Feliza Mirasol is the science editor for 

Feliza Mirasol

Gefion, a new artificial intelligence (AI) supercomputer built on an AI data center infrastructure known as NVIDIA DGX SuperPOD (1), is now operational in Copenhagen, Denmark, the Novo Nordisk Foundation announced on Oct. 23, 2024. The supercomputer was launched at an event in Copenhagen, where it was symbolically “turned on” by His Majesty King Frederik X of Denmark; Jensen Huang, founder and CEO of NVIDIA, a US-based supercomputing company; and Nadia Carlsten, CEO of the Danish Centre for AI Innovation (DCAI).

Following its launch, Gefion is being readied for customers, beginning with a pilot phase in which select customers interested in using AI will use it to accelerate innovation in many areas, from quantum computing to drug discovery to societal challenges, such as the transition to green energy.

“Gefion provides our Danish enterprises with entirely new opportunities,” said Morten Bødskov, the Minister for Industry, Business, and Financial Affairs, Denmark, in a press release. “Gefion will drive the advancement of the green transition, enable tailor-made solutions, and strengthen the competitive standing of our companies in the global market. In a time of heightened international competition, this supercomputer acts as a vital enabler for advancing Danish businesses into the future. This ground-breaking technology represents an important opportunity for Danish companies and researchers to develop innovative solutions to future challenges.”

A public–private partnership between the Novo Nordisk Foundation and the Export and Investment Fund of Denmark (EIFO) resulted in the establishment of the new supercomputer. This partnership funded and established DCAI, a new company that owns and will operate Gefion.

“It’s a remarkable achievement that it has taken only six months from announcement to completion of this complex state-of-the-art supercomputer,” said Carlsten. “I am extremely proud of the team that came together and collaborated to turn this vision into a reality, delivering a leading capability that is now ready for customers to start testing new use cases. Gefion is the game-changer that many innovators had been waiting for.”

Huang added in the release, “Denmark recognizes that to innovate in AI, the most impactful technology of our time, it must foster a domestic AI infrastructure and ecosystem. The Gefion supercomputer will supercharge the scientists of Denmark with local AI computing infrastructure to drive advancements in life sciences, climate research, and quantum computing.”

Gefion is powered by 1,528 graphic processing units (GPUs) (NVIDIA H100 Tensor Core GPUs) and is interconnected using networking (NVIDIA Quantum-2 InfiniBand). According to the press release, “Denmark up to now had no GPU-accelerated supercomputers, and a thorough consulting process with relevant stakeholders across the country had identified access to computing power as a key roadblock to progress in Denmark’s otherwise thriving AI-based research ecosystem.”

Digital Realty, a global data center provider, hosts the supercomputer in an AI-ready data center facility in Denmark, which is designed and built sustainably, running on 100% renewable energy, according to the press release. Gefion was assembled and installed by Eviden, a European-based high-performance computing company.

In addition to the Novo Nordisk Foundation’s funding, EIFO contributed DKK 100 million (US$15 million) and owns a 15% minority stake in DCAI.

“Establishing Gefion is a milestone, and it fits very well with the Novo Nordisk Foundation’s vision of improving people’s health and the sustainability of society and the planet, as it creates new opportunities and can accelerate finding new solutions to pressing challenges,” said Mads Krogsgaard Thomsen, CEO of the Novo Nordisk Foundation, in the release. “In the future, we must cooperate even more with exceptional partners from all over the world if we are to solve the enormous challenges facing not only our own countries but the planet.”

Researchers will have the opportunity to engage with expert teams from NVIDIA in selected flagship project areas to co-develop solutions to complex problems. These areas include pharmaceuticals and biotechnology research, accelerating the green transition; and developing fault-tolerant (i.e., error-free) quantum computing using an open-source hybrid quantum computing platform (NVIDIA CUDA-Q).

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With DKK 600 million (US$87.4 million) in funding from the Novo Nordisk Foundation, the new supercomputer offers the potential to accelerate innovation in drug discovery.

