Overcoming the challenges of off-the-shelf allogeneic cell therapies

June 20, 2022

Chimeric antigen receptor (CAR) T-cell therapy has emerged as one of the major breakthroughs in cancer immunotherapy in the last decade. However, the use of autologous T cells to manufacture CAR products has several disadvantages, according to Dr. Jason Litten, a clinical consultant and former chief medical officer at Artiva Biotherapeutics.

"We all recognize the limitations of an autologous product," said Litten, who has spent the last five years working to advance cell therapy in oncology. As the industry looks to move to "off-the-shelf" allogeneic CAR T cell products, he contends there are a number of important scientific and regulatory challenges that will need to be overcome.

Litten, who spoke to ScienceBoard.net at the 2022 Biotechnology Innovation Organization (BIO) International Convention in San Diego, noted that with allogeneic therapies there is the opportunity to give multiple doses while autologous products "are limited in that way."

Although allogeneic T cells present many advantages over autologous T cells, which must be generated from each patient's cells, they also come with specific challenges that need to be overcome to reach clinical success, including manufacturing them at scale.

"My interactions with regulatory bodies have suggested that while [allogeneic] may be ready for the clinic from a clinical and scientific standpoint, the manufacturing has not yet been refined to a place where the agency is ready to approve it as a therapeutic," Litten said. "That is the first, second, and third challenge of bringing new cell and gene therapies to the clinic."

Watch the video below to learn more.


Struggle to include women in clinical trials continues despite gains
Though female participation in clinical trials has been steadily improving over the years, most of the women enrolled in trials are white and not members...
Patient advocacy organizations look to partner with pharma companies
Patient advocacy organizations are looking to partner with pharmaceutical companies, offering resources and expertise to maximize the impact and efficiency...
How to develop a sustainable portfolio for cell, gene therapy platforms
Michael Retterath, a Biotechnology Innovation Organization International Convention 2022 panelist and chief business officer at Spark Therapeutics, spoke...
Biotech industry execs, not scientists, remain male-dominated
A panel at the 2022 Biotechnology Innovation Organization International Convention will explore how to close the gender gap in the biotech industry and...
The ‘voice of the patient’ needs to be heard in clinical trials: study
Patient recruitment and retention are among the biggest challenges facing clinical research, particularly in studies targeting rare diseases that have...
New era of non-viral DNA-delivered gene therapy seen emerging
Advancements in nucleic acid-encoded therapeutics over the past decade have sparked the emergence of a new era in non-viral DNA-delivered gene therapy,...
Biotech innovator recounts decades-long journey to create drug discovery technology
Dr. Stan Crooke, PhD, founder, chairman, and chief executive officer of RNA therapy company Ionis Pharmaceuticals, pioneered development of the antisense...
Biotech industry to gather at BIO International Convention in San Diego
More than 11,000 attendees from around the globe will be in San Diego, June 13-16, for the 2022 Biotechnology Innovation Organization (BIO) International...

Copyright © 2022 scienceboard.net

Last Updated 7/20/2022 2:31:42 PM