The company has spent six years working on a platform focused on cell potency and recovery; it says it has cracked one of the biggest problems in cell therapy: extracting enough potent cells to treat chronically sick patients.
Industry and academic players are testing, under non-disclosure, that platform, known as the Curate Cell Processing System.
It is an automated system that has the potential to enable up to a 50% reduction in the total cost of autologous cell therapy production and a like reduction in the days required to produce a CAR-T dose, according to the company.
In addition, it more than doubles the recovery of patient-derived white blood cells and CD3+ T cell subsets, with exceptional purity in a single-step, closed microfluidic system, added the developer.
Recovering naïve and central memory T cells
Curate Bioscience’s chief technology officer, Tony Ward, told BioPharma-Reporter how the system has "industry-leading" ability to produce more high-quality white blood cells for CAR-T oncology cures.
“Today, autologous cell therapy manufacturing typically starts with five steps, taking longer than four hours to obtain a white blood cell preparation for T-cell selection and activation.
“Across these steps, one can lose up to 90% of the cells of interest. The Curate system is highly superior, isolating white cells with high recoveries, without bias or damage, in an easy-to-use closed microfluidic system with just a single step taking about 45 minutes. There is minimal operator hands-on time. On average, our system recovers more than 4-fold more T central memory cells than density-based methods. Our single platform also provides greater than 3-log wash efficiency in a single pass and can concentrate the product to industry needs without breaking the closed loop sterility."
He said the platform is looking to address a fundamental challenge for the industry: inconsistent and low recovery starting cell material.
“The Curate System’s gentle processing delivers a higher yield of more naïve, minimally manipulated T cells, which should enable better engraftment and persistence profiles for making improved therapies. Recovering more naïve and central memory T cells of the highest quality is key to optimizing the end-to-end production workflow. It reduces days, process steps, and the associated costs of cell culture expansion, along with dramatically reducing capital infrastructure spending and skilled labor requirements.”
And the company is now planning a broader commercial launch by Q4 2022 for its cGMP-manufactured system and consumables, said chief business officer, Gaurav Vij. “We are on track with select major biopharmas, CDMOs, and life science tools companies participating in our technology access program for early evaluation and qualification.”
Leveraging IP portfolios
The company was actually established two decades ago, with the licensing of substantial IP portfolios from Princeton University, Mass General Hospital, and other early leaders in microfluidic deterministic separation technology.
“The potential to efficiently separate rare cell populations for diagnostic use was terrific, and, during that time, we out-licensed selective fields with the benefit of a cross-license back of more IP.
“Around 2015, we moved toward internal technology development, and in 2017, we focused on the challenge of separating WBCs for CAR-T and other cell therapy applications, advancing our product realization and building an exceptional internally-developed IP portfolio.
“Our Curate Cell Processing System now can help provide greater cells of exceptional quality to improve manufacturing curative therapies for patients facing intractable diseases,” said its CEO Michael Grisham.
And Curate Biosciences has seen plenty of interest from the venture capital side:
“We’ve raised US$50m in equity funding to date, of which US$33.5m was raised over the past two years in our first venture/strategic rounds led by Vensana Capital and Amgen Ventures, with participation by another major healthcare industry leader and our prior angel round investors.
“The strength of our technology portfolio also leveraged non-equity funding from grants and in-license agreements that contributed intellectual property to the company,” said CFO Jason Walsh.