Cue Biopharma Announces Strategic Transition in Leadership to Further Enable Next Stage of Growth with Disruptive Autoimmune Therapeutic Candidates
Cue Biopharma (Nasdaq: CUE) announced a strategic leadership transition, appointing Dr. Usman "Oz" Azam as President and CEO effective September 29, 2025. Current CEO Daniel Passeri will transition to Strategic Advisor.
Dr. Azam brings over 25 years of drug development leadership experience, including notable roles at Inspirna, Empyrean Neuroscience, Tmunity Therapeutics, and Novartis, where he helped secure the first FDA approval for CAR-T cell therapy. The transition aligns with Cue Biopharma's strategic focus on autoimmune disease, particularly advancing their first-in-class tolerogenic biologic CUE-401, which aims to restore immune homeostasis and potentially revolutionize autoimmune disease treatment.
Cue Biopharma (Nasdaq: CUE) ha annunciato una transizione strategica della leadership, nominando il dottor Usman "Oz" Azam come Presidente e Amministratore Delegato a partire dal 29 settembre 2025. L'attuale AD Daniel Passeri passerà al ruolo di Consulente Strategico.
Il dottor Azam porta oltre 25 anni di esperienza nella leadership nello sviluppo di farmaci, tra ruoli significativi in Inspirna, Empyrean Neuroscience, Tmunity Therapeutics e Novartis, dove ha contribuito a ottenere l'approvazione FDA per la prima terapia CAR-T. Questa transizione è in linea con l'orientamento strategico di Cue Biopharma verso le malattie autoimmuni, in particolare avanzando il loro biologico tollogenico di prima classe CUE-401, che mira a ripristinare l'omeostasi immunitaria e potrebbe rivoluzionare il trattamento delle malattie autoimmuni.
Cue Biopharma (Nasdaq: CUE) anunció una transición estratégica de liderazgo, nombrando al Dr. Usman "Oz" Azam como Presidente y CEO a partir del 29 de septiembre de 2025. El actual CEO Daniel Passeri realizará la transición a Asesor Estratégico.
El Dr. Azam aporta más de 25 años de experiencia en liderazgo en el desarrollo de fármacos, con roles destacados en Inspirna, Empyrean Neuroscience, Tmunity Therapeutics y Novartis, donde contribuyó a obtener la primera aprobación de la FDA para la terapia CAR-T. Esta transición se alinea con el enfoque estratégico de Cue Biopharma hacia las enfermedades autoinmunes, avanzando especialmente su biológico tolerogénico de primera clase CUE-401, cuyo objetivo es restablecer la homeostasis inmunitaria y podría revolucionar el tratamiento de las enfermedades autoinmunes.
Cue Biopharma (Nasdaq: CUE)는 전략적 리더십 전환을 발표하며 Usman "Oz" Azam 박사를 2025년 9월 29일부로 회장 겸 최고경영자로 임명했습니다. 현 CEO 다니엘 파세리은 전략 자문가로 전환합니다.
Azam 박사는 의약품 개발 리더십 분야에서 25년이 넘는 경력을 보유하고 있으며, Inspirna, Empyrean Neuroscience, Tmunity Therapeutics, 노바티스(Novartis) 등에서 중요한 역할을 수행했고, CAR-T 세포 치료의 FDA 최초 승인을 돕는 데 기여했습니다. 이 전환은 Cue Biopharma의 자가면역 질환에 대한 전략적 초점과 일치하며, 특히 1급으로 분류되는 내성 유발 생물학적 제제 CUE-401의 개발을 가속화해 면역 항상성을 회복하고 자가면역 질환 치료에 혁신을 가져올 수 있습니다.
Cue Biopharma (Nasdaq: CUE) a annoncé une transition stratégique de leadership, nommant le Dr. Usman “Oz” Azam comme Président et PDG à compter du 29 septembre 2025. Le PDG actuel Daniel Passeri assumera le rôle de Conseiller Stratégique.
Le Dr Azam apporte plus de 25 ans d'expérience en leadership dans le développement de médicaments, notamment chez Inspirna, Empyrean Neuroscience, Tmunity Therapeutics et Novartis, où il a contribué à l'obtention de la première approbation par la FDA d'une thérapie CAR-T. Cette transition s'aligne sur l'orientation stratégique de Cue Biopharma envers les maladies auto-immunes, en particulier en faisant progresser leur biologic tologénique de première classe CUE-401, qui vise à rétablir l'homéostasie immunitaire et pourrait révolutionner le traitement des maladies auto-immunes.
