Clinical Pipeline

Braincure Biotech has one of the largest pipeline in the world for the treatment of Alzheimer’s disease and has a comprehensive approach to product development. This approach involves developing antibodies, vaccines and small molecules against both Abeta and Tau protein both for the treatment and prevention of the disease. All of the company’s product candidates were discovered utilizing its proprietary ImmunoTX and Smolecs technology platforms. Braincure Biotech currently has three products in clinical development.

Breaincreuzen is a fully humanized IgG4 monoclonal antibody that binds all forms of misfolded Abeta to prevent and break up Abeta aggregation and promote Abeta disaggregation. Braincreuzen has an excellent safety profile due to its IgG4 backbone that allows it to activate microglial cells just enough to promote engulfment of Abeta, but not strongly enough to induce inflammatory signaling. The IgG4 isotype suggests a favorable safety profile by allowing the microglia to clear Abeta from the brain without producing an inflammatory response, therefore allowing Braincreuzen to be dosed higher than other anti-amyloid antibodies, while ensuring and maintaining a good safety profile.

Braincreuzen was independently selected from among 25 agents for use in the first-ever Alzheimer’s disease prevention trial. The trial, a $10 million project, is the cornerstone of the global Alzheimer’s Prevention Initiative.

TCX-16 is an active vaccine that is wholly owned by Braincure Biotech and is currently in Phase I/II clinical trials for Alzheimer’s disease. The product is designed to stimulate a patient’s immune system to produce antibodies that specifically target the misfolded version of Abeta to prevent beta amyloid plaque deposition and to enhance plaque clearance. TCX-16 consists of an Abeta peptide anchored in a bilayer of liposomes with four palmitic acid chains. Preclinical data demonstrate a high efficacy in plaque reduction and memory restoration. TCX-16 has a very favorable safety profile characterized by a lack of local inflammation and a mechanism of action independent of inflammatory T-cells.

TCX-16 is also investigated as a treatment for Alzheimer’s disease in people with Down Syndrome, a clinical study is currently in preparation. Individuals with Down syndrome (also known as trisomy 21) have an extra copy of chromosome 21, the chromosome on which the gene for amyloid precursor protein resides. As a consequence, these individuals have a rate of Alzheimer’s disease that is 3-5 times that of the general population and develop the disease at a younger age.