Tord Labuda has entered the role as CEO of Alzinova, bringing extensive experience from leading positions in the pharmaceutical industry. The company is in an exciting development phase, as the clinical phase Ib study with the Alzheimer’s vaccine ALZ-101 is expected to be completed in early 2025. In preparation for phase II, Alzinova is actively exploring opportunities for licensing agreements with a larger pharma company.

First North-listed Alzinova is developing two drug candidates for Alzheimer’s disease: the vaccine candidate ALZ-101 and the antibody ALZ-201, which are specifically designed to protect the brain’s nerve cells.

The goal is to attack one of the underlying causes of Alzheimer’s disease – the toxic accumulations of the peptide amyloid-beta (Aβ) oligomers in the brain. The vaccine aims to help the body’s immune system generate antibodies to neutralize the oligomers and prevent damage to the synapses of brain cells. The overarching vision is to achieve a complete cure for the disease.

Main candidate ALZ-101

The lead candidate ALZ-101 is an oligomer-specific vaccine with best-in-class potential according to the company. This disease-modifying immunotherapy is currently being tested in a phase Ib clinical trial divided into three parts: Part A1, A2, and Part B. Part A1 has been completed and indicated good safety and tolerability. The extension, part A2, aims to generate knowledge regarding a higher dose of ALZ-101, while part B aims to provide data on long-term safety and immunological response for an upcoming phase II study.

In September, the first study subject completed their last visit in the phase Ib study. All study participants in the extension part are expected to complete their last visits during the first quarter of 2025. After that, a phase II study awaits, which could lead to several potentially value-enhancing milestones.

New CEO at the helm

Since October 1, Dr. Tord Labuda, M.Sci., PhD, new CEO of Alzinova. BioStock reached out to Labuda to learn more about his views on Alzinova’s chances of success and what motivated his transition from a large pharmaceutical company to a small development company.

Could you start by telling us about your professional background?

– I have over 17 years of experience in the pharmaceutical industry. I started my career after a PhD in tumour immunology from Lund University and ten years in academic research positions in Sweden and abroad. During my career, I have had the privilege of holding several senior positions internationally, focusing primarily on research and development, but also in commercial areas.

– A significant part of my experience comes from my time at Danish Leo Pharma, where I worked between 2008 and 2023. My most recent position there was as Vice President and head of Global Clinical Development. I have also held roles as President and Japan Representative Director, Vice President R&D Asia-Pacific, and Vice President R&D and Medical Affairs, Japan, within the same company.

– After my time at Leo Pharma, I worked as a senior consultant in the biotech, medtech, and pharma sectors. This experience gave me a broad insight into different aspects of the industry. In addition, I am on the board of NanoEcho, a listed company specializing in cancer diagnostics.

What made you choose to accept the offer to become CEO of Alzinova?

– Several factors led me to accept the CEO role at Alzinova. I was primarily attracted by the company’s innovative pipeline and its great potential to improve the lives of millions of people affected by Alzheimer’s disease.

– Alzinova is in an exciting development phase with its lead candidate ALZ-101 in clinical phase, which provides good opportunities to drive the project forward towards the market. I saw an opportunity to contribute with my broad experience in the pharmaceutical industry, especially in clinical development and commercialisation.

– In addition, I was attracted by the opportunity to lead a dynamic team in a smaller company, where you can work more flexibly and agilely than in large pharmaceutical companies. Alzheimer’s is an area with a high unmet medical need and increasing industry interest, which makes the timing right to drive Alzinova’s project forward.

– All in all, I felt that this was an exciting challenge where I really could contribute to realizing the company’s vision of developing groundbreaking treatments for Alzheimer’s disease.

Many who transition from big pharma to a small biotech company usually emphasize faster decision-making paths, less bureaucracy, and a significantly higher level of innovation. Do you endorse that description?

