New Hope For Dementia Including Alzheimer’s Disease
In 2023, FDA authorized TrueBinding to provide TB006 through an expanded access program allowing early access to this promising investigational treatment, and was renewed in 2024 and 2025.
Our Mission: Revolutionizing Patient Care
TrueBinding is optimizing patient care through its revolutionary pipeline of monoclonal antibody therapeutics, providing targeted treatments for a diverse range of diseases and medical conditions. By harnessing the power of our proprietary platform technology, we rapidly develop and deliver highly specific and effective monoclonal antibodies—ushering in a new era of precision medicine that holds the promise of improved patient outcomes and enhanced therapeutic options.
As part of our commitment to expanding access to innovative treatments, TrueBinding received FDA approval in 2023 for an Expanded Access Program (EAP) under an Intermediate-Size Patient Protocol—the only one of its kind approved that year. This program, renewed in 2024 and 2025, enables eligible patients with serious or life-threatening conditions to access promising investigational therapies when no comparable alternatives exist.
TB006 is made available exclusively through an FDA-authorized Expanded Access Program and clinical trials. The safety and effectiveness of TB006 have not been established in the broader patient population.
Through bold innovation and patient-focused development, TrueBinding is redefining what’s possible in biotherapeutics.
Accelerating Biopharmaceutical Innovation
TrueBinding's contract development and manufacturing services offer unparalleled benefits for clients in the biopharmaceutical industry. By leveraging our advanced technology and expertise, our teams can accelerate the development process, ensuring rapid and efficient production of high-quality monoclonal antibodies, ultimately enabling clients to bring their innovative therapies to market faster and more cost-effectively.
TB006 Expanded Access Program
TThe FDA-authorized Expanded Access Program (EAP) for investigational TB006 permits eligible patients with dementia, including Alzheimer’s disease to request access to the product outside of clinical trials. The program is intended for patients with serious or life-threatening conditions who are unable to participate in clinical studies and who lack satisfactory alternative treatment options.
TB006 is an investigational drug, and its safety and effectiveness have not been established. The Expanded Access Program operates in accordance with FDA regulations while clinical development of TB006 continues.
Completion of Phase 1b/2a Clinical Trial for Alzheimer's Disease
Topline data from a one-month TB006 treatment regimen shows improvements in Clinical Dementia Rating-Sum of Boxes (CDR-SB) in patients, indicating the potential of slowing or reducing clinical decline. Key secondary endpoints were consistent with the primary findings.
Latest News
April, 2025
The FDA has renewed the Expanded Access Program (NCT05959239) for TB006 in treating dementia and Alzheimer's disease. This renewal allows existing patients to continue receiving TB006 outside of traditional clinical trials and offers hope for patients seeking alternative treatment options.
November, 2025
In a recent abstract published in Neuro-Oncology, TrueBinding partnered with UCSF to present new findings under a supplement of the journal’s 2025 volume.
Vo A. H., Yang E., Raleigh D. R., Lan N., Savic R., Butowski N. “TIP-02. Evaluation of TB006, a Galectin-3 antibody, for the treatment of Glioblastoma.” Neuro-Oncology, vol. 27, supplement 5, Nov. 2025, p. v420.
Nov 18, 2024
TrueBinding has cleared an FDA IND application for TB006 for potential disease modification of Parkinson’s Disease. A multi-center, placebo-controlled, Phase 2A trial (NCT06773962) of TB006 in the U.S. will be evaluating the safety and efficacy of this treatment in patients with early to mild Parkinson’s Disease.