Callan JMB Inc. to Oversee Manufacturing and Quality Control of Attune Biotech's IND Clinical Trials for lodonal™ in the Treatment of Long COVID
Callan JMB will Provide Independent Manufacturing Oversight and Governance as lodonal™ Undergoes Clinical Trials for Underserved Patient Population
SPRING BRANCH, Texas, March 11, 2026 (GLOBE NEWSWIRE) -- Callan JMB Inc. (NASDAQ:CJMB), ("Callan JMB" or the "Company"), an integrative logistics company empowering the healthcare industry and emergency management agencies through fulfillment, storage, monitoring, and cold chain logistics services, today announced that it has agreed with Biostax Corp d/b/a Attune Biotech Inc. ("Attune"), a clinical-stage biopharmaceutical company with a diversified therapeutic pipeline, to support its investigational new drug clinical trials for the treatment of Post-Acute Sequelae of SARS-CoV-2 infection ("PASC"), commonly known as Long COVID.
The Company previously announced in January 2026, that it had signed a strategic teaming agreement with Attune, whereby Callan JMB serves as independent third-party overseer of Attune's manufacturing, quality assurance and control, and deployment operations. Under this agreement, Callan JMB will provide the following services and oversight for IND 181314 for JKB-122 (lodonal™), including Contract Manufacturing Organization (CMO) qualification and validation, comprehensive batch record review, supply chain verification and integrity confirmation, surge manufacturing capacity assessment, and distribution pathway validation.
Attune has received notification that the U.S. Food and Drug Administration (FDA) has received and assigned Investigational New Drug (IND) application number 181314 for JKB-122 (lodonal™) for treatment of Long COVID, which remains a condition for which no FDA-approved therapies are currently indicated. Patients of Long COVID are currently underserved, with approximately 20 million Americans estimated to be living with Long COVID or persistent post-COVID symptoms1. In addition, the U.S. Department of Health and Human Services (HHS) has issued formal guidance titled "Long COVID as a Disability Under the ADA, Section 504, and Section 1557" (last reviewed July 2025), confirming that Long COVID may qualify as a disability under federal civil rights statutes where symptoms substantially limit major life activities.
"When we signed the agreement with Attune at the beginning of the year, we were excited by the potential that several of their products demonstrate to address conditions that remain significantly underserved, such as Long COVID," said Wayne Williams, Founder and Chief Executive Officer of Callan JMB. "This is the latest step in the development of their product pipeline, and we are proud to serve as the overseer of their manufacturing and governance. The development of these types of products is critical to addressing these underserved conditions, and with our experience managing federal health programs, we can help accelerate this work efficiently while ensuring compliance with federal regulations."
"Our partnership with Callan JMB is essential to the work we are doing, ensuring that we meet the stringent guidelines set out by the federal government, as we undergo this next phase in the development of lodonal™ for the treatment of Long COVID," said Noreen Griffin, Chief Executive Officer of Attune. "With their long-standing federal relationships and experience as well as proven operational framework, Callan JMB is uniquely suited to support the continued advancement of our development pipeline and the launch of upcoming clinical trials."
lodonal™ (JKB-122) is a first-in-class TLR4 antagonist for immune restoration, currently in development across five parallel clinical programs including Long COVID, HIV immune non-responders, autoimmune hepatitis, metabolic liver diseases (MASLD/MASH), and chronic immune pain. Under IND 181314, Attune intends to initiate a randomized, double-blind, placebo-controlled, multi-center Phase 2b/3 clinical trial evaluating the safety, tolerability, and efficacy of JKB-122 (lodonal™) in adults diagnosed with PASC or Long COVID. The product remains investigational and has not been approved by the U.S. Food and Drug Administration. JKB-122 is protected by issued intellectual property extending through 2041.
About Callan JMB Inc.
Callan JMB Inc. is a vertically integrated logistics company empowering the healthcare industry and emergency management agencies through fulfillment, storage, monitoring, and cold chain logistics services to secure medical materials and protect patients and communities with compliant, safe, and effective medicines. Our combined expertise in supply chain logistics, thermodynamics, biologics, inventory management, regulatory compliance and emergency preparedness is unparalleled in the industry. We offer a gold standard in client experience with customizable interfaces, next-level reliability in shipping and environmental sustainability in our specialty packaging.
About Biostax Corp d/b/a Attune Biotech Inc.
Biostax Corp, operating as Attune Biotech, is a clinical-stage biotechnology company developing JKB-122 (lodonal™) as a host-directed immunomodulatory therapy designed to recalibrate dysregulated innate immune signaling. The company focuses on diseases characterized by chronic inflammation, immune dysfunction, and persistent inflammatory signaling. Attune advances its programs through established regulatory pathways, validated CMC standards, biomarker-informed development strategies, and intellectual property protection extending through 2041.
Forward-Looking Statement
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act") (which Sections were adopted as part of the Private Securities Litigation Reform Act of 1995). Statements preceded by, followed by or that otherwise include the words "believe," "anticipate," "estimate," "expect," "intend," "plan," "project," "prospects," "outlook," and similar words or expressions, or future or conditional verbs, such as "will," "should," "would," "may," and "could," are generally forward-looking in nature and not historical facts. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the Company's actual results, performance, or achievements to be materially different from any anticipated results, performance, or achievements for many reasons. The Company disclaims any intention to, and undertakes no obligation to, revise any forward-looking statements, whether as a result of new information, a future event, or otherwise. For additional risks and uncertainties that could impact the Company's forward-looking statements, please see the Company's Registration Statement Under the Securities Act of 1933 on Form S-1, including but not limited to the discussion under "Risk Factors" therein, which the Company filed with the SEC and which may be viewed at http://www.sec.gov/.
Investor Contacts:
Valter Pinto, Managing Director
KCSA Strategic Communications
[email protected]
212.896.1254
1 Yale Medicine. Long COVID: Economic and Public Health Impact Overview, 2023.