Denmark’s First AI Supercomputer for Drug Discovery Now Operational Under Novo Nordisk Foundation Commitment

ViaNautis Bio (ViaNautis), a UK-based biotechnology company specializing in delivering targeted genetic nanomedicines, announced on Oct. 28, 2024 that it has entered a collaboration agreement with Eli Lilly and Company (Lilly) in which Lilly will use ViaNautis’ proprietary polyNaut platform to develop precision therapeutics carrying genetic cargos. The collaboration aims to precisely deliver these therapeutics to prioritized tissues to address significant unmet medical needs.

Under the agreement, Lilly will pay ViaNautis an initial upfront payment with the short-term potential of making additional payments, including research-based milestones. ViaNautis is eligible to receive further milestones and royalties contingent upon specific cargo-loaded polyNaut-based products entering clinical development and reaching and reaching commercialization.

“This collaboration with Lilly is a testament to our polyNaut platform, which is also driving a highly differentiated emerging pipeline for severe life-limiting diseases. Combining our scientific know-how to precisely deliver genetic nanomedicines targeting difficult-to-reach sites, with Lilly’s extensive drug development and commercialization expertise will accelerate the creation of novel therapies to improve patient outcomes,” said Francesca Crawford, PhD, co-founder of ViaNautis, in a company press release.

The company’s proprietary polyNaut nanovesicles are designed to precisely target specific tissues and cell types to deliver genetic materials. The technology aims to improve the current delivery of genetic medicines and hold the potential to transform treatment for various diseases, according to the company in the press release.

“I am very excited about our collaboration with Lilly to develop novel genetic medicines for patients in need. I want to thank [Crawford] and the team for their hard work in getting to this key milestone, and I look forward to working with Lilly to accelerate our shared vision of delivering targeted genetic medicines,” said Adi Hoess, MD, PhD, chief executive officer of ViaNautis, in the release. The company is currently working on a pipeline of therapeutics in the central nervous system and cystic fibrosis disease fields (1).

Nanovesicles are being researched as alternatives to extracellular vesicles (EVs) for various applications, including drug delivery. As mediators of intercellular communication, EVs have gained growing interest from researchers for their potential use in the field of regenerative medicines or as a drug delivery vehicle. However, because EVs are derived from stem cells or progenitor cells, their use is limited primarily due to a lack of efficient and scalable production methods (2).

As a result, researchers are turning to nanovesicles, particularly biofabricated cell-derived nanovesicles, as an alternative to EVs that are offer scalable, efficient, and cost-effective production (2). Meanwhile, further research has been underway to develop and test simplified and rapid production methods for cell-derived nanovesicles that offer advantages over traditional methods in terms of yield and cost-effectiveness (3), which are anticipated to offer new approaches to therapeutic drug delivery.

 (accessed Oct. 30, 2024).
2. Ilahibaks, N. F.; Lei, Z.; Mol, E. A.; et al. Biofabrication of Cell-Derived Nanovesicles: A Potential Alternative to Extracellular Vesicles for Regenerative Medicine. 

 (12),1509. DOI: 10.3390/cells8121509
3. Goh, W. J.; Zou, S.; Ong, W. Y.; et al. Bioinspired Cell-Derived Nanovesicles versus Exosomes as Drug Delivery Systems: a Cost-Effective Alternative. 

The partnership will use ViaNautis’ proprietary polyNaut technology platform to develop genetic medicines that can precisely target tissue types.

Lilly and ViaNautis Bio Partner on Development of Novel Therapeutics Delivering Genetic Cargo

Monte Rosa Therapeutics, a Boston, Mass.-headquartered clinical-stage biotechnology company specializing in novel molecular glue degrader (MGD)-based medicines, announced on Oct. 28, 2024,  that it entered into a global exclusive development and commercialization license agreement with Novartis. The agreement is worth potentially up to $2.1 billion and aims to advance vav guanine nucleotide exchange factor 1 (VAV1) MGDs, including MRT-6160, a drug candidate being evaluated in an ongoing Phase I single ascending dose (SAD)/multiple ascending dose (MAD) healthy volunteer study for immune-mediated conditions.

