Cue Biopharma Announces Appointment of Matteo Levisetti, M.D. as Senior Vice President of Clinical Development

Appointment to strengthen clinical development capabilities with a strategic and visionary immunotherapy leader as Cue Biopharma advances its pipeline of drug development programs

CAMBRIDGE, Mass., Feb. 17, 2021 (GLOBE NEWSWIRE) -- (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, announced today it has appointed Dr. Matteo Levisetti as senior vice president of clinical development, effective February 22, 2021. Dr. Levisetti joins Cue Biopharma with extensive drug development experience in the pharmaceutical and biotech industries, where he led global clinical development and regulatory strategies for multiple clinical development programs in immuno-oncology, and autoimmune and inflammatory diseases.

“We are very pleased to welcome Matteo to Cue Biopharma,” said Ken Pienta, M.D., acting chief medical officer of Cue Biopharma. “Dr. Levisetti brings highly pertinent academic, medical and clinical development expertise in immunology and oncology which will enhance our clinical insights and development strategies at this important juncture. Matteo has an unwavering commitment to help develop promising, breakthrough therapies with the potential of significantly enhancing the lives of patients. Matteo and I will be working closely together overseeing Cue Biopharma’s ongoing CUE-101 Phase 1 dose escalation monotherapy trial and its combination trial KEYNOTE-A78, where it will be evaluating CUE-101 with KEYTRUDA® (pembrolizumab) as first-line treatment for HPV+ R/M HNSCC. Matteo will also help oversee CUE-102/A02, our second lead candidate in the IL-2 CUE-100 series, designed to target Wilms’ tumor 1 (WT1) specific T cells for the treatment of patients with solid and hematological cancers, as the company prepares for an Investigational New Drug (IND) filing in early 2022.”

Dr. Levisetti commented, “I am thrilled to be joining the Cue Biopharma team, as CUE-101 and the Immuno-STAT™ platform represents a potential breakthrough in immunotherapy for oncology and immune-mediated inflammatory diseases, and I look forward to advancing the development of these important potential new therapeutics with the goal of bringing selective immune modulation to patients suffering from a broad range of cancers and autoimmune diseases.”

About Matteo Levisetti

Matteo Levisetti brings extensive experience leading global clinical development for mid and large-size pharmaceutical companies. Prior to joining Cue Biopharma, Matteo served as Chief Medical Officer at DNAtrix directing and managing clinical operations and regulatory strategy for several clinical trials. Matteo also served as Chief Medical Officer at Dauntless Pharmaceuticals where he was responsible for all aspects of clinical development of endocrinology and oncology assets. Previously, Matteo directed immuno-oncology programs as Executive Director of Clinical Development at Mirati Therapeutics. Before joining Mirati, Matteo served as Global Head & Vice President, Translational Medicine, Immunology and Inflammation at Roche Pharma Research & Early Development and held several senior positions with Pfizer, including Global Clinical Lead. While working with Pfizer, Matteo led multiple early clinical development programs across several therapeutic areas, including endocrinology, immunology and oncology. Earlier in his career, Matteo held joint appointments as Assistant Professor in the Departments of Medicine, Pathology, and Immunology at Washington University School of Medicine. Matteo received his MD from the University of Chicago Pritzker School of Medicine, completed residency training in internal medicine at the University of Chicago Hospitals, and completed subspecialty training in endocrinology and a research fellowship in immunology with Dr. Emil R. Unanue at Washington University School of Medicine, St. Louis, Missouri.

About Cue Biopharma

Cue Biopharma, a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body to transform the treatment of cancer, infectious diseases and autoimmune diseases. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) is designed to harness the body’s intrinsic immune system without the need for ex vivo manipulation.

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

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Cautionary Note Regarding 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, that are intended to be covered by the safe harbor created by those sections. Such forward-looking statements include, but are not limited to, those regarding: the potential of the CUE 100 series for anti-tumor activity; the potential benefits of the company’s Immuno-STAT™ platform biologics; the anticipated results of the company’s drug development efforts, including study results; the company’s expectations regarding regulatory developments and expected future operating results; and statements regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives. 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 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. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s limited operating history, limited cash and history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts 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 COVID-19, including possible effects on the company’s operations and clinical 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 participants in clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance 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; the company’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 the company’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 the company in this press release is based only 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 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.

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Cue Biopharma, Inc.

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