Catalent Collaborates With Grid Therapeutics to Develop Novel Targeted Immuno-Oncology Therapy

Catalent Pharma Solutions recently announced it has signed a multi-year agreement with Grid Therapeutics, LLC, for the development and manufacture of Grid’s lead therapeutic candidate for the treatment of solid tumors. Grid is an oncology-focused biotech company building on the innovative science first developed by Edward F. Patz, Jr. MD, and his team of scientists at Duke University Medical Center.

Under the agreement, Catalent Biologics will employ its proprietary GPEx cell line technology to develop cell lines and manufacture antibodies with a view to optimizing the process for cGMP bulk drug production. The project will be undertaken at Catalent’s state-of-the-art Madison, WI, biomanufacturing facility.

Grid’s research is based upon a novel approach to identify specific tumor immunoglobulin G (IgG) antibodies from patients with early stage cancer. Grid used a unique strategy to obtain the sequence of its lead IgG3 antibody directly from B cells in cancer patients.

“Grid Therapeutics is excited to partner with Catalent to develop this novel, human-derived antibody for the treatment of cancer. We feel Catalent Biologics is well positioned to bring this novel antibody to the clinic,” commented Edward F. Patz, Jr. MD, CEO of Grid Therapeutics.

“Catalent regularly and successfully partners with innovator companies looking to bring new, important therapies to market faster, and a patient derived IgG3 monoclonal antibody would be a significant advancement in optimized treatments,” commented Mike Riley, Vice President & General Manager of Catalent Biologics.

Catalent’s proprietary GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, through to commercial-scale production. To date, seven GPEx-based antibody and protein products are approved and marketed, and 34 therapeutic candidates are currently in the clinic across the world.

Catalent performs GPEx programs at its state-of-the-art commercial biomanufacturing facility in Madison, WI, which was completed in June 2013. Designed for flexible cGMP production from 10 liters up to 1,000 liters, and non-GMP production up to 250 liters, the site features extensive single-use technologies and unidirectional flow to maximize efficiency and safety. In 2016, Catalent announced the commencement of work to extend its Madison facility and add 22,000 square feet of space accommodating two x 2,000-liter bioreactors that will allow the company to support late-phase clinical and commercial production of up to 4,000-liter batches. This extension is due to be commissioned in the last quarter of 2017. For more information, visit www.catalentbiologics.com.

Grid Therapeutics is a biotech company based on the innovative science first developed by Edward F. Patz, Jr., MD, and his team of scientists at Duke University Medical Center. Located in Durham, NC, Grid is developing the first human-derived targeted immunotherapy for cancer. The antibody was discovered in exceptional outcome early stage lung cancer patients who did not progress to develop metastasis. The antibody was isolated from patient’s B-cells using state-of-the-art molecular genomic techniques. GT103, the company’s lead asset, is expected to initiate a Phase 1 clinical trial in advanced-stage solid tumor patients in the first half of 2019. For more information, visit www.gridtherapeutics.com.