Under the agreement, Novartis will pay Monte Rosa $150 million up front in exchange for exclusive worldwide rights to develop, manufacture, and commercialize MRT-6160 and other VAV1 MGDs. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, starting with the initiation of Phase II clinical studies of MRT-6160. Monte Rosa is also eligible to receive tiered royalties on ex-US net sales.

Novartis will be responsible for all clinical development and commercialization of MRT-6160, starting at the Phase II clinical phase. Monte Rosa, meanwhile, will remain responsible for completing the ongoing Phase I clinical study for the drug candidate. In addition, Monte Rosa will co-fund any Phase III clinical development. The company will also share any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the United States.

“We are thrilled to announce this agreement with Novartis, a key player in immune-mediated conditions, and we are excited about the transformative potential it provides for Monte Rosa and MRT-6160. We expect this will accelerate and broaden the scope of clinical development of MRT-6160 to advance this unique, orally bioavailable modality while retaining substantial value for Monte Rosa. We believe the transaction validates our unique and industry leading QuEEN discovery engine, and it further increases our conviction to rationally design and develop highly selective and safe MGDs for undruggable targets, including in the areas of immunology and inflammation, metabolism, and genetic diseases,” said Markus Warmuth, MD, chief executive officer, Monte Rosa Therapeutics, in a company press release. “The financial resources provided by this agreement are expected to extend our operational runway, enable us to advance our pipeline to potential value-creating milestones and anticipated proof-of-concept readouts, and further leverage our QuEEN discovery engine.”

MRT-6160 is a potent, highly selective, and orally bioavailable investigational degrader of VAV1, which is known as a key signaling protein found downstream of both T- and B-cell receptors. According to preclinical studies, MRT-6160 demonstrated deep degradation of VAV1, which resulted in a significant decrease in cytokines linked to immune-mediated conditions. It also showed no detectable effects on other proteins. The candidate has shown promising activity in preclinical models of multiple immune-mediated conditions (1,2).

"Novartis has had a long-standing interest in molecular glue degraders, which offer the potential to tackle challenging biological targets. We are excited about their application in immunology and the early progress we have seen by Monte Rosa in this space and with MRT-6160. We look forward to advancing MRT-6160 and learning more about its potential to provide a new therapeutic option for people living with a range of immune-mediated conditions,” said Fiona Marshall, president, Biomedical Research, Novartis, in the press release. “Novartis is committed to bringing forward new therapeutic options for these patients, and we are happy to be working with Monte Rosa to harness the potential of this approach to address unmet medical needs.”

1. Cartwright, A.; Desai, F.; Vora, S.; et al. MRT-6160, a VAV1-Directed Molecular Glue Degrader, Reduces Joint Inflammation and Autoantibody Production in a Collagen-Induced Arthritis Autoimmune Disease Model. Poster presented at Digestive Disease Week 2024, Washington, DC, May 21, 2024.
2.Cartwright, A.; Vora, S.; Gyger, L.; et al. MRT-6160, a VAV1-Directed Molecular Glue Degrader, Inhibits Disease Progression in a T-cell Transfer Mediated Colitis Model Concomitant with Reduced Calprotectin Expression. Poster presented at EULAR 2024—Annual European Congress of Rheumatology, Vienna, Austria, June 14, 2024.

The collaboration aims to advance clinical development of a Phase I drug candidate, MRT-6160, and to explore other therapeutic opportunities across multiple indications.

Novartis and Monte Rosa Therapeutics Form $2.1 Billion Global License Agreement for MGD-based Therapeutics

Shawn Li, principal scientist at Merck & Co., known as MSD outside the Unites States and Canada, talked about the importance of properly characterizing HCPs in the biomanufacturing process.

AAPS PharmSci 360: The Importance of HCP Analysis in Biomanufacturing

® spoke with Xuanwen (Shawn) Li, PhD, Principal Scientist at Merck & Co., known as MSD outside of the United States and Canada, during AAPS PharmSci 360 about the importance of properly analyzing host cell proteins (HCPs) during the biomanufacturing process.

