Interview with Haritha Samaranayake CMO of Aurealis Therapeutics | Professional journey, AUP-16 clinical trials in DFU & development plans for oncology

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What was the journey that took Haritha Samaranayake to his current role as CMO? What are the current advances in the clinical trials of Diabetic Foot Ulcers? How can the Aurealis technology be leveraged for cancer treatment? We discussed this and more in the interview with Haritha so let’s get started.

Could you please share briefly about your journey and what has lead you to your current role as CMO?

First of all, I am a medical doctor by training, I have been working in Sri Lanka as a physician before coming to Finland in 2005. From the early part of my medical career, I was interested in cancer. That was an interesting period in cancer treatment. On one hand, there has always been the need to develop new treatments to cancer patients and on the other hand, during that period the novel targeted therapies were being introduced and the foundation was being laid to develop immunotherapies and gene therapies. During this period, I had the opportunity to visit Singapore for a training and during this training I got exposed to cancer research and gene therapy. I thought that gene therapy has the potential to deliver targeted therapies to cancer patients with minimal toxicities. This curiosity to learn more about gene therapies is the one that brought me to Finland in 2005.

After coming to Finland, I did a second degree in molecular medicine and biotechnology and I also completed a PhD in cancer gene therapy in malignant glioma, which is a very aggressive type of brain cancer, in Professor Seppo Ylä-Herttuala’s group. There, I met Tomas Wirth; he was one of my thesis supervisors.

Aurealis had a very ambitious goal: to develop a multi-targeting technology that can enable multi-target treatments in a single therapeutic entity. This is the starting point when I joined Aurealis in 2013 and started my work here.

What is it that you like the most about being chief medical officer and also what is it that keeps you motivated and passionate about the work you do?

When I joined Aurealis we had an idea on a piece of paper: to develop a therapeutic product for wound healing. Today, that therapeutic product is a phase 2 clinical product. I have been with this product throughout all its development process, guiding it and nurturing it through its path, like a child. That is what motivates me the most: to see something that you have nurtured for so many years being successful.

Can you give us a summary about our phase 1 clinical trial for diabetic foot ulcers which was a study that culminated already in March 2023?

AUP-16 is a genetically engineered lactic acid bacteria that can produce 3 different human therapeutic proteins and it is aimed at treating patients with diabetic foot ulcers. This product is also applicable for other chronic wounds, but diabetic foot ulcer is the clinical indication that we are currently testing.

During March 2023, we completed the phase 1 study. A Phase 1 study is a study where we test the safety and tolerability of a product in humans. In this Phase 1 study, we saw that the patients we treated with this product tolerated this product very well and it was very safe and there were no safety concerns.

To my knowledge this is the first study to test a product of this nature in patients with diabetic foot ulcers and we were also very encouraged to see that even though this was a small study, most of the patients, in fact 83% of the patients who received the high dose of AUP-16, achieved complete wound closure.

Could you please share anything that you are able to share with us about the phase 2 clinical trial in Diabetic Foot Ulcers?

Yes, we submitted the clinical trial application for a phase 2 clinical study, and we received the approval to start this study in May 2023. The phase 2 study is being conducted in Germany, Poland and Italy. Professor Alberto Piaggesi is the Global Coordinating Investigator for the study and we are planning to randomize 60 patients.

We recruited the first patient in the end of July 2023, and we were able to treat the first patient already in August. I am looking forward to see how this study keeps progressing!

Can you share what is it that the Aurealis platform can bring to oncology more specifically to ovarian and bladder cancer?

Aurealis multi-targeting technology is a powerful platform to deliver targeted therapies to cancer. AUP-55 is our lead oncology product, currently in pre-clinical development. AUP-55 modulates the tumor micro-environment and activates the anti-tumor immune response to treat cancer. Our current lead indications are ovarian cancer that has metastasized to peritoneal cavity and bladder cancer that has not responded to BCG therapy. We are currently planning to start the pre-clinical studies with AUP-55 in relevant animal models to test the efficacy of this product in these two cancer models.


About The Aurealis Therapeutics Team Interviews

The Aurealis Therapeutics Team Interviews were launched in April 2022 as a project to allow our different stakeholders to get to know the people that stand behind the Aurealis Therapeutics technology and daily operations. In each interview, we invite interviewees to share about their journey, passion, and motivation as well as an update of Aurealis most current activities. As a result, the Aurealis therapeutics Team interviews also aim to inform about the latest developments at the company.

About AUP-16

AUP-16 is a genetically engineered Lactococcus Cremoris, a non-pathogenic, probiotic bacteria, expressing human basic fibroblast growth factor (FGF2, bFGF), interleukin-4 (IL4) and macrophage colony stimulating factor (CSF1, mCSF) – all in one product and accepted as one active pharmaceutical ingredient from regulatory perspective. AUP-16 is topically applied on chronic wounds and covered by wound dressing (e.g. in diabetic foot ulcers, venous leg ulcers and pressure ulcers). In the wound AUP-16 acts as millions of bioreactors producing the therapeutic proteins, which are designed to i) halt chronic inflammation in the wound, ii) induce growth of new blood vessels, and iii) promote granulation tissue formation and skin re-epithelization – all in one product.

About Aurealis Therapeutics

Aurealis Therapeutics AG is a Swiss-Finnish clinical-stage synthetic biology company creating bacteria-based multi-factor cell and gene therapies for chronic wounds and cancer. The company’s lead clinical assets are the first-in-class four-in-one cell and gene therapies AUP-16 for chronic wounds and AUP-55 for cancers. Aurealis therapies are based on proprietary technology involving genetically engineered Lactococcus Cremoris acting as millions of small immune-activating bioreactors producing multiple human therapeutic proteins (cytokines, growth factors, antibody fragments) to effectively and safely re-educate the distorted host immune microenvironment to a proper state.

For more information:

Laurent Décory, COO


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