Levels of nine blood proteins can accurately predict high or low risk of serious cardiovascular events

Levels of nine blood proteins can accurately predict high or low risk of serious cardiovascular events

6/21/2016

 

A study published online today in the Journal of the American Medical Association (JAMA) details the first successful effort to measure at scale the levels of more than a thousand proteins in blood in patients with coronary heart disease (CHD), and describes the identification of a combination of nine specific proteins whose levels taken together can accurately predict the risk of future heart attacks, strokes, heart failure or death. This nine-protein model is more accurate for predicting risk of such adverse events than any currently measured risk factors (e.g., cholesterol, blood pressure, diabetes, smoking or age). A diagnostic test based on these findings is in development for release later this year.

“There is a critical need in medicine to correctly identify individuals who are at high risk of devastating cardiovascular events and to be able to tailor treatments to these individuals rather than treating all patients the same,” said Peter Ganz, MD, Chief of the Cardiology Division at Zuckerberg San Francisco General Hospital and Professor of Medicine at University of California, San Francisco, who led the study. “The discovery of different protein levels in blood that can be used to predict the risk of cardiovascular events gives us a much-needed tool to enable more personalized management of individual patients with heart disease.”

The research described in JAMA involved measuring 1,130 different proteins in nearly 2000 individuals with apparently stable coronary heart disease, who were followed up to 11 years. Initially, two hundred different proteins were identified whose blood levels could be related to the risk of heart attacks, strokes, heart failure and death, and ultimately a combination of nine proteins was selected based on their combined accuracy and sensitivity. Application of these findings to CHD patient samples demonstrated that some of those who were deemed clinically stable instead had a high risk of adverse cardiovascular outcomes, while other patients with the same clinical status had a very low risk. Briefly, individuals who all carried the same clinical diagnosis of stable coronary heart disease had a risk of an adverse cardiovascular event that varied by as much as ten-fold, as revealed by analysis of the levels of the nine proteins in their blood.

Repeating this nine-protein measurement over time also showed that people approaching serious cardiovascular events or death had a far greater increase in their protein score than people who were not approaching a new event. The ability to pinpoint those individuals who are at high risk or whose risk is rising may ultimately provide guidance on which patients need to be treated most intensively. It may also guide the appropriate use of medical treatments that are expensive or that carry a significant risk of side effects.

“Existing risk measures based on genomics, clinical risk factors and routine laboratory measures just don’t work very well in patients with coronary heart disease,” said study author Stephen Williams, MD, PhD, Chief Medical Officer of SomaLogic, the company that developed the new protein measurement technology used collaboratively with the UCSF investigators in the JAMA study. “Our approach uniquely allows us to measure thousands of proteins accurately in each patient sample, which provided the basis for identifying the specific proteins that are important for predicting cardiovascular risk.”

This study also marks a significant advance for “personalized” or “precision” medicine. As noted in an accompanying editorial written by Dr. Marc Sabatine of Brigham and Women’s Hospital in Boston, “the quest for personalized medicine is an important one, and the work by Ganz et al. is a welcome step in that direction.” The study’s findings suggest that – at least for some diseases – a protein-based discovery program that does not depend on pre-existing knowledge of pathophysiology can lead to a more personalized risk assessment than any other evaluations available, including those based on genetic findings.

“This has been a particularly gratifying example of a fruitful academic and industry scientific collaboration to pave the way to evaluating true risk across not only cardiovascular disease, but perhaps a wide range of different diseases and conditions,” said Dr. Williams. “We believe that our technology will uniquely accelerate the realization of precision medicine, and are actively engaged with many other academic and corporate partners in several disease areas where there is significant unmet medical need.”

In addition to further evaluation of the results described in the JAMA paper, there is an ongoing discovery program to identify proteins that can predict the risk of cardiovascular disease in additional patient populations, including lower-risk individuals who appear healthy but may actually be at high risk of coronary heart disease due to high cholesterol, high blood pressure, diabetes or smoking, or higher-risk individuals with kidney disease or HIV infection. There are also development efforts underway to make a test based on the findings described in the JAMA paper available through the SomaLogic CLIA laboratory by early fall of this year.