“Host cell proteins are process-related impurities in biopharmaceutical manufacturing. The identification and control of a high-risk host cell protein in biopharmaceutical development is critical to ensure biopharmaceutical product quality and shelf life,” Li stated. For example, he explained, certain HCPs can have direct biological effect, and some HCPs can degrade the drug product or formulation excipients such as polysorbate. “The host cell protein issue can lead to significant delay or product withdrawal … Therefore, it's extremely important to understand how to properly analyze host cell proteins in biopharmaceutical manufacturing,” Li said.

, scheduled on Wednesday, Oct. 23, at 3:45 pm MT (2:45 pm PT, 5:45 pm ET), he focuses on the identification and control for one of a group of high-risk HCPs called the polysorbate-degradative enzyme. With an analytical toolbox developed at Merck, the company can better understand polysorbate degradation in biologics. One assay Li highlights in his talk is activity-based protein profiling (ABPP). “In short, ABPP can overcome the dynamic range issue of trace levels of high-risk host cell protein to drug substance and really enable the identification of those low abundance enzymes, while also providing activity information,” he said.

Attendees can visit Merck at Booth #3344. AAPS PharmSci 360 is taking place Oct. 21–23 at Salt Lake City, Utah.

Xuanwen (Shawn) Li, PhD, Principal Scientist, Merck & Co.

Shawn Li is a principal scientist and scientific supervisor in the Analytical Research & Development, Mass Spectrometry group at Merck & Co. Inc. His research is focused on mass spectrometry-based biologics and vaccine characterization for chemistry, manufacturing, and controls (CMC) development and regulatory submission. Prior to joining Merck in 2018, Li worked as a research scientist at Eli Lilly and Company on protein characterization. Before his industry career, Li was a director of the mass spectrometry facility at the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania. Li received a PhD in proteomics at the Hunan Normal University in China and completed his post-doctoral training in clinical pharmacology and bioanalysis at the University of Pennsylvania.

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At AAPS PharmSci 360, Karunakar Sukuru, global vice-president, Catalent Pharma Solutions, discussed lipid-based formulations and tackling bioavailability challenges for oral biologics.

AAPS PharmSci 360: LBFs and Tackling Oral Biologic Formulations

® spoke with Karunakar Sukuru, RPh, PhD, global vice president of Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, about the advantages and new challenges with lipid-based formulations (LBFs). Sukuru also discussed the challenges of addressing bioavailability in the search for developing oral formulations for biologics.

“Lipid-based drug delivery systems are not new,” Sukuru said, noting, though, that although lipid-based drug delivery systems exist, there is, today, an increased need for them, particularly considering that of the almost 8500 or so molecules—small molecular entities—in development, 70% of them are poorly bioavailable. “Because [these small molecules] are either poorly soluble, or poorly soluble and poorly absorbed, [that] is where the lipid-based formulation comes into play … they have a very demonstrated and valuable utility,” he stated. LBFs enhance bioavailability, so that a molecule may not necessarily need to have aqueous solubility.

Meanwhile, delivering biologics or proteins through an oral route is very challenging because of their high molecular weight. “[There] [are] certain limitations; the body does not allow absorb[tion of] these high molecular weights … with most monoclonal antibodies or biologics, they are in the hundreds of 1000s of Daltons [in size],” Sukuru pointed out. “However, there are a lot of efforts going on, and novel formation and answers are showing good promise, where they open the tight junctions, facilitating the absorption of the molecules,” he added. Another challenge he emphasized is stabilizing the biologic molecule once it is delivered to the intestine, where it would otherwise be destroyed by an acidic environment.

Attendees can visit Catalent at Booth #1141 at AAPS PharmSci 360, which is taking place on Oct. 20–23, 2024 in Salt Lake City, Utah.

