In the News
November 18, 224 - TrueBinding has cleared an FDA Investigational New Drug (IND) application for TB006, for potential disease modification of Parkinson’s Disease.
“FDA IND approval for TB006 is a major achievement for TrueBinding and a significant potential advancement for the treatment of Parkinson’s Disease worldwide,” said Alan K. Jacobs, M.D., FAAN, Chief Medical Officer of TrueBinding. “This first-in-class therapy harnesses the power of antibody selectivity to target the protein, Galectin-3, offering a promising new option for patients with no available disease-modifying treatment options.”
A multi-center, placebo-controlled, Phase 2A trial (NCT) 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. The trial will enroll adults aged 50 to 80 years of age who have confirmed Hoehn and Yahr grade 1 or 2 Parkinson’s Disease, less than five (5) years since diagnosis, and currently on no other Parkinson’s Disease medications or only immediate-release Levodopa-containing therapy. The estimated enrollment for the trial is 62 patients, and the estimated primary completion date is Q1 2026.
July 9, 2024 - TrueBinding Inc's TB006 Receives FDA Approval for Investigator Initiated Trial (IIT) in Adult Autism Spectrum Disorder (NCT06500637)
TrueBinding Inc. has achieved a major milestone by receiving FDA approval for the Investigational New Drug (IND) application of TB006 to treat adult Autism Spectrum Disorder (ASD). This clinical trial, which is multi-center, double-blind, and placebo-controlled, aims to evaluate the safety and effectiveness of TB006 in addressing core symptoms of ASD in adults.
Immune dysregulation and persistent neuroinflammation, often marked by increased microglial activation, are key molecular mechanisms associated with ASD. Galectin-3 (Gal-3), a galactoside-binding lectin, is crucial in driving neuroinflammation and the proliferation of microglia. TrueBinding has developed TB006, a monoclonal antibody designed to neutralize Gal-3. The NCT06500637 identifier will assist in monitoring and documenting the trial’s progress, helping to advance knowledge and treatment strategies for ASD.
May 26, 2024 - TrueBinding Inc's TB006 Receives FDA Renewal Approval for Expanded Access Program (NCT05959239)
In May 2023, the FDA granted the initial approval for the use of TB006 in treating patients with dementia and Alzheimer’s disease under the Compassionate Use, or the Expanded Access Program (EAP). This milestone marked a significant advancement in the treatment options available for patients with no other medical treatment. Following this, the FDA reviewed the EAP protocol again and, in May 2024, approved the renewal. This renewal underscores the ongoing confidence in the efficacy and safety of TB006 and reflects continued support for its use in managing dementia and Alzheimer’s disease.
April, 2024 - TrueBinding Inc's TB006 Receives Hong Kong Department of Health’s Approval for Named Patient Program
In April 2024, the Hong Kong Department of Health approved the Named Patient Program (NPP) for the use of TB006 in treating patients with dementia or Alzheimer’s disease. TrueBinding is dedicated to assisting patients around the globe and offering hope to those who have exhausted other treatment options by providing access to our innovative investigational drug. The program is currently actively recruiting patients. For more information, please click here.
November 03, 2023 - NewsBreak- TrueBinding EAP Program Makes Treatment Available to Alzheimer’s Patients & it’s Making a Difference
TrueBinding's Alzheimer's drug candidate, TB006, has shown promising results in a phase 2a clinical trial by not only slowing disease progression but also improving cognition and function in patients with moderate to severe forms of Alzheimer's after one month of treatment. A follow-up Open Label Extension (OLE) study confirmed these positive outcomes, revealing that 47 percent of participants completing a three-month treatment program showed signs of disease reversal or cognitive improvement. To address the long FDA approval process, TrueBinding obtained authorization for an Expanded Access Program (EAP), allowing compassionate use of TB006 for patients before formal approval. The EAP is essential for patients with advanced Alzheimer's who may be excluded from ongoing clinical trials due to disease progression. TB006 has demonstrated the potential to both slow and reverse Alzheimer's without significant side effects, offering hope to patients and caregivers facing the challenges of the disease.
November 03, 2023 - Valiant CEO- Charting a New Course in Alzheimer’s Treatment: Dongxu Sun’s Story
In this interview with Dongxu Sun, CEO of TrueBinding, the focus is on their groundbreaking approach to Alzheimer's Disease (AD) treatment. TrueBinding's TB006, a monoclonal antibody drug, demonstrated the remarkable ability to reverse memory loss in AD animal models, a significant advancement. Their successful clinical trial in 2021 for AD patients has brought renewed hope for those suffering from the disease. Dongxu Sun reflects on the importance of early business advice and expresses his goal of acquiring capital for upcoming clinical trials. He acknowledges the need for constant innovation in drug development and shares that flexibility and adaptation based on scientific progress are often underestimated aspects of running a company. For him, success in 2023 means successfully conducting the first clinical trial, which boosts his confidence to develop innovative drugs for various diseases and improve the lives of patients through pioneering treatments.
