What strategic changes have you brought about within the business due to COVID-19?

 The COVID-19 pandemic highlighted a number of issues within the life science market. Many of which were pushed to the fore in this unprecedented situation. One critical aspect was speed. Research has never reached such speeds for innovation and development; an industry taskforce was able to reduce the standard antibody discovery timeline, to identify potential clinical candidates for SARS-CoV-2, from 18 months to 7 months ¹. Aptamer Group used this focus on speed to test the capabilities of its Optimer platform, which generates binders as antibody alternatives for a wide range of applications. We were able to identify Optimer binders to SARS-CoV-2 in just 17 days ². This prompted Aptamer Group to offer a new premium service to our customers; developing Optimers from concept to validated binders in as little as 4 weeks. Our standard discovery process stands at 10-12 weeks, but this new service is opening up the potential for rapid discovery and pipeline acceleration at all stages of development.  

With the explosion of interest in Optimer binders over the past year, including numerous large commercial deals and collaborations signed across top pharma and biotechnology partners, there has been a need to restructure and further automate internal production processes. The new processes have allowed Aptamer Group to streamline discovery for increased speed and capacity.

Throughout the pandemic, traditional supply chains suffered huge disruption. There have been instances where the operations at Aptamer Group have been at risk due to limited supply of disposables, such as PCR tips to operate our automated platforms ³. To overcome initial problems, we worked with local research centres and businesses to share capabilities and capacity. To prevent further issues, we have implemented improved monitoring and management of inventory and built increased redundancy into our supply chain. End-to-end visibility has emerged as a major need for our supply chain management, and we have incorporated the potential to activate alternative sources where possible to future safeguard supply.

What are the major plans/launches/investments in store for 2022?

As we continue into 2022, Aptamer Group is continuing to see expansion across each of our key Optimer application areas, therapeutics, bioprocessing, diagnostics, and research reagents. To support our partners, we are developing internal small-scale manufacturing capabilities, which will help to speed development projects further. As the number of large scale Optimer development projects we are undertaking continues to grow we anticipate expanding our development facilities in the coming year to support this.

Additional exciting new development plans for Aptamer Group, that are progressing internally for launch in 2022, will see improvements to the Optimer development platform. This will extend our service offering, with the ability to develop Optimer binders to an even wider target range, further tune target affinity and offer improved performance to increase the potential application of Optimer binders.

Are you exploring new markets/regions as a part of your growth plan?

 Life science has always been a global community and Aptamer Group has long worked with international partners. However, as part of recent growth in Aptamer Group, we have seen increased traction and interest in Optimer technology in the burgeoning South Asian life science market. We have ongoing collaborations with Takeda, WuXi AppTec and PinotBio, and have established a relationship with BizCom Japan to market and sell Optimer discovery and development services to this region.

We are seeing increased penetrance of the Optimer platform in the field of drug conjugates. Ongoing campaigns with several partners, such as AstraZeneca, WuXi AppTec and Pinotbio, seek to use Optimers as drug delivery vehicles, carrying a variety of payloads from gene therapy to chemotherapeutics. There is a clear unmet need in the market for antibody alternatives that can enable improved therapeutic delivery, for increased safety and the ability to tackle new diseases and Optimers offer a potential solution to meet this need.

The Optimer platform consists of three target type specific discovery processes. One of these enables the discovery of binders for small molecule targets, such as hormones and antibiotics. These are targets that the industry has long struggled to monitor via rapid, point-of-care processes, and our platform is enabling this. We are working with multiple partners to develop novel diagnostic and monitoring solutions in this space that could revolutionise patient care.

Finally, the third current major area of growth at Aptamer Group is in the application of Optimer binders for bioprocessing to enable the manufacture of the next generation of the biologics we are seeing coming to clinic and improve current processes. The existing offerings for the manufacture of gene therapies deliver low binding capacities and offer limited cleaning-in-place protocols. As this industry matures, more modern solutions are going to essential. The Optimer platform can potentially provide significant improvements in downstream purification of viral vectors for gene therapy manufacturing. 

What new/unique trends do you foresee within the life sciences space in the coming years?

 We are just beginning to see the adoption of oligonucleotides as realistic alternatives to proteins within the life sciences. This is evidenced by: increased numbers of siRNA and ASOs being approved and progressing through the clinic; researchers exploring delivery and targeting approaches for CRISPR; the expansion of oligonucleotide binders, such as Optimers, into the market; and the global success of the first mRNA-based vaccines during the pandemic. As researchers and developers gain confidence in this modality, we anticipate that its use will rise across the industry, allowing new diseases to be treated and improved patient tolerability and compliance.

Many of the current oligonucleotide therapeutics suffer with targeting issues to deliver them to the site of action. At Aptamer Group, we already see companies across the globe working to improve this with novel delivery systems that could improve targeting and thereby improve the efficiency of these therapeutics. The use of drug delivery systems offers numerous benefits, to improve the effective therapeutic dose at the active site and reduce off-target sites for increased patient tolerability, and over the coming years these molecules should progress to the market.