Cue Biopharma (Nasdaq: CUE) hat eine strategische Führungstransition angekündigt und Dr. Usman „Oz“ Azam zum Präsidenten und CEO ab dem 29. September 2025 ernannt. Der aktuelle CEO Daniel Passeri wird zum Strategischen Berater wechseln.
Dr. Azam bringt mehr als 25 Jahre Führungserfahrung in der Medikamentenentwicklung mit, darunter bedeutende Stationen bei Inspirna, Empyrean Neuroscience, Tmunity Therapeutics und Novartis, wo er dazu beigetragen hat, die erste FDA-Zulassung für CAR-T-Zelltherapie zu erreichen. Der Übergang steht im Einklang mit Cue Biopharmas strategischem Fokus auf Autoimmunerkrankungen, insbesondere bei der Weiterentwicklung ihres ersten in der Klasse befindlichen tolerogenen Biologikums CUE-401, das darauf abzielt, das Immunsystem zu stabilisieren und potenziell die Behandlung von Autoimmunerkrankungen zu revolutionieren.
Cue Biopharma (Nasdaq: CUE) أعلنت عن انتقال استراتيجي في القيادة، بتعيين الدكتور عثمان “Oz” أزام كالرئيس والمدير التنفيذي اعتبارًا من 29 سبتمبر 2025. سي переход المدير التنفيذي الحالي دانيال باسيري إلى مستشار استراتيجي.
يجلب الدكتور أزام أكثر من 25 عامًا من الخبرة القيادية في تطوير الأدوية، بما في ذلك أدوار بارزة في Inspirna وEmpyrean Neuroscience وTmunity Therapeutics وNovartis، حيث ساعد في تمهيد أول موافقة من FDA لعلاج CAR-T بالخلايا. هذا الانتقال يتماشى مع التركيز الاستراتيجي لـ Cue Biopharma على أمراض المناعة الذاتية، مع تقدمها بشكل خاص في biologic tolérgénية من فئة أولى CUE-401، والذي يهدف إلى استعادة توازن المناعة وقد يحدث ثورة في علاج الأمراض المناعية الذاتية.
Cue Biopharma（纳斯达克股票代码：CUE）宣布进行战略领导层过渡，任命Usman “Oz” Azam 博士为总裁兼首席执行官，任期自2025年9月29日起生效。现任首席执行官 Daniel Passeri 将过渡为战略顾问。
Azam 博士带来超过25年的药物开发领导经验，曾在 Inspirna、Empyrean Neuroscience、Tmunity Therapeutics 和诺华（Novartis）担任重要职务，在推动 CAR-T 细胞治疗获得 FDA 首次批准方面发挥了作用。这一过渡符合 Cue Biopharma 在自身免疫疾病领域的战略重点，特别是在推进其第一类耐受性生物制剂CUE-401的开发，该药旨在恢复免疫稳态，可能彻底改变自身免疫疾病的治疗。
- Strategic appointment of Dr. Azam brings extensive drug development and commercialization expertise
- Company's renewed focus on autoimmune disease with promising CUE-401 candidate
- Retention of former CEO as Strategic Advisor ensures continuity and institutional knowledge
- Leadership transition may cause temporary organizational adjustments
- Shift in focus to autoimmune disease represents strategic pivot from previous directions
Insights
CEO transition signals strategic pivot to autoimmune focus, leveraging new leader's extensive drug development expertise for advancing promising CUE-401 candidate.
This leadership transition represents a calculated strategic shift for Cue Biopharma. The appointment of Dr. Usman Azam as CEO signals the company's decisive pivot toward prioritizing its autoimmune disease pipeline, particularly its tolerogenic biologic CUE-401. Dr. Azam's extensive background—spanning 25+ years across the entire drug development value chain with specific expertise in T cell therapeutics from his time at Novartis—directly addresses the company's current developmental needs.
The company's positioning of CUE-401 as potentially the "Keytruda" of autoimmune disease reveals significant internal confidence in this asset. This analogy is particularly noteworthy as Keytruda (pembrolizumab) transformed cancer treatment and became a multi-billion dollar blockbuster. The stated goal of enabling "deep and durable remissions to free patients from lifelong therapies" suggests a paradigm-shifting approach rather than incremental improvement over existing treatments.
This leadership change appears meticulously planned, with the outgoing CEO Daniel Passeri remaining as Strategic Advisor to ensure continuity. Dr. Azam's specific experience with T-cell therapeutics at Novartis—where he helped deliver the first FDA-approved CAR-T therapy—provides directly applicable expertise to Cue's immunomodulatory platform technology. His track record launching novel modalities could prove crucial as Cue advances its first-in-class candidates toward commercialization.
