Alzinova has appointed board member Dr Carol Routledge as acting CEO. The move comes as the company continues its search for a permanent CEO after Kristina Torfgård announced her resignation from the post in the spring. BioStock contacted Routledge to learn more about her interim role as Alzinova prepares for phase II with its Alzheimer’s therapeutic vaccine ALZ-101.

“It has been a fantastic journey, and I am very proud of what we at Alzinova have achieved during my time as CEO. With strong data from the phase Ib study and with upcoming important milestones, I am convinced that the company has an exciting future with the goal of offering a therapeutic vaccine for Alzheimer’s disease through strategic partnering.”

These are the words of Alzinova’s outgoing CEO Kristina Torfgård, who announced her wishes to step down from the company in April. During her four and a half years at the helm of the company, Torfgård led Alzinova’s Alzheimer’s vaccine candidate ALZ-101 to a phase Ib clinical study, completing part A1 of the study with good results showing high safety and tolerability in patients.

Under her leadership, Alzinova has also commenced and reached several milestones for an extension of the study, part B, where all patients were dosed with the final dose in April 2024. Additionally, the company has also commenced a high dose cohort of the phase Ib study, known as part A2, where all patients have received the first dose of ALZ-101. The aim of the two extensions is to obtain valuable information about long term safety and immunological response for a future phase II trial.

Dr Carol Routledge becomes acting CEO

Since Torfgård’s announcement, Alzinova has been on the hunt for her replacement. Torfgård’s last day as CEO was July 31, 2024, and while a permanent CEO has yet to be recruited, last week the company announced that the board member Dr Carol Routledge had been appointed as acting CEO.

Routledge, who holds a BSc and PhD in Neuropharmacology & Neuroscience, as well as an MBA, has more than 35 years’ experience in UK and US-based pharmaceutical and biotechnology companies focusing on preclinical drug profiling, translational medicine, clinical development  and drug acquisition for NCEs (new chemical entities) and biopharmaceuticals. She has played a key role within GSK Biopharmaceuticals, including leadership in pharmaceutical research and development across multiple therapeutic areas, particularly in the areas of neuroscience and immunoinflammatory disease with an emphasis on translational medicine.

Routledge has previously held roles including Director of Research and Managing Director of EDoN, a global early detection initiative for Alzheimer’s disease at Alzheimer’s Research UK. She has also held the roles of Chief Medical and Scientific Officer at Small Pharma, a neuropharmaceutical biotech developing treatments for mental health disorders.

Alzinova rides a wave of optimism in the Alzheimer’s field

The executive management change at Alzinova is coming at an exciting time for the Alzheimer’s drug development field. Since 2021, we have seen the first regulatory approvals for Alzheimer’s treatments that actually tackle one of the root causes – the toxic accumulation of the amyloid-beta (Aβ) protein oligomers in the brain. Read more about this here.

These approvals have sparked a sense of increased optimism in the field, driving positive momentum among investors who have started taking a closer look at drug developers with strong potential to deliver new Alzheimer’s drugs. Alzinova is one of those. The Swedish biotech company, also taking aim at Aβ with lead candidate ALZ-101, recently raised more than SEK 30 million in an oversubscribed rights issue. The funds will help Alzinova get through phase Ib and continue preparations for phase II, putting the company in a more favorable position for strategic partnering in the future. Read more here.

BioStock reached out to Dr Carol Routledge to learn more about how her career experience, not only within other biotech and pharma companies, but also as a board member for Alzinova since 2018, will contribute to the company’s progress as a clinical stage company during this period of transition.

Carol, why are you ideally placed to lead Alzinova during this period of transition?