– Absolutely, there is no doubt that there is less bureaucracy and faster decision-making processes in smaller companies. What’s most interesting, however, is innovation.  If we look at the large pharmaceutical companies, the costs of developing a new drug have skyrocketed. We are talking about a whopping USD 6.16 billion per approval (Forbes Aug 9, 2023) and their spending on research and development is increasing by about 6 per cent annually. Despite these massive investments, many large companies have a lower return on their R&D. Some even report negative results.

– However, the picture looks different when we look at the smaller biotech companies, which have proven to be really effective. Between 2013 and 2022, they accounted for most of the 398 new drugs approved by the FDA. And the exciting thing is that more and more of these smaller companies retain the rights to their medicines. In 2013, only 23 per cent did so, but by 2022 the figure had increased to 75 per cent. These companies account for over half of all new FDA-approved drugs but only use roughly 16 per cent of the industry’s total R&D budget.

– So, while big pharma companies struggle with rising costs and declining returns, biotech companies have proven to be more flexible and innovative. They are more successful in effectively bringing new treatments to the market. That is also what I am aiming for with Alzinova.

What experiences do you bring from your previous positions, and what do you consider particularly useful in your new role?

– I have been fortunate to work in the pharmaceutical industry in many different roles, and this experience has given me a broad understanding of the entire process, from research to clinical studies and product launch. This understanding will be valuable in my new role at Alzinova.

– One of the things I bring is my experience in leading global clinical development programs. It helps me navigate the existing requirements and regulations, particularly now that we are nearing the end of our phase Ib study and planning for the next step.

– I have also worked extensively on commercialisation, which means that I understand how important it is to position our candidates correctly and communicate their value to different stakeholders. That will be crucial when we start looking for licensing agreements.

– Having worked in both large and smaller biotech companies has taught me the importance of flexibility and resource efficiency. This is really needed in a dynamic environment like Alzinova’s. Of course, my international experience gives me a good perspective on how the pharmaceutical market works globally. It will be beneficial as we build partnerships and plan for the future.

You intend to out-license ALZ-101 to a larger pharmaceutical company before the phase II study begins. In other words, you are now on the opposite side of the negotiating table. What will be most important to secure the best deal possible?

– We are in a strong position as our phase Ib study is nearing completion. Positive results from the study will be crucial to attract potential partners. In addition, we are seeing increased interest from major pharmaceutical companies in Alzheimer’s treatments, which puts us in a good position.

– One of my priorities will be communicating ALZ-101’s unique features and potential. Timing is crucial in ensuring a beneficial agreement, and we strive to be proactive in our conversations to find the right partner.

– In conclusion, I am optimistic about our chances of securing a successful license agreement, especially if we continue to deliver positive data. Driving these discussions and identifying the right partner will be central to my work going forward.

You are now facing a series of important milestones. What will be your primary tasks for the next six months?

– The next six months will be really exciting for Alzinova, and I look forward to taking on several important tasks. Our primary focus will be to drive the phase Ib study of ALZ-101 towards completion. At the beginning of the summer, we received positive feedback from an independent expert group, the Data Safety Monitoring Board (DSMB), which gave us the green light to proceed according to plan.

– One of my most important tasks will be ensuring we get the maximum value from the study’s data. We expect results from the B part (in the autumn) and the A2 part in the next six months, providing us with data from the entire study. This creates a more comprehensive picture of the vaccine candidate’s ability to generate an immune response and a clearer picture of the entire study’s overall results, making it easier when we present to potential partners. This is also strategically important for the planning of the phase II study.

– In parallel, I will explore opportunities for license agreements with major pharmaceutical companies ahead of phase II.

– In addition, I look forward to working closely with our team to optimize our R&D efficiency. As mentioned earlier, we can be more flexible and innovative as a smaller biotech company. I want to ensure that we fully take advantage of this opportunity.

– In summary, we will drive our clinical studies forward in the coming months, prepare for the next phase, and position Alzinova for future success in Alzheimer’s treatment.

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