Cue Biopharma Appoints Dr. Usman Azam as CEO, Pivots to Autoimmune Disease Focus with CUE-401
Key Insights
Cue Biopharma has appointed Dr. Usman Azam as President and CEO, effective September 29, 2025, bringing over 25 years of drug development experience including CAR-T cell therapy leadership at Novartis.
The company is strategically pivoting to prioritize autoimmune disease (search) development, focusing on advancing its first-in-class tolerogenic biologic CUE-401 into clinical trials.
CUE-401 is designed as a bifunctional molecule combining TGF-beta (search) with IL-2 mutein to restore immune homeostasis and tolerance, with potential to disrupt standard autoimmune disease (search) treatment.
Cue Biopharma has announced a strategic leadership transition with the appointment of Dr. Usman "Oz" Azam as President and Chief Executive Officer, effective September 29, 2025. The clinical-stage biopharmaceutical company is simultaneously pivoting its focus toward autoimmune disease (search) development, prioritizing its first-in-class tolerogenic biologic CUE-401 for clinical advancement.
Daniel Passeri, who previously served as CEO, will transition to a Strategic Advisor role to provide ongoing support to the company. The leadership change comes as Cue Biopharma shifts its strategic focus from its broader portfolio to concentrate on autoimmune therapeutic development.
Leadership Transition Brings Extensive Industry Experience
Dr. Azam brings over 25 years of drug discovery and development leadership to Cue Biopharma. His experience spans the entire drug development value chain, including clinical trial design, execution, and product launches. Most recently, he served as CEO of Inspirna (search), Inc., a privately held clinical-stage biopharmaceutical company focused on novel cancer (search) drug development.
His career includes leadership positions at several prominent companies in the cell and gene therapy space. As President and CEO of Tmunity Therapeutics (search), Dr. Azam was involved in developing genetically engineered CAR-T cell therapies for solid tumor applications. Notably, 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 (search).
Dr. Azam's extensive experience also includes leadership roles at major pharmaceutical companies including Pfizer Pharmaceuticals, Aspreva Pharmaceuticals, Johnson & Johnson, and GlaxoSmithKline (GSK). Additionally, he served as CEO of Empyrean Neuroscience (search), a genetic engineering company advancing neuroactive compounds targeting central nervous system disorders.
Strategic Focus on Autoimmune Disease
The leadership transition aligns with Cue Biopharma's strategic pivot toward autoimmune disease (search) development. "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, outgoing CEO of Cue Biopharma.
Dr. Azam expressed enthusiasm about the company's lead autoimmune asset: "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 (search). I look forward to effectively driving CUE-401 through clinical development, creating value by addressing significant unmet medical need."
CUE-401: A Novel Tolerogenic Approach
CUE-401 represents Cue Biopharma's lead autoimmune asset and is designed to act mechanistically as a master switch for regulatory T cell (search) (Treg) differentiation and tolerance induction. The drug candidate is described as a highly innovative bifunctional molecule that combines a TGF-beta (search) breathing-mask moiety with Cue Biopharma's clinically validated interleukin (IL-2) mutein in a single injectable biologic.
The company's proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells (search)), and its biologics are designed to harness the curative potential of the body's intrinsic immune system without the adverse effects of broad systemic immune modulation.
Pasha Sarraf, M.D., Ph.D., chairman of the board of Cue Biopharma, highlighted the potential impact of CUE-401: "As the Company focuses on autoimmunity, we believe CUE-401's tolerogenic mechanism has the potential to become the 'Keytruda' for autoimmune disease (search), enabling deep and durable remissions to free patients from lifelong therapies and chronic disease."
Broader Portfolio and Strategic Partnerships
While prioritizing autoimmune disease (search) development, Cue Biopharma continues to advance other programs in its pipeline. The company's portfolio includes the partnered program CUE-501 and clinical-stage CUE-100 series assets, for which the company plans to secure strategic partners.
The company develops a novel class of injectable biologics designed to selectively engage and modulate disease-specific T cells (search) directly within the patient's body for the treatment of both autoimmune disease (search) and cancer (search). Headquartered in Boston, Massachusetts, Cue Biopharma is led by an experienced management team with deep expertise in immunology, immuno-oncology, and the design and clinical development of protein biologics.