– I have been an active member of the Alzinova’s Board of Directors for a number of years, so I have a very good understanding of the company’s mission to develop treatments with best-in-class potential to combat Alzheimer’s disease. I am very familiar with the company’s development plans, with the dedicated team who are delivering these plans, and with the excellent progress the company has made over the past few years that bring it closer to realising its ambitions. In addition, I have over 35 year’s experience in UK and US pharmaceutical and biotechnology companies discovering and developing drugs for the treatment of a number of different disorders with a key focus on neurological and psychiatric therapeutic indications. I have experience managing a semi-philanthropic dementia fund with a key focus on identifying and developing novel disease-modifying mechanisms for the treatment of diseases that cause dementia, and I have also spent a number of years as Director of Research at Alzheimer’s Research UK gaining a thorough understanding of Alzheimer’s disease and its impact on patients and their families. This experience will be crucially important in supporting me in the role of CEO of Alzinova, a role that I am extremely excited about and privileged to have the opportunity to take on.

You have been part of Alzinova’s Board since 2018. How would you evaluate Alzinova’s progress since then?

– Since the time I joined the Board, Alzinova have made significant progress. These include the following:

• the mechanism of action of ALZ-101 and ALZ-201 is better understood based on the preclinical profiling that has been completed.
• a GMP manufacturing process was established for ALZ-101 and clinical material successfully produced, with further improvements of the process ongoing for the planned phase II.
• the first part of the phase Ib study, evaluating the safety, tolerability, pharmacodynamic and immunological effects of ALZ-101 in early AD patients has been completed and Parts A2 (high-dose) and B (safety extension) are well underway. Part A1 results are positive, showing a correlation between antibody levels following vaccination with ALZ-101 and effects on biomarkers associated with Alzheimer’s disease.

– In addition, significant progress has been made in terms of introducing Alzinova’s novel treatment approaches to potential partners, in particular highlighting the potential for best-in-class for this approach in terms of safety and efficacy, i.e. the potential for an improved benefit/risk profiled compared to marketed treatments as well as the health economics where our vaccine candidate has a large advantage compared to other treatments.

– Finally, Alzinova have successfully raised appropriate funds to cover the costs of progressing its assets towards and into clinical development. In particular, this year the subscription period for Alzinova’s rights issue resulted in an oversubscription of 106.2 per cent, raising approximately SEK 30.8 million after issue costs, providing the company with the necessary resources to continue its clinical development. Overall, an incredibly successful period that sets the company up well for progressing/partnering their assets.

What are going to be your top priorities in this interim role?

– My first priority is to get to know the entire team at Alzinova much better than I currently do and to support them in any way that I can. In addition, there are a number of key milestones and value-enhancing targets that are well underway to further strengthen our position. These include completion of all stages of the phase Ib and finalising preparation work for the next phase of clinical development; the latter includes key milestones in both CMC and clinical development. As previously communicated by Alzinova, a big target is partnering, so this will of course also be a focus of mine. With the funds Alzinova has received from the successful share issue and the positive clinical results obtained to date, the company has positioned itself as a top actor in the Alzheimer’s field, and we aim to capitalize on that.

With recent developments in the field regarding regulatory approvals, how is Alzinova positioned?

– The first disease-modifying drugs have recently been approved in a number of countries including the United States. So, for the first time, there is clear evidence demonstrating that it is possible to modify the progression of Alzheimer’s disease. Whilst these drugs have their limitations in terms of clinical efficacy and side effect profiles, the fact that they are able to slow disease progression and have real impact on this disease gives hope to patients and their families.

– Regarding regulatory challenges, Alzinova faces the same ones that other companies developing Alzheimer’s treatments face, and the same regulatory challenges as the above recently marketed drugs. However, given the unique approach that Alzinova are taking with ALZ-101 and ALZ-201 in specifically targeting toxic beta amyloid oligomers, it is predicted that these treatments have the potential for a better side effect profile and possibly a better efficacy profile. We have also had several reviews throughout the phase Ib study as well as results from part A1 of the study that confirms the favourable safety and tolerability profile observed in all dose groups. This strengthens our case and belief in that we are on the right track with our vaccine candidate.

What can you tell us about the recruitment process for a permanent CEO and the Board’s thinking around finding the right candidate for that position?

– The recruitment for a permanent CEO is well under way with initial interviews ongoing.  Clearly the Board intend to run a very thorough recruitment process as it is crucial that the right person, with the appropriate experience and ambition, is ultimately taken on board to propel the company forwards.

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