Business
DifGen Pharmaceuticals and Aveva Drug Delivery Systems Lead U.S. Technology Transfer and Platform Development Collaboration for Multi-Indication Immune Restoration Therapy with Active IND Programs and Phase 2b/3 Authorization in PASC
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.
About this update from Callan Jmb Inc.
[{"type":"text","content":"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.","length":436,"tagName":"p"},{"type":"text","content":"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.","length":319,"tagName":"p"},{"type":"text","content":"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.","length":256,"tagName":"p"},{"type":"text","content":"Clinical Development Programs and IND Status","length":44,"tagName":"p"},{"type":"text","content":"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.","length":189,"tagName":"p"},{"type":"text","content":"In addition, Biostax has pending IND submissions planned for:","length":61,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"HIV Immune Non-Responders (INR)","length":31,"tagName":"p"}]},{"val":[{"type":"text","content":"HIV Virologically Failing Therapy","length":33,"tagName":"p"}]},{"val":[{"type":"text","content":"Chronic Pain associated with immune dysfunction","length":47,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":111,"olType":false},{"type":"text","content":"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.","length":182,"tagName":"p"},{"type":"text","content":"PASC Program – Fast Track and EUA Filed; FDA Study May Proceed Received","length":71,"tagName":"p"...