Altus Publishes Results of Pioneering Technology to Develop Alternative Delivery Methods for Monoclonal Antibody Therapeutics Using Crystalline Formulations
Wednesday
CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 11, 2003--Altus Biologics Inc. announced today the publication of studies demonstrating the applicability of its proprietary protein crystallization drug delivery technology, Crystalomics(TM), to the delivery and large scale development of monoclonal antibodies (MAbs). Crystallization of macromolecule pharmaceuticals, particularly antibodies, can offer significant advantages, such as high concentration, controlled or extended release of activity and improved delivery options such assubcutaneous injections of antibodies requiring high doses. Monoclonal antibodies are the largest class of products under development in the pharmaceutical industry.
The study design and results are published in the current issue of Proceedings of the National Academy of Sciences (PNAS) in an article titled, "Crystalline Monoclonal Antibodies for Subcutaneous Delivery".
The results from this study indicate that high concentration, low viscosity crystalline suspensions provide an improved product and method for delivery of MAbs that would otherwise be difficult or impossible to administer subcutaneously. Dr. Alexey Margolin, Vice-President of Science at Altus commented, "To our knowledge, this is the first time that crystalline monoclonal antibodies have been successfully produced in large scale and explored for therapeutic use. Our data supports the potential application of crystalline suspensions of MAb therapeutics for the generation of high concentration, low viscosity formulations for subcutaneous administration that rapidly dissolve following injection. This approach is commercially feasible; proteins can be batch crystallized with good yields into a range of small crystals that demonstrate excellent physical/chemical protein stability upon storage with full retention of biological activity. Altus' technology provides great value to developers of antibody therapeutics, as well as other classes of proteins. These findings are important steps forward for our drug delivery business as it demonstrates the validity of this approach in drug development."
Study Design and Results
Batch-process methods were devised to produce crystalline suspensions of three approved therapeutic antibodies: Rituxan® (rituximab), Herceptin® (trastuzumab), and Remicade® (infliximab). The methods developed for crystallization provide crystals in high yield that demonstrated excellent physical and chemical stability as well as retention of biological activity in vitro. The low viscosity, highly concentrated formulations of crystalline MAbs demonstrated an extended serum pharmacokinetic (PK) profile and high bioavailability compared to the soluble MAbs delivered intravenously. Finally, it was also demonstrated that the crystalline formulation of trastuzumab was effective in inhibiting tumor growth in a pre-clinical model of human breast cancer.
About Altus®
Altus Biologics Inc. is a privately held life sciences company that has developed a unique, powerful and proprietary protein crystallization technology, known as Crystalomics(TM), to enable the rapid commercialization of high-value protein-based products. Altus focuses on the commercialization and development of targeted therapies for the treatment of gastrointestinal and metabolic diseases. Altus' technology allows its products to act chiefly by creating a highly stable protein therapeutic that enables oral delivery of the protein to the gastrointestinal tract that provides a localized or topical effect within the gastrointestinal (GI) lumen. Through its branded products portfolio, the company's vision is to be the worldwide leader in the rapid and efficient development of valuable orally delivered proteins. The company has a series of products in various stages of research and development all leveraging the Crystalomics technology. Crystalomics is also proving to be an innovative drug delivery technology that can transform proteins into highly concentrated, stable, and pure crystalline products that offer significant advantages in the overall route of administration, safety, and storage of protein therapeutics, as well as in the manufacture of small-molecule drugs. Altus has numerous development partners and is constantly evaluating the opportunity to expand its product development efforts through partnering opportunities. Altus® and Crystalomics(TM) are trademarks of Altus Biologics Inc.
For more information on Altus, visit the company's website at www.altus.com. |