Reference: Ganz P et al. (2016). Development and Validation of a Protein-Based Risk Score for Cardiovascular Outcomes Among Patients with Stable Coronary Disease. Journal of the American Medical Association. Doi:10.1001/jama.2016.5951


SomaLogic raises up to $60.5 million from Visium Healthcare Partners to support strategic growth initiatives

SomaLogic raises up to $60.5 million from Visium Healthcare Partners to support strategic growth initiatives

3/1/2016

SomaLogic, Inc., and Visium Healthcare Partners, LP today announced that SomaLogic will receive up to $60.5 million through a combination of debt and equity financing from Visium. The proceeds will be used to support SomaLogic’s continued growth, including its primary focus on the development of novel life science tools and clinical diagnostics based on the company’s proprietary proteomics technology. Specific terms of the agreement were not disclosed.

“We are very pleased to partner with Visium Healthcare Partners, who have created a customized financing structure that enables us to meet our capital needs and continue to execute our strategic growth initiatives,” said Byron Hewett, Chief Executive Officer of SomaLogic. “This investment underlines their recognition of our significant potential, and gives us the opportunity to leverage their deep healthcare sector expertise during the critical next stage of SomaLogic’s development.”

“SomaLogic’s proprietary SOMAmer and SOMAscan technologies provide researchers and clinicians with a level of proteomic information that promises to revolutionize how diseases are diagnosed and treated,” said Avi Amin, MD, Partner of Visium Healthcare Partners. “We believe that SomaLogic is an incredibly compelling emerging healthcare company and expect that this investment will help accelerate the realization of their ambitious vision and vast potential.”

SomaLogic’s technology platform gives researchers and clinicians critical tools for protein biomarker discovery, diagnostics development and pharmaceutical innovation. SOMAmer reagents, which are at the center of SomaLogic’s proteomics platform, are a new class of superior protein-binding reagents that combine the best properties of both monoclonal antibodies and traditional aptamers. The SOMAscan assay, which incorporates 1,310 different SOMAmer reagents, efficiently, accurately, and rapidly measures proteins across a wide range of concentrations in small volumes of multiple biological sample types, accelerating the discovery of biomarkers across a wide range of diseases and conditions.

“We welcome Visium as a long-term financial partner supporting our rapidly expanding efforts to provide state-of-the-art, sensitive, accurate and highly multiplexed proteomics tools for both clinical and research needs,” said Larry Gold, PhD, Founder and Chairman of SomaLogic. “This infusion of growth capital provides us with the opportunity to more quickly realize our ultimate goal of delivering much-needed new diagnostics tests to the clinic.”


The University of Oxford and SomaLogic Announce wide-ranging agreement to use SOMAscan in translational research

The University of Oxford and SomaLogic Announce wide-ranging agreement to use SOMAscan in translational research

2/8/2016

The University of Oxford and SomaLogic announced today that they have agreed to undertake a number of collaborative projects that will employ SomaLogic’s proprietary SOMAmer reagents and SOMAscan assay technologies to discover and characterize protein biomarkers for a range of clinical diseases and conditions. In order to maximize the collaborative nature of these projects and accelerate the translation of discoveries into clinical testing, the agreement also includes the build-out of a SOMAscan assay service laboratory at Oxford under the direction of SomaLogic personnel.

“We welcome SomaLogic to Oxford, one of Europe’s largest centers for biotechnology research,” said Simon Lovestone, Professor of Translational Neuroscience. “This agreement is a model for how we can bring together the best of industry, academia and the National Health Service to improve healthcare outcomes for patients in the UK and beyond. SomaLogic will benefit from access to Oxford’s world-leading research to develop and refine its products, while we will benefit from access to technology that can enhance what we do.”

“We are excited to closely join our proteomics technologies and knowledge with the biomedical expertise of Oxford’s world-class researchers,” said Byron Hewett, CEO of SomaLogic. “The massive data that will be generated from this agreement should rapidly lead to new applications of our technologies to the clinical diagnosis and management for many diseases and conditions.”

Compared to other current proteomic technologies, SomaLogic’s platform gives researchers unprecedented power for protein biomarker discovery, diagnostics development, and pharmaceutical innovation. SOMAmer reagents, which are at the center of SomaLogic’s proteomics platform, are a new class of superior protein-binding reagents that combine the best properties of both monoclonal antibodies and traditional aptamers. The SOMAscan assay, which incorporates 1,310 different SOMAmer reagents, efficiently, accurately and rapidly measures proteins across a wide range of concentrations in small volumes of multiple biological sample types, accelerating the discovery of biomarkers across a wide range of diseases and conditions.

