A breakthrough discovery
The Swedish company Hamlet Pharma provides new therapeutic solutions using a peptide-based molecular approach for targeting and killing tumour cells with greater precision. With HAMLET and its synthetic drug candidate Alpha1H, the company has an effective cancer drug pipeline with a high degree of selectivity against a variety of cancers. Recent successful outcomes include initial Phase I/II clinical trial data, proving that Alpha1H acts with high efficacy without any detectable toxicity.
The company is based on a serendipitous discovery by the group of Professor Catharina Svanborg, founder of Hamlet Pharma. The company is led by an experienced management team, supported by a strong Board of Directors and dedicated group of legal/business advisors. CEO Dr. Mats Persson brings to the company over 25 years’ experience in clinical drug development obtained at LEO Pharma Denmark and Astra Zeneca, while Prof. Svanborg (chairman/CMO) guarantees scientific excellence from discovery to clinical trials.
The ideal cancer treatment should combine great efficacy with high selectivity. Our proprietary drug complex is derived from the human breast milk protein, alpha-lactalbumin, and represents a therapeutic solution with high tumor-killing capacity, high target specificity, no demonstrated toxicity, killing more than 40 different types of tumor cells. The EU-funded HAMLET-BC project will advance this drug complex in combination with the synthetic drug candidate Alpha1H into the clinical development pipeline as an early-stage treatment for bladder cancer, which has the highest recurrence rate among all cancer types.
Hamlet Pharma’s lead product: Alpha1H as NMIBC therapeutics
While exploring its primary anti-tumour activity, Hamlet Pharma successfully identified the N-terminal peptide from alpha-lactalbumin (the major active domain of HAMLET) and oleic acid (Figure 1.2) as the ‘’business end’’ of the molecule. The investigational medical product Alpha1H is a complex between the synthetic alpha1 peptide and oleic acid, formed under highly controlled conditions. Alpha1H mimics the anti-tumour effects of HAMLET and offers the possibility of large-scale production at GMP quality. Based on the company’s extensive experience with HAMLET, the development of its synthetic variant, Alpha1H, has rapidly and successfully reached important milestones, with recently announced first successful results of the clinical trial with Alpha1H in the Phase I/II clinical trial in 40 NMIBC patients (trial started May 2018). The placebo-controlled double-blinded clinical studies shows high efficacy of Alpha1H without any drug-related side effects.
Hamlet Pharma’s management has decided to focus on NMIBC as primary indication for Alpha1H, based on the high clinical need, large patient group (2.02 million patients in Europe) and the outcome parameters to establish drug efficacy are well defined. The ongoing Phase I/II trial clearly demonstrates the competence of Hamlet Pharma and the feasibility of this approach. With its proprietary lead product Alpha1H, Hamlet Pharma is on track to become the first company launching an effective and safe treatment for NMIBC.
Hamlet Pharma is now advancing HAMLET and the synthetic drug candidate Alpha1H along the clinical development pipeline as anti-cancer therapeutic for early stage bladder cancer. 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). Recent successful outcomesinclude initial Phase I/II clinical trial data, proving that Alpha1H acts with high efficacy without any detectable toxicity.
With the EIC Accelerator funding, Hamlet Pharma will finalise Phase I/II clinical safety and efficacy studies and advance development of Alpha1H towards a Phase III trial (i.e. ready for licensing deal or IPO). Conversations with potential licensing partners and investors are ongoing. Alpha1H will be an important showcase of the impact HAMLET will have on cancer treatment (expected cumulative revenues: €350M five years after market approval). Generated revenues will be reinvested into development of HAMLET for other cancer indications.
We have developed:
- A unique HAMLET-based cancer therapeutic, Alpha1H
- Proven safety and efficacy in patients with superficial bladder cancer
- Promising dose escalation data in a bladder cancer model as a basis for clinical studies
- Strong patent portfolio (>50 patents)
- Highly competent and experienced team
- Strong collaborative networks in Europe
Uniqueness of our approach
The unique approach of Hamlet Pharma is to develop an anti-cancer therapeutic based on a synthetic-variant of the protein-lipid complex in human breast milk, alpha-lactalbumin and oleic acid. The alpha-lactalbumin protein, known to be essential for the survival of lactating mammals, has not been studied for its tumour-killing properties until now.
Board and Executive Team
Catharina Svanborg received her MD in 1974 and Ph.D. in 1978 and has been the Professor of Clinical Immunology at Lund University since 1989. In 1996, Svanborg was elected Fellow of the Royal Swedish Academy of Science. Her research is extremely influential, with strong international networks. From 1979 to 1980, Svanborg was a visiting Professor at Imperial College and from 2008 to 2010, she was Principal Investigator at the Singapore Immunology Network. Her awards include the Domagk award, the non-restricted grant award (BMS), the Kennedy Visiting Professorship Award at Imperial College, London, the Edwin H. Beachey Distinguished Visiting Professorship Award at the University of Tennessee, the Jubilee Award of the Swedish Medical Society, the Nordic Söderberg Award and the Scientist of the Year Award, 2014. Svanborg has published more than four-hundred papers and mentored some forty-five graduate students, as well as several postdoctoral fellows who now pursue successful careers..
Doctor of Medicine, University of Gothenburg, 1986. Dr. Lomberg specializes in the clinical development of pharmaceuticals focused on clinical studies. Lomberg has over twenty years of senior management experience in international companies such as GlaxoWelcome, Bayer, NMCT, and Quintiles. Since 2008, Helena Lomberg runs her own company, BCT Consulting, and works primarily as a consultant for smaller biotech companies and conducts clinical trials.
Ulla Trägårdh graduated as LL.M (Master of Laws) in 1972 and has been active as a lawyer since 1979. She has run operations in both small and large and international law firms over the years. She specializes in insolvency law, M&A and real estate and has been regularly appointed as a trustee in bankruptcy during the years 1983-2020. Ulla Trägårdh currently works to a lesser extent through a sole proprietorship in collaboration with Trägårdh law firm.
Bill received his PhD from Lund University and has since held professorships at both Lund University and Swedish University of Agricultural Sciences (SLU). Since 2006, he serves as Director of the Max Planck Institute for Chemical Ecology in Jena, Germany. He is also Honorary Professor at Friedrich-Schiller-Universität and guest professor at SLU.
Between 2014 and 2020, he served as Vice President of the entire Max Planck Society.
Bill has received numerous national and international awards, most recently The Gold Medal of the Royal Swedish Academy for Agriculture and Forestry and The Order of Merit of the Federal Republic of Germany. He is a member of several academies, among them The Royal Swedish Academy of Sciences and The German National Academy of Sciences Leopoldina. Through Bill, we have access to extensive international networks, along with his broad experience in taking scientific research to the commercial market.
Martin has more than 20 years of experience from the pharmaceutical and food processing industries, including R&D Project Manager at Tetra Pak and Gambro. He received his PhD in Chemistry in 2007 from Lund University, and combines a solid scientific background with strong leadership and communication skills. He has negotiated collaboration agreement with major global corporations and brings strong stakeholder management skills.
Mats Persson is a molecular biologist by training and received his Ph.D. in 1991. He developed a broad knowledge of Drug Development and has held several senior positions within R&D. He was a member of the R&D leadership team at LEO Pharma in Denmark where he was responsible for external R&D collaborations including academic partnerships and commercial alliances. Persson has more than twenty years of experience in clinical research and development at AstraZeneca and from development projects in clinical phases I through IV.
14
million
new cancer cases each year
25
million
cases within the next two decades
1.
trillion