About the facility
The 32,800-square-foot, state-of-the-art, CGMP-compliant facility is designed with the flexibility to expand in capacity and scope to support the manufacture of cell-based therapies.
Kincell Bio will stump up US$6 million for the facility upfront and will then make milestone-driven payments over the next three years. The company intends to grow the site's capabilities and leverage enterprise-wide expertise to manufacture a broad portfolio of autologous and allogeneic products.
Imugene managing director and CEO Leslie Chong said: “We are delighted to have found a strong partner for the development and manufacturing of our CAR T Azer-cel program.
“We are confident that this strategic partnership with Kincell will enable Imugene to reach key upcoming data inflection points and extend the company’s cash runway to 2026.
“Moreover, this partnership allows us to focus on our key capabilities, namely the development of novel cancer treatments.
“With the transaction, we look forward to continuing to work with many of our former manufacturing colleagues in a new relationship as our contract development and manufacturing organisation partner.”
Kincell CEO Bruce Thompson said: “The acquisition of this facility and experienced team, which is actively manufacturing CGMP-compliant products that can support late-stage and/or pivotal clinical trials, accelerates our ability to expand our service offerings for cell therapy developers.
“The facility’s location in Research Triangle Park (RTP) will facilitate access to talent in a fast-growing and attractive biotech hub.
“Additionally, we’re excited that the manufacturing supply agreement enables us to partner with Imugene, an innovative immunotherapy company, to optimise and progress an allogeneic CAR T product candidate into later-stage development for patients with significant unmet medical needs.”