LinusBio Raises $16 Million to Scale Growth and Deliver Tangible Outcomes

The company set to unveil an early autism and ALS detection and treatment platform

New York City – January 13, 2023 – LinusBio, a leader in precision exposome sequencing, today announced it raised over $16 million in Series A funding to deliver a novel platform that bridges genomics, the environment, and biological response.

Historically, many health conditions, such as autism spectrum disorder, have lacked biological tests to aid in diagnosis, monitor progression, or serve as objective endpoints in clinical trials. LinusBio’s proprietary platform introduces precision exposome biomarkers that can facilitate discovery across these domains.

The technology has the potential to fundamentally transform how complex disorders are diagnosed and treated – from autism to gastrointestinal disorders to amyotrophic lateral sclerosis (ALS) to renal disease and cancers.

Furthermore, the LinusBio platform can substantially improve clinical trials by providing data equal to over 500 liquid biopsies or blood samples, but all from a single strand of hair. It is the first technology platform that maps the molecular dynamics of human physiology in a time-dependent manner. The platform can help identify novel compounds for health conditions where genomic biomarkers have previously had limited success. The company is already using this platform in two pharma-sponsored trials and is in the process of partnering with several organizations within the healthcare and pharma ecosystem.

LinusBio Lab
LinusBio’s technology examines human physiology at the molecular level through a strand of hair, leveraging proprietary laser and robotics technology.

The company’s initial focus is on neurological disorders. One of the company’s early technologies, StrandDx™-ASD, can assess the likelihood of autism at birth with 80% to 90% accuracy, and assist with personalized treatment decisions.

As a result, LinusBio’ early autism diagnostic aid has been granted an FDA Breakthrough Designation, reserved for innovations that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” The solution has received CE Mark designation in the European Union as a diagnostic aid.

Early detection is critical for those on the autism spectrum. In fact, the National Institutes of Health found that some children that are diagnosed and treated early make substantial progress.

Dr. Manish Arora, Co-Founder and CEO, LinusBio

“Our mission is simple: to deliver better outcomes for people and families affected by complex health conditions,” said Manish Arora, PhD., Co-Founder and CEO of LinusBio. “We chose to focus on autism first for many considerations, an important one of them is the dramatically different trajectory in cases of an early detection and effective intervention. The impact on the patient and the patient’s family can be substantial. We’re proud to launch the LinusBio platform to meet the tremendous need for better, faster, and comprehensive diagnostics and treatments for a range of conditions and diseases.”

The company’s program pipeline also comprises advanced biomarkers for ALS, oncology (including pediatric cancer), gastroenterology (inflammatory bowel disease) and mental disorders (psychosis & schizophrenia).  

The round was led by GreatPoint Ventures and Bow Capital. Other investors included Divergent Investments, Nicole Shanahan (President, Bia-Echo Foundation), the David Bellet Family Office, Gillian Sandler, and Sanford Robertson (Co-Founder of Francisco Partners and former board member of Salesforce), among others.

“Every day, every week, every month that certain diseases fester undetected and untreated impacts a patient’s long-term outlook,” said Ashok Krishnamurthi, Managing Partner, GreatPoint Ventures. “We’re looking forward to working with LinusBio to scale their solutions and bring them to market to meet vital needs.”

“Our mission is to help shorten the path of innovation from science to society,” said Rafi Syed, General Partner, Bow Capital. “We’re proud to collaborate with LinusBio, which has great potential to transform the implications of complex diseases.”

LinusBio’s technology examines human physiology at the molecular level through a strand of hair. Leveraging proprietary laser and robotics technology, LinusBio analyzes these strands and collects thousands of data points to measure individuals’ biological response to their lifespan environmental exposures. LinusBio is the first technology platform that maps the molecular dynamics of human physiology in a time-dependent manner.

“This technology is very exciting for those impacted by autism and many other conditions, as well as their families,” said Amol Deshpande, Founder of Divergent Investments, and the CEO and Co-Founder of Farmers Business Network. “LinusBio has the opportunity to fundamentally transform the healthcare industry.”

