Highlights
- The strategic manufacturing and process development collaboration involves the sale of IMU's CGMP manufacturing facility in North Carolina to Kincell.
- Kincell will acquire the facility for up to US$6 million in upfront and milestone-driven payments.
- IMU anticipates US$32 million in savings over three years with staff cost reductions, manufacturing efficiencies, and overhead savings.
- Kincell will manufacture IMU's azer-cel to support its current clinical trials.
Imugene Limited (ASX: IMU) has entered into a strategic manufacturing and process development partnership with Kincell Bio, LLC. This collaboration includes the sale of IMU's Current Good Manufacturing Practice (CGMP) manufacturing facility located in North Carolina, along with transfer of the process and analytical development activities to Kincell.
Details of the strategic partnership
According to the asset purchase agreement between the parties, Kincell will acquire CGMP-compliant cell therapy manufacturing facility of IMU for up to US$6 million in upfront and milestone-driven payments.
The parties have entered into a manufacturing supply agreement, under which Kincell will manufacture IMU's azer-cel to support its current clinical trials. Additionally, Imugene will transfer azer-cel’s process and analytical development to Kincell to facilitate process and method optimisation for commercial readiness.
The CGMP-compliant facility, spanning 32,800 square foot, is designed to be flexible in capacity and scope. This flexibility allows for expansion to support the manufacture of various cell-based therapies.
Kincell plans to enhance the site's capabilities while leveraging its expertise across the enterprise to manufacture a wide range of autologous and allogeneic products.
Rationale for strategic partnership
The partnership allows Imugene to focus on its core capabilities of developing cancer treatments.
With this development, Imugene anticipates US$32 million in savings over the next three years, attributed to reductions in staff costs, enhanced manufacturing efficiencies, and decreased overhead expenses.
By outsourcing azer-cel process development to Kincell and transferring the manufacturing facility and staff, Imugene is streamlining operations, resulting in a 50% reduction in staff while extending its cash reserves until 2026.
This strategic collaboration in manufacturing and process development is aimed at bolstering the supply of azer-cel for IMU’s clinical studies.
Meanwhile, for Kincell, the acquisition of CGMP manufacturing facility accelerates its ability to broaden its service offerings for cell therapy developers. Kincell plans to increase its capability and commitment to offer top-notch development and manufacturing assistance for the immunocellular therapy market.
Additionally, the facility's position in Research Triangle Park (RTP) will provide easy access to skilled professionals in a rapidly expanding and appealing biotech centre.
IMU shares traded at AU$0.088 apiece at the time of writing on 16 April 2024.