Independent oversight reinforces manufacturing, supply chain integrity, and federal readiness for a platform designed to scale across multiple indications
SPRING BRANCH, Texas, March 27, 2026 (GLOBE NEWSWIRE) -- Callan JMB Inc. (NASDAQ: CJMB) (“Callan JMB” or the “Company”), an integrative logistics and operational infrastructure company empowering the healthcare industry and emergency management agencies through fulfillment, storage, monitoring, and cold chain logistics services, today announced its role as an independent infrastructure and oversight partner in a collaboration led by DifGen Pharmaceuticals and Aveva Drug Delivery Systems, alongside Biostax Corp (“Biostax”), doing business as Attune Biotech (“Attune”), and SGP Holdings. The collaboration supports U.S.-based technology transfer, formulation development, and manufacturing scale-up for the JKB-122 (Lodonal™) immune restoration platform.
Callan JMB’s role focuses on independent validation across manufacturing, quality systems, and supply chain operations—helping ensure consistency, compliance, and readiness as the program advances toward Phase 2b/3 clinical development and potential large-scale manufacturing and deployment. This includes alignment with federal standards associated with agencies such as the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. This support may also include packaging, serialization, and product traceability coordination to support regulatory compliance and potential federal deployment requirements.
Independent third-party oversight helps ensure compliance, documentation, and operational integrity across clinical, government, and commercial healthcare programs, particularly those involving regulated manufacturing, controlled storage, product traceability, and coordinated distribution infrastructure.
The work builds on Callan JMB’s previously announced agreement supporting Attune’s multi-asset therapeutic pipeline and reflects the Company’s expanding role supporting regulated healthcare programs that require compliant logistics, manufacturing oversight, and operational infrastructure capable of supporting clinical development, commercialization, and government program deployment.
Wayne Williams, President and Chief Executive Officer of Callan JMB, stated: “Callan JMB has deep experience supporting complex, regulated programs where execution, compliance, and visibility are critical. Our role is to provide independent infrastructure and oversight across manufacturing, storage, monitoring, packaging, and distribution—helping ensure these programs are built to scale and ready for real-world clinical, commercial, and government deployment.”
Biostax is advancing programs in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), Autoimmune Hepatitis (AIH), Metabolic Dysfunction–Associated Steatotic Liver Disease (MASLD), and Metabolic Dysfunction–Associated Steatohepatitis (MASH), with additional programs planned in HIV immune non-responders, HIV virologically failing therapy, and chronic pain associated with immune dysfunction. These programs are supported by a shared CMC, pharmacology, and safety framework designed to enable development across multiple indications using a platform-based approach.
Noreen Griffin, Chief Executive Officer of Biostax Corp d/b/a Attune Biotech, said: “This marks an important step in advancing our program into a platform model. Establishing U.S.-based manufacturing and a unified CMC framework creates the foundation for multi-indication development and future commercialization. Callan JMB was selected for its ability to provide independent oversight across manufacturing and supply chain systems—helping ensure the level of rigor, compliance, and readiness required for federal programs and large-scale deployment.”
The lead PASC program for JKB-122 (Lodonal™) has received FDA authorization to proceed under an active Investigational New Drug application, with a Phase 2b/3 clinical study designed to evaluate immune restoration and functional recovery in post-infectious illness. The platform strategy includes development across multiple indications supported by shared manufacturing and regulatory infrastructure.
DifGen Pharmaceuticals and Aveva Drug Delivery Systems are leading formulation development and manufacturing expansion across multiple dose strengths, titration and maintenance regimens, sustained-release formulations, pediatric programs, and stability optimization, supported by U.S.-based GMP manufacturing scale-up.
Ramandeep Singh Jaj and Santhanakrishnan Srinivasan, Founders and Co-CEOs of DifGen Pharmaceuticals, stated: “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.”
The collaboration reflects broader industry momentum toward platform-based therapeutic development and integrated manufacturing strategies designed to support multiple indications, scalable manufacturing, and coordinated distribution infrastructure.
About Callan JMB Inc.
Callan JMB Inc. (NASDAQ: CJMB) is a vertically integrated logistics and operational infrastructure company empowering the healthcare industry and emergency management agencies through fulfillment, storage, environmental monitoring, cold chain logistics, packaging, serialization, and supply chain coordination services. The Company supports regulated healthcare programs requiring compliant logistics, controlled environments, product traceability, and operational infrastructure for clinical development, commercial distribution, and government program deployment. Callan JMB’s expertise spans supply chain logistics, thermodynamics, biologics, inventory management, regulatory compliance, and emergency preparedness, providing secure and reliable infrastructure for critical healthcare programs.
About Biostax Corp d/b/a Attune Biotech Inc.
Biostax Corp d/b/a Attune Biotech Inc. (“Attune”) is a clinical-stage biotechnology company with a diversified pipeline of therapeutic assets and fully U.S.-based cGMP manufacturing capability. The company's lead program, Lodonal™ (JKB-122), is an immune restoration therapeutic platform designed to restore immune homeostasis and is being developed across multiple clinical indications. The company leverages 505(b)(2) regulatory strategies, platform manufacturing, and strategic public-private partnerships to advance capital-efficient drug development and scalable therapeutic platforms.
About DifGen Pharmaceuticals / Aveva Drug Delivery Systems
DifGen Pharmaceuticals and Aveva Drug Delivery Systems are U.S.-based pharmaceutical development and manufacturing organizations specializing in formulation development, drug delivery technologies, and GMP manufacturing scale-up. The organizations support platform-based drug development programs across multiple dosage forms, strengths, and release profiles, supporting clinical development and commercial manufacturing.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the development, manufacturing, scale-up, and potential deployment of JKB-122 (Lodonal™), and Callan JMB’s role in supporting manufacturing oversight, logistics infrastructure, and regulated healthcare and government programs. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in these statements. These risks and uncertainties include, but are not limited to, regulatory approvals, clinical development outcomes, manufacturing scale-up, government program participation, and other factors described in Callan JMB’s filings with the U.S. Securities and Exchange Commission. Callan JMB undertakes no obligation to update any forward-looking statements except as required by law.
Investor Contacts:
Valter Pinto, Managing Director
KCSA Strategic Communications
CallanJMB@kcsa.com
212.896.1254
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