Arora, the CEO of LinusBio, is an environmental epidemiologist and exposure biologist. He is a recipient of a Presidential PECASE award from the White House, the highest civilian award given to early career scientists. Drs. Christine Austin, PhD., and Paul Curtin, PhD., also co-founded the company and serve on the leadership team.

The funding will be used to grow the LinusBio team, deliver more positive outcomes across more health conditions, and develop a world-class platform that will serve as a central hub for diagnostics and treatment.

About LinusBio

LinusBio (Linus Biotechnology Inc.) is a patient-centric, breakthrough science precision exposome medicine company headquartered in New York, NY. The Company’s program pipeline comprises precision exposome medicine biomarkers and target discovery across disease domains for which historically no molecular endpoints have been available in medical practice or for clinical trials, including CNS (autism spectrum disorder, amyotrophic lateral sclerosis), gastroenterology (inflammatory bowel disease), renal disease and oncology. For more information, visit www.linusbio.com.

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For media inquiries: press@linusbio.com

Novozymes and LinusBio announce collaboration to accelerate scientific discovery in Biohealth


Novozymes, the world leader in biological solutions, and LinusBio (Linus Biotechnology Inc.), a leader in precision exposome sequencing, today announced the companies are forming a collaboration to test a new, non-invasive technology in a clinical trial. The project will apply LinusBio’s environmental biodynamics platform, enabling detailed temporal mapping of harmful compound exposure, to a clinical trial of probiotics sponsored by Novozymes’ human health unit, Novozymes OneHealth. The clinical trial will assess exposure to heavy metals, such as lead, and a broad range of environmental pollutants, and is part of a larger clinical program from Novozymes OneHealth.

As part of the project, LinusBio will conduct a comprehensive study examining lead and other harmful chemical levels. Utilizing a single strand of hair, LinusBio’s proprietary exposome and biological response sequencing platform can generate data similar to several hundred liquid biopsies and reconstruct the subjects’ exposure to environmental toxicants over time. The study will be conducted in Mexico, where environmental lead exposure remains a significant public health issue1. Lead exposure is also prevalent in many other countries where lead was previously used in gasoline, household paint, water pipes and other products2.

According to the World Health Organization, lead is now known to produce a spectrum of injuries across multiple body systems3. Lead can affect children’s brain development, resulting in reduced intelligence quotient (IQ), behavioral changes and reduced educational attainment. The neurological and behavioral effects of lead are believed to be irreversible. Lead exposure may also cause anemia, hypertension, renal impairment, immunotoxicity and toxicity to the reproductive organs.

“We are very excited to embark on this groundbreaking venture with Novozymes,” says Dr. Manish Arora, co-founder and CEO of LinusBio. “Lead exposure has a detrimental impact on health, especially in children. Currently, there are no effective methods to eliminate lead once it has entered the body. We are aiming, together with Novozymes, to change that. This joint project combines innovative technology and a fresh approach that can offer a major advance in solving the longstanding problem of lead exposure.”

“The collaboration with LinusBio in translating complex exposome data into biological insights and critical global health benefits will be key to advancing our leading biosolution pipeline,” says Dr. Delphine Saulnier, Health Science Lead of the Protective Health Venture at Novozymes OneHealth. “By combining this knowledge with our Data Science platform, the collaboration will give us a technical edge for pursuing new opportunities and further strengthen existing OneHealth solutions”, says Dr. Kimmo Makinen, Product Innovation Director at Novozymes OneHealth.

References:

  1. Tellez-Rojo, M. M., Bautista-Arredondo, L. F., Tamayo-Ortiz, M., Cantoral, A., Estrada-Sanchez, D., Kraiem, R., Pantic, I., Romero, M., Fuller, R., & Trejo-Valdivia, B. (2020, October). First National Report of Blood Lead Levels in Mexican Children: An Analysis to Inform Public Health Actions and Policy. In ISEE Conference Abstracts (Vol. 2020, No. 1).
  • Rees, N., & Fuller, R. (2020). The toxic truth: children’s exposure to lead pollution undermines a generation of future potential. UNICEF.

