The Swiss Pharma firm is a pioneer in the antibody-drug conjugation (ADC) field, with its subsidiary Genentech being the developer of one of only two such products on the market (Kadcyla).
In the agreement with Catalent, the firm is looking to develop next-generation molecules coupling different therapeutic modalities through use of the site-specific protein-modification and linker technology SMARTag.
“We have multiple ongoing pharma partnerships, but see this deal with Roche as an important collaboration for our SMARTag platform,” VP of Catalent Biologics, Mike Riley, told Biopharma-Reporter.com.
The platform itself was developed by Redwood Bioscience, acquired by Catalent in 2014, and the contract development and manufacturing organisation (CDMO) will perform certain work in this deal primarily through the Redwood subsidiary based in Emeryville, California.
Riley added the agreement is part of his firm’s flexible model,” which includes licensing the “SMARTag technology for partners to perform internal development and manufacturing [while still having] the ability to leverage our beginning to end suite of technologies, such as our GPEx platform, analytical services, biologics manufacturing, regulatory support, clinical packaging and supply services to support our partner’s path to clinic.”
Roche is paying Catalent $1m upfront, but Catalent has the potential to receive up to $618 million in development and commercial milestones.
As part of the deal, Roche will access the highly stable hydrazino-Pictet-Spengler (HIPS) conjugation technology within the SMARTag platform.
“This is a proprietary chemistry that provides a highly stable carbon-carbon linkage between the protein and the rest of our linker/payload,” Riley explained. “We believe this is a strong differentiator for our platform, as it ensures our conjugates are highly stable.”
Biomolecule conjugation is traditionally done with hydrazide or aminooxy nucleophiles under acidic conditions to yield hydrazone or oxime products that are relatively stable, yet susceptible to hydrolysis.
However, HIPS has certain advantages over this, according to Redwood, exhibiting a combination of product stability and speed near neutral pH that is “unparalleled by current carbonyl bioconjugation chemistries.”