Catalent Pharma Solutions and Vaccinex confirmed their agreement earlier today to jointly develop an antibody-drug conjugate (ADC) using Catalent’s proprietary SMARTag® conjugation platform and GPEx® cell line engineering technologies, and Vaccinex’s proprietary ActivMAb® technology. The collaboration will focus on developing the ADC against an undisclosed cancer target.

Multiple preclinical models
Catalent and Vaccinex will evaluate the novel ADC in various preclinical models and move it into cell line and process development, utilizing Catalent’s proprietary GPEx technology and development and manufacturing capabilities at its state-of-the-art Madison, Wisconsin facility.

“By combining a Vaccinex ActivMAb antibody with Catalent’s SMARTag conjugation technology, we can generate a unique, differentiated molecule to treat cancers overexpressing this particular target,” noted Raymond E. Watkins, Senior Vice President and Chief Operating Officer of Vaccinex, clinical-stage immunotherapy company engaged in the discovery and development of human therapeutic monoclonal antibodies to treat cancer and neurodegenerative diseases.

“Partnering with an innovative [companies] like Vaccinex [helps us] to develop a product that has the potential to deliver better outcomes for patients,” said Mike Riley, Vice President & General Manager of Catalent Biologics.

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“The opportunity to leverage these complementary technology platforms provides great promise to produce a differentiated ADC product,” he added.

Photo 1.0: Catalent booth – CPhI 2016

Catalent’s proprietary SMARTag site-specific protein-modification and linker technologies were developed to enable the generation of homogenous bioconjugates engineered to enhance potency, safety and stability.

Although antibody-drug conjugates combine the targeted binding specificity and pharmacological advantages of monoclonal antibodies and other targeted recombinant proteins with the potency advantages of small molecule chemotherapy agents and other therapeutic payloads via conjugation with chemical linkers, the first generation ADCs had a variety of development challenges.

One of these challenges was the difficulty creating conjugates with a uniform and optimal drug-to-antibody ratio (DAR) for each type of payload, variability in the site of payload conjugation, instability of chemical linkers and poor production efficiency.

The SMARTag™ technology, developed by Redwood Bioscience which was acquired by Catalent in 2014, overcomes many limitations associated with conventional protein chemistries that produce heterogeneous products with variable conjugate potency, toxicity and stability.

The technology employs natural post-translational modifications found in human cells to create “chemical handles” at predetermined sites on protein molecules. These sites can then be stably chemically conjugated to many different payloads. The control afforded by the technology enables identification of superior drugs from libraries of differentially designed conjugates.

To date, Catalent’s propriatary SMARTag technology has demonstrated compatibility with clinically validated ADC payloads including maytansine, auristatin, pyrrolobenzodiazepine (PBD) and duocarmycin.

GPEx® technology
Catalent’s GPEx® technology is based on a proprietary, pseudo-typed, high-performance vector that efficiently generates high-performance, highly stable and high-yielding mammalian production cell lines in a wide variety of mammalian host cells. To date, eight GPEx-based antibody and protein products are approved and marketed, and over 45 therapeutic candidates are currently in the clinic across the world.

Discovery and optimization platform
ActivMAb is Vaccinex’s antibody discovery and optimization platform. It combines the advantages of both viral panning and cell sorting to enable the efficient identification of high-affinity, fully human antibodies from antibody libraries expressed in mammalian cells.

A fusion protein of immunoglobulin heavy chain with a vaccinia membrane protein (Ig-VMP) has been developed that enables efficient expression on the surface of vaccinia virus, an enveloped mammalian virus, as well as on the surface of the infected cell.

Last Editorial Review: November 30, 2017

Featured Image: Laboratory. Courtesy: © 2017. Fotolia | Used with permission. Photo 1.0: Catalent booth at CPhI 2016 Courtesy: © 2017. Sunvalley Communication, LLC | Used with permission.

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