About Novozymes
Novozymes is the world leader in biological solutions. Together with customers, partners, and the global community, we improve industrial performance while preserving the planet’s resources and helping build better lives. As the world’s largest provider of enzyme and microbial technologies, our bioinnovation enables higher agricultural yields, low-temperature washing, energy-efficient production, renewable fuel, and many other benefits that we rely on today and in the future. We call it Rethink Tomorrow. www.novozymes.com

About Novozymes OneHealth
Novozymes has established Novozymes OneHealth to market solutions within human health under one umbrella. The aim is to help people live healthier and better lives by use of probiotics and enzymes. By finding the one in a trillion solution, Novozymes OneHealth will help to solve profound consumer challenges related to modern lifestyle. www.novozymesonehealth.com

NASDAQ OMX: NZYM-B • 6,500 employees • DKK 15 billion turnover • 30+ industries • 700+ products

About LinusBio
LinusBio (Linus Biotechnology Inc.) is a patient-centric, precision exposome medicine company headquartered in New York, NY. The company’s program pipeline comprises precision exposome medicine biomarkers and target discovery across disease domains for which historically no molecular endpoints have been available in medical practice or for clinical trials, including CNS (autism spectrum disorder, amyotrophic lateral sclerosis), gastroenterology (inflammatory bowel disease), renal disease and oncology. For more information, visit www.linusbio.com.

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For media inquiries: press@linusbio.com

LinusBio Recognized at the 2022 Mount Sinai Innovation Awards


The biotech startup, that developed a novel precision exposome sequencing platform, has been selected as the winner of the Transaction of the Year award

On Monday October 24 2022, the Icahn School of Medicine at Mount Sinai hosted the 8th annual Mount Sinai Innovation Awards, celebrating numerous honors that recognize significant contributions in biomedical education and industry.

Dr. Manish Arora Speaks at the Innovation Awards ceremony. Photo by Monika Graff Contact: mg@monikagraff.com

Drs. Manish Arora, Christine Austin and Paul Curtin – co-founders of LinusBio – were presented with the Transaction of the Year award. The award recognizes a notable technology from the Mount Sinai Health System that represents a major breakthrough in research and a strong commercial partnership for advancement. LinusBio was selected for its novel approach in developing and commercializing precision exposome sequencing for complex diseases, achieving significant diagnostic and prognostic advancements. Moreover, the company was recognized for its subsequent milestones, including U.S. FDA Breakthrough Device designation for the StrandDx-ASD platform – a diagnostic aid for Autism Spectrum Disorder.

“Our mission is nothing short of transforming the manner in which complex diseases are diagnosed and treated,” said Dr. Manish Arora, co-founder and CEO at LinusBio, “Our platform offers a novel approach: we are looking beyond the genomic components of disease – an area that so far has been neglected for many health conditions. By doing so, we aim to assist families, individuals, and healthcare providers to improve and enhance health.

Right to left: Dr. Manish Arora, Dr. Christine Austin, Dr. Paul Curtin, Dr. Erik Lium. Photo by Monika Graff Contact: mg@monikagraff.com

Linus Biotechnology Inc. Receives FDA Breakthrough Device Designation for StrandDx™-ASD Exposome Sequencing Diagnostic


NEW YORK, Dec. 7, 2021 /PRNewswire/ — Linus Biotechnology Inc., a leader in precision exposome sequencing, today announced that the U.S. Food and Drug Administration Center for Devices and Radiological Health has granted the Company’s StrandDx™-ASD diagnostic aid the designation as a Breakthrough Device for Autism Spectrum Disorder (ASD).

The FDA Breakthrough Device designation aims to expedite the review of innovative technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Diagnosing ASD can be difficult because there is no FDA-approved molecular biomarker, like a blood test, to identify the disorder. Current ASD diagnosis relies on behavioral observation and it is usually diagnosed at approximately 4 years of age by an experienced professional. However, many children receive a final diagnosis at a much later age and do not receive the benefits of early intervention.

StrandDx™-ASD is based on novel molecular biomarkers developed using Linus Biotechnology’s proprietary exposome and biological response sequencing platform, utilizing a single strand of hair. According to the Breakthrough Device designation label, the intended use of StrandDx™-ASD will extend to patients from birth to 21 years, where the test will assess the likelihood of ASD in children from birth to 18 months old, and aid in diagnosis of ASD in patients aged 18 months to 21 years.

