MIRAMAR, Fla., March 25, 2026 /PRNewswire/ -- DifGen Pharmaceuticals and Aveva Drug Delivery Systems today announced a strategic platform collaboration with Biostax Corp d/b/a Attune Biotech, SGP Holdings, and Callan JMB to lead U.S.-based technology transfer, platform formulation development, manufacturing scale-up, and support future clinical development programs for the JKB-122 upstream immune restoration platform.

The collaboration includes the technology transfer of Biostax's FDA-reviewed Chemistry, Manufacturing, and Controls (CMC) program and establishes platform manufacturing and formulation control across all dosing strengths ranging from 0.05 mg to 35 mg, including immediate-release and sustained-release formulations.

This collaboration represents the transition of JKB-122 from a single-indication development program into a platform-based development and manufacturing program designed to support multiple clinical indications under a unified CMC and regulatory framework.

Clinical Development Programs and IND Status

Biostax is currently advancing multiple clinical programs under the JKB-122 platform, including Post-Acute Sequelae of SARS-CoV-2 (PASC / Long COVID), Autoimmune Hepatitis, MASLD, and MASH.

In addition, Biostax has pending IND submissions planned for:

• HIV Immune Non-Responders (INR)
• HIV Virologically Failing Therapy
• Chronic Pain associated with immune dysfunction

These programs are supported by a shared CMC, pharmacology, and safety platform, allowing multiple indications to be developed under a unified regulatory and manufacturing framework.

PASC Program – Fast Track and EUA Filed; FDA Study May Proceed Received

The lead program for the platform is PASC (Long COVID). The company has filed for Fast Track designation and Emergency Use Authorization (EUA) and is currently awaiting agency response.

The FDA has completed review of the Phase 2b/3 protocol and has informed 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 authorization allows the company to proceed into its Phase 2b/3 clinical program for PASC.

Platform Formulation Strategy Across 0.05 mg to 35 mg

DifGen and Aveva are leading 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 programs
• Stability and shelf-life optimization
• U.S.-based GMP manufacturing and commercial scale-up

This platform approach allows a single pharmaceutical and manufacturing system to support multiple diseases and dosing strategies while maintaining regulatory and manufacturing consistency.

Sustained-Release Program for MASLD/MASH Under 505(b)(2)

DifGen and Aveva are supporting development of sustained-release formulations (10 mg and 35 mg) for MASLD and MASH under the FDA 505(b)(2) regulatory pathway, allowing the program 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, supporting compliance with federal program requirements, including BARDA, the Department of Defense, and the Veterans Administration.

Independent third-party validation is an important component of ensuring cGMP compliance across multiple dose strengths and formulations and supporting federal procurement and deployment programs.

Executive Statements

Ramandeep Singh Jaj and Santhanakrishnan Srinivasan, Founders and Co-CEOs of DifGen Pharmaceuticals, commented:

"We are very excited to be part of this collaboration and to support the advancement of what we believe is a highly innovative upstream immune restoration platform. This program is unique in that it is built around a platform formulation and manufacturing strategy across multiple dose strengths and multiple indications. As the platform expands into additional indications, we look forward to supporting not only manufacturing and formulation development, but also a broader role in supporting future clinical development programs built on this platform."

Ms. Noreen Griffin, President of Biostax Corp d/b/a Attune Biotech, added:

"This collaboration represents an important step in the evolution of our program from a single-indication development effort into a true platform therapeutic program. By transferring our FDA-reviewed CMC program and establishing U.S.-based manufacturing and formulation control across all dosing strengths, we are building the foundation necessary to support multiple clinical indications, federal programs, and future commercialization. We believe this upstream immune restoration platform has the potential to address multiple diseases driven by immune dysregulation and chronic inflammation, and this collaboration provides the manufacturing, formulation, and oversight infrastructure necessary to support that vision."

Why Upstream Immune Restoration Matters

Many chronic diseases, including Long COVID, HIV immune dysfunction, MASLD/MASH, autoimmune diseases, and chronic pain syndromes, are increasingly understood to be driven not only by the primary disease trigger but by persistent immune dysregulation and chronic inflammation. By targeting upstream immune pathways and restoring immune balance rather than targeting a single downstream disease pathway, platform therapies such as JKB-122 may have the potential to be used across multiple diseases where immune dysfunction is a central driver of disease progression.

This platform-based approach may allow a single therapeutic and formulation platform to be developed across multiple indications, potentially improving development efficiency, manufacturing scalability, and patient access across a range of chronic inflammatory and immune-mediated diseases.

Media Contact:

DifGen Pharmaceuticals / Aveva Drug Delivery Systems
Roberta Loomar
Title: Global General Counsel
Email ID: 411095@email4pr.com
Phone: +1 (954) 605 1796

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SOURCE DifGen Pharmaceuticals LLC