October 23, 2023 - Healthcare Business Today- You Can’t Reverse Aging, But TrueBinding May Be Able To Reverse Alzheimer’s
TB006 is an investigational Alzheimer's medication developed by TrueBinding, currently in clinical trials and an Expanded Access Program (EAP). What sets it apart is its potential to reverse Alzheimer's symptoms without significant side effects. With the aging U.S. population, there's a growing need for healthcare and resources to promote healthy aging, including early Alzheimer's screening. In 2023, other Alzheimer's treatments like lecanemab and donanemab aim to slow the disease but come with serious side effects and cannot reverse it. TB006's promising results in improving cognition and function offer hope for changing the course of Alzheimer's, potentially redefining healthy aging and offering more graceful and independent aging opportunities.
October 19, 2023 - California Business Journal - How TrueBinding Is Making A Change In The Way People View An Alzheimer’s Disease Diagnosis
A team of researchers at TrueBinding, Inc., based in Foster City, California, is working on a potential treatment, TB006, for Alzheimer's Disease, which currently has no approved cure. Alzheimer's is a slow-progressing dementia that robs patients of memories, cognition, motor skills, and self-management, affecting more than 5.8 million Americans. Existing treatments focus on slowing the progression of the disease, but they come with undesirable side effects and do not reverse the damage caused. In contrast, TB006 aims to both slow and reverse Alzheimer's effects. Early results from a Phase 2a clinical trial showed improvements in brain function and cognition with minimal side effects. A follow-up study saw around 47% of participants showing signs of disease reversal or cognitive improvement after three additional months of treatment. TB006 is currently available through an Expanded Access Program, offering hope to Alzheimer's patients and their families.
July 11, 2023 - WESH 2 News Today - Clinical Trial Offering Hope for Local Alzheimer’s Patients
A Central Florida family dealing with Alzheimer's disease has finally received an opportunity for treatment after multiple attempts to join a study. Cheryl and Ron Hogrefe have been managing Cheryl's condition since her diagnosis in 2016. Inspired by Cheryl's caregiving for her own mother with Alzheimer's, Ron has taken on the role of caregiver. Cheryl recently joined a clinical trial for TB006, an antibody-based therapy designed to block toxic proteins and reduce inflammation in the brain. Under the care of Dr. Malisa Agard, Cheryl's cognitive abilities have shown signs of improvement, providing hope for the couple and potentially paving the way for future treatments for Alzheimer's patients.
April 21, 2023 - Alzheimer’s News Today - Disease Reversal and Cognitive Improvement
TrueBinding's investigational therapy TB006 has shown promising results in a study involving Alzheimer's disease patients. Nearly half of the patients treated with TB006 for three months or longer showed signs of disease reversal or cognitive improvement. The study builds upon previous data from a Phase 2a trial that demonstrated clinical improvement with TB006 but did not reach statistical significance compared to a placebo. [The reduction in CDR-SB score by TB006 compared to the placebo had a p-value of 0.08, 0.03 points higher than the statistically significant p-value of 0.05.] TrueBinding plans to discuss the data with the FDA to expedite the therapy's development. TB006 is an antibody-based therapy designed to block Galectin-3, a protein associated with the formation of toxic protein aggregates and inflammation in Alzheimer's disease. Preclinical studies have indicated that TB006 can reduce aggregation and inflammation while improving cognitive performance. The company intends to conduct a Phase 2b study to further investigate the potential of TB006 in treating Alzheimer's disease.
March 28, 2023 - Cision PR Newswire - Disease Reversal in Just Three Months
TrueBinding, a biotherapeutic company, announced early results from an Open-Label Extension (OLE) study of its TB006 drug for Alzheimer's Disease. The study showed potential for disease reversal and sustained clinical benefits beyond the drug's phase 2a trial success, with a significant number of participants experiencing disease stabilization or improvement. The company plans to discuss these results with the FDA in hopes of a rapid development pathway for TB006.