Oxford is well placed to exploit the wealth of information generated by the SOMAscan technology. The agreement comes as Oxford completes work on its Big Data Institute, which will focus on the analysis of large data sets in an effort to improve detection, treatment and prevention of a range of conditions, adding to work in the existing Target Discovery Institute, which looks for potential new targets for treatments. Overall, the university’s medical research ranges from initial lab work to clinical application in hospitals and health centers, with centers of excellence investigating a range of conditions from cancer and Alzheimer’s to rare tropical diseases. Much of that research can benefit from further proteomics support.

About Medical Sciences at Oxford University
Oxford University’s Medical Sciences Division is one of the largest biomedical research centers in Europe, with over 2,500 people involved in research and more than 2,800 students. From the genetic and molecular basis of disease to the latest advances in neuroscience, Oxford is at the forefront of medical research. The university is rated the best in the world for medicine and life sciences, and it is home to the UK’s top-ranked medical school. It has one of the largest clinical trial portfolios in the UK and great expertise in taking discoveries from the lab into the clinic. Partnerships with the local NHS Trusts enable patients to benefit from close links between medical research and healthcare delivery. More information at www.ox.ac.uk/research

About SomaLogic
SomaLogic, Inc., is a privately held biomarker discovery and clinical diagnostics company based in Boulder, Colo. The company’s mission is to use its proprietary modified aptamer-based proteomic technologies to develop a wide range of enhanced protein-analysis tools and reagents for the life sciences community; to facilitate biomarker discovery and validation for diagnostic and therapeutic applications; and to develop and commercialize clinical diagnostic products that will improve the delivery of health care by offering timely and accurate diagnostic information to physicians and their patients. Further information about SomaLogic can be found at www.somalogic.wpengine.com


Matthew (“Matt”) Norkunas, M.D., announced as new SomaLogic CFO

Matthew (“Matt”) Norkunas, M.D., announced as new SomaLogic CFO

2/8/2016

SomaLogic, Inc., announced today that Matthew (“Matt”) Norkunas, M.D., joined the company as Chief Financial Officer (CFO).

“We are excited that Matt has agreed to join us during this critical growth period for SomaLogic,” said Byron Hewett, Chief Executive Officer. “His unique combination of experience and knowledge matches up well with our needs as we continue our transition from a start-up company to a successful business organization.”

“I look forward to working with the amazing SomaLogic team to realize the full potential of their R&D work over the past 15 years,” said Dr. Norkunas. “Their powerful technology should transform many areas of the life sciences and healthcare, and I am excited to help lead those efforts.“

Prior to SomaLogic, Dr. Norkunas was a Senior Research Analyst at Marsico Capital Management in Denver, focused on biotech, pharma, life sciences, and diagnostics companies. While at Marsico, he valuated companies at both the private and public level, spearheading firm participation in a number of capital market transactions for companies in the space, including secondary equity, IPO, crossover and debt financings.

In addition to his experience in the venture capital industry, Dr. Norkunas is a board-certified anesthesiologist. During his medical career he also served three years as the Vice President of New Business Development for AABP, a private physician group in New York City that grew rapidly under his business development leadership, including the foundation of a new regional anesthesia program. Dr. Norkunas actively participated in various clinical trials during these years, authored scientific publications and presentations and developed two patents (pending) for medical devices. He received his anesthesia training at Mount Sinai in New York, and earned his M.D. from the University of Maryland Medical School, his M.B.A. from Columbia University, and his B.A. in Biology from St. Mary’s College of Maryland.


SomaLogic completes agreement with Bristol-Myers Squibb for expanded access to SOMAmer reagents

SomaLogic completes agreement with Bristol-Myers Squibb for expanded access to SOMAmer reagents

1/11/2016

SomaLogic, Inc., announced today that it signed an agreement with the Bristol-Myers Squibb Company (NYSE-BMY) to provide expanded access to its proprietary SOMAmer reagents. The agreement covers both the 1,310 reagents available in the current public version of the SOMAscan assay, as well as custom SOMAmer reagents developed through SomaLogic’s SOMAmer Discovery Service specifically for Bristol-Myers Squibb. Specific terms of the agreement were not disclosed.

