Callan JMB to Oversee Manufacturing and Quality Control for Attune’s Lodonal™ IND 181314
Callan JMB has agreed to oversee manufacturing, quality assurance and supply chain validation for Attune Biotech’s IND 181314 for JKB-122 (lodonal™) in Phase 2b/3 Long COVID trials. The FDA assigned this IND to study immune restoration in an estimated 20 million U.S. patients underserved by current therapies.
1. Partnership Agreement with Attune
Callan JMB signed an agreement to serve as independent third-party overseer for Attune Biotech’s investigational new drug (IND) application 181314 for JKB-122 (lodonal™), targeting Post-Acute Sequelae of SARS-CoV-2 infection (Long COVID). The collaboration builds on a strategic teaming agreement executed in January 2026.
2. Scope of Manufacturing and Quality Control
Under the contract, Callan JMB will execute CMO qualification and validation, perform comprehensive batch record reviews, verify supply chain integrity, assess surge manufacturing capacity, and validate distribution pathways to ensure compliance with federal regulations.
3. Clinical Trial and Market Opportunity
The FDA has assigned IND 181314 for a randomized, double-blind, placebo-controlled Phase 2b/3 trial evaluating safety, tolerability, and efficacy of lodonal™ in adults with Long COVID. Approximately 20 million Americans suffer persistent post-COVID symptoms, representing a significant underserved market with no approved therapies.