Novel cancer treatments should ideally combine efficacy with selectivity. Tissue toxicity and side-effects are still the norm, however. Although new, targeted therapies act with greater precision, the notion of tumour-specific cell death is justly regarded with skepticism. The Swedish company Hamlet Pharma provides new cancer treatments based on a new molecular approach for targeting and killing tumour cells with greater precision. Its proprietary drug complex, HAMLET (‘Human Alpha-lactalbumin Made LEthal to Tumour cells’) represents a ground-breaking discovery, killing >40 different types of tumour cells. The synthetic peptide based drug candidate Alpha1H offers a therapeutic solution with high tumour-killing capacity, high target specificity and no demonstrated toxicity. As such, it has the potential to revolutionize cancer treatment. Hamlet Pharma is now advancing the synthetic drug candidate Alpha1H along the clinical development pipeline as anti-cancer therapeutic for early stage bladder cancer.
HAMLET is a ground-breaking innovation that has the potential to revolutionize cancer treatment.
HAMLET goes beyond current cancer-specific therapies in the following aspects: HAMLET and its family members Alpha1H and BAMLET represent a novel class of biologicals with high tumour-killing capacity and high degree of specificity
• HAMLET was discovered in human breast milk and consists of the human milk protein alpha-lactalbumin in a complex with oleic acid that has been structurally characterized in great detail (Nature Com, 2021).
• The second-generation drug product of HAMLET, called ‘Alpha1H’, is synthetically produced at drug quality (GMP-compliant) in large quantities;
• The first results of the clinical placebo-controlled Phase I/II clinical studies in 40 NMIBC patients show astonishing and significant anti-cancer effects of Alpha1H (1.7mM) without any drug-related side effects.
• The dose-escalation study of 8.5mM and 17 mM of Alpha1H show clear evidence of a dose-dependent effect, with increased tumor response but still low toxicity.
The company is focusing on bladder cancer given the high clinical need for more effective and safe treatment options. Bladder cancer has the highest recurrence rates (70%) and treatment costs per patient among all cancer types (total costs in Europe: >€4.9 billion). Current NMIBC treatments (surgery, chemotherapy, immunotherapy) are suboptimal: they have significant side effects and limited efficacy, resulting in a high tumor recurrence rate (70%).
Alpha1H is important showcase the impact the HAMLET concept on cancer treatment. Generated revenues will be reinvested into development of HAMLET for other cancer indications. In the HAMLET-BC project, Hamlet Pharma has advanced Alpha1H along the clinical development pipeline as an anti-cancer therapeutic for early stage bladder cancer. Recent successful outcomes include the placebo-controlled Phase I/II clinical trial, proving data to show that Alpha1H acts with high efficacy without any detectable toxicity. With the EIC Accelerator funding, Hamlet Pharma has finalized the Phase I/II clinical safety and efficacy studies and advance development of Alpha1H towards a Phase III trial, including dose-finding studies.
The investigational product, Alpha1H, which is a second‐generation product of HAMLET, is formed by a synthetic peptide corresponding to the alpha1 domain of α‐lactalbumin in complex with oleic acid. Alpha1H reproduces important cellular responses of HAMLET and the tumoricidal activity both in preclinical and clinical settings.
