LUND, Sweden, June 22, 2026
Hamlet BioPharma AB has announced a significant expansion of its U.S. clinical development program for Alpha1H, a novel human breast milk-derived therapeutic candidate for bladder cancer, through a newly signed clinical trial agreement with the University of Iowa, one of the leading institutions in bladder cancer research and treatment. The collaboration will broaden the evaluation of Alpha1H to include patients with Carcinoma In Situ (CIS), a highly aggressive and therapy-resistant form of non-muscle-invasive bladder cancer (NMIBC). The expansion marks an important milestone for the company as it seeks to address a major unmet medical need among patients who fail current standard therapies and often face the prospect of radical bladder removal to prevent progression to invasive disease. The study will be conducted under Hamlet BioPharma’s existing U.S. Investigational New Drug (IND) application through a protocol amendment submitted to the U.S. Food and Drug Administration (FDA), further advancing Alpha1H toward broader clinical validation.
Targeting High-Risk Bladder Cancer with Significant Unmet Need
Bladder cancer remains one of the most common urological malignancies worldwide, with recurrence and treatment resistance posing major clinical challenges. Among the most difficult forms of the disease is BCG-unresponsive Carcinoma In Situ, a high-grade, flat tumor that can rapidly progress to muscle-invasive cancer if not effectively controlled. Current standard treatment relies heavily on Bacillus Calmette-Guérin (BCG) immunotherapy, yet an estimated 30% to 50% of patients fail to achieve durable responses.
For many of these individuals, radical cystectomy, or complete bladder removal, becomes the only remaining treatment option. Alpha1H is being evaluated as a potential alternative approach designed to preserve bladder function while targeting cancer cells through a differentiated biological mechanism. The expansion into this difficult-to-treat patient population reflects increasing confidence in the therapy’s potential following positive scientific and clinical evaluations conducted by experts at the University of Iowa.
Collaboration with Leading Bladder Cancer Experts Accelerates Development
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The partnership brings together Hamlet BioPharma, scientists from Lund University, and the University of Iowa’s internationally recognized bladder cancer program, led by Professor Michael O’Donnell, a prominent authority in bladder cancer immunotherapy and clinical research. Following a comprehensive review of Alpha1H’s mechanism of action, published clinical findings, and translational research data, University of Iowa investigators identified a strong rationale for evaluating the treatment in patients with resistant CIS.
The institution operates one of the highest-volume NMIBC programs in the United States and has extensive experience conducting early-stage bladder cancer clinical trials. Its research efforts encompass tumor immunology, biomarker development, personalized medicine, and innovative therapeutic approaches. By leveraging this expertise, the collaboration aims to generate important clinical insights regarding Alpha1H’s safety, efficacy, and potential role in the treatment landscape for high-risk bladder cancer patients.
Advancing Alpha1H Toward Future Clinical and Commercial Opportunities
The expansion of the Alpha1H program represents a strategic step in Hamlet BioPharma’s broader effort to establish innovative therapies for cancers with limited treatment options. Alpha1H is derived from naturally occurring molecules found in human breast milk and has demonstrated promising anti-tumor activity in previous studies. Researchers believe the therapy may offer a unique mechanism capable of selectively targeting malignant cells while preserving healthy tissue. The upcoming clinical trial will further explore its potential in patients with severe, treatment-resistant disease, while also contributing valuable data that may support future regulatory and commercial development.
As precision medicine and targeted cancer therapies continue to reshape oncology care, Alpha1H’s advancement highlights growing interest in novel biologically derived treatments capable of addressing unmet needs in urologic oncology. With support from leading academic investigators and an established regulatory pathway, Hamlet BioPharma is positioning Alpha1H as a promising candidate for patients facing limited options in advanced non-muscle-invasive bladder cancer.
Source: Hamlet BioPharma press release
