BOSTON, MA, USA I February 22, 2023 I Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, announced today a collaboration and option agreement with Ono Pharmaceutical Co., Ltd. (“Ono”), for CUE-401, a bispecific protein designed to induce and expand regulatory T cells (Tregs) for the treatment of autoimmune and inflammatory diseases.

The strategic collaboration with Ono is an important advancement in Cue Biopharma’s corporate development plan to seek third party support to further develop its CUE-400 series and provides dedicated resources and capabilities to help advance CUE-401 toward the clinic. In preclinical studies, CUE-401 has demonstrated induction and expansion of Tregs, with the potential to address a broad range of autoimmune and inflammatory diseases.

Under the terms of the agreement, Ono will pay Cue Biopharma an upfront payment and fully fund all research activities related to CUE-401 through a specified option period. During this option period Cue Biopharma will be responsible for the research and development of CUE-401. Upon Ono’s exercise of its option to license CUE-401, Cue Biopharma will receive an option exercise payment and be eligible for development and commercial milestone payments up to an aggregate of approximately $220 million, as well as tiered royalties on sales. Upon any such exercise, Ono will receive worldwide rights to develop and commercialize CUE-401, with Cue Biopharma retaining a 50% co-development and co-commercialization right in the United States.

“This strategic collaboration with Ono Pharmaceutical, a leading Japanese pharmaceutical company with a track record of scientific innovation, is a significant accomplishment for Cue Biopharma, as it allows us to further develop this promising biologic through the support of a strategic partner,” stated Daniel Passeri, chief executive officer of Cue Biopharma. “Through this important partnership we have secured resources and capabilities necessary to help advance CUE-401 towards the clinic, while preserving potential value to our shareholders through a 50:50 collaboration right for the U.S. market.”

“We appreciate Cue Biopharma’s proprietary platform, protein engineering abilities, as an emerging new therapeutic modality and are thrilled to work with Cue Biopharma’s biologics team through this collaboration agreement.” said Toichi Takino, Senior Executive Officer/Executive Director, Discovery & Research of Ono Pharmaceutical. “We hope to add CUE-401 into our portfolio to help patients suffering from autoimmune and inflammatory diseases.”

About CUE-401
CUE-401 is a preclinical, bispecific fusion protein designed to induce and expand regulatory T cells (Tregs) through the delivery of transforming growth factor beta (TGF-β) and interleukin 2 (IL-2) with therapeutic potential across a range of T-cell mediated autoimmune and inflammatory diseases.

About Ono Pharmaceutical Co., Ltd.
Ono Pharmaceutical Co., Ltd., headquartered in Osaka, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. Ono focuses its research on oncology, immunology, neurology and specialty research with high medical needs as priority areas for discovery and development of innovative medicines. For further information, please visit the company’s website at

About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the body’s intrinsic immune system as T cell engagers without the need for ex vivo manipulation or broad systemic immune modulation.

Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.

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SOURCE: Cue Biopharma