Nov 11, 2021
Funding Will Support Groundbreaking Development of Sepsis Endotypes Test
Burlingame, Calif., November 11, 2021 — Inflammatix, a pioneering molecular diagnostics company, announced today that the National Institute of General Medical Sciences, part of the National Institutes of Health, has awarded the company a Small Business Innovation Research (NIH SBIR)Direct-to-Phase IIgrantof $1.7 million. The funding will be used to develop a rapid diagnostic that will identify immune subtypes (“endotypes”) of sepsis to enable better therapy selection and resource allocation.
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host immune response to infection. While over 100 clinical trials have been conducted attempting to modulate the immune response to sepsis, there have been no successful approvals of immunomodulatory therapies. Before COVID-19, sepsis claimed approximately 270,000 lives each year in the U.S. and was estimated to be responsible for 20 percent of all deaths worldwide. Severe COVID-19 is also a form of sepsis.
“In sepsis, the body’s immune system becomes dysregulated and starts to damage the patient directly. For decades, physicians have hoped that modulating the immune response to sepsis would improve outcomes, but this hasn’t yet come to pass. We believe that patients with sepsis are too variable for a ‘one-size-fits-all’ approach to therapy and have shown that identifying immune subtypes of sepsis may allow for a precision approach to treatment,” said Inflammatix CEO and Co-Founder Tim Sweeney, MD, PhD.
He continued, “Fifty years ago, cancer was known primarily by anatomy: breast, skin, blood. The advancement of precision medicine has brought an understanding of each cancer’s unique molecular profile, which has unlocked revolutionary therapies and driven improvements in survival. We believe that critical illness, and sepsis in particular, can benefit from the same approach. We are grateful for the support from the NIH for our novel approach, which may allow the medical community to identify improved treatment regimens, leading to the discovery of new targets or pathways for endotype-specific therapies and/or the repurposing of available drugs. Our ultimate goal is to definitively link a patient sepsis subtype with a therapeutic intervention, to make a meaningful improvement in the treatment of sepsis globally.”
The company’s work has identified three unique sepsis subtypes (“endotypes”) using host immune mRNA signatures, and these endotypes may be differentially responsive to therapy. The NIH funding will enable further development of the endotypes signature and development of a rapid, 30-minute test on the company’s proprietary point-of-care system. Further work will identify existing or new therapeutics that match to the endotypes for clinical study. The company is actively working with therapeutics partners on this approach.
The Inflammatix approach – known as host-response diagnostics – rapidly reads the immune system using multiple mRNA biomarkers and a machine learning algorithm. The company is developing other host-response diagnostic tests that identify the presence and type of infection (viral or bacterial) and predict the risk of severe disease, which could enable physicians to make more informed decisions for patients with acute infection and sepsis. All tests will run on the company’s cartridge-based, point-of-care system in under 30 minutes.
About Inflammatix
Inflammatix is a molecular diagnostics company that is reimagining diagnostics by reading the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Future tests will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, CA-based company is funded by leading medical technology investors including Khosla Ventures, Northpond Ventures, D1 Capital Partners, Think.Health Ventures, and others. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).
Contacts
Michelle McAdam, Chronic Communications, Inc.
[email protected]
310.902.1274
Mar 16, 2021
Burlingame, Calif., March 16, 2021 — Inflammatix, a pioneering molecular diagnostics company, announced today the closing of a $102 million Series D round of financing to support development and commercialization of its novel immune response diagnostics portfolio. D1 Capital Partners led the round, with participation from the company’s existing investors, including Northpond Ventures, Khosla Ventures, Think.Health, and OSF Healthcare Ventures.
“We are thrilled to welcome D1 Capital Partners to our strong investor syndicate, and look forward to bringing host response diagnostics to market”
Sepsis caused more than five million deaths annually worldwide before the COVID-19 pandemic, and severe COVID-19 has been recognized as viral sepsis. In addition, antibiotic resistance is directly responsible for more than 700,000 deaths annually worldwide. Traditional methods for diagnosing acute infections are slow and are often inaccurate because they only look for pathogens in the bloodstream, despite the fact that most infections never enter the bloodstream. As a result, patients with suspected infection are often inappropriately treated with antibiotics, contributing to antibiotic resistance. Sepsis is often missed altogether.
Inflammatix’s diagnostics rapidly read the patient’s immune response to infections across multiple mRNA biomarkers using machine learning algorithms. The company’s tests can identify the presence and type of infection (viral or bacterial), and the risk of severe disease, including severe COVID-19, to enable physicians to make more informed decisions. The tests are designed to be run on the company’s sample-to-answer, cartridge-based, point-of-care Myrna™ test system, which produces results in under 30 minutes.
The funds will enable regulatory clearance and global commercialization of the Myrna system, and the InSep™ acute infection and sepsis test, which is designed to enable improved triage and decision-making in the emergency department and other acute care settings. Funds will also support continued development of the company’s pipeline of diagnostic tests, including the ViraBac EZ™ acute infection test. Virabac EZ is designed to be run from a simple fingerstick to identify whether a suspected infection is bacterial or viral, helping physicians in primary care, urgent care, and other outpatient clinical settings to determine when to prescribe antibiotics.
