BioSeizer - Model LipAD - Proprietary Lipid-Assembled Drug Delivery Platforms Technology

Prolonging Duration of Effect: BioSeizer^®Technology

Many different types of drugs are quickly metabolized and removed from circulation, limiting the duration of their effect following a single dose. Frequent dosing may compensate for a short duration of effect, but this is not always a good solution. Frequent dosing of drugs delivered by injection can be inconvenient, painful and carries an increased risk of infection.

Our proprietary BioSeizer^® technology entraps drugs to control the rate at which a therapeutic molecule is released from a lipid nanoparticle once in the body. BioSeizer^® nanoparticles consist of a drug wrapped within multiple layers of lipid membrane, precisely designed to release the drug at a constant rate as each layer collapses over time. This technology can be applied to a wide range of molecular payloads, including biologics, small molecules and oligonucleotides. Our technology for sustained release has advantages in many applications.

We are developing several new therapies using BioSeizer^®, including TLC599 for osteoarthritis, TLC399 for the treatment of eye diseases, and TLC590 for postsurgical pain.

TLC has a proprietary solution for pharmaceutical product development called BioSeizer^®. Our BioSeizer^® technology uses multi-layer lipid membranes to encapsulate therapeutically active molecules, providing an exceptionally long duration of drug release. BioSeizer^® nanoparticles are precisely designed to release the payload at a constant rate as each layer collapses over time. In addition, BioSeizer^® works to extend the duration of therapies based on both small molecules as well as large, biologic molecules.

Lipid molecules, such as phospholipids, contain two domains, a hydrophilic, or water-loving, head and a hydrophobic, or water-repelling, tail. In a solution with water, lipid combinations could naturally create bilayers in which the hydrophobic tails are aligned with each other facing away from the aqueous portion of the solution while the hydrophilic heads face the water. Lipid bilayers are key components of cell membranes, nuclear membranes and other membrane structures in the cell.

By carefully modifying lipid combination and the process of bilayer formation, we drive these phospholipids into liposomes as well as into more complex structures. Each of these structures has unique drug release properties and our ability to control the formulation enables us to tailor the PK of each product candidate to specific clinical needs.

Unlike other extended release formulations, BioSeizer^® formulations are not implants or large-size particles. Rather, BioSeizer^® formulations allow local injections into sensitive tissues such as the eye or inflamed joints using much smaller gauge needles, an advantage that we believe will be welcomed by both patients and clinicians. In contrast to processes used for many other injectable products, our manufacturing process uses sterile filtration at near-end stage, rather than an entirely aseptic process from raw material to final product.

Product

TLC599, TLC399, TLC590

Application

Reducing frequency of drug administration

• Versatility for delivering drugs such as antibody, Fab, scFv, peptide, aptamer, DNA, siRNA and small molecules
• Ability to design the API`s releasing profile
• Providing immediate availability of free API
• Prolonging the retention time of APIs at the disease site
• Reducing the side effects of APIs due to systemic exposure
• Fully biodegradable components
• Protection by composition of matter patents