Catalent, Sanofi collaborate on SMARTag, ADCs

Catalent’s tech will help Sanofi evaluate site-selective payload conjugation to enhance ADC PK, efficacy and safety

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SOMERSET, N.J.Catalent Pharma Solutions and Paris-based pharma giant Sanofi have launched a joint venture to develop Sanofi’s proprietary antibodies using Catalent’s SMARTag antibody drug conjugate (ADC) platform. Catalent’s precision protein-chemical engineering technology will enable Sanofi to evaluate site-selective payload conjugation to enhance ADC pharmacokinetics, efficacy and safety. The financial terms were not disclosed.
 
Sanofi teams will be carrying out the joint research at Catalent’s facility in Emeryville, Calif., formerly headquarters to Redwood Bioscience Inc., according to Catalent. In October 2014, Catalent announced the purchase of the remaining stake in Redwood Bioscience after in-vivo and in-vitro proof-of-concept milestones were achieved and an improved toxicity profile was demonstrated with SMARTag ADCs compared with conventional ADCs.
 
“We are pleased to enter this agreement with Sanofi as we jointly work toward the goal of creating better drugs to meet patient needs,” Barry Littlejohns, Catalent’s president of Advanced Delivery Technologies, stated in a news release. “Through in-vivo toxicology studies, we have demonstrated that ADCs generated using Catalent’s SMARTag platform have a better toxicity profile than a conventional ADC, while efficacy studies also point to an improved therapeutic index. We look forward to partnering with Sanofi to support the development of their next generation of ADC products.”
 
“Catalent has been in discussions with a number of potential partners on the SMARTag platform, and partner interest has continued to grow based on continued strong data,” Michael Riley, vice president and general manager of Catalent Biologics tells DDNews. “Sanofi will now have the ability to leverage SMARTag to optimize their ADCs in development.”
 
“Our goal with the SMARTag technology is to partner with leading ADC developers to help them commercialize their next generation of products,” Riley continues. “This agreement provides the opportunity to leverage our technology with a leader in the industry, with the ultimate goal of helping Sanofi to get better ADCs to market.”
 
The SMARTag platform “provides precise payload positioning and defined stoichiometry of payload-protein ratios,” he adds. “The control afforded by the technology enables identification of superior drugs from libraries of differentially designed conjugates. While many in the industry have recognized the benefits of ‘site specific’ technologies to create homogeneous ADCs, a key differentiator of the SMARTag system vs. most other available ADC technologies is the ability to specifically select the site [or sites] of conjugation on the antibody.”
 
“Our studies have shown that varying this site of payload conjugation can have measurable impact on ADC performance,” he explains. “By offering partners the ability to test multiple conjugation sites on a given antibody, the SMARTag system allows for ADC optimization that is analogous to a structure-activity relationship study traditionally used in small-molecule development.”
 
According to Amy Ba of Sanofi’s global R&D communications, “Sanofi has been evaluating the site-specific conjugation field, and the SMARTag platform is one of several that we have been evaluating.”
 
Sanofi has a strong commitment to the field of oncology and evaluates antibody-drug conjugates as a potential solution to improve the lives of cancer patients,” Ba tells DDNews. “Sanofi has the great opportunity to launch six new medicines in 2015 with one new launch every six months for a total of 18 new medicines by 2020. As part of our research program, Sanofi has a strong commitment to oncology. Our goal is to invest more in projects and emerging fields.”
 
Catalent’s 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 create one or more aldehyde tags at designated sites on protein molecules, the company states. 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, according to the company.


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