Exelixis and Catalent have signed 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 proprietary 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.

Separate agreement
In September 2020, Exelixis and Catalent entered into a separate agreement under which Catalent is applying its SMARTag bioconjugation platform to build ADCs using monoclonal antibodies from Exelixis’ growing preclinical pipeline.

Under the terms of the new agreement, Exelixis will make an upfront payment to Catalent of US $ 30 million in exchange for rights to the three biologics programs.

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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.

Rapid advancement
“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.”

Nobel Prize in Chemistry
The SMARTag technology platform was developed by Redwood Bioscience based on discoveries in the lab of Carolyn R. Bertozzi, Ph.D, the winner of the 2022 Nobel Prize in Chemistry* and Chair of Redwood’s scientific advisory board. [1]

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.

Note: * The Royal Swedish Academy of Sciences awarded the Nobel Prize in Chemistry 2022 jointly to Carolyn R. Bertozzi, Morten Meldal and K. Barry Sharpless for the development of click chemistry and bioorthogonal chemistry.

[1] Bertozzi CR, The Bioorthogonal Chemistry Journey, from Laboratory to Life. Presented to the members of The Royal Swedish Academy of Sciences on December 8, 2022.

Featured image: An incubator for cell culture experimentation. Photo courtesy: © 2020 – 2022 Jaron Nix on Unsplash. Used with permission.

This article was last edited on December 9, 2022.

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