Legend Biotech Partners with Noile-Immune to Advance Cell Therapies for Solid Tumors Using PRIME Technology

Recently, Legend Biotech (“Legend Biotech”), a cell therapy R&D company, announced a collaboration agreement with Noile-Immune Biotech (“Noile-Immune”), an innovative cancer immunotherapy biopharmaceutical company. Legend Biotech and Noile-Immune will jointly focus on two specific cancer targets. Under the agreement, Legend Biotech will have the right to apply Noile-Immune’s core PRIME (Proliferation inducing and migration enhancing) technology to its cell therapy pipeline to develop CAR-T and/or TCR-T cell therapies capable of secreting IL-7 and CCL19. In addition, Legend Biotech will pay Noile-Immune approximately USD 70 million in partial development, regulatory, and commercial milestone payments, while Noile-Immune will be entitled to receive royalties from the commercial sales of the products.

Noile-Immune, founded in April 2015 and headquartered in Tokyo, Japan, is a clinical-stage biotechnology company focused on the development and commercialization of CAR-T therapies for solid tumors. Its PRIME technology promotes the expansion, accumulation, and enhanced induction of memory function of CAR-T and/or TCR-T cells, as well as patients’ own T cells, within solid tumors.

The principle of PRIME technology is to genetically engineer T cells to express cytokines and chemokines, such as IL-7 and CCL19. IL-7 promotes T cell proliferation while maintaining T cell stability, whereas CCL19 recruits peripheral T cells and dendritic cells into lymphoid tissues.

Previous studies have demonstrated that next-generation CAR-T cells co-expressing IL-7 and CCL19 exhibit a proliferative capacity twice that of conventional CAR-T cells. Furthermore, they can effectively induce substantial infiltration of endogenous human T cells and dendritic cells into the tumor parenchyma of solid tumors, thereby mediating tumor cell killing.

Currently, Legend Biotech has established a robust pipeline in the field of cell therapy, with its clinical trials in China and the United States progressively advancing into Phase II and Phase III stages. Its most advanced BCMA CAR-T therapy, LCAR-B38M/JNJ-452, has been granted Orphan Drug Designation, Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA), as well as PRIME designation by the European Medicines Agency (EMA). This collaboration with Noile-Immune will further accelerate the development of its cell-based therapeutics.

In March this year, GenScript Biotech (01548-HK), the parent company of Legend Biotech, announced that it had submitted a proposal to The Stock Exchange of Hong Kong Limited under Application Guidance Note 15 regarding the proposed spin-off (“Proposed Spin-off”) of its cell therapy business through an independent listing on a recognized stock exchange in the United States via a registered public offering.

The announcement further disclosed that the Stock Exchange of Hong Kong Limited has approved the proposed spin-off by GenScript. On March 9, 2020 (New York time), Legend Biotech confidentially submitted a draft registration statement to the U.S. Securities and Exchange Commission in connection with the proposed initial public offering of American Depositary Shares representing its ordinary shares. In the future, Legend Biotech may be spun off from GenScript and list independently in the United States.