2024 is shaping up to be “the year of iPSCs"

Axol CEO Summer Review (Jan-Jun 2024).

Image Credit: Mongta Studio/Shutterstock.com

We’ve seen a real shift in the industry towards in vitro technology, with strong headwinds coming from key places including the US, Japan and Europe. From the top level, the iPSC market is growing at a CAGR of 10.61%, which represents an increase from last year.

That’s not surprising given the challenges faced by the global industry in 2023, with difficult macroeconomic conditions, high interest rates and a contraction in some areas of the pharma and biotech market. When I reflect on our response to this, I’m delighted by the efforts of everyone in the company, who always work to our 6 company values (Collaboration, Transparency, Performance, Diversity & Inclusion, Integrity and Accountability), alongside the ongoing support from our board. We recorded a strong performance in the midst of uncertainty and, given the positive signals from the iPSC industry so far this year, I’ve never been more confident in our capabilities.

We’ve spent the first half of 2024 focusing on our key messages: quality iPSC manufacturing, high-level science and a relentless focus on helping our clients across the spectrum of their needs. I often hear clients and partners praising us on our “one-stop shop” approach, and I think that represents a significant strength of Axol in an increasingly crowded market.

So without further ado, let’s take a look at our key events and activities from January to June of this year so far.

January

Across the company, we returned from our festive break refreshed, recharged and ready to make an impact. We began 2024 with our pledge to support the growth of the iPSC market by making it simpler for groups who want to access iPSC technology; from first-timers, to those with existing projects, to those who wish to build large systems and scale up. Alongside this, we doubled down on our quality manufacturing messaging and compiled a new 2024 Axol Bioscience Directory to simplify our offerings for clients.

I’ve received excellent feedback about the directory, and especially about the client-focused messaging including our new phrase for 2024: iPSCs? What can we do to help? This new message encapsulates our values perfectly, offering clients our extensive expertise and “one-stop shop” setup to help them with any aspect of their work.

February

We celebrated the extra day in February with the news that our iPSC production facility quality management system (QMS) had been re-certified as ISO 9001 compliant. ISO 9001 is a globally recognized quality management standard, so this re-certification demonstrated our commitment to maintaining an industry-leading QMS with excellent quality manufacturing capabilities. This robust foundation means our clients are confident when choosing us to fuel their in vitro projects with high-quality, consistent iPSC products.

We continued the quality and confidence conversation with an excellent webinar “QC, Functional QC & iPSCs: the importance in better human disease modeling”. We see functional QC (fQC) as the next step in the quality chain, and this webinar was an excellent overview of what that might look like for our key cell types and why we’re so passionate about quality cell manufacturing.

February also brought the first conferences of the year. We visited Boston for the Society for Laboratory Automation and Screening (SLAS) International Conference where we presented two posters on quality cell manufacturing. We then headed to Palm Springs for the 19th Annual Huntington's Disease Therapeutics Conference, presenting our research on advanced in vitro Huntington’s Disease models.

The international travel continued with the Japanese Safety Pharmacology Society (JSPS) 15th Annual Meeting in Osaka, discussing how we can support the Japanese iPSC market with licenses and diverse biosamples from key diseases including ALS, Alzheimer's Disease and Huntington's Disease. At Axol, we recognize the critical role that pharmaceutical companies in Japan play in advancing iPSC technology, so we've ensured to dedicate time and effort to understanding the unique challenges of the Japanese biopharma industry.

We finished up closer to home with the World Organoid Research Day (WORD) Conference in Cambridge. I always appreciate the face-to-face meetings at life sciences conferences and catching up with industry partners. It’s also a great way to identify trends, get a feel for where the industry is currently at, and get valuable feedback on our “one-stop shop” offerings.

March

As Spring started to rear its head, we had the opportunity to speak about our exciting human iPSC-derived cardiomyocytes for cardiotoxicity screening and drug discovery programs. We were delighted to officially launch our new axoCells Atrial Kit at the SOT 63rd Annual Meeting, alongside two discussion documents: our ongoing work licensing an innovative protocol developed by a team at The Crick Institute, which aims to produce purer populations of left ventricular cardiomyocytes, and the identification of a metabolic maturation media to enhance cardiomyocyte maturity.

We enjoyed discussing these concepts at SOT 2024 as part of our wider work in the cardiac and cardiotoxicity space, including external CiPA validation of our axoCells ventricular cardiomyocytes and the chamber-specific functional characterization of our atrial and ventricular cardiomyocytes. We produced our handy 2024 Cardiac Guide to summarize how we're supporting in vitro cardiac safety pharmacology projects.

March also saw three key regulatory drivers helping to continue the momentum that we saw from the FDA Modernization Act 2.0. Firstly, the UK Government announced increased funding (doubled from £10 million to £20 million) and an action plan for new approach methodologies (NAMs). We also saw the approval of the NIH Common Fund’s Complement-ARIE program which seeks to accelerate the development, standardization, validation, and use of NAMs.

