Valo Health LLC

Novo Nordisk is adding on to its cardiovascular drug pipeline with the acquisition of Cardior Pharmaceuticals, a genetic medicines developer whose lead program is in mid-stage clinical testing in heart failure. The Danish pharmaceutical giant said Monday that it has committed up to €1.025 billion (about $1.1 billion) to acquire Cardior. Novo Nordisk did not provide a financial breakdown of the deal, other than to say that the sum includes an upfront payment as well as development and commercial milestones that were not specified. Hanover, Germany-based Cardior discovers and develops genetic medicines intended to prevent, repair, and even reverse diseases of the heart. Its drugs are antisense oligonucleotides, a class of medicines that employ small pieces of DNA or RNA to stop production of a disease-causing protein. Cardior’s RNA medicines specifically target non-coding RNA. While this type of RNA does not encode a protein, it does regulate certain cellular processes. Cardio says that by targeting non-coding RNAs, its antisense oligonucleotides can act on several disease pathways, which in turn offers a therapeutic effect in heart diseases. Lead Cardior program CDR132L is designed to block a microRNA molecule called miR-132. This non-coding RNA has been studied for its role in neuronal cells, inflammation, and cancer. Cardior’s focus is on the role that excessive miR-132 activity has on the heart. The drug candidate is designed to selectively block abnormal levels of miR-132, which could in turn halt and partially reverse the effects of heart failure, a condition affecting the heart muscle’s ability to pump blood to the rest of the body. While current treatment options address heart failure symptoms, Cardior claims its drug address an underlying cause of the disorder. In a 28-patient Phase 1b study, results showed Cardior’s intravenously infused CDR132L was safe and well tolerated. Additionally, results from this placebo-controlled, dose-escalating study showed improvement in cardiac function. The results were published in 2021 in the European Heart Journal. After reporting those data, Cardior went on to raise a €64 million (about $69.3 million) Series B round of financing to continue clinical development of CDR132L, which is currently in Phase 2 testing in heart failure. This drug is also in preclinical development for two additional indications: heart failure with preserved ejection fraction and dilated cardiomyopathy. Two other Cardior programs are in preclinical development for hypertrophic cardiomyopathy. While Novo Nordisk’s metabolic disorder drugs continue to drive record sales, the company has said its growth strategy includes expanding into adjacent areas, such as cardiovascular conditions. In 2021, Novo Nordisk paid $100 million up front to acquire global rights to a Prothena drug in development for the cardiomyopathy caused by the rare disease hereditary transthyretin amyloidosis. That antibody drug is currently in Phase 2 testing under Prothena. Last fall, Novo Nordisk paid $60 million up front for three preclinical cardiovascular drugs from Valo Health. The pharma giant characterizes the Cardior acquisition as “an important step forward in Novo Nordisk’s strategy to establish a presence in cardiovascular disease.” “We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to halt or partially reverse the course of disease for people living with heart failure,” Martin Holst Lange, executive vice president for development at Novo Nordisk said in a prepared statement. Image: Magicmine, Getty Images

BOSTON, March 4, 2024 /PRNewswire/ -- Valo Health, Inc (Valo), a technology company focused on utilizing large scale data and artificial intelligence (AI) driven computation to discover and develop therapeutics, today announced full enrollment in the company's Phase 2 Spectra clinical trial. Spectra is a multi-center randomized, double-blind, placebo-controlled study to evaluate the potential benefit of oral OPL-0401 in patients with moderately severe or severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR). OPL-0401 is an investigational small molecule Rho kinase (ROCK) 1/2 inhibitor and a potential first-in-class oral option for patients with diabetic retinopathy (DR), where the current treatment options are limited to patients with more severe or advanced vision-threatening levels and consist mainly of intravitreal injections and laser treatment. The company anticipates a topline readout before the end of 2024. Valo would like to thank the patients and trial investigators for their participation and contributions to the study. "We are encouraged by the full enrollment of our Phase 2 trial ahead of our projected timeline, a strong testament to the potential that new therapies could bring for patients felt by the healthcare providers participating in this trial," said Valo's Chief Medical Officer, Victor Shi, MD. "We are so grateful to the Spectra trial investigators, recognizing the opportunity and confidence in identifying a more effective or convenient therapy over current therapeutic options, for their support through trial enrollment completion." "Diabetic retinopathy has an estimated prevalence of approximately 11 million