“Now for the first time in the history of medicine we have the prospect that, by studying a single strand of hair, physicians, patients, families and scientists can get the physiological equivalent of a blood-test for autism,” said Dr. Neil Kurtz, MD, physician, psychiatrist and neurologist, and an advisor and director of the Company.

“As our first precision exposome diagnostic, StrandDx™-ASD is being developed to help guide patient care for ASD, a disorder that now affects 1 in 44 children in the U.S. Molecular biomarkers, like StrandDx™-ASD, are a major step forward in precision medicine for autism and illustrate the potential to deploy individualized early intervention,” said Manish Arora, PhD, BDS, MPH, Edith J. Baerwald Professor and Vice Chair of the Department of Environmental Medicine and Public Health at the Icahn School of Medicine at Mount Sinai and co-founder and Chief Scientific Officer of the Company. “This designation is a major milestone for Linus Biotechnology Inc. We look forward to working closely with the FDA to prioritize development of StrandDx™-ASD and moving it forward toward commercialization,” added Dr. Arora.

The Precision Exposome Sequencing Platform described is based on technology developed by Dr. Manish Arora and other faculty members at the Icahn School of Medicine at Mount Sinai and licensed to Linus Biotechnology Inc. Mount Sinai and Mount Sinai researchers, including Manish Arora, have a financial interest in Linus Biotechnology Inc. 

About Linus Biotechnology Inc.

Linus Biotechnology is a patient-centric, breakthrough science precision exposome medicine company headquartered in New York, NY. The Company’s program pipeline comprises precision exposome medicine biomarkers and target discovery across disease domains for which historically no molecular endpoints have been available in medical practice or for clinical trials, including CNS (autism spectrum disorder, amyotrophic lateral sclerosis), gastroenterology (inflammatory bowel disease), renal disease and oncology. For more information, visit www.linusbio.com.

About the Mount Sinai Health System

The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. We advance medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,300 primary and specialty care physicians; 13 free-standing joint-venture centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, and Long Island; and more than 30 affiliated community health centers. The Mount Sinai Hospital is ranked in U.S. News & World Report’s “Honor Roll” of the top 20 U.S. hospitals and among the top in the nation by specialty: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Urology, and Rehabilitation. Mount Sinai Kravis Children’s Hospital is ranked in U.S. News & World Report’s “Best Children’s Hospitals” among the country’s best in four out of 10 pediatric specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked among the Top 20 nationally for ophthalmology. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report’s “Best Medical Schools,” aligned with a U.S. News & World Report “Honor Roll” Hospital, and No. 14 in the nation for National Institutes of Health funding. Newsweek‘s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and top five globally, and Mount Sinai Morningside as top 20 globally, and “The World’s Best Specialized Hospitals” ranks Mount Sinai Heart as No. 1 in New York and No. 4 globally and the Division of Gastroenterology as No. 3 globally. For more information, visit https://www.mountsinai.org or find Mount Sinai on FacebookTwitter and YouTube.

Contact: contact@linusbio.com

SOURCE Linus Biotechnology Inc.

Related Links

https://strand-dx.com/

Mount Sinai Spin-Off Linus Biotechnology Inc. to Revolutionize Precision Medicine with Exposome Sequencing


NEW YORK, Nov. 17, 2021 /PRNewswire/ — Linus Biotechnology Inc. (“LinusBio” or the “Company”) and Mount Sinai Innovation Partners (MSIP) today announced an exclusive worldwide license and collaboration agreement in progress with the Icahn School of Medicine at Mount Sinai (Icahn Mount Sinai), the medical school of the Mount Sinai Health System (Mount Sinai). LinusBio is a novel biotechnology company dedicated to developing and commercializing molecular exposome and biological-response sequencing for complex diseases for which genomic sequencing alone cannot sufficiently characterize underlying biological disease pathways.