February 28, 2023 - Type B, End of Phase 2, FDA Meeting Granted
The FDA has granted TrueBinding a Type B, end of phase 2, teleconference face-to-face meeting. This meeting will focus on discussing the rapid development pathway for their drug, TB006, in the treatment of Alzheimer's disease. TrueBinding has completed phase 2 clinical trials and seeks to accelerate the drug's approval process. The meeting will involve presenting data on the drug's efficacy and safety, as well as its potential benefits for Alzheimer's patients. By granting this meeting, the FDA shows a willingness to collaborate with TrueBinding and provide guidance on the next steps for regulatory clearance.
December 6, 2022 - TrueBinding's TB006 Antibody Shows Promise in Treating Alzheimer's Disease
TrueBinding Inc., a clinical-stage biotherapeutics company, presented data on their investigational monoclonal antibody, TB006, at the Clinical Trials on Alzheimer's Disease (CTAD) Conference. In a Phase 1b/2 trial involving patients with mild to severe Alzheimer's disease (AD), TB006 showed improvements in cognition and function and was well tolerated. The antibody also demonstrated positive results in PET and MR imaging, indicating dissolution of toxic amyloid plaque. TB006 targets Galactin-3 (Gal-3), a protein involved in the aggregation of pathogenic factors in AD. The company is encouraged by the early clinical data and aims to potentially reverse the course of AD. Further studies are underway to assess long-term safety and efficacy.
November 11, 2022 - TrueBinding's TB006 Shows Remarkable Improvements in Cognition and Function in Alzheimer's Disease Trial
TrueBinding Inc. has announced the exciting results of its Phase 1b/2 proof-of-concept trial for TB006, a monoclonal antibody for the treatment of Alzheimer's disease. The trial demonstrated significant improvements in cognition and function after just one month of treatment. Patients showed improvements in the Clinical Dementia Rating-Sum of Boxes (CDR-SB), indicating a potential slowing or reduction of clinical decline. Secondary endpoints further supported these findings, and amyloid beta (Aβ) 42 plasma levels were reduced. TB006 was well-tolerated with minimal adverse events and no serious adverse events. These promising results highlight the potential of TB006 to improve the lives of Alzheimer's disease patients and may even reverse disease progression.
July 8, 2022 - Crunchbase News - TrueBinding Raises $100 Million to Tackle Alzheimer's
Foster City-based TrueBinding raised $100 million through a recent funding round to address neurodegenerative diseases such as Alzheimer's. The biotech startup, which received clearance from the FDA last year, is currently conducting a clinical trial expected to conclude in October. TrueBinding is among several companies, including Insilico Medicine, Cognito Therapeutics, Alzheon, and Neuron23, that have secured significant funding to develop treatments for Alzheimer's, a condition that affects approximately 5.8 million individuals in the U.S. and incurs substantial healthcare costs.
May 20, 2022 - Successful Completion of Patient Recruitment in Phase II Alzheimer's Study: A Promising Step towards Novel Antibody Treatment
The search for a cure for Alzheimer's disease is of utmost importance due to the profound impact this neurodegenerative condition has on individuals, families, and society as a whole. Alzheimer's is a progressive disease that robs individuals of their memories, cognitive abilities, and independence. It not only affects the quality of life of those diagnosed but also places a significant burden on their loved ones who often become caregivers.
The completion of patient recruitment in the Phase II Alzheimer's study (NCT05074498) marks a significant milestone in the research of Alzheimer's disease treatment. The study focuses on evaluating the safety and short-term efficacy of the innovative antibody TB006, which targets human Galectin-3. With the successful screening of enough patients, the goal of randomizing 140 participants has been achieved.
TrueBinding Inc. expresses its heartfelt gratitude to the dedicated patients and their caregivers who volunteered for this study. Additionally, the company extends its appreciation to the approximately 20 investigators and their teams across the United States who conducted the trial. Their invaluable contributions have been instrumental in making this study possible. Anticipation is building as exciting results are expected to be unveiled in just a few months.
Mar 24, 2022 - Advancing the Fight Against Alzheimer's: Phase II Efficacy Study Commences with Promising Phase Ib Results
The Phase II efficacy portion of the study aims to evaluate the potential therapeutic benefits of our innovative treatment for Alzheimer's disease. Our team is excited to expand the scope of the study by involving a larger number of patients, which will provide us with more robust data and insights. With the inclusion of multiple sites across the US, we aim to enhance the diversity of participants and ensure the generalizability of our findings.
As we move forward with the Phase II efficacy portion, we will closely monitor the progress and response of each enrolled patient, employing rigorous protocols and assessments. The data collected from this study will contribute to advancing our understanding of potential treatment options for Alzheimer's disease and bring us one step closer to finding effective interventions for patients and their families.
