TrueBinding Inc.

Single-Patient EA Policies/Criteria The FDA has developed a guidance whereby patients who have no treatment alternatives and cannot participate in a clinical trial may receive investigational treatments from companies.  This program is called Expanded Access.  In order to be eligible, patients must demonstrate that they have exhausted all available medications to treat their disorder, meaning they have taken available medications and have no further benefit, are intolerant to other medications, or have contraindications to other medications.  They must also demonstrate that there are either no clinical trials available in their locale, or that they are not eligible to participate in other clinical trials. The key decision for physicians and patients is whether they believe the benefits of treatment outweigh the risks.

TrueBinding has prepared an expanded access protocol for which treating physicians can apply on behalf of their patients.  Once enrolled in the protocol, patients receive monthly (every 28 days) IV infusions of TB006.  Treatment may continue indefinitely, however it may be discontinued whenever desired.  The protocol contains some patient monitoring suggestions, however other than adverse events there are no data to report to TrueBinding. You may receive a copy of the protocol and the Investigator’s Brochure by contacting us .  A Confidentiality Disclosure Agreement will be sent to you.  Once executed, the documents will be sent.  If you have a patient who qualifies and is interested, you may apply for the program by accessing the application .  You will be notified of approval within 7 days of the application.  If the application is approved, you must participate in a short training session.  This covers preparation of the IV drug product, collection and reporting of adverse events, and other elements of Good Clinical Practices (GCPs).

When this is complete, drug will be sent to you.  You must provide IV administration supplies, including saline, tubing, and administration equipment.

You may receive a copy of the protocol and the Investigator’s Brochure by contacting us .  A Confidentiality Disclosure Agreement will be sent to you.  Once executed, the documents will be sent.  If you have a patient who qualifies and is interested, you may apply for the program by accessing the application .  You will be notified of approval within 7 days of the application.  If the application is approved, you must participate in a short training session.  This covers preparation of the IV drug product, collection and reporting of adverse events, and other elements of Good Clinical Practices (GCPs).

When this is complete, drug will be sent to you.  You must provide IV administration supplies, including saline, tubing, and administration equipment. Available Therapies via Single-Patient EA TrueBinding, Inc. is pleased to offer their lead pipeline compound, TB006, on a compassionate use basis to patients with Alzheimer’s disease (AD) and related dementias.  TB006 is a humanized monoclonal antibody which targets galectin-3 (Gal-3), an endogenous protein involved in a number of neurological and metabolic disorders.  There are two antibodies approved for AD, aducanumab (Aduhelm Ò ) and lecanemab (Leqembi Ò ).  TB006 differs from these antibodies in two important ways.  First, the two approved antibodies are direct inhibitors of beta amyloid, the protein involved in the formation of neurofibrillary tangles and amyloid plaques in the brain.  TB006, by blocking the action of Gal-3, inhibits not only beta amyloid but precursors of other oligomers and neurofibrillary tangles such as tau, alpha-synuclein, and apolipoprotein E4.  Secondly, the two approved antibodies are indicated in AD patients who are in their early phase (MCI-early AD) and have PET imaging evidence of amyloid plaques.  TB006 is being studied in patients with established disease on the mild-moderate-severe (Mini Mental Status Exam score range of 24 or less) regardless of their amyloid status.