Boehringer Ingelheim and Cue Biopharma Forge Strategic Partnership to Advance Targeted Autoimmune Therapy

(IN BRIEF) Boehringer Ingelheim has entered into a multi-year collaboration with Cue Biopharma to develop and commercialize CUE-501, a first-in-class bispecific compound designed to selectively deplete harmful B cells in autoimmune diseases. The innovative therapy uses Cue’s Immuno-STAT™ platform to engage virus-specific T cells and target B cells with high precision, potentially improving outcomes and safety. The deal includes an upfront payment of $12 million, research support, and up to $345 million in milestone payments, plus royalties. This partnership aims to accelerate the delivery of more effective, targeted therapies to patients earlier in their treatment journey.

(PRESS RELEASE) INGELHEIM, 16-Apr-2025 — /EuropaWire/ — Boehringer Ingelheim has announced a strategic research collaboration and licensing agreement with Cue Biopharma, Inc. (Nasdaq: CUE), aimed at developing and commercializing Cue Biopharma’s innovative candidate, CUE-501—a potential first-in-class bispecific biologic designed to deplete disease-causing B cells in autoimmune and inflammatory conditions.

This collaboration significantly strengthens Boehringer’s pipeline in autoimmune and inflammatory diseases, an area where patients often face limited and unsatisfactory treatment options. CUE-501 is a preclinical-stage compound developed using Cue Biopharma’s proprietary Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform. It is designed to bind a specific membrane protein expressed on B cells, while simultaneously engaging virus-specific memory killer T cells. The targeted approach aims to eliminate harmful B cells and dampen the autoimmune response, potentially delivering superior efficacy and safety compared to existing B cell-depleting therapies.

“We are excited to expand our immunology pipeline with Cue Biopharma’s promising approach, which could allow us to intervene earlier in the patient journey and offer long-term disease control,” said Dr. Carine Boustany, U.S. Research Site Head and Global Head of Immunology and Respiratory Diseases Research at Boehringer Ingelheim. “Cue’s T-cell engager platform offers the precision we need to develop more personalized and durable autoimmune treatments.”

Under the multi-year agreement, Cue Biopharma will collaborate with Boehringer to further the development of CUE-501 and explore additional bispecific B cell-targeting therapies for autoimmune diseases. Cue Biopharma will receive an upfront payment of $12 million and ongoing research support. The company is also eligible for up to $345 million in potential milestone payments related to research, development, and commercialization, as well as royalties on future product sales.

“This partnership represents a significant milestone for Cue Biopharma,” said Daniel Passeri, CEO of Cue Biopharma. “Working with Boehringer Ingelheim allows us to further validate our Immuno-STAT™ platform while advancing a potentially breakthrough therapy that redirects antiviral memory T cells to eliminate disease-driving B cells with high precision.”

The agreement exemplifies both companies’ commitment to advancing more selective, safer, and effective therapies for patients suffering from chronic autoimmune conditions.

Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer Ingelheim takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable and equitable tomorrow. Learn more at https://www.boehringer-ingelheim.com (Global) or https://www.boehringer-ingelheim.com/uk (UK). 

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 curative potential of the body’s intrinsic immune system through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation.

Headquartered in Boston, Massachusetts, Cue Biopharma is led by an experienced management team with deep expertise in immunology and protein engineering as well as the design and clinical development of protein biologics.

For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: Cue Biopharma’s belief that its Immuno-STAT platform stimulates targeted immune modulation through the selective modulation of disease-relevant T cells and the applicability of its platform across many cancers and autoimmune diseases; Cue Biopharma’s business strategies, plans and prospects for the CUE-500 series, including the company’s belief that CUE-501 is a novel bispecific designed to deplete B cells for the treatment of autoimmune and inflammatory diseases; and Cue Biopharma’s potential receipt of future research development and commercial milestone-based payments as well as royalty payments on net sales under the collaboration and license agreement with Boehringer Ingelheim and other expected benefits of the collaboration. Forward-looking statements, which are based on certain assumptions and describe Cue Biopharma’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding Cue Biopharma’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause Cue Biopharma’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, Cue Biopharma’s ability to successfully shift its focus to its autoimmune programs; Cue Biopharma’s ability to maintain its collaboration with Boehringer Ingelheim; Cue Biopharma’s limited operating history, limited cash and a history of losses; Cue Biopharma’s ability to achieve profitability; Cue Biopharma’s ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; potential setbacks in Cue Biopharma’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or Cue Biopharma’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates such as CUE-501; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on Cue Biopharma’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; Cue Biopharma’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; Cue Biopharma’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of Cue Biopharma’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by Cue Biopharma in this press release is based only on information currently available to Cue Biopharma and speaks only as of the date on which it is made. Cue Biopharma undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Intended Audiences Notice

>This press release is issued from Boehringer Ingelheim’s Corporate Headquarters in Ingelheim, Germany (as well as the headquarters of Cue Biopharma in Boston, MA, USA). Through this press release, Boehringer intends to provide information about its global business. Please be aware that information relating to the approval status and labels of approved products of Boehringer may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer does business.

Media Contact:

Dr Reinhard Malin
press@boehringer-ingelheim.com

Linda Ruckel
linda.ruckel@boehringer-ingelheim.com

Phone +49 – 6132 – 77 0
Fax +49 – 6132 – 72 0

SOURCE: Boehringer Ingelheim