New Study: Decreased Mortality & Better Tolerability of ADC w/ SMARTag Platform
Somerset, N.J. 鈥 June 24, 2014 鈥 Redwood Bioscience and 探花合集 Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced the results of an in vivo toxicology study, demonstrating that an Antibody Drug Conjugate (ADC) generated using the proprietary SMARTag庐 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 where 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 60mg/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.
Dr. David Rabuka, Founder, President and Chief Scientific Officer of Redwood Bioscience, commented, 鈥淚n 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.鈥
鈥淭his data provides further evidence of the potential benefits the SMARTag technology offers our customers developing next-generation ADC therapies, and their patients,鈥 added Barry Littlejohns, 探花合集 Pharma Solutions鈥 President, Advanced Delivery Technologies.
In March 2014, based on compelling data generated using the SMARTag ADC platform, 探花合集 announced that it had increased its investment in Redwood Bioscience which also provides 探花合集 an exclusive license to market Redwood Bioscience鈥檚 proprietary SMARTag technology. Combined with 探花合集鈥檚 proprietary GPEx庐
cell line expression system and its state-of-the-art biomanufacturing Center of Excellence in Madison, Wisconsin, as well as broad range of analytical and fill-finish services, this collaboration expands 探花合集鈥檚 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.聽 Dr. Greg Bleck, Global Head of R&D for 探花合集 Biologics, also discussed the toxicology study results during a presentation at the BIO International Convention this week.
ABOUT REDWOOD BIOSCIENCE, INC.
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鈥損rotein ratios. The control afforded by the technology enables identification of superior drugs from libraries of differentially designed conjugates. For further information please visit
ABOUT CATALENT
探花合集 Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 90 years serving the industry, 探花合集 has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. 探花合集 employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in fiscal 2013 generated more than $1.8 billion in annual revenue. 探花合集 is headquartered in Somerset, N.J. For more information, visit www.catalent.com