“We are enthusiastic about the transformative potential of Inflammatix’s host response diagnostic approach to significantly improve two major issues in healthcare today: the inefficient, and often inaccurate, diagnosis of infection and sepsis, and the over-prescription of antibiotics,” said James Rogers, Analyst at D1 Capital Partners. “We are delighted to lead this round and look forward to the upcoming commercialization of the first of these novel tests, and to playing a role in the continued development of additional indications for this unique diagnostics approach.”
“We are thrilled to welcome D1 Capital Partners to our strong investor syndicate, and look forward to bringing host response diagnostics to market,” said Inflammatix CEO and Co-Founder Tim Sweeney, M.D., Ph.D. “By quickly providing actionable information about disease, Inflammatix expects to equip physicians to make better clinical decisions that benefit both patients and healthcare systems.”
About Inflammatix
Inflammatix is a molecular diagnostics company that is reimagining diagnostics by reading the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform, Myrna, in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, D1 Capital Partners, Think.Health Ventures, the Stanford StartX Fund, and OSF Ventures.
ViraBac EZ has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00034.
About D1 Capital Partners
D1 Capital Partners is a global investment firm that operates across public and private markets. The firm combines the talent and operational excellence of a large, premier asset management firm with the flexible mandate and long-term time horizon of a family office. Founded in 2018 by Daniel Sundheim, D1 focuses on investing in the global internet, technology, telecom, media, consumer, healthcare, financial, industrial, and real estate sectors.
Contacts
Michelle McAdam, Chronic Communications, Inc.
[email protected]
310.902.1274
Mariesa Kemble
[email protected]
608.850.4745
Oct 29, 2020
Second Tranche of BARDA Funding Supports Diagnostic Designed to Read Immune System and Rapidly Diagnose Acute Infection at Point of Care
Burlingame, Calif., October 29, 2020 — Inflammatix a pioneering molecular diagnostics company, announced today a contract extension of $7.4 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, to further develop its point-of-care test and system to diagnose infection by reading the immune system. The contract is part of a BARDA contract worth up to $72 million, if all options are exercised.
The new funding will support continued development and commercialization of Inflammatix’s sample-to-answer, point-of-care MyrnaTM test system, which is designed to read RNA using machine learning and produce results in under 30 minutes, as well as continued development of the ViraBac EZTM test (formerly known as HostDx Fever), which reads gene expression patterns in the immune system to identify whether a suspected infection is bacterial or viral, enabling physicians to quickly and accurately determine when to prescribe antibiotics. The test will use a fingerstick collection and capillary blood sample, and is designed for use in primary care, urgent care and other outpatient clinical settings.
One of the biggest threats to global health today is antibiotic resistance. Increasing and incorrect antibiotic use leads to antibiotic-resistant bacteria that become more difficult and costly to treat, and more deadly. Today, an estimated 30 percent of antibiotics are inappropriately prescribed to patients because their infections are not obviously bacterial or viral in origin.1 In addition, almost three million Americans each year become infected with bacteria that are resistant to antibiotics, with more than 35,000 dying as a direct result.2 New diagnostic methods that can help better direct antibiotics to only those patients that need them will be an important element in combatting antibiotic resistance, ensuring that proven therapies can continue to fight disease and save lives.
“We are pleased to continue to partner with BARDA in the development of our ViraBac EZ test and Myrna instrument. Enabling physicians to make more informed decisions about which patients need antibiotics and which can avoid them has the potential to transform patient care at the point of care,” said Tim Sweeney, M.D., Ph.D., co-founder and chief executive officer of Inflammatix.
“In the physician’s office, current methods for diagnosing infections are slow, produce inconsistent results, and/or do not provide the information we need to confidently prescribe treatment,” said David Lin, MD, family medicine specialist with Sutter Health, Sacramento, California. “Having a test that allows us to quickly make more informed decisions about which patients are infected and could benefit from antibiotics would have a meaningful impact on patient care.”
About Inflammatix
Inflammatix is a molecular diagnostics company that is reimagining diagnostics by reading the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, the Stanford StartX Fund, Think.Health Ventures, and OSF Ventures. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00034.
References
- Hersh AL, King LM, Shapiro DJ, Hicks LA, Fleming-Dutra KE. Unnecessary antibiotic prescribing in US ambulatory care settings, 2010-2015. Clin Infect Dis. 2020; ciaa667, org/10.1093/cid/ciaa667.
- Antibiotic/Antimicrobial Resistance. U.S. Centers for Disease Control and Prevention website. Updated July 20, 2020. Accessed October 7, 2020. https://www.cdc.gov/drugresistance/index.html.
Media Contacts
For Inflammatix:
Mariesa Kemble
[email protected]
608.850.4745
Sep 29, 2020
New Data Shows Inflammatix Machine Learning-Based Approach of Reading Immune System is Superior to IL-6 and Other Measures in Predicting Patients at High Risk for Severe COVID-19
Burlingame, Calif., September 29, 2020 — Inflammