Callan JMB Secures Oversight Role in Lodonal Phase 2b/3 Manufacturing Scale-Up
Callan JMB will provide independent infrastructure and oversight for U.S. scaling of the JKB-122 (Lodonal™) immune restoration platform as it enters Phase 2b/3 clinical development. Services include compliance alignment with BARDA, Defense and Veterans Affairs, packaging, serialization and traceability to support large-scale manufacturing and federal deployment readiness.
1. Collaboration Role and Scope
Callan JMB has joined a collaboration with DifGen Pharmaceuticals, Aveva Drug Delivery Systems and Attune Biotech to support U.S.-based tech transfer, formulation development and manufacturing scale-up for the JKB-122 (Lodonal™) immune restoration platform. The company will provide independent validation across manufacturing, quality systems, supply chain operations, packaging, serialization and traceability to ensure consistency, compliance and operational integrity.
2. Regulatory and Federal Standards Alignment
CJMB’s oversight services will align manufacturing and quality systems with requirements from BARDA, the Department of Defense and the Department of Veterans Affairs. This alignment covers documentation, controlled storage protocols and serialization processes designed to support potential federal deployment and large-scale commercial distribution.
3. Clinical Advancement and Multi-Indication Strategy
The Lodonal platform is advancing into Phase 2b/3 trials under an active IND, targeting post-acute sequelae of SARS-CoV-2 infection and additional indications such as autoimmune hepatitis, MASLD and MASH. A shared CMC framework and U.S.-based GMP manufacturing scale-up will enable multiple dose strengths, sustained-release formulations, pediatric programs and stability optimization.