Hamlet BioPharma AB is a pharmaceutical company with strong links to research, working with natural and biological substances. Pulse 2.0 interviewed Hamlet BioPharma Chairman of the Board Professor Catharina Svanborg to learn more.
Professor Catharina Svanborg’s Background
What is Professor Catharina Svanborg’s background? Professor Svanborg, MD and PhD is a professor at Lund University in Sweden, a Fellow of the Royal Swedish Academy of Sciences, and has been a recipient of national and international awards. Professor Catharina Svanborg is also the founder and chairman of Hamlet BioPharma, a science-driven company pharmaceutical company focused on developing treatments for cancer and infections.
Professor Catharina Svanborg said: “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. The discovery of new immuno-regulatory molecules to treat infections added to the portfolio created Hamlet BioPharma.
Academic and Research Credentials
The scientists working with Hamlet BioPharma have a strong academic presence and trackrecord of publications in leading international journals (Google citation index >100.
The scientists have developed a platform that assists the company’s drug development efforts and adds new discoveries.
Three Phase II clinical trials with positive results
Hamlet Biopharma has demonstrated through its clinical trials:
— Positive clinical phase II results for patients with recurrent acute cystitis treated with the Interleukin-1 receptor inhibitor anakinra
— Positive results for patients with severe bladder pain treated with the same compound.
— Positive results and Fast Track designation from the FDA for patients with bladder cancer treated with the tumor-killing compound Alpha1H.
Patents and Intellectual Property
The company holds a rich patent portfolio across multiple therapeutic areas, including cancer and infections. This extensive intellectual property position illustrates Hamlet BioPharma potential as a leader in innovative therapeutic solutions.”
Formation Of Hamlet BioPharma
How did the idea for Hamlet BioPharma come together? Professor Catharina Svanborg shared: “We recognized the huge potential of the tumor-killing molecule HAMLET and decided to develop a company structure to take this discovery to the clinic. Our approach has been very successful, with potent clinical effects of the Hamlet-based drugs.”
Core Products
What are the company’s core products and innovations, especially now Hamlet Pharma has merged with Select Immune to make Hamlet BioPharma? Professor Svanborg explained:
Alpha1H
The company’s leading drug candidate, Alpha1H, has shown promising results in treating bladder cancer patients. Alpha1H acts by targeting tumor cells with high specificity, leading to their selective destruction via apoptosis, with no effect on healthy tissues. This unique mechanism of action in combination with is low toxicity positions Alpha1H as a potential alternative to traditional therapies, which often come with significant side effects.
Alpha1H has the potential to be used as both a prophylactic and therapeutic agent in bladder cancer patients. Thus, Hamlet BioPharma is well-positioned to address significant unmet medical needs in oncology. Based on successful randomized, placebo-controlled data and further dose-finding and technical analyses, Alpha1H now has Fast Track status with the FDA and is in the process of conducting Phase III studies.
IL1-RA (anakinra)
Hamlet BioPharma is actively investigating new treatment options for bacterial infections, specifically molecules that act by strengthening the antibacterial defense. IL-1RA (anakinra) therapy was selected for clinical development based on extensive research into the disease mechanisms defining acute cystitis.
Novel anti-infection molecules are in the pipeline.
Work In Cancer And Other Infections
Can you tell us about the work you’ve been doing with Hamlet Pharma for your work in cancer and, most recently, other infections?
Professor Catharina Svanborg noted:
“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.”
Differentiation From The Competition
What differentiates Hamlet BioPharma from its competition? Professor Catharina Svanborg acknowledged:
“Our strong innovation capabilities, combined with a company culture that emphasizes scientific leadership and drug development, is what we believe in.”
Future Company Goals
What are some of Hamlet BioPharma’s future company goals? Professor Catharina Svanborg pointed out:
“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 future.”
“The company is actively engaging in partnering discussions to reach its commercial and development goals.”
Challenges Faced
What challenges have Professor Catharina Svanborg and the team faced in building the company? Professor Catharina Svanborg acknowledged:
“The scientists and company board have managed, with great effort, to develop a new model for maintaining control of the company, integrating science, clinical competence, and financial leadership.”
Significant Milestones
What have been some of the company’s most significant milestones? Professor Catharina Svanborg cited:
“One notable milestone was the initial results from the placebo-controlled study of Alpha1H, which demonstrated its efficacy in treating bladder cancer. This was a pivotal step in validating the drug’s potential and setting the stage for further clinical development.”
“Another key milestone was receiving FDA Fast Track status for Alpha1H for the treatment of bladder cancer. This designation facilitates expedited development and review processes, highlighting the drug’s potential to address unmet medical needs.”
“Additional recent milestones are the positive clinical data in two controlled Phase II studies using anakinra for the treatment of recurrent acute cystitis marked another significant achievement. The encouraging clinical results from anakinra-treated patients suffering from bladder pain syndrome represent a crucial step forward in improving the quality of life for these patients.”
Favorite Memory
What has been your favorite memory working for the company so far? Professor Catharina Svanborg concluded:
“I found my garden full of journalists from international media outlets when we published the first paper on HAMLET in PNAS (The Proceedings of the National Academy of Science) on the exciting, tumor-killing properties of this molecule. I asked everyone to come back when we had shown positive effects in the clinic. We are thrilled we were able to make the arduous journey from discovery to clinic – to hopefully launching it to market in the coming years.”
