With the number of blockbuster drugs approaching patent expiration and pharma companies struggling to maintain pipeline and portfolios with in-house programs, companies are increasingly turning to licensing, aquisitions and partnerships. Early-stage licensing deals tend to carry more risk for pharma companies in-licensing. To offset this risk, additional data may be required from the pharma partner to confirm any internal research performed by the biotech/out-licensing company.

Mini-case study. MD Biosciences helps a medium-sized biotech company to develop Rheumatoid Arthritis drug for out-licensing in under two years.

A medium-sized biotech company approached us with a compound that showed some efficacy in rheumatoid arthritis (RA) with a business goal of out-licensing the potential drug within two years. In order to push this compound through in approximately 18 months, a strategic and precisely timed development program needed to be established. MD Biosciences was able to present the sponsor with a program that entailed 25 preclinical studies over the course of 18 months. This was made possible by modifying models such as the rapid 10-day Collagen Antibody-induced arthritis (CAIA) model using ArthritoMab™ antibody cocktail. Each study was customized specifically to address the appropriate questions, building from one study to the next.

The outcome was a successful preclinical program in which 25 carefully designed studies were executed with rapid turn-around times and quality, consistent results. This is critical to allow data comparison over the course of the development period. After 18 months, the compound was developed to an appropriate stage and the company succeeded in out-licensing in a multi-billion dollar deal, indicating this development program as central to the success.

The collagen antibody induced arthritis model (CAIA, also called anti-collagen induced arthritis) uses of cocktail of 4 collagen type II (CII) antibodies to induce arthritis. The antibodies bind to well-defined epitopes associated with arthritis. In this way, the CAIA model and the K/BxN model are very similar, relying on passive transfer of antibodies to induce arthritis. The severity, mechanisms of action and length of disease are similar giving similar disease scores and histology.

There are however, significant differences, which make running the CAIA model an advantage over the K/BxN:

• Epitope location: GP6i is ubiquitously expressed while CII has a restricted distribution and is concentrated in the joints ensuring antibody is directed to the site of interest.
• K/BxN sera is an undefined polyclonal mixture that can vary batch to batch. The CAIA model uses the ArthritoMab™ Antibody cocktail which is a defined and standardized mixture so there is no batch variation.
• With CAIA, arthritis is induced by clinically relevant anti-collagen antibodies.
• There is no need to maintain expensive colonies.
• Easy and constant availability of induction material.
• No waiting for animals to develop arthritis before harvesting sera.
• No concerns about colonies going down through sickness or breeding issues.