One interesting development we are seeing with Optimer technology is the development of wearable sensors. Optimer binders can be tailored to undergo binding-induced conformational changes, termed structural switching, and they can do this reversibly. Using a system where the binders can bind and dissociate reversibly means that the receptors (Optimers) are being spontaneously regenerated. The timescales for the Optimer refolding process can take anywhere from microseconds to hundreds of milliseconds, a time range that is much faster than any practical measurement you would take in a patient. This gives us the ability to continuously interrogate the system using devices like wearable sensors. You do not have that capability with other binder formats like antibodies. We are working with partners to develop non-invasive microneedle wearable sensors based on affinity, which could, in the long-term, provide real-time assessment of health status in patients. Use of these would cut clinic visits, remove the wait on test results and allow fast responses to any physiological changes. 

Finally, the Optimer platform enables a wider target range to be pursued by researchers, from small molecules to proteins and even cells and tissues. Offering this ability to the top scientists and researchers around the world will enable them to deliver new bioprocessing, therapeutic and diagnostic solutions that can improve current patient care by bringing better medicines to market, faster.

How is the diagnostic market evolving post-pandemic?

 The pandemic has increased awareness of the importance of the diagnostics industry, as we all continue to rely on accurate diagnostics to keep our economies open. Specifically, home-based testing has increased during the pandemic, with the public becoming more familiar with diagnostic test use. The movement of diagnostics from the clinic to point-of-care and even into patients' homes has been on the horizon for diagnostic developers for some time. Following the pandemic this has accelerated with an increased number of clinical trials using remote patient monitoring. This could move to an increased expectation from patients to be able to self-monitor within their own environments and the subsequent necessary progress from the diagnostic industry to support this. Also, the speed of diagnostic tests in the post-pandemic world is increasing with many of our partners using Optimer binders to develop rapid, point-of-care tests.

As movement and logistics around the globe were limited during the pandemic, supply chains quickly revealed the market's reliance on protein-based binders. Suppliers were unable to meet the demand for many important protein tool reagents being used to advance COVID-19 research, slowing timelines and limiting work ^{4, 5} . These protein tools rely on cold supply chains for shipment, which caused concerns around the availability, security and cost implications of this during the pandemic ⁶. For researchers working outside the field of COVID-19, many were unable to access their workspace for months. During this time, the malfunction of basic equipment, such as freezers, meant that vital samples and protein reagent supplies were lost, obliterating years of work for some scientists.

Together these problems revealed the need to reshape supply chains with the use of alternative, more stable offerings that can provide simpler, lower cost and more secure logistics to circumnavigate this, now and in the future. Optimer binders are based on oligonucleotide molecules rather than proteins. Even at elevated temperatures, they are highly stable, overcoming the need for cold chain supply—Aptamer Group ship Optimers at room temperature as standard. Equally, as Optimers are manufactured via solid-phase synthesis, they do not compete for the same cell-based biomanufacturing facilities as proteins opening new customer supply avenues. We have seen many customers turn to Optimer binders in place of using legacy antibodies due to these product benefits ⁷ and we anticipate that this trend will continue across the diagnostic market as antibody alternatives come to the fore.

References

1. UK Bioindustry Association. Novel COVID-19 Antibody Therapy Candidates Identified by Leading UK Biotech Consortium. Available at: https://www.bioindustry.org/news-listing/novel-covid-19-antibody-therapy-candidates-identified-by-leading-uk-biotech-consortium.html
2. York Press. Biotech experts seeking to improve health treatments. Available at: https://www.yorkpress.co.uk/news/19389451.aptamer-group-frame-press-business-award-2021/
3. STAT News. How blackouts, fires, and a pandemic are driving shortages of pipette tips — and hobbling science. Available at: https://www.statnews.com/2021/04/28/pipette-tips-shortage/
4. The Wall Street Journal. Shortage of Test Components Forces Labs to Beg, Borrow and Improvise. Available at: https://www.wsj.com/articles/shortage-of-test-components-forces-labs-to-beg-borrow-and-improvise-11586102401
5. As Brazil's COVID-19 testing lags, available labs go unused. Available at: https://uk.reuters.com/article/uk-health-coronavirus-brazil-testing/as-brazils-covid-19-testing-lags-available-labs-go-unused-idUKKCN21X36X
6. Contract Pharma. Reshaping the pharmaceutical supply chain. Available at: https://www.contractpharma.com/content-microsite/covid-19/2021-03-01/reshaping-the-pharmaceutical-supply-chain
7. Aptamer Group and ProAxsis Limited enter partnership to improve global logistics and stability of diagnostic tests. Available at: https://proaxsis.com/aptamer-group-and-proaxsis-limited-enter-partnership-to-improve-global-logistics-and-stability-of-diagnostic-tests/