Karunakar (Karu) Sukuru, RPh, PhD, Global Vice President, Rx Product Development, Pharma and Consumer Health, Catalent Pharma Solutions

Karunakar Sukuru (Karu) RPh, PhD is the global vice president of Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions. With over 29 years of experience in the pharmaceutical industry, he has led the development and manufacturing of various drug delivery systems and technologies and has been responsible for product development and execution of projects globally. Sukuru had technical oversight of more than a dozen contract development and manufacturing organizations worldwide while working at Endo Pharma. In his current role at Catalent, he works with hundreds of pharmaceutical clients, including leading biopharma companies, globally. He has developed innovative controlled-release platform technologies in softgel form (three granted patents) and has over 27 pending patent applications in the field of modified shell and fill suitable for capsules for enteric and colonic delivery and lyophilization. After completing his PhD in Pharmaceutics from IIT-BHU, India, in 1995, Sukuru began his career at Natco Pharma in India, where he developed a variety of oral dosage forms for two years. He then joined Banner Pharmacaps in India, and later in Banner Pharmacaps USA, he worked on softgel and gel enrobed tablets. Sukuru joined Endo Pharma in 2006 and Catalent in 2016 as the vice president of Product Development. He is also a registered pharmacist.

At AAPS PharmSci 360, Karunakar Sukuru, RPh, PhD, the global vice-president-Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, discussed lipid-based formulations and tackling bioavailability challenges for oral biologics.

Karunakar Sukuru, RPh, PhD, the global vice-president-Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, spoke on recent challenges and trends in softgel formulations. 

AAPS PharmSci 360: Challenges and Trends in Softgel Formulations

® spoke with Karunakar Sukuru, RPh, PhD, the global vice-president-Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, during AAPS PharmSci 360 to discuss recent challenges and trends in softgel formulations.

“Recent challenges are mostly related to enhancing the solubility and making those solubilized molecules stabilized in the systems, particularly in softgels, and enhancing the bioavailability,” Sukuru said. He noted that there is an increasing demand for non-animal products by the industry, particularly in Europe where gelatin, an animal byproduct, is used as a shell component. Although gelatin is a good material to use in terms of its ability to make robust, subgenerative capsules, it also has some disadvantages, such as cross-linking challenges, Sukuru pointed out. “That is where [there is need] to address both the non-animal byproduct need, using plant-based materials, as well as … the cross linking issues,” he stated.

, which is on Monday, Oct. 21, at 3:30 pm MT (2:30 pm PT, 5:30 pm ET), centers around the missed opportunity for superior bioavailability and the ability to develop moderated drug release products using softgels. “Softgel is one of the most versatile dosage forms, and you could deliver [a] drug through any orifice in the body, literally,” Sukuru said. “There are products that we manufacture commercially to deliver through oral route, ophthalmic route, nasal, otic, vaginal, and every route of delivery, but it's very underutilized. [Futhermore] there are a lot of myths and misconceptions about softgels being very expensive. No, they are not. In fact … compared to spray drying and some other bioavailability enhancing technologies, they are not.”

Attendees can visit Catalent at Booth #1141 at AAPS PharmSci 360, which is taking place on Oct. 20–23 in Salt Lake City, Utah.

Karunakar (Karu) Sukuru, RPh, PhD, Global Vice-President-Rx Product Development, Pharma and Consumer Health, Catalent Pharma Solutions

Karunakar Sukuru (Karu) RPh, PhD is the global vice-president of Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions. With over 29 years of experience in the pharmaceutical industry, he has led the development and manufacturing of various drug delivery systems and technologies and has been responsible for product development and execution of projects globally. Sukuru had technical oversight of more than a dozen contract development and manufacturing organizations worldwide while working at Endo Pharma. In his current role at Catalent, he works with hundreds of pharmaceutical clients, including leading biopharma companies, globally. He has developed innovative controlled release platform technologies in softgel form (three granted patents) and has over 27 pending patent applications in the field of modified shell and fill suitable for capsules for enteric and colonic delivery and lyophilization. After completing his PhD in Pharmaceutics from IIT-BHU, India, in 1995, Sukuru began his career at Natco Pharma in India, where he developed a variety of oral dosage forms for two years. He then joined Banner Pharmacaps in India, and later in Banner Pharmacaps USA, he worked on softgel and gel enrobed tablets. Sukuru joined Endo Pharma in 2006 and Catalent in 2016 as the vice-president of Product Development. He is also a registered pharmacist.