people in the United States and remains an underserved illness, especially in earlier stages of the disease," said Graeme Bell, Interim Chief Executive Officer of Valo Health. "The study of OPL-0401 for oral delivery represents the potential for significant improvement in the treatment of this progressive and debilitating disease. In addition, we leveraged Valo's Opal Computational Platform™, our end-to-end drug discovery and development platform, to identify biomarkers that may predict which patients are likely to progress to the next stage of DR, and are hopeful to gain further insights from Spectra that could potentially benefit future patients and clinical trial design and execution." Valo used its Opal Platform and unique access to real-world evidence to evaluate the diabetic retinopathy patient population and OPL-0401 and its potential. The company's internal pipeline of product candidates and discovery programs utilize Opal, and the learnings from these programs are integrated and utilized to further develop its computational capabilities. "There remains a tremendous unmet need for safe and effective oral therapeutics that can slow the progression of NPDR and PDR and improve diabetic retinopathy severity levels," said Charles C. Wykoff, MD, PhD, Director of Research at Retina Consultants of Texas in Houston and Spectra Lead Investigator. "Today, physicians often delay treating patients with NPDR with current FDA-approved therapeutics because of the need for repeated intravitreal injections. Spectra is a well-designed, proof of concept study that I hope will yield positive results for patients with NPDR." About OPL-0401 OPL-0401 is a ROCK (Rho kinase) 1/2 inhibitor with unique physiochemical properties that make it suitable as an oral treatment option for patients with vascular diseases of the eye such as DR. OPL-0401 has been found to be generally safe and well tolerated in Phase 1 and 2 studies (sponsored by Sanofi prior to our acquisition of the program) of > 200 healthy volunteers including elderly, and individuals with renal insufficiency. OPL-0401 has demonstrated evidence of pharmacologic activity in a non-ophthalmologic human vascular disease proof-of-principle study. OPL-0401 is an investigational agent and has not been approved by the U.S. Food and Drug Administration (FDA), and its safety and efficacy have not been established. About Valo Health Valo Health, Inc is a technology company focused on utilizing large scale data and AI-driven computation to discover and develop therapeutics. Valo aims to fully integrate human-centric data across the entire drug development life cycle into a single unified architecture, thereby accelerating the discovery and development of life-changing drugs while simultaneously reducing costs, time, and failure rates. The company's Opal Computational Platform™ is an end-to-end drug discovery and development platform with a unified architecture designed to transform data into valuable insights that may accelerate discoveries and enable Valo to advance a robust pipeline of programs, initially focused on cardiovascular metabolic renal, oncology, and neurodegenerative disease. Founded by Flagship Pioneering and headquartered in Boston, MA, Valo also has offices in Lexington, MA, and New York, NY. To learn more, visit valohealth.com. Contacts Investors: Graeme Bell, gbell@valohealth.com Media: Kate Clayton, kclayton@valohealth.com

DUBLIN, Feb. 27, 2024 /PRNewswire/ -- The "Artificial Intelligence / AI in Drug Discovery Market by Offering, Process (Target selection, Validation, Lead Generation, Optimization), Drug Design (Small Molecule, Vaccine, Antibody, PK/PD), Dry Lab, Wet Lab (Single Cell analysis) & Region - Global Forecast to 2028" report has been added to ResearchAndMarkets.com's offering. The artificial intelligence (AI) in drug discovery market is projected to reach USD 4.9 billion by 2028 from USD 900 million in 2023, at a CAGR of 40.2% Players adopted organic as well as inorganic growth strategies such as product launches and enhancements, and investments, partnerships, collaborations, joint ventures, funding, acquisition, expansions, agreements, sales contracts, and alliances to increase their offerings, cater to the unmet needs of customers, increase their profitability, and expand their presence in the global market. In 2022, North America accounted for the largest and the fastest-growing regional market for AI in drug discovery. North America hosts numerous pharmaceutical giants and biotechnology innovators that are actively exploring AI's capabilities in drug discovery. These industry leaders are investing significantly in AI-driven research and development, driving market growth. North America's well-established regulatory framework for pharmaceuticals and healthcare facilitates the integration of AI technologies while ensuring compliance with industry standards and guidelines. The above-mentioned factors will drive the market of AI in drug discovery in North America. AI expedites the identification and validation of potential drug targets by analyzing intricate biological data. This accelerates the selection of biologically relevant targets for therapeutic interventions. AI techniques such as machine