Xcell Biosciences, Inc.

SAN FRANCISCO--( BUSINESS WIRE )--Xcell Biosciences Inc. (Xcellbio), an instrumentation company focused on cell and gene therapy applications, today announced it has advanced its collaboration with Labcorp with the installation of a new AVATAR™ Foundry system at the healthcare company’s Ann Arbor, Michigan site. This installation, part of the beta access program for Xcellbio’s latest instrument, allows scientists at Labcorp to extend the potency benefits observed in small-scale workflows on the previously installed AVATAR Odyssey platform up to large-scale automated cell therapy manufacturing workflows. Xcellbio has developed the AVATAR incubator system for cell and gene therapy research and development with the AVATAR Odyssey system designed for small-scale research and process development needs. Its latest platform, the AVATAR Foundry system, is a current good manufacturing platform (cGMP) that delivers novel capabilities for improving the potency of cell and gene therapies. These capabilities are especially important for cell therapies targeting solid tumors, which often face overwhelming challenges in the hostile tumor microenvironment (TME). “After using the AVATAR Odyssey system for more than two years, we have seen results demonstrating benefits for both cell therapy expansion rates and anti-tumor potency. We are eager to scale our workflows with the new AVATAR Foundry instrument, which could allow us to support customers early in their development of novel manufacturing techniques for cell and gene therapies,” said Maryland Franklin, Ph.D., vice president and enterprise head of cell and gene therapy at Labcorp. “This technology complements our strong capabilities in analytical testing and our commitment to using potency assays and downstream analytics for monitoring and release of candidate therapies to provide delivery of only the most effective and reliable products.” Labcorp scientists have used AVATAR incubation technology to study the effectiveness and performance of cell therapy candidates grown in standard culture conditions versus those grown in customized levels of oxygen and pressure. The use of these custom conditions during cell expansion metabolically rewires therapeutic cells to improve their survival and persistent tumor killing activity in the harsh TME. Labcorp scientists have been going beyond in vitro studies with ongoing in vivo experiments to further evaluate this approach. “Labcorp has long been one of Xcellbio’s closest collaborators, and we are pleased to include them as early members of our beta access program for the AVATAR Foundry,” said Brian Feth, co-founder and CEO at Xcellbio. “We look forward to seeing the innovative ways they will use this platform to enhance their already impressive cell and gene therapy work.” To learn more about the beta access program for the AVATAR Foundry platform, please visit https://www.xcellbio.com/ . About Xcell Biosciences Xcellbio is driven by its mission to enhance the performance and safety of cell and gene-based therapies through the design and development of revolutionary technology platforms. The company’s commercial instruments and software allow researchers to discover novel insights into immune and tumor biology and enable the translation of these insights at patient scale through the development of its pioneering cGMP cell therapy manufacturing platform. Based in San Francisco, Xcellbio can also be found online at www.xcellbio.com .

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. 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. See Also: ASCO 2024: Verastem’s combo therapy for pancreatic cancer hits early trial success Biogen enters deal to acquire HI-Bio for $1.8bn AmplifyBio scientists will collaborate with the Xcell team to create new cell therapy manufacturing methods utilising the AVATAR Foundry platform. 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 . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

Companies will jointly work through process development, preclinical analysis, and first-in-human trials using Xcellbio’s AVATAR Foundry™ platform SAN FRANCISCO & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Xcell Biosciences Inc. (Xcellbio), an innovative technology company focused on cell and gene therapy manufacturing applications, and AmplifyBio, a rapidly growing contract development and manufacturing organization, today announced the launch of a partnership designed to streamline and improve the manufacturing process for engineered T-cell receptor (TCR) therapies targeting solid tumors. Preliminary results of this work will be presented at the annual meeting of the International Society for Cell & Gene Therapy (ISCT 2024), taking place May 29 – June 1 in Vancouver, British Columbia. “We are focused on enabling the development of a broad range of advanced therapies and believe there are significant opportunities for improving upon therapies that work effectively for solid tumors, from concept to commercialization,” said J. Kelly Ganjei, President and CEO of AmplifyBio. “There is a pressing need for more effective and potent therapies, and we believe that working with the Xcellbio team and their unique AVATAR Foundry platform will allow us to make significant progress in that journey, and the results from this work will help create a better sandbox for our clients.” Across the cell and gene therapy field, scientists are looking for ways to boost the fitness and potency of T cells to turn them into more effective therapies for solid cancers, enabling therapeutic options to patients that are not available today. “Current cell therapies have been highly effective for liquid tumors, but little progress has been made for the vast majority of patients with solid tumors. With low oxygen levels, low pH, and other hostile factors, the microenvironment within solid tumors makes it very difficult for T cells to kill cancer cells,” said James Lim, co-founder and Chief Scientific Officer of Xcellbio. “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 utilizing non-viral workflows to produce scalable and cost-effective therapies.” Xcellbio previously developed the AVATAR incubator system for cell and gene therapy research and development. Its AVATAR Foundry platform is a cGMP cell therapy manufacturing platform that delivers novel capabilities for improving the potency of cell and gene therapies. In this partnership, scientists from AmplifyBio will work with the Xcellbio team to develop novel cell therapy manufacturing methods based on the AVATAR Foundry platform. The efforts will focus on identifying key elements for successful manufacture of TCR therapies, such as product characterization matrix, correlation to metabolic profile, and potency. An IND filing is expected next year to target human papillomavirus-positive (HPV+) tumors using an engineered TCR therapy. Brian Feth, co-founder and CEO at Xcellbio, commented: “We are pleased to team up with AmplifyBio, which has a strong track record in supporting the discovery, development, and manufacture of candidate therapies. We’re excited to work together to demonstrate that T cells grown in the AVATAR system can achieve higher potency and greater tumor-killing activity compared to T cells grown in traditional incubators. This has tremendous potential to one day make a difference for patient care.” Scientists from AmplifyBio and Xcellbio will present their joint poster, “Adapting T Cells for the Tumor Microenvironment (TME) During Manufacturing for Improved Anti-Tumor Potency,” at ISCT 2024 (poster #933). It will include data about how T cells were metabolically conditioned in the AVATAR system to improve their fitness and potency. To learn more about the beta access program for the AVATAR Foundry platform, please visit . About AmplifyBio AmplifyBio is a contract research and manufacturing organization founded on the principle that all development and scale-up of advanced modality drugs should be done with commercial and clinical goals in mind. AmplifyBio launched with an initial offering of industry-leading preclinical toxicology, safety, and efficacy testing in an agile environment with analytics capabilities that serve the dynamic safety requirements of modern modalities. Since then, they have developed drug characterization and optimization service capabilities and opened a GMP manufacturing facility, to provide complete concept-to-commercial partnership for the commercialization of advanced therapies. . About Xcell Biosciences Xcellbio is driven by its mission to enhance the performance and safety of cell and gene-based therapies through the design and development of revolutionary technology platforms. The company’s commercial instruments and software allow researchers to discover novel insights into immune and tumor biology and enable the translation of these insights at patient scale through the development of its pioneering cGMP cell therapy manufacturing platform. Based in San Francisco, Xcellbio can also be found online at .