SMARTag Toxicology Study Demonstrates Decreased Mortality & Better Tolerability

Redwood Bioscience and Catalent Pharma Solutions recently announced the results of an in vivo toxicology study, demonstrating that an Antibody Drug Conjugate (ADC) generated using the proprietary SMARTag platform has a better toxicity profile than a conventional ADC.

The study, conducted in a rat model by Redwood Bioscience, Inc., compared the effects of a single dose of 6, 20, or 60 mg/kg of a SMARTag ADC conjugated to a cytotoxic payload using the proprietary HIPS chemistry, to an ADC generated with traditional conjugation methods.

Results showed that the SMARTag ADC was well tolerated and provided statistically significant survival benefits versus the conventional ADC, particularly at high doses in which the conventional ADC resulted in mortality. Elevations in liver enzymes and decreases in platelet counts and reticulocytes were also observed with the conventional ADC at 20- and 60-mg/kg treatments, whereas these effects were only seen with the highest dose of the SMARTag ADC. In addition, the toxicokinetic analysis showed that the SMARTag ADC had greater exposure and longer circulating half-life than the conventional ADC comparator.

“In summary, the study showed that the SMARTag ADC was a less toxic treatment and, taken together with the efficacy studies, points to an improved therapeutic index for the SMARTag ADC compared to the conventionally conjugated ADC,” said Dr. David Rabuka, Founder, President, and Chief Scientific Officer of Redwood Bioscience.

“This data provides further evidence of the potential benefits the SMARTag technology offers our customers developing next-generation ADC therapies, and their patients,” added Barry Littlejohns, Catalent Pharma Solutions’ President, Advanced Delivery Technologies.

In March 2014, based on compelling data generated using the SMARTag ADC platform, Catalent announced that it had increased its investment in Redwood Bioscience, which also provides Catalent an exclusive license to market Redwood Bioscience’s proprietary SMARTag technology. Combined with Catalent’s proprietary GPEx cell line expression system and its state-of-the-art biomanufacturing Center of Excellence in Madison, WI, as well as broad range of analytical and fill-finish services, this collaboration expands Catalent’s capabilities to help its customers develop more and better biologic treatments.

Toxicology study results have been published and are available in the Journal of Bioconjugate Chemistry. Dr. Greg Bleck, Global Head of R&D for Catalent Biologics, also discussed the toxicology study results during a presentation at the BIO International Convention.

To arrange a meeting with Catalent executives at the conference please contact Richard Kerns at NEPR – richard@nepr.eu. For more information about SMARTag technology, please contact Jennifer Mitcham at jennifer.mitcham@catalent.com.

Redwood Bioscience is developing a precision protein-chemical engineering technology to produce next-generation antibody-drug conjugates and other semi-synthetic biotherapeutics. The proprietary SMARTag site-specific protein modification and cytotoxin-linker technologies developed by Redwood enable the generation of homogenous bioconjugates engineered to enhance potency, safety, and stability. The technology employs natural post translational modifications found in human cells to site specifically create one or more aldehyde tags on protein molecules. These chemical handles are then stably conjugated to cytotoxic payloads to prevent their systemic release. The SMARTag platform provides precise payload positioning and defined stoichiometry of payload-protein ratios. The control afforded by the technology enables identification of superior drugs from libraries of differentially designed conjugates. For more information, visit www.redwoodbioscience.com.

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable clinical and commercial product supply. For more information, visit www.catalent.com