Exactmer Secures FASST Grant to Revolutionize Oligonucleotide Synthesis

Exactmer is excited to announce that it has been awarded a Flexible, Agile, Scalable and Sustainable medicines manufacturing (FASST) grant from the Innovate UK Transforming Medicine Manufacturing program. The grant, valued at £1,234,617, supports the 24-month BioNanostar project, a collaborative effort between Exactmer, the University of Manchester and Imperial College London. This consortium is uniquely positioned to develop a streamlined bioprocess for oligo assembly that promises increased efficiency, sustainability, and cost-effectiveness. 

About BioNanostar: 

The Sustainable Bioprocess for Oligonucleotide Manufacture using Nanostar Sieving (BioNanostar) project aims to revolutionize the synthesis of oligonucleotides (oligos), which are crucial in gene therapy, diagnostics, and drug delivery. Current manufacturing methods, such as Solid Phase Synthesis (SPS), face significant challenges, including high Process Mass Intensity (PMI) and cost inefficiencies, limiting large-scale production. 

Exactmer’s innovative Nanostar Sieving technology offers a transformative solution to oligo synthesis. By employing a liquid-phase process and membrane filtration, Nanostar Sieving facilitates the precise and scalable iterative addition of nucleotide monomers to a growing Nanostar hub. The BioNanostar grant will combine this technology with enzyme chemistry to create a greener, more sustainable manufacturing process. Advanced modeling techniques will be employed to fully optimize reaction and process parameters. 

Project Objectives: 

The BioNanostar project aims to enhance process efficiency by combining Nanostar Sieving with enzyme technology for linear oligo assembly in aqueous media, guided by advanced digital modelling techniques. It also seeks to promote sustainability by reducing the use of organic solvents and other chemicals, utilizing natural nucleotides as building blocks.  

Jason Micklefield, Professor of Chemical Biology at the University of Manchester said, “current oligonucleotides synthesis is highly step and atom inefficient, relies on large quantities of deleterious reagents and creates a huge amount of harmful waste. We aim to address this by developing more sustainable and cleaner oligonucleotides synthesis using enzymes operating under benign aqueous conditions.” 

Additionally, the project focuses on ensuring scalability by developing advanced membranes optimized for aqueous media and designing bio-synthesizers for commercial-scale production. 

Impact: 

“We are thrilled to partner with the University of Manchester and Imperial College London on this groundbreaking project,” said Piers Gaffney, CSO of Exactmer. “BioNanostar has the potential to significantly advance oligonucleotide synthesis, making it more efficient and environmentally friendly, ultimately benefitting a wide range of therapeutic applications.” 

The BioNanostar project aims to create a novel, adaptable method for oligonucleotide biomanufacture, addressing a broad spectrum of diseases and reducing final product costs. The integration of cutting-edge technologies aligns with the competition’s goals, promising significant advancements in the bioprocessing and biomanufacturing of oligos. 

Exactmer joins forces with leading institutions to secure Innovative Technologies Award

Exactmer is excited to announce the successful application to the Innovative Technologies for Nucleic Acid Medicines Manufacturing competition, delivered by the Innovate UK Transforming Medicine Manufacturing programme. Exactmer will work in collaboration with CPI, Queen Mary University of London and AstraZeneca, forming a consortium of leading experts in membrane production, nanofiltration, oligo manufacture and commercialisation. 

The consortium will receive £1.8 million funding for a 24-month long project aimed at Maximising Efficiency of Liquid Phase Oligo Synthesis (MELOS). The project will focus on improving the process efficiency and sustainability of Exactmer’s Nanostar Sieving technology for liquid-phase synthesis of oligonucleotides at large scale. 

Oligonucleotides, or oligos, are short chains of nucleotides that are used in a variety of applications, including gene therapy, diagnostics, and drug delivery. The current methods for manufacturing oligos are often inefficient and environmentally unfriendly. Nanostar Sieving technology is a new approach to oligo synthesis that uses a membrane to separate the growing oligo from unreacted monomers, allowing for more efficient and sustainable production of oligos. 

The MELOS project will focus on improving the following aspects of the Nanostar Sieving technology: 

  • Process efficiency: The team will develop new chemistries and process conditions to improve the yield and throughput of the Nanostar Sieving process. 
  • Sustainability: The team will develop methods to reduce the use of solvents and other chemicals in the Nanostar Sieving process. 
  • Scalability: The team will develop methods to scale up the Nanostar Sieving process for commercial production of oligos. 

“We are excited to be working on this project with such a talented team of partners,” said Piers Gaffney, CSO of Exactmer. “The MELOS project has the potential to revolutionize the way oligos are manufactured, making them more affordable and accessible to patients.” 

This is a significant step forward in the development of the Nanostar Sieving technology. The MELOS project is expected to lead to improved process efficiency, sustainability, and scalability of the technology, and in the future it could benefit millions of patients worldwide.

