TB006 Expanded Access Program

Hawaii Whole Person Healing Collective and Dr. Christopher Lawinski MD Announce Participation in the TB006 Expanded Access Program

Hawaii Whole Person Healing Collective and Dr. Chrstopher Lawinski, MD are pleased to announce our participation in the Expanded Access Program (EAP) for TB006, an investigational monoclonal antibody therapy developed by TrueBinding, Inc. In a clinical phase 2a trial, TB006 has shown promise in improving cognitive and functional outcomes in the study’s patients with Alzheimer’s disease and related dementias. If you have a loved one suffering from this debilitating disease, then this medication could be a turning point in your journey.

TB006 It works by binding to and lowering amounts of Galectin-3, a different mechanism than any of the currently approved Alzheimer’s medications. Galectin-3 binds to amyloid beta and acts like glue causing amyloid beta proteins to stick to one another and form larger plaques. These plaques then deposit in the tissue between neurons, blocking signals and leading to cognitive impairment. In addition, Galectin-3 is proinflammatory and activates the brain’s immune system (microglial cells) leading to neural inflammation and nerve cell damage/destruction. Galectin-3 is generally very high in the brains of patients with Alzheimer’s disease. TB006 prevents Galectin-3 from attaching to amyloid beta (blocking amyloid plaque formation) and prevents it from causing microglial activation. In doing so, TB006 may potentially decrease the amount of beta amyloid plaques and lower inflammation allowing nerve cells to heal and function more optimally.

What is an EAP?

The EAP, also known as a Compassionate Use Program, is an FDA registered clinical trial designation that is designed to make promising drugs available to patients before the final FDA approval process, since without the EAP, affected patients may not survive long enough to benefit from the drug after its approval. The FDA allows eligible patients to access investigational treatments when there is no satisfactory alternative treatment available. TB006 was approved for compassionate use (EAP) for dementia in June 2023.

What is the evidence for TB006 so far?

After prerequisite studies in laboratory animals, and pharmacokinetic studies in human patients, TB006 was first studied for efficacy in a Phase 1b/2a RCC (Randomized Control Trial), whose preliminary data were revealed in 2022. This data showed a 63% improvement in CDR-SB (Clinical Dementia Rating – Sum of Boxes) score within one month of treatment compared to placebo. In another trial, called an Open-Label Extension Trial, preliminary results here also demonstrate that about 50% of patients show signs of symptom reversal.

What Are the Side effects?

TB006 has been well tolerated in clinical trials, with the most common side effects being mild infusion-site reactions, headaches, upset stomach, and back pain. The currently approved anti-plaque AD treatments all have a black box warning due to the high incidence of ARIA (amyloid-related imaging abnormalities) reported in their clinical trials. However, to date, only one asymptomatic ARIA has been reported in the TB006 trials

Who Is Eligible?

Are 56 years or older
Have been diagnosed with Alzheimer’s disease or a related dementia
Have documented cognitive and functional decline from a primary medical provider, resulting in a risk of self injury if left unattended.
Failed at least one dementia medication
Are unable to enroll in another clinical trial due to availability or eligibility restrictions
Have a designated adult caregiver who can provide regular assessments
Able to comply with the program procedures, including the ability to travel to the named
clinic for monthly visits.

Pricing

During the EAP, the enrolled patients are responsible for the cost of the medication and for compensating the clinic for professional time and service fees. Fees are as follows:

$500 Initial Screening and Consultation: Includes initial consultation with the physician, EKG, and orders for the necessary lab and imaging tests, including a brain MRI and LGAL3 gene testing from Endo DNA. (Genetic testing and EKG price included, other lab work and imaging will be billed to insurance).

Infusion Cost: Monthly infusion is required for the initial course of treatment. Please contact our office for pricing.

How to Enroll?

Interested patients or caregivers should contact us to schedule a screening consultation for $500. For this service, our team will evaluate eligibility, perform a history or physical exam including EKG, and SNP genetic testing, etc. We will discuss the risks and benefits of participation, submit all the requisite orders for lab and imaging testing, and submit your application to the drug sponsor for approval .

For additional information about TB006 and the Expanded Access Program, visit TrueBinding’s website at, www.truebinding.com or contact us directly using our contact information below.

Hawaii Whole Person Healing Collective and Dr. Christopher Lawinski MD are committed to providing innovative treatment options for Alzheimer’s disease and related dementia. We are excited to offer TB006 as part of our dedication to improving patient care and quality of life.