Neogene Therapeutics Announces Approval of Clinical Trial Application for its First Phase 1 Trial of Novel, Fully-Individualized TCR Therapy to Treat Advanced Solid Tumors

SANTA MONICA, Calif. & AMSTERDAM–()–Neogene Therapeutics, Inc., a global biotechnology company focused on discovering, developing, and manufacturing novel, transformative TCR therapies targeting neoantigens in solid cancers, today announced the approval of the company’s first Clinical Trial Application (CTA) by the Dutch regulatory authority for a Phase 1 study of NT-125, an autologous, fully-individualized, multi-specific TCR therapy for the treatment of advanced solid tumors. The Phase 1 study will enroll adult patients with various types of advanced solid tumors in partnership with the Netherlands Cancer Institute (NKI), an internationally acclaimed research institute and leading cancer clinic.

“This authorization and transition to a clinical-stage company marks a significant milestone for Neogene and reinforces our ambition to make an impact on patients with advanced solid cancers with a novel, fully-individualized therapy,” said Carsten Linnemann, Ph.D., President, Chief Executive Officer, and Co-Founder of Neogene. “At this new stage of growth, we remain focused on advancing our unique pipeline of fully-individualized and shared neoantigen TCR therapies with the goal of changing the paradigm of solid cancer treatment.”

NT-125 is an investigational, autologous, fully-individualized, multi-specific TCR therapy targeting neoantigens for the treatment of advanced solid tumors. NT-125 is designed to contain up to five distinct neoantigen-specific TCRs per patient in a single cell product of highly functional engineered T cells, allowing multiple neoantigens presented by HLA class I and HLA class II molecules to be targeted with the goal to create a more impactful TCR therapy for more patients. NT-125 aims to reduce the probability of antigen escape and potentially maximize the depth and durability of clinical responses in a patient population with difficult to treat tumors and high unmet need.

“Patients with recurrent and metastatic solid tumors currently have a high unmet need and limited effective treatment options. We look forward to evaluating the safety and clinical activity of NT-125 as a potential new treatment option for this patient population,” said Dr. Raphael Rousseau, M.D., Ph.D., Chief Medical Officer of Neogene. “Neogene’s approach to T cell therapy allows us to develop a fully-individualized treatment with a unique set of up to five specific TCR genes for each patient that may overcome the current limitations of cell therapies for solid cancers.”

About Neogene Therapeutics

Neogene is a global biotechnology company focused on discovering, developing, and manufacturing novel, transformative TCR therapies targeting neoantigens in solid cancers. As a pioneer in T cell therapy, Neogene is advancing a pipeline of fully-individualized TCR therapies as well as TCR therapies targeting shared neoantigens, including mutated KRAS (mKRAS) and mutated TP53 (mTP53). Neogene’s team has deep gene and cell therapy expertise and a shared mission to bring next generation transformative TCR therapies to patients with solid cancers worldwide.

For more information, please visit www.neogene.com and follow Neogene Therapeutics on LinkedIn.

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