February 8, 2022 - TrueBinding Inc's TB006 Receives FDA Approval for Phase II Clinical Trial in Acute Ischemic Stroke (NCT05156827)
TrueBinding Inc has successfully obtained FDA approval for the Investigational New Drug (IND) application of TB006, marking a significant milestone for the company. TB006 is now poised to enter the phase II clinical trial stage for the treatment of Acute Ischemic Stroke (AIS). Acute Ischemic Stroke is a medical condition caused by the sudden interruption of blood flow to the brain, leading to severe neurological impairment. This phase II trial aims to evaluate the safety and efficacy of TB006 in patients suffering from AIS, with the goal of providing a potentially groundbreaking therapeutic option for this debilitating condition. The NCT05156827 identifier will facilitate tracking and documentation of the trial's progress, contributing to the accumulation of knowledge and advancements in AIS treatment.
October 15, 2021 - Promising Clinical Trial Shows Safe, Short-Term Treatment with Antibody TB006 Offers Potential Cognition Improvement in Alzheimer's Disease
The ongoing clinical trial with the identifier NCT05074498 focuses on evaluating the safety, short-term duration, and cognition improvement potential in Alzheimer's disease. The trial specifically investigates the effects of an antibody called TB006. Let's explore each aspect in more detail.
1. Safe: The clinical trial initially conducted a phase involving healthy volunteers to assess the safety profile of the antibody TB006. So far, there have been no reported adverse events or negative reactions associated with the treatment. This suggests that the antibody is well-tolerated by individuals without Alzheimer's disease. The positive safety profile in healthy volunteers is an encouraging indication for further investigation in patients with Alzheimer's.
2. Short: The duration of the treatment in this clinical trial is relatively short, lasting only one month. This short-term intervention allows researchers to evaluate the immediate effects of the antibody TB006 on cognition and gather preliminary data regarding its efficacy within a limited timeframe. While longer-term studies are necessary to assess sustained benefits, short-term trials can provide important insights into the potential cognitive improvements achievable with TB006.
3. Expected Cognition Improvement: The decision to proceed with the clinical trial in Alzheimer's disease patients is based on strong pre-clinical data, which has shown promising results in terms of cognition improvement. Pre-clinical studies are conducted in laboratory settings using animal models or in vitro experiments. The positive findings from these studies have provided compelling evidence that the antibody TB006 has the potential to enhance cognition in individuals with Alzheimer's disease. The clinical trial aims to validate and expand upon these pre-clinical findings in human participants, ultimately determining the antibody's efficacy and safety in a real-world scenario.
April 23, 2021 - FDA Clears TrueBinding's TB006 for Clinical Development in Alzheimer's Disease Treatment
On April 23, 2021, TrueBinding, Inc. received clearance from the FDA to proceed with the clinical development of TB006, their lead product candidate for the treatment of Alzheimer's Disease (AD). TB006 aims to reduce the aggregation of amyloid-β (Aβ) and tau proteins and mitigate neuroinflammation, both of which contribute to the manifestation of AD. The company plans to initiate a Phase I trial for TB006 in healthy volunteers during the Summer of 2021. In animal model studies, TB006 has shown promising potential in mitigating AD, and TrueBinding believes it can offer improved treatment options for AD patients. TB006 is a monoclonal antibody targeting Galectin-3, a novel drug target discovered by TrueBinding, which is known to promote the aggregation of Aβ and tau proteins. Alzheimer's Disease is a chronic progressive neurodegenerative disorder characterized by the accumulation of toxic oligomers involving Aβ and tau proteins. TrueBinding, Inc. is a clinical-stage biotherapeutics development company that focuses on creating molecules for various disease areas with unmet medical needs, including neurodegenerative diseases like AD.
March 9, 2021 - FDA Clears TrueBinding's TB006 for Clinical Development in COVID-19 Patients with Underlying Conditions
On March 9, 2021, TrueBinding, Inc. announced that the FDA has granted clearance for its lead product candidate, TB006, to proceed with clinical development for reducing the severity of underlying diseases in COVID-19 patients. TB006 aims to mitigate acute severe deterioration in ambulatory COVID-19 patients with underlying conditions like diabetes, cardiovascular disease, and cancer. TrueBinding, Inc. plans to initiate a Phase I Trial for TB006 in mild to moderate COVID-19 patients in spring 2021. In pre-clinical evaluations, TB006 demonstrated anti-inflammatory and anti-fibrotic properties that could help modulate the immune response and reduce the risk of pulmonary fibrosis in COVID-19 patients with comorbidities. TrueBinding, Inc. is a biotherapeutics development company focused on creating molecules for various medical needs, including immuno-oncology and neurological disorders.
