Interview with Catharina Svanborg of Hamlet BioPharma

Tell us about Hamlet BioPharma and how the company was set up?  

Catharina Svanborg is the founder and chairman of Hamlet BioPharma, a science driven pharmaceutical company focused on developing treatments for cancer and infections.  The discoveries on which the company is built were made by a competent and committed team of international scientists and experts, who continue to develop new drug candidates. This innovative company is listed on Spotlight Stock Market and has built a robust portfolio of 15 pharmaceutical projects, including multiple candidates in clinical phase II trials.

The company has been recognized for its groundbreaking discoveries, particularly the development of HAMLET, a tumoricidal complex, which has demonstrated broad anti-tumor activity across various cancer types. In light of that discovery we decided to develop a company structure to take this discovery to the clinic. Later on the discovery of new immuno-regulatory molecules, to treat infections, added to the portfolio and created Hamlet BioPharma.

Hamlet has made significant strides in the clinical trials space. Could you share more about the breakthroughs you’ve achieved in your recent trials and how they align with Hamlet’s overall mission?

Successful Phase II Study: Alpha1H – Treatment for Bladder Cancer 
Hamlet BioPharma’s drug candidate Alpha1H effectively kills bladder cancer cells and has shown very promising results against bladder cancer in animal models, both as an acute and long-term treatment. Hamlet BioPharma has therefore chosen bladder cancer as the first cancer indication for the commercialization of Alpha1H and has effectively advanced the development of the drug and the clinical trials required for approval. Based on successful randomized, placebo-controlled data and additional dose-finding and technical analyses, Alpha1H now has Fast Track status with the FDA and is in the process of conducting Phase III studies.  Bladder cancer is one of the most common forms of cancer and is difficult to treat, with a high recurrence rate.

Successful Phase II study: Immunotherapy as an alternative to antibiotic treatment for recurrent urinary tract infections 
Hamlet BioPharma has recently announced positive results from a Phase II clinical trial comparing immunotherapy to antibiotics. The use of anakinra (IL-1RA), is patented by the company for the treatment of recurrent acute cystitis. The study was conducted in collaboration with clinical specialists in Giessen, Germany, and treatment with anakinra reduced symptoms and the number of recurrent infections and improved quality of life.

The efficacy was comparable to antibiotics, which is a very promising result. Immunotherapy with anakinra can thus reduce the need for antibiotics, and is a very important step in the fight against resistant bacteria. In addition, the normal bacterial flora can be preserved, which in turn helps to counteract antimicrobial resistance. The next step is a more comprehensive analysis of the study results, which will be submitted for scientific publication.

Successful Phase II Study: Immunotherapy for Severe Pain Conditions – Treatment of Severe Bladder Pain 
The use of the substance anakinra (IL-1RA), patented by the company for the treatment of bladder pain conditions, has previously shown promising effects as an off-label treatment in this patient group. Just before the summer of 2024, new data were reported from the first part of a controlled clinical study where a significant portion of patients responded positively to treatment with anakinra. Pain decreased, and quality of life improved in this severely affected patient group. Additionally, laboratory tests showed a convincing reduction in pain-related molecules after the treatment, supporting a direct effect of the treatment at the molecular level.

For patients with severe bladder pain, there are currently no drugs with lasting effects, as common painkillers are ineffective. Some patients benefit from morphine treatment or surgery, involving bladder removal.

As a leader in your industry, what do you see as the most pressing challenges in conducting clinical trials today, and how is Hamlet working to overcome them? 

Part of the success is due to our extensive network of partners and specialists helping us navigate the clinical and regulatory landscape. Hamlet BioPharma has direct conatcts with key opinion leaders, who have been engaged in conducting the clinical studies. Without such contacts, organising clinical studies would be much more problematic, expensive and time consuming.

Our medical understanding of the main indications also helps to design and execute precise clinical trials that address the right questions in a disease context. This approach helps us to meet regulatory standards and, hopefully accelerate the pathway to market.

Can you elaborate on the role of innovation at Hamlet, particularly in the design and execution of your clinical trials. How does it set you apart from competitors in the industry? 

We have established a results driven technology platform to engage expert advise and leading technology in parallel, during the clinical trials. The platform is run in collaboration with the sceintists scientists, to ensure competence and state of the art technology. Innovation is at the core of our product pipeline, along with experetiese expertise and experience in the drug development process, especially in least clinical trial design and execution.

We have access to advanced analytical methods and state-of-the-art equipment as part of a technology platform in collaboration with Lund University. This platform engages expert advice and operates in parallel with our clinical trials, profiting from insights into disease progression and the mechanism of action of our treatments. This comprehensive scientific base and knowledged-based approach provides us with a competitive edge not least in chosing clinical indications suitable for each drug and building suitable organisation arouund around clinical trials.

Looking forward, what are the key milestones you expect Hamlet to achieve in both its clinical trials and overall growth strategy over the next five years? 

Hamlet BioPharma’s primary objective is to bring its leading drug candidates to the market, to ensure that patients will benefit from innovative treatments. The company is also committed to advancing  very promising drug candidates in its pipeline, that can be further tested in clinical settings and generate additional value for the company in the coming years.

The company is actively engaging in partnering discussions with our main assets that has shown positive results in phase II clinical trials, with the aim to reach commercial and development goals.

As a CEO, what leadership principles have been most critical to your success at Hamlet and how do you foster a culture of innovation, and collaboration within your company? 

Strong innovation capabilities, combined with a company culture that emphasizes scientific and commercial leadership and drug development is what we believe in. We surround yourself with experts in different fields, from clinical to regulatory, and leverage their insights to drive progress.

What are some of the biggest lessons you’ve learned in growing Hamlet, and what advice would you give to other entrepreneurs looking to scale their businesses in today’s competitive environment – in your case health and pharmaceuticals?

Stay optimistic, stay close to your core competence, and keep your investors happy (not always possible).

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