On April 16, 2024 Imugene, Ltd. ("Imugene")(ASX: IMU) and Kincell Bio, LLC ("Kincell"), reported a strategic manufacturing and process development partnership, which includes the sale of Imugene’s North Carolina Current Good Manufacturing Practice (CGMP) manufacturing facility and the transfer of process and analytical development activities to Kincell (Press release, Imugene, APR 16, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/3e21bcbd-4451-a69a-db91-69476faaf963/Imugene_and_Kincell_Bio_Announce_Strategic_Partnership.pdf [SID1234642076]).
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Under the terms of an asset purchase agreement between Imugene and Kincell, Kincell will acquire Imugene’s CGMP-compliant cell therapy manufacturing facility in North Carolina for a total consideration of up to $6M USD in upfront and milestone-driven payments. Both parties have entered into 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 optimization for commercial readiness.
Leslie Chong, Managing Director and Chief Executive Officer of Imugene, commented, "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 organization partner."
Bruce Thompson, CEO of Kincell, 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 optimize and progress an allogeneic CAR T product candidate into later-stage development for patients with significant unmet medical needs."
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 intends to evolve the site capabilities while leveraging enterprise-wide expertise to manufacture a broad portfolio of autologous and allogeneic products.