Nanotein Technologies
Reagent for Superior Cellular Therapy Manufacturing

The astounding response of CAR-T cell therapy in some patients, including both children and adults (for whom other treatments have failed), has opened up new avenues for cancer treatment. From small to large biopharma and biotech companies, everyone is working on developing cell therapies. However, the CAR-T industry often struggles to produce modified T cells in adequate quantity and quality, resulting in manufacturing failures. As most patients undergo radiotherapies or cytotoxic treatments, prior to CAR-T therapy, the patient’s own T-cells often get damaged or are destroyed. As a result, there are just too few remaining healthy T-cells that can be harvested and converted into therapeutically functioning CAR-Ts, resulting in the manufacturing failure. Collecting more peripheral blood mononuclear cells from patients is often not an option as it could be fatal to the patient and would also incur additional significant expense. Consequently, there is a constant need to grow more, high quality modified CAR-T cells, with each T-cell collection from the prospective patient.

An innovative biotechnology startup, Nanotein Technologies, addresses this issue with its protein-based solutions that allow biopharma companies to produce longer-lived and more clinically effective CAR-T cells in a larger quantity, and more quickly than other approaches. The company is a spinout from Lawrence Berkeley National Lab, where the idea began. Curtis Hodge—PhD, Co-Founder, and CEO of Nanotein Technologies, together with support from Co-Founder, Greg Hura, PhD—engineered a tunable and flexible platform technology to offer protein-based solutions that accelerate CAR-T expansion, increasing the number of cells produced per treatment.Furthermore, by providing more control over the types of T-cell subsets that are produced in an expansion, this platform technology allows manufacturers to shift therapeutic profiles, enhancing the longevity and effectiveness of the final cell therapy product.

"Our plug-and-play platform technology enables us to manipulate the cell surface of any cell with any antibody or combination of antibodies," says Hodge.

Truly, Nanotein is bringing innovation to the most crucial manufacturing steps. Its novel cell activation and expansion reagent dramatically accelerates the development process and enables manufacturers to grow T-cell cultures with new cell population profiles in unusually large amounts. Unlike some other cell activation and expansion reagents, Nanotein's T cell activation and expansion product is soluble in nature. Companies just add this expansion product to cells and continue with the process. "This underlying platform is a self-assembling protein-based nanoparticle that tightly binds and orients antibodies to interact optimally with the cell," says Hura. In essence, it enables Nanotein to develop better and a more varied array of products, to meet the different needs and desires of their biopharma customers.

The innovative solution has already started impacting the market. For example, they were chosen by QB3, a UC Berkeley-UCSF incubator, as a 2019 cohort of Biotech/Biopharma for their innovative technologies and potential market impact. The company is currently beta-testing its platform technology with a few select CAR-T companies. Nanotein plans to aggregate the feedback on their first formulation. Based on the market's response for a desirable final profile of cells, the company will further refine the formulation process and begin GMP production.

Nanotein has partnered with Polaris Pharmaceuticals, Inc., a cGMP manufacturer of biologics, and their main investor. Polaris is currently producing research grade nanoparticles and intends to produce GMP grade material in their Northern California facility later this year. "We are also in discussion with global distribution companies to commercialize our product," says Hodge. Next year, Nanotein will focus on beta testing, producing research grade and GMP product, completing additional internal validation, and attracting potential customers. So far, the great response from potential customers and investors has encouraged Nanotein to launch the product as soon as possible in the market.

Nanotein seeks to fill the need for new innovations that could revolutionize the cancer treatment space by producing longer-lived, more clinically effective CAR-T cells.