- Usman Azam, M.D., is appointed President and Chief Executive Officer of Cue Biopharma, effective September 29, 2025
- Daniel Passeri, Chief Executive Officer of Cue Biopharma, transitions to Strategic Advisor to provide ongoing support to the Company
- Cue Biopharma prioritizes autoimmune disease for next stage of growth with focus on advancing first-in-class tolerogenic biologic CUE-401 into the clinic
BOSTON, Sept. 29, 2025 (GLOBE NEWSWIRE) -- -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, today announced that Usman “Oz” Azam, M.D., has been appointed President and Chief Executive Officer (CEO) of Cue Biopharma, effective September 29, 2025. Daniel Passeri will transition from his current role as CEO to one of Strategic Advisor, effective as of the same date.
“This strategic transition in leadership is a timely and important step forward, enhancing the Company’s next stage of corporate development with a prioritized focus on autoimmune disease,” said Daniel Passeri, chief executive officer of Cue Biopharma. “Dr. Azam‘s significant experience across the entire drug development value-chain, including clinical trial design and execution, as well as product launches is invaluable for advancing the Company’s first-in-class tolerogenic drug candidate CUE-401 for autoimmune diseases, our partnered program CUE-501 and for securing strategic partners for our clinical-stage CUE-100 series assets.”
Dr. Azam brings over 25 years of drug discovery and development leadership as well as operating expertise to Cue Biopharma. Most recently, Dr. Azam served as CEO of Inspirna, Inc., a privately held clinical stage biopharmaceutical company focused on the discovery and development of novel cancer drugs. Prior to Inspirna, Dr. Azam served as CEO of Empyrean Neuroscience, a genetic engineering company, advancing a pipeline of neuroactive compounds targeting disorders of the central nervous system. As President and CEO of Tmunity Therapeutics, he was involved in developing genetically engineered CAR-T cell therapies for solid tumor applications in cancer. He served as Global Head of the Cell and Gene Therapies unit at Novartis where he helped deliver and launch the first-ever FDA approval for a CAR-T cell therapy in hematologic cancers. Dr. Azam is well-respected in the industry for his extensive experience in leadership roles across both innovative biotechnology and large pharmaceutical companies, namely Pfizer Pharmaceuticals, Aspreva Pharmaceuticals, Johnson & Johnson, and GlaxoSmithKline (GSK). The learnings across these roles and his in-depth experience with T cell therapeutics make him well-suited to foster the Company’s next stage of growth.
“I am very pleased to be taking on the role of CEO and working closely with the Cue Biopharma team at this important stage of the Company’s development,” said Dr. Azam. “What has me most excited about joining the Company is CUE-401, a molecule designed to restore immune homeostasis and tolerance, with the potential to disrupt the standard of care in autoimmune disease. I look forward to effectively driving CUE-401 through clinical development, creating value by addressing significant unmet medical need.”
Pasha Sarraf, M.D., Ph.D., chairman of the board of Cue Biopharma stated, “Cue’s board is pleased to welcome Oz as our new President and CEO. As the Company focuses on autoimmunity, we believe CUE-401’s tolerogenic mechanism has the potential to become the ‘Keytruda' for autoimmune disease, enabling deep and durable remissions to free patients from lifelong therapies and chronic disease. The Board is energized to partner with Oz to bring this vision to life. Additionally, we extend our deep gratitude and sincere appreciation to Dan for his leadership and forward-looking vision navigating the company through the many challenges that have faced the biotech industry over the years. He has provided us with the foundation for continued success and growth.”
From the Cue Biopharma Team
We look forward to continuing to work with Dan in his new role as Strategic Advisor and thank him for his dedication and commitment to the development of novel therapeutics for patients suffering from life-threatening diseases.
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 without the adverse effects of broad systemic immune modulation. CUE-401, the company’s lead autoimmune asset, is designed to act mechanistically as a master switch for regulatory T cell (Treg) differentiation and tolerance induction. It is a highly innovative bifunctional molecule combining a TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin (IL-2) mutein in a single injectable biologic.
Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology 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.
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: the executive transitions and the dates thereof; the company’s beliefs regarding the potential benefits and applications of its drug candidates and programs, including CUE-401’s potential to disrupt the standard of care in autoimmune disease; the company’s plans to secure strategic partners for its clinical-stage CUE-100 series assets; and the company’s business strategies, plans and prospects. 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. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. 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 ability to shift its focus to its autoimmune assets; the company’s limited operating history, limited cash and a history of losses; the company’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; 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 or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; 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 the company’s 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 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.
Investor Contact
Marie Campinell
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com
Media Contact
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com
FAQ
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