learning enable rapid analysis and decision-making, reducing the time and resources required for drug discovery processes. This efficiency gains a competitive edge in the fast-paced pharmaceutical landscape. Therefore, aforementioned factors will drive the growth of this market. On the other hand, the inadequate availability of skilled labor is key factor restraining the market growth to a certain extent over the forecast period. Services segment is estimated to hold the major share in 2022 and also expected to grow at the highest over the forecast period. Based on offering, the AI in drug discovery market is bifurcated into software and services. The 2022 and segment expected to account for the largest market share of the global AI in drug discovery services market in 2022 and expected to grow fastest CAGR during the forecast period. Access to AI technology and expertise through services reduces the barriers for pharmaceutical companies to adopt AI in drug discovery. This is particularly beneficial for smaller companies without extensive in-house AI capabilities, enabling them to harness the power of AI without significant upfront investments. Machine learning technology segment accounted for the largest share of the global AI in drug discovery market. Based on technology, the AI in drug discovery market is segmented into machine learning, natural language processing (NLP), context aware processing, and other technologies. The machine learning segment accounted for the largest share of the global market in 2022 and expected to grow at the highest CAGR during the forecast period. Machine learning enables the creation of predictive models that anticipate the behavior of potential drug candidates within the human body. This aids in identifying compounds with the highest likelihood of success, reducing the costs and time associated with unsuccessful candidates. Machine learning contributes to the development of personalized treatment strategies by analyzing patient data to predict individual responses to drugs. This facilitates tailoring treatments based on genetic, molecular, and clinical information, leading to more effective outcomes, which helps accelerate the drug discovery process are some of the factors supporting the market growth of this segment. Small Molecule Design and Optimization segment expected to hold the largest share of use case segment of the market in 2022. Based on use cases, the AI in drug discovery market is divided into small molecule design and optimization, understanding disease, safety and toxicity, vaccine design and optimization, antibody and other biologics design and optimization. In 2022, the small molecule design and optimization segment accounted for the largest share of the AI in drug discovery market. AI is employed in small molecule design and optimization for two main purposes. Firstly, it aids in identifying hit-like or lead-like compounds by screening existing chemical libraries or through generative de novo design. Secondly, AI optimizes the identified hits, ensuring favorable properties like binding affinity, toxicity, and synthesis, ultimately leading to the development of more effective and safer drug candidates. These factors contribute to the development and refinement of AI algorithms tailored for drug discovery use cases. This report provides insights into the following pointers: Analysis of key drivers (growing number of cross-industry collaborations and partnerships, growing need to control drug discovery & development costs and reduce time involved in drug development, patent expiry of several drugs), restraints (shortage of AI workforce and ambiguous regulatory guidelines for medical software), opportunities (growing biotechnology industry, emerging markets, focus on developing human-aware AI systems, growth in the drugs and biologics market despite the COVID-19 pandemic), and challenges (limited availability of data sets) influencing the growth of AI in drug discovery market. Product Development/Innovation: Detailed insights on upcoming technologies, research and development activities, and product launches in the AI in drug discovery market. Market Development: Comprehensive information about lucrative emerging markets. The report analyzes the markets for various types of AI in drug discovery solutions across regions. Market Diversification: Exhaustive information about products, untapped regions, recent developments, and investments in the AI in drug discovery market. Competitive Assessment: In-depth assessment of market shares, strategies, products, distribution networks, and manufacturing capabilities of the leading players in the AI in drug discovery market. Company Profiles Key Players Nvidia Corporation Exscientia Google Benevolentai Recursion Insilico Medicine Schrodinger, Inc. Microsoft Corporation Atomwise Inc. Illumina, Inc. Numedii, Inc. Xtalpi Inc. Iktos Tempus Labs Deep Genomics, Inc. Verge Genomics Bpgbio, Inc. Benchsci Valo Health Insitro Other Players Tencent Predictive Oncology, Inc. Iqvia Inc Labcorp Celsius Therapeutics Cytoreason Owkin Cloud Pharmaceuticals Evaxion Biotech Standigm Bioage Labs Envisagenics Aria Pharmaceuticals, Inc. 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