MIRAMAR, Fla., March 25, 2026 /PRNewswire/ — DifGen Pharmaceuticals and Aveva Drug Delivery Systems have unveiled a significant strategic collaboration with Biostax Corp, operating as Attune Biotech, SGP Holdings, and Callan JMB. This partnership aims to lead the U.S.-based technology transfer, platform formulation development, and manufacturing scale-up for the JKB-122 upstream immune restoration platform.
The collaboration encompasses the technology transfer of Biostax’s FDA-reviewed Chemistry, Manufacturing, and Controls (CMC) programme. It establishes platform manufacturing and formulation control across all dosing strengths, which range from 0.05 mg to 35 mg, including both immediate-release and sustained-release formulations.
This collaboration signifies the evolution of JKB-122 from a single-indication development programme to a comprehensive platform-based development and manufacturing initiative, designed to support multiple clinical indications under a unified CMC and regulatory framework.
Clinical Development Programs and IND Status
Biostax is currently advancing a range of clinical programmes under the JKB-122 platform, which include:
- Post-Acute Sequelae of SARS-CoV-2 (PASC / Long COVID)
- Autoimmune Hepatitis
- MASLD
- MASH
Additionally, Biostax has pending Investigational New Drug (IND) submissions planned for:
- HIV Immune Non-Responders (INR)
- HIV Virologically Failing Therapy
- Chronic Pain associated with immune dysfunction
These initiatives are supported by a shared CMC, pharmacology, and safety platform, which facilitates the development of multiple indications under a unified regulatory and manufacturing framework.
PASC Program – Fast Track and EUA Filed
The lead programme for this platform is PASC (Long COVID). The company has filed for Fast Track designation and Emergency Use Authorization (EUA) and is currently awaiting a response from the agency.
The FDA has completed its review of the Phase 2b/3 protocol and has communicated to the company:
“We have completed the review of your IND and concluded that it is reasonably safe to proceed with your proposed Phase 2b/3 study, as amended. We will issue the Study May Proceed letter with non-hold comments by April 20th.”
This authorisation permits the company to advance into its Phase 2b/3 clinical programme for PASC.
Platform Formulation Strategy
DifGen and Aveva are spearheading the technology transfer and expansion of platform formulation and manufacturing across all dosing strengths, including:
- Immediate-release titration doses: 0.05 mg to 5 mg
- Maintenance dosing platform
- Sustained-release formulations: 10 mg and 35 mg
- Pediatric dosing programmes
- Stability and shelf-life optimisation
- U.S.-based GMP manufacturing and commercial scale-up
This platform approach enables a unified pharmaceutical and manufacturing system to support various diseases and dosing strategies while ensuring regulatory and manufacturing consistency.
Sustained-Release Program for MASLD/MASH Under 505(b)(2)
DifGen and Aveva are facilitating the development of sustained-release formulations (10 mg and 35 mg) for MASLD and MASH under the FDA 505(b)(2) regulatory pathway. This approach allows the programme to leverage existing safety and pharmacology data while developing new formulations and indications.
Third-Party Oversight and Federal Program Readiness
Callan JMB will provide independent third-party oversight and validation of manufacturing, quality systems, and supply chain operations. This is crucial for compliance with federal programme requirements, including BARDA, the Department of Defense, and the Veterans Administration.
Independent third-party validation is vital for ensuring compliance with current Good Manufacturing Practices (cGMP) across multiple dose strengths and formulations, supporting federal procurement and deployment initiatives.
Conclusion
The JKB-122 platform is set to address a variety of chronic diseases characterised by immune dysregulation and chronic inflammation. By focusing on upstream immune pathways, therapies such as JKB-122 may provide innovative solutions across multiple conditions, enhancing the potential for improved patient outcomes.