Exactmer Awarded £2M for Alternative Oligo Chemistries

Exactmer is delighted to announce it has been awarded €2.49M (£2.15M) from the European Innovation Council (EIC) through its Transition programme, to fund ground-breaking research in the synthesis and manufacture of oligonucleotide (oligo) therapeutics. The funding will fast-track the development of new oligo chemistries for Exactmer’s patented Nanostar Sieving technology, which enables the large-scale manufacture of exact polymeric pharmaceuticals.

‘Alternative Chemistry for Oligonucleotide Synthesis using Nanostar Sieving’, ALTOLIGO, will develop innovative synthesis routes to revolutionise the production of oligos, using greener and cheaper methodologies, and alleviating burdensome supply-chains. In contrast to current methodologies, which rely on the classical phosphoramidite approach using solid-phase platforms, Nanostar Sieving employs the liquid phase for synthesis, making the process inherently scalable. Moving away from dependence on solid supports allows for novel, non-classical syntheses to be developed and optimised, pushing the boundaries for efficiency in oligo production.

Exactmer’s CEO, Prof. Andrew Livingston said: “Exactmer is a technology innovator in oligo manufacture. Our Nanostar Sieving platform harnesses over a decade of research at the forefront of membrane technologies, from the Livingston Group at Queen Mary University of London, and provides a step-change in exact polymer manufacturing. This makes it the ideal platform to address the needs of the oligo synthesis market. This EIC Transition funding will enable us to deliver cheaper and more-efficient oligo manufacturing methods, ultimately bringing these innovative therapeutics to all patients in need.”

The EIC Transition programme offers start-ups and small to medium enterprises (SMEs) grants of up to €2.5 million to fund activities that go beyond the experimental proof of principle, addressing both technology and market development. The programme is being financed through the UKRI Horizon Europe Guarantee funding in the UK.

Exactmer began as a spin-out company from Imperial College in December 2017, and is now a fast-growing SME based in Londoneast-UK Technical Park in Dagenham, East London. Contact us at [email protected] if you are interested in partnering on our oligo synthesis work developing through ALTOLIGO, or to find out more about our work in this area.

Exactmer awarded with SMART Grant from Innovate UK

Exactmer is pleased to announce that it has been awarded a SMART Grant from Innovate UK. Innovate UK drives productivity and economic growth by supporting businesses to develop and harness the potential of new ideas.

Through this 16-month long project, due to start later this year, Exactmer will develop a disruptive new approach for the synthesis of multi-functional Polyethylene Glycols (mfPEGs).

PEGs help to regulate the transport and retention of medicine in the body and can be used as linkers in Antibody Drug Conjugates (ADCs). ADCs have been developed as a ‘magic-bullet’ for cancer treatment, delivering toxic payloads directly to cancer cells; however, the linkers currently used in ADCs are unadaptable and ‘cargos’, such as drugs, dyes, or cell-penetrating agents, cannot be attached to the linker, ultimately limiting the efficacy of ADC therapeutics.

Through this SMART project Exactmer will use its proprietary Nanostar Sieving technology platform to produce PEGs, comprising sequences of Exactmer’s completely-new, EG-based monomers, each containing a side-group designed to attach useful cargos. When polymerised, these monomers will form multi-functional PEGs (mfPEGs) and will be used as linkers in ADCs. By increasing water-solubility, drug-to-antibody ratios and enabling incorporation of multifunctional components, mfPEGs could revolutionise ADC therapeutics.

Exactmer looks forward to contributing to the development of improved ADCs in the next years. Contact us at [email protected] if you would like to know more about our work in this area.

New Facilities

Exactmer is excited to announce the opening of new facilities at our premises in the Londoneast-UK Business and Technical Park in Dagenham, East London. The new space will house a Membrane Casting facility, for the manufacture and production of proprietary membranes used in our Nanostar Sieving platform. The facility will also accommodate membrane-related R&D activities. This marks the beginning of an exciting expansion for Exactmer as we begin growing our Membrane Manufacturing operations, and will streamline the commercialisation of the Nanostar Sieving platform and products.

Exactmer has grown rapidly over the last year, having also acquired new R&D lab and office space. This has enabled the company to establish new partnerships and research activities, and expand our manufacturing capabilities across both our oligonucleotide and exact-PEG syntheses services.

Exactmer awarded Knowledge Transfer Partnership with Queen Mary University of London

Exactmer, together with Queen Mary University of London (QMUL), has been awarded its first Knowledge Transfer Partnership (KTP), from Innovate UK.

Through this KTP, Exactmer and QMUL will develop new synthesis methods for exact Polyethylene Glycol polymers (PEGs), using Exactmer’s proprietary Nanostar Sieving platform. When added to therapeutics drugs, PEGs help to regulate the transport and retention of the medicine in the body. Their water solubility also lends them useful in drug delivery scaffolds and nanomedicine. However, current manufacturing limitations means that producing PEGs is difficult to do accurately; to do so is challenging, time-consuming and expensive.

To solve this, Exactmer is developing its breakthrough technology, Nanostar Sieving, to revolutionise PEG manufacturing. Through the KTP, QMUL and Exactmer will address manufacturing and analytical challenges and will accelerate the commercialisation of exact-PEGs for applications in the PEGylated drugs and Antibody Drug Conjugates markets.