“We’re excited that Bristol-Myers Squibb has selected our SOMAmer reagents as tools for their drug discovery and development research,” said Byron Hewett, Chief Executive Officer of SomaLogic. “We look forward to a long and productive relationship between their scientists and ours as we work with them to integrate our technology into their research.”

SOMAmer (Slow Off-rate Modified Aptamer) reagents are a new generation of protein-binding molecules that combine the best properties of antibodies and traditional aptamers. Each SOMAmer reagent consists of a unique, short single-stranded DNA sequence that incorporates several bases that have been modified to include “protein-like” side chains. These unique chemical properties confer on SOMAmer reagents both high affinity and specificity for their target proteins as well as high durability and reproducibility, making them attractive reagents for virtually every laboratory assay that currently relies on antibodies.

To date, SomaLogic has developed thousands of SOMAmer reagents to a broad array of different proteins critical to normal and disease biology, and it continues to expand its publicly available SOMAmer reagent library at regular intervals. SomaLogic currently offers individual research users access to several hundred of its individual SOMAmer reagents, as well as the discovery of “fit-for-purpose” custom SOMAmer reagents through its SOMAmer Discovery Service.


SomaLogic and Otsuka scientists publish paper describing therapeutic potential of novel SOMAmer reagent for rheumatoid arthritis

SomaLogic and Otsuka scientists publish paper describing therapeutic potential of novel SOMAmer reagent for rheumatoid arthritis

12/7/2015

In a “Fast Track” article published in the journal Nucleic Acid Therapeutics*, researchers from SomaLogic and Otsuka Pharmaceutical describe a series of studies that demonstrate that treatment with a novel Slow Off-rate Modified Aptamer (SOMAmer) molecule can significantly delay the onset and reduce the severity of rheumatoid arthritis (RA) in a cynomolgus monkey model of the disease. The SOMAmer molecule used in these studies, named SL1026, was initially selected for its ability to directly bind and block the signaling of the critical inflammatory protein interleukin-6 (IL-6), which is known to be involved in RA onset and progression.

“SL1026 represents a new class of drug candidates for the treatment of diseases where interleukin-6 plays a central role, including cancer and other inflammatory diseases in addition to RA,” said Nebojsa Janjic, Chief Science Officer at SomaLogic. “These initial studies reinforce and extend the large potential of SOMAmer molecules as therapeutic agents.”

The researchers tested SL1026 in a total of 24 cynomolgus monkeys. Pharmacokinetic studies of the molecule in 12 monkeys across a range of doses established the dosing regimen for determining its effects on rheumatoid arthritis onset and progression in the other 12 animals. The complete results are available in the Nucleic Acid Therapeutics manuscript, which is available to all readers under an “open access” license.

“Our collaboration with Otsuka researchers over the past several years has been incredibly productive and gratifying,” said Byron Hewett, Chief Executive Officer at SomaLogic. “Its world-class expertise in drug development has made it a terrific partner for exploring the promise of our rapidly growing SOMAmer reagent library for addressing critical unmet need for novel therapeutics. We believe that the RA work is just the first of what will be many successful studies.”

Although there is no cure for RA, there are several treatment options for trying to manage the disease. Notable among these is the biological agent Actemra® (tocilizumab, Genentech), an antibody based drug that binds the IL-6 receptor protein, thus preventing IL-6 signaling through its receptor. Because it is based on nucleic acids rather than amino acids, SL1026 offers certain advantages over antibody-based drugs such as tocilizumab, including the lack of an immune response to the drug itself (as demonstrated in the published manuscript), and a more consistent chemical rather than biological synthesis method.

SomaLogic scientists can select SOMAmer reagents that specifically bind virtually any protein of interest, including those that are known to be important drug targets across a wide range of diseases and conditions.

*Hirota M. et al. (2015). Chemically Modified Interleukin-6 Aptamer Inhibits Development of Collagen-Induced Arthritis in Cynomolgus Monkeys. Nucleic Acid Therapeutics DOI: 10.1089/nat.2015.0567.