A cGMP cell therapy manufacturing system, AVATAR Foundry is designed to enhance the potency of cell and gene therapies. Credit: Gorodenkoff / Shutterstock.com.

AmplifyBio and Xcell Biosciences have announced a strategic collaboration to advance the manufacturing process for engineered T-cell receptor (TCR) therapies.

The alliance will focus on optimising and enhancing the production process of TCR therapies targeting solid tumours.

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The companies will utilise the AVATAR Foundry platform of Xcellbio and work together through the process development, preclinical assessment and first-in-human clinical trials.

Xcell previously developed the AVATAR incubator system, which is instrumental in cell and gene therapy research and development.

A cGMP cell therapy manufacturing system, AVATAR Foundry is designed to enhance the potency of cell and gene therapies.

AmplifyBio scientists will collaborate with the Xcell team to create new cell therapy manufacturing methods utilising the AVATAR Foundry platform.

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The joint efforts will concentrate on detecting critical factors for the successful production of TCR therapies. They include establishing a product characterisation matrix, understanding the correlation to the metabolic profile, and ensuring potency.

An Investigational New Drug application (IND) filing for an engineered TCR therapy targeting human papillomavirus-positive (HPV+) tumours is anticipated in 2025.

Xcell Biosciences co-founder and chief scientific officer James Lim stated: “Current cell therapies have been highly effective for liquid tumours, but little progress has been made for the vast majority of patients with solid tumours.

“With low oxygen levels, low pH and other hostile factors, the microenvironment within solid tumours makes it very difficult for T cells to kill cancer cells.

“Our joint development work with Amplifybio will demonstrate how the AVATAR Foundry will improve the manufacturability and potency of engineered TCRs by significantly reducing manufacturing times and utilising non-viral workflows to produce scalable and cost-effective therapies.”

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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