Staying in the US, the FDA Modernization Act 3.0 was introduced in the US House of Representatives, building on the momentum from the FDA Modernization Act 2.0 to expand alternatives to animal models (including stem cell-based assays) for pre-clinical drug testing. We're excited to see the downstream impact of these regulatory drivers and welcome the recognition of in vitro technology at the government/policy level.

April

April was Parkinson’s Disease Awareness month, giving us an opportunity to remember our "why". It was also a great reminder that, in the immortal words of Stephen Brannan, we need to "hurry up!" with our efforts to drive wider adoption and advancement of iPSC technology for neurodegenerative disease research and drug discovery. If you work in the Parkinson’s Disease space then please get in contact: we have Parkinson’s Disease patient lines available to license alongside custom lab services (axoServices^TM) and in-house expertise.

In keeping with our efforts to finger the industry pulse, we also launched a poll to our LinkedIn community asking “where will iPSCs have the biggest impact?” The winner, unsurprisingly, was “early drug discovery” with “compound screening” and “patient stratification models” as close runners-up. These research polls are a valuable resource and give me confidence that the industry supports our ultimate mission to unlock iPSC technology for better human disease models.

We also visited Napa Valley California for The Membrane Physiology Symposium, hosted by our friends at Nanion Technologies, and The Francis Crick Institute for the London Stem Cell Network 7th Annual Symposium. Nanion and The Crick represent two of our valued collaborators, so we always enjoy the opportunity to connect with them at events and keep them up-to-date with our research.

May

We launched our new axoCells Astrocytes line (ax0704) which represents the fastest and most affordable astrocytes on the market. This is a great testament to our manufacturing capabilities and our deep understanding of the industry; we know many scientists are using rat astrocytes with long protocols (sometimes >100 days!), so in line with our pledge, we were delighted to offer an accessible and affordable alternative that represents a genuine upgrade on the existing status quo.

May also saw us launch our much-anticipated axoCells Catalog, a comprehensive document highlighting our axoCells range, comprising human iPSC-derived cells optimized for use in advanced in vitro model systems. This document lays out the data and ordering information for our key neurons, neuroinflammatory cells and cardiomyocytes and I’ve heard excellent feedback from clients about how useful this document has been.

This month was also significant for Axol as a company, as we were awarded People Insight’s Outstanding Workplace Award 2024 and announced several promotions for our staff members. One of my greatest pleasures is seeing our employees develop their skills and confidence, so I was delighted to see us awarded for the positive culture we are creating centered around our core company values of Transparency, Accountability, Collaboration, Diversity & Inclusivity, Performance and Integrity.

To cap it all off, we reached 8000 followers on LinkedIn- an impressive number that represents the growing support we have in the life sciences community. I experienced this support in-person at the Brain Health Life Sciences Summit where we discussed our working unlocking iPSC technology for neurodegenerative disease research.

June

We were delighted to announce several new distribution partners that will support us in our mission to unlock iPSC technology for researchers around the world. With Lubio Science (Switzerland), Cambridge Bioscience (UK and Ireland), BioCat (Germany and Austria) and MineBio (China) joining our existing distribution partners Koma Biotech (Korea) and Cosmo Bio (Japan), we’re in an even stronger position to support the global iPSC industry with our quality products and expertise. If you work in any of these territories, please contact our distribution partners and they will be happy to help.

June brought ALS Awareness Day, giving us an opportunity to discuss our work with axoLines ALS lines and progress towards an ALS “clinical trial in a dish” model for patient stratification. We’ve summarized our work in our Focus on ALS document which contains information about our ALS lines, projects we’ve completed and our vision for an ALS patient stratification model.

We also visited the MPS World Summit 2024 where we discussed our work powering advanced in vitro MPS platforms with our high-quality axoCells. This happened alongside the exciting news that we are joining the 3Rs Collaborative Microphysiological Systems Initiative, comprising 82 representatives from 39 institutions. The 3Rs-MPS Initiative is an excellent opportunity for us to contribute to the advancement of MPS systems which have huge potential in research and drug discovery.

Lastly, in June, we successfully completed an internal fundraise from our supportive long-term shareholders, underpinning their belief in Axol Bioscience and the potential of iPSC technology. This will fund working capital for growth and future M&A activity.

Looking ahead

It never fails to amaze me just how much we manage to achieve in six months! When I look back at this year so far, I’ve seen a significant step change in our efforts, messaging and impact, buoyed by a genuine shift in industry attitudes towards in vitro technologies. With half a dozen distribution partners, Axol has never been more influential or had such a strong global presence, so I’m excited to continue working towards our mission of unlocking better human disease models for biopharma.

As always, I’d like to end this review by highlighting the hard work and diligence of everyone in Axol Bioscience. Without them, we would not have coped so well in a challenging economic market or made the scientific impact we have so far. I’m also grateful for the ongoing efforts of the board who provide invaluable guidance and support as we navigate the ever-changing life sciences landscape. I’m excited to see how far we can go with such a great team of hard-working individuals all pulling in the same direction.

If you’d like to discuss anything I’ve mentioned in this review, then please feel free to contact [email protected].

Until next time, let’s keep working hard to drive better therapies for patients worldwide.

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