Interview with Hanna-Riikka Kärkkäinen Head of Quality and Regulatory Affairs at Aurealis Therapeutics | Professional career, AUP-16 PRIME designation, FDA Advice & more

What was the journey that took Hanna-Riikka Kärkkäinen to her current role as Head of Quality and Regulatory Affairs? What does having the PRIME designation for AUP-16 mean? What was the result of the FDA Advice that Aurealis had with respect of AUP-16? How are the preparations to take AUP-16 to the world moving forward? We discussed this and more in the interview with Hanna-Riikka so let’s get started.

Could you share with us a bit of your journey into the biotech industry and what inspired you to specialise in Quality and Regulatory Affairs?

I have always been interested in gene technology and I have had the feeling that I want to do something to help people. Thus, I studied Biotechnology first in Turku University of Applied Sciences and then later in the University of Jyväskylä. I came to Kuopio to do my master’s thesis at Ark Therapeutics. After some years working on research and manufacturing development, I tried my wings on the field of small molecules while working for a contract research organisation. During those years, my interest towards quality increased but I also realised that I missed biotech. Then, a possibility to work as Quality Manager at Aurealis Therapeutics opened and here we are. Regulatory affairs is also close to my heart and thus, I am grateful to lead both quality and regulatory aspects of Aurealis’ daily operations.

In your role as Head of Quality and Regulatory Affairs, what does a typical day look like for you and what things about your work do you find the most fulfilling?

My days vary a lot depending on the status of Aurealis’ projects. The common thing is that I work closely with our internal team but also with our contract research organisations and consultants. I am the internal quality and regulatory support person, so we discuss quality events and other issues occurred, development and regulatory plans and strategies, plan and prepare for authority meetings and audits, etc. I really like working with the different teams no matter what the topic is. The most fulfilling feeling is when you have worked hard for a submission, no matter whether it is a clinical trial application or a briefing book for a scientific advice; when all documentation is ready and submitted, I feel relief, joy and pride.

The PRIME status awarded to one of our products, AUP-16, has been an important milestone for the company. Could you share what does it mean and why this is important?

Priority medicines (PRIME) is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. The scheme is based on close interaction and early dialogue with developers of promising medicines and EMA to optimise development plan and speed up the evaluation of these medicines.

In case of AUP-16, the patients who are suffering from non-healing Diabetic Foot Ulcers (nhDFUs), experience poor quality of life, with reduced mobility, risk of infections, hospitalisation, amputation or even death. As AUP-16 has been granted PRIME designation, recognising its potential to address the unmet medical need in nhDFUs, we hope that AUP-16 reaches patients earlier. 

Now, let’s explore a little bit what happened behind-the-scenes. Could you please take us through the process leading to this milestone (PRIME) and what can we expect moving forward?

At first, we had a pre-submission meeting with EMA’s PRIME team to introduce AUP1602-C, shortly discuss the unmet medical need, and the potential AUP1602-C could have. The feedback and opinion of the PRIME team was positive and we started preparing the PRIME eligibility request documentation package. In this detailed package we presented the major public heath interest, the unmet medical need for the nhDFUs, AUP-16’s potential to address this unmet medical need, and the data we have collected during non-clinical and clinical studies. After receiving the designation, we have been in contact with our PRIME team to organise next steps.

First, we meet with our PRIME coordinator and start organising an introductory meeting with the PRIME team and our rapporteur to raise awareness of regulatory requirements. Later, we can have iterative scientific advice meetings on the overall development plans and key issues; closer to the marketing authorisation application, we can have a submission readiness meeting to discuss, for example, the development status and dossier maturity, and potential regulatory challenges. There is also a possibility for accelerated assessment of marketing authorisation application. By stating all these, the benefit of the PRIME designation is clear. 

On a different topic, we at Aurealis Therapeutics have been building our global capabilities to be ready for the US and other markets. The FDA Advice is key in this process, could you please share where are we currently at on this topic? 

We had a successful pre-IND meeting with the FDA. These meetings usually occur early in the therapy development stage and they are there to help and guide trial strategies. These meetings can also help facilitate faster therapy approval processes. For US, FDA has slightly different expectations and ways of working than EMA, and as US is the largest healthcare market, we are really proud that no red flags were identified during pre-IND meeting. There were only minor points that we are currently addressing. This shows that the data and processes we have created are extremely robust, allowing us to confidently prepare for the next steps up to Phase 3 and marketing authorisation not only in EU but also in the US.

In 2022, Aurealis signed an exclusive license and collaboration agreement with Xbiome for the clinical development and commercialisation of AUP-16 in China. Could you give us and update on how this collaboration has unfolded throughout the past couple years as well as what is the current status?

In my view, this and the previous question about FDA show that Aurealis truly is a global company, able to successfully address regulatory requirements in multiple geographies.

We have established a strong collaboration with Xbiome, from the management of the companies to other functions, such as, clinical, manufacturing, and regulatory. We have frequent discussions with Xbiome colleagues to understand their specific needs and support them the best we can.

First, we had to understand how Chinese authorities work. The National Medical Products Administration (NMPA) oversees drugs and medical devices as EMA and FDA do; the Centre for Drug Evaluation (CDE) evaluates clinical trial applications. Compared to EMA, the NMPA and CDE tend to require more information in earlier stages. Therefore, we had to prepare a lot of additional documentation about safety, toxicity, and quality control. It was quite challenging, and we are glad that the Chinese authorities have acknowledged the quality of the dossier provided and authorise AUP-16 Phase 2 in China.

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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