The Company plans to develop a technology platform that will build on breakthroughs in exposome sequencing by Drs. Manish Arora, Christine Austin and Paul Curtin at Mount Sinai’s Department of Environmental Medicine and Public Health, which has been an NIH Center for the novel frontier science since 2019. LinusBio’s program pipeline comprises precision exposome medicine biomarkers and target discovery across disease domains for which historically no molecular endpoints have been available in clinical trials including CNS (autism spectrum disorder, amyotrophic lateral sclerosis), gastroenterology (inflammatory bowel disease), renal disease and oncology. Subject to regulatory approvals, the Company intends to launch its first product with StrandDx™- ASD a molecular biomarker for autism spectrum disorder that can be applied at birth.

“This work illustrates the potential for using novel exposomic technologies as diagnostic tools that can guide patient care. These tools would be a major step in precision medicine for autism and illustrates what sets Mount Sinai apart from programs that solely focus on genetics to individualize patient care.” said Robert Wright, MD, the Chair of the Department of Environmental Medicine and Public Health and Director of the Mount Sinai Institute for Exposomic Research.

“Sequencing the exposome and biological response at a molecular level using our proprietary environmental biodynamics platform is furthering our understanding of disease through a completely novel approach. LinusBio’s commercial sequencing laboratory will accelerate bringing applications to patient populations with huge unmet needs,” said Manish Arora, PhD, BDS, MPH, Edith J. Baerwald Professor and Vice Chair of the Department of Environmental Medicine and Public Health at the Icahn School of Medicine at Mount Sinai and co-founder of the Company.

“We look forward to working with LinusBio, as it aims to become a leader in precision exposome medicine and drives forward our mission to bring Mount Sinai’s innovative, patient-first discoveries to society,” said Erik Lium, PhD, President, Mount Sinai Innovation Partners and Executive Vice President and Chief Commercial Innovation Officer, Mount Sinai Health System.

The exposome sequencing technology above is based on intellectual property developed by Mount Sinai faculty and licensed to LinusBio. Mount Sinai and Mount Sinai faculty, including Drs. Arora and Curtin, have a financial interest in LinusBio.

About Mount Sinai Innovation Partners (MSIP)
MSIP is responsible for driving the real-world application and commercialization of Mount Sinai discoveries and inventions, and the development of research partnerships with industry. Our aim is to translate discoveries and inventions into health care products and services that benefit patients and society. MSIP is accountable for the full spectrum of commercialization activities required to bring Mount Sinai inventions to life. These activities include evaluating, patenting, marketing and licensing new technologies, building research collaborations and partnerships with commercial and nonprofit entities, material transfer and confidentiality, coaching innovators to advance commercially-relevant translational discoveries, and actively fostering an ecosystem of entrepreneurship within the Mount Sinai research and health system communities. For more information, visit www.ip.mountsinai.org.

About Linus Biotechnology Inc.
Linus Biotechnology is a patient-centric, breakthrough science precision exposome medicine company headquartered in New York, NY. For more information contact jan.glassner@linusbio.com.

About the Mount Sinai Health System
The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. We advance medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,300 primary and specialty care physicians; 13 free-standing joint-venture centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, and Long Island; and more than 30 affiliated community health centers. The Mount Sinai Hospital is ranked in U.S. News & World Report’s “Honor Roll” of the top 20 U.S. hospitals and among the top in the nation by specialty: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Urology, and Rehabilitation. Mount Sinai Kravis Children’s Hospital is ranked in U.S. News & World Report’s “Best Children’s Hospitals” among the country’s best in four out of 10 pediatric specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked among the Top 20 nationally for ophthalmology. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report’s “Best Medical Schools,” aligned with a U.S. News & World Report “Honor Roll” Hospital, and No. 14 in the nation for National Institutes of Health funding. Newsweek‘s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and top five globally, and Mount Sinai Morningside as top 20 globally, and “The World’s Best Specialized Hospitals” ranks Mount Sinai Heart as No. 1 in New York and No. 4 globally and the Division of Gastroenterology as No. 3 globally. For more information, visit https://www.mountsinai.org or find Mount Sinai on FacebookTwitter and YouTube.

SOURCE Linus Biotechnology Inc.

Related Links

https://strand-dx.com/