Novo Nordisk Invests $2.7 Billion in Cardiac Organ-on-a-Chip Technology to Accelerate Cardiovascular Drug Development

Sep 28, 2023 08:05 CST Updated 08:05

Novo Nordisk

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September 28, 2023 / eMedClub News /--On September 25, Novo Nordisk and Valo Health jointly announced that they had reached an agreement based on Valo'sOpal™ Computational Platform, leveraging real-world patient data, AI-supported small molecule discovery andBiowire®Human Tissue Modeling Platform for the Discovery and Development of New Therapies for Cardiometabolic Diseases.Valo Authorized to Develop Novo Nordisk's Three Preclinical Drug Programs for Cardiovascular Diseases;Valo will receive a total of $60 million in upfront payments and potential near-term milestone payments, and is eligible for milestone payments on up to 11 programs.Totaling up to 2.7 billion US dollars。

▲ Image Source:Novo Nordisk Official Website

Computational methods are having a significant and growing impact on drug development.Valo Health, Inc. is a technology company focused onUtilizing large-scale data and AI-driven computingTo discover and develop treatments. Valo's goal is to fully integrate human-centered data throughout the entire drug development lifecycle into a unified architecture, thereby accelerating the discovery and development of life-changing drugs while reducing costs, time, and failure rates. The company's Opal™It is an end-to-end drug discovery and development platform with a unified architecture, designed to transform data into valuable insights that can accelerate discovery and enable Valo to advance a robust pipeline of programs, initially focused on cardiometabolic-renal, oncology, and neurodegenerative diseases. Valo was founded by Flagship Pioneering and is headquartered in Boston, USA.

In the process of new drug development, researchers often conduct experiments on animals to verify the physiological effects of individual factors on the tested animals, including toxicity tests.The FDA previously required animal studies to be conducted before any drug could be approved for human use.Later, it was discovered that preclinical studies based on animal safety, toxicology, and metabolism have limited predictive value for the successful development of drugs. Thanks to the advancement of biotechnology,Organoids and organ-on-a-chip can replace animals and have been proven to be excellent alternatives to animal models in preclinical research.Can pre-detect the efficacy and safety of candidate drugs, thereby increasing the success rate of candidates entering clinical trials and significantly reducing drug development costs, offering more advantages than animal and in vitro cell culture.In August 2022, the FDA approved the world's first drug entirely based on "organ-on-a-chip" research for clinical trials, marking a milestone event in the industry.. This experiment was conducted in collaboration between Sanofi and Hesperos to treat two rare autoimmune demyelinating nerve diseases, for which research had previously been impossible due to the lack of ideal animal models.

On September 29, 2022, the U.S. Senate passed the FDA Modernization Act 2.0 (FDA Modernization Act 2.0, S.5002), which means that the FDA has ended the mandatory requirement for animal testing of new drugs and generic drugs.The bill does not completely ban animal testing, but allows pharmaceutical companies to choose to use it in appropriate places after the FDA issues this bill.Frequent financing events in the fields of organoids and organ chips at home and abroad have become a major hotspot in biopharmaceutical investment and financing.Dozens of companies in China and abroad are dedicated to developing organ chips, human body chips, and disease model chips for new drug development. In addition to Valo, major foreign organ chip companies include Emulate, TissUse, Hesperos, CN Bio Innovations, Draper Laboratory, Mimetas, Nortis, Micronit Microtechnologies B.V., Kirkstall, Cherry Biotech SAS, and Else Kooi Laboratory. These companies have developed various types of organ chips, including brain chips, liver chips, kidney chips, lung chips, heart chips, and intestine chips.

China has also issued multiple policies to support the development of this field.In the notice issued by the Ministry of Science and Technology in 2021, "Malignant Tumor Disease Models Based on Organoids" was listed as one of the first key special tasks in the "14th Five-Year Plan" National Key Research and Development Program; the Center for Drug Evaluation (CDE) also included organoids in the guidelines for gene therapy and gene-modified cell therapy products — "When there is a lack of suitable animal models to meet the experimental needs, alternative models such as organoids can be used for experiments."

Valo Acquires from TARA BiosystemsBiowire® is precisely this type of human heart tissue chip., for integrated and high-fidelity rapid preclinical cardiac risk assessment, disease modeling in heart disease drug development, and conducting in vitro clinical trials.

TARA Biosystems, founded in 2014, leverages iPSC and tissue engineering technology to develop a novel and scalable mature cardiac tissue platform, Biowire®, for cardiovascular research.An innovative method for growing heart cells around silk threads, with heart cell scaffolds that interlock like magic pieces.These engineered cardiac tissues can simulate the cardiac physiological microenvironment and have the potential to replace costly in vivo animal cardiac safety studies, assessing drug safety, efficacy endpoints, and cardiovascular disease research for cardiovascular disease-type drugs. TARA has collaborated with more than 30 pharmaceutical companies developing cardiac disease drugs, including global giants such as GSK and Amgen. On April 5, 2022, TARA Biosystems was acquired by Valo Health, which combined TARA's Biowire® platform with its own Opal Computational Platform™.Created the world's first 3D organoid heart model and AI-driven drug development platform.

Biowire® technology stems from the innovative research of Professor Milica Radisic of Chemical Engineering and Applied Chemistry at the University of Toronto, Canada, which was published in the journal *Nat Methods* in 2013. She is also the Canadian Research Chair in Functional Cardiovascular Tissue Engineering and a fellow of the Royal Society of Canada, the Canadian Academy of Engineering, and the American Institute for Medical and Biological Engineering. In 2017, she received the Steacie Prize, which is awarded annually to an engineer or scientist aged 40 or younger in recognition of their significant contributions to research in Canada.Professor Radisic was the first person in the world to use electrical pulses and a specially designed bioreactor to guide isolated heart cells to assemble into a beating structure, and is also a co-founder of Tara Biosystems.

▲Professor Milica Radisic, Image Source:University of Toronto Official Website

▲ Image Source:Nature Official Website

On January 24, 2019, Tara Biosystems announcedInternational Journal CellThe first article about itsBiowire™II PlatformThe peer-reviewed research paper. The main author of the paper is Professor Radisic, who provides a detailed introduction of Biowire within the text.™How Platform II Creates Various Types of Human Cardiac Tissues In Vitro, and Describes How Researchers Generate Human Disease Tissue Models from Patient-Derived iPSC Cardiomyocytes.Biowire™The II platform accurately simulates the complex movements of the human heart by applying biomimetic electrical and mechanical stimulation to Cardiotype cardiac model tissues. It is the only platform on the market capable of providing accurate predictions of cardiac function across three major applications: integrated and high-fidelity cardiac testing for rapid preclinical cardiac risk assessment, disease modeling for cardiac drug discovery, and conducting in vitro clinical trials.In addition, the Biowire™ II platform uniquely combines elastic sensing elements, with engineered tissues suspended on the elastic sensing elements, allowing for non-destructive measurement of the force exerted by cardiac tissues during contraction and evaluation of the safety and efficacy of drug compounds related to the heart.

▲Biowire™ II Platform, Image Source: Cell Official Website

References:

1.doi: 10.1016/j.cell.2018.11.042.

2.https://news.engineering.utoronto.ca

3.doi:10.1038/nmeth.2524.

4.https://www.novonordisk.com

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