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Exelixis, Catalent Enter New License Agreement for Three ADC Programs

New discovery programs focused on three oncology targets with potential to develop antibody-drug conjugates for a variety of solid tumor indications.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Exelixis, Inc.  and Catalent, Inc. entered a new license agreement under which Catalent’s Redwood Bioscience subsidiary will grant Exelixis an exclusive license to three target programs with lead antibody and/or ADC candidates. The ADC candidates have been developed using Catalent’s SMARTag technology, and each of the licensed antibodies has potential for development as an ADC or other biologic therapy using a variety of technologies to which Exelixis has access through its partner network. In September 2020, the companies entered a separate agreement under which Catalent is applying its SMARTag bioconjugation platform to build ADCs using monoclonal antibodies from Exelixis’ preclinical pipeline.
 
Catalent will receive an upfront payment of $30 million in exchange for rights to the three biologics programs. Exelixis will fund the development work conducted by Catalent until development candidate selection is complete, after which Exelixis will assume responsibility for conducting preclinical, clinical, and commercial activities. Catalent will be eligible for development and sales milestone payments, as well as sales-based royalties.
 
“Exelixis is committed to building a robust biologics pipeline, and this agreement expands our portfolio to include three highly promising targets with broad potential in multiple solid tumor indications, including bladder, breast, lung, ovarian, pancreatic, and other cancers,” said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer, Exelixis. “We believe that the antibodies, ADCs and data Catalent has generated to date will enable rapid advancement of these programs, enabling an acceleration of our in-house biotherapeutics pipeline. We are excited for this new opportunity to continue our work together to advance additional programs that have the potential to provide patients with new therapeutic options.”
 
“Catalent Biologics is a leader in applying precision protein engineering and novel chemistries to develop optimized therapeutics,” said Mike Riley, President, Division Head for BioProduct Delivery, Catalent Biologics. “Our versatile SMARTag platform and growing portfolio of preclinical ADCs against promising targets create multiple opportunities for Catalent to partner with leading biopharmaceutical companies, such as Exelixis. We expect the new license agreement with Exelixis will yield innovative and differentiated therapies with the potential to improve care and outcomes for cancer patients.”
 
The SMARTag technology platform was developed by Redwood Bioscience based on discoveries in the lab of Carolyn Bertozzi, recent winner of the Nobel Prize in Chemistry and Chair of Redwood’s scientific advisory board.  The platform provides optimized site-specific protein-modification, as well as linker and payload technologies for ADCs and other bioconjugates. The SMARTag platform overcomes the limitations associated with traditional protein chemistries that produce heterogeneous products with variable conjugate potency, toxicity, and stability, and enables the development of ADCs with a wider therapeutic window and improved manufacturability.

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