The KTP programme is a collaboration between universities and businesses in the UK, to help overcome challenges of innovation and address specific obstacles to technology development. It is a partially-government funded initiative which gives companies access to the know-how and expertise of academic institutions, through a project designed to address a specific business need.

For more information on the Nanostar Sieving platform and our exact-PEG polymers, please contact the Exactmer team at [email protected].

 

Exactmer wins Startup Pitch and Partner Award at BioVaria, Munich

Exactmer is delighted to have been awarded the Startup Pitch and Partner award in the ‘Emerging’ category, at BioVaria 2022.

Exactmer’s winning pitch on the development of our proprietary Nanostar Sieving technology for oligonucleotide synthesis was chosen by a jury of leading investors, in a showcase of 13 hand-picked start ups from across Europe.

BioVaria is Europe’s leading showcasing event for life-science technologies, targeting technology scouts, business developers and investors, and bringing together Europe’s leading tech transfer professionals, innovators from academia and representatives of the global biotech and pharma industry.

This year’s event was held in Munich in May, bringing together over 230 life-science innovators to the two-day event, with more than 60 licensable innovations presented by leading players from all over Europe, from therapeutic and diagnostic approaches to platform technologies.

Read the full feature here.

Future Leaders Fellowships granted to Dr. Jiang in collaboration with Exactmer for the development of breakthrough technology

Exactmer is excited to announce that Dr. Zhiwei Jiang has been selected as one of eighty-four of the most promising science and research leaders, the successful leaders will benefit from a total of £97.8m investment to tackle major global challenges and to commercialise innovations in the UK. The Future Leaders Fellowships scheme helps universities and businesses in the UK recruit, develop and retain the world’s best researchers and innovators.

Dr. Jiang received his PhD degree from Imperial College London as a membrane scientist, and afterwards contributed as Research Associate for 5 years. During this period, he developed ultrathin membranes dedicated for molecular separations that outperformed the commercial membranes available on the market. He also worked closely with BP and ExxonMobil where he participated in the filing of patents for the development of two-dimensional materials as separation membranes.

 

He will be working in collaboration with Exactmer during his fellowship to advance membrane technology. Exactmer is a fast-growing company based in East London, developing a proprietary technology platform to break through the barriers of making exact polymers such as oligonucleotides, PEGylated drugs and ADC linkers. Oligonucleotide medicines work by interfering with how genes are expressed to limit the production of detrimental proteins and have shown success in the treatment of rare diseases. This next-generation therapeutic class is now being explored to treat chronic diseases that affect much larger patient populations.

 

At the heart of Exactmer’s platform is a molecular separation membrane, used to separate a growing polymer from residual monomers. Dr. Jiang’s Future Leaders Fellowships will last for 4 years, and it aims to fabricate membranes with well-defined and controlled pore size, which can withstand the harsh chemical environments required for polymer synthesis. Dr. Jiang’s collaboration with Exactmer will lead to the development of an entirely new membrane class known as isoporous organic solvent nanofiltration membranes (iOSN).

 

Dr. Jiang will work on the development of the membrane technology that will bring considerable advances in the synthesis of exact polymers at Exactmer. This will allow the manufacturing of high purity and high yield products, assist Exactmer to develop their technology for the upcoming demand in the oligos market, and subsequently help millions of patients around the world.

 

 

Please visit the following link for more information about the Future Leaders Fellows:

84 new Future Leaders Fellows and £100m for next round announced – UKRI

Accelerating Your Innovation Through Powerful Partnering

The SCOUT project, launched by CPI to help Scottish SMEs overcome challenges of innovation, hosted a webinar on February 9th 2022, centred on ‘Powerful Partnering’. At this event, Andrew Livingston outlined Exactmer’s journey and the successful partnership that supported its development.

In 2021, Exactmer became a central part of Grand Challenge 3, from the new Medicines Manufacturing Innovation Centre (MMIC), aimed at collaboratively revolutionising the manufacture of oligonucleotides. The collaboration, which includes AstraZeneca and Novartis, enables the partners to utilise their combined expertise across scale-up, analytics, and process development, ultimately transforming the oligonucleotide supply chain. The MMIC employs a ‘Grand Challenge’ model, consisting of collaborative projects that bring together effective partnerships to address key issues raised by pharmaceutical industry consortia.

Andrew was joined by representatives from the MMIC, as well as Astra Zeneca’s Terry Reed, and Barrie Cassey from CPI. The webinar explored the opportunities and challenges encountered in developing successful partnerships, with the stakeholders sharing insights and experiences that help accelerate innovation process.

You can catch the webinar on-demand, here.

Alnylam becomes a partner in the Medicines Manufacturing Innovation Centre

Exactmer is delighted to welcome to Alnylam Pharmaceuticals as a partner to the collaboration with the Medicines Manufacturing Innovation Centre, revolutionising oligonucleotide manufacturing. Together with CPI, AstraZeneca, and Novartis, we’re working together to overcome barriers to the scalable, affordable, and sustainable manufacture of oligonucleotides.

See the full press release on the CPI website.