Cue Biopharma Reports Two Objective Responses (1 cPR and 1uPR) in First Interim Update of… | News

Early data from combination study of CUE-101 and KEYTRUDA® (pembrolizumab) support synergistic activity; of four patients treated with dose escalation in the 2 mg/kg and RP2D 4 mg/kg cohorts, two have partial responses (1 confirmed and 1 unconfirmed) and two show reductions in target lesions Updated data on the CUE-101 monotherapy further builds confidence in the potential as a therapeutic single agent with a clinical benefit rate of 50% reported to date in the RP2D (4 mg/kg) monotherapy expansion trial and a emerging improved overall survival rate that supports the hypothesis that CUE-101 selectively stimulates cancer-relevant CD8+ T cells

CAMBRIDGE, Mass., Jan. 26, 2022 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a new class of injectable biologics designed to selectively engage and modulate targeted T cells directly in the patient’s body, will provide a clinical update at the conference. telephone call and today’s webcast at 4:30 p.m. IS. Live and archived versions of the event can be accessed via the website.

Members of Cue Biopharma’s leadership team will provide an update on the company’s ongoing clinical trials with CUE-101, its lead and representative IL-2 product candidate of the CUE-100 series. CUE-101 is currently in a Phase 1b clinical trial for the treatment of recurrent/metastatic HPV+ squamous cell carcinoma of the head and neck in the third line and beyond. Discussion will focus on recent data updates from the Phase 1b monotherapy dose extension trial and dose escalation combination trial evaluating first-line CUE-101 with KEYTRUDA® (pembrolizumab) from Merck. Management will also provide an update on the Company’s pipeline development progress of the IL-2-based CUE-100 series, including CUE-102, along with an Investigational New Drug (IND) filing. ) scheduled for the first quarter of 2022, along with updates on its strategic objectives and planned milestones.

Webcast Details

About Cue Biopharma Cue Biopharma, a clinical-stage biopharmaceutical company, is designing a new class of injectable biologics to selectively engage and modulate targeted T cells directly in the patient’s body to transform the treatment of cancer, diseases infectious and autoimmune diseases. The company’s proprietary Immuno-STAT™ (selective targeting and alteration of T cells) platform is designed to harness the body’s intrinsic immune system without the need for ex vivo manipulation.

Based in Cambridge, Massachusetts, the company is led by an experienced management team and an independent Board of Directors with deep expertise in immunology and immuno-oncology as well as in the design and clinical development of biological proteins.

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Forward-looking statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be within the scope of security created by these rubrics. These forward-looking statements include, but are not limited to, those regarding: the Company’s estimate of the period over which it expects to have cash available to fund its operations; the company’s belief that the Immuno-STAT platform drives targeted immune modulation through the selective engagement of disease-relevant T cells; and the company’s business strategies, plans and outlook. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking words such as “believe”, “expect”, “may”, “will,” “should”, “do”, “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 fact included in this press release regarding strategies, the outlook, financial condition, operations, costs, plans and objectives of the company are forward-looking statements.Important factors that could cause the actual results and financial condition of the company to differ materially from those indicated in the dec forward-looking statements include, among other things, the company’s limited operating history, limited cash and loss history; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts, including negative or inconclusive results from its preclinical studies, its ability to obtain required approvals from the United States Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the scope of any approved indications; adverse effects caused by public health pandemics, including COVID-19, including possible effects on the Company’s trials; negative or inconclusive results from the Company’s clinical trials or preclinical studies or serious and unexpected drug-related side effects or other safety issues experienced by clinical trial participants; delays and changes in regulatory requirements, policies and guidelines, including potential delays in submitting required regulatory submissions to FDA; the company’s dependence on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future; operations and clinical the company’s ability to maintain and enforce necessary patents and other intellectual property protections; competitive factors; general economic and market conditions and other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recent annual report on Form 10 -K and any subsequently filed quarterly report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based solely on information currently available to the company and speaks only as of the date on which it is made. The Company undertakes no obligation to update publicly any forward-looking statements, written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact George B. Zavoico, Ph.D. Vice President, Investor Relations and Corporate Development Cue Biopharma, Inc. [email protected]

Media Contact Darren Opland, Ph.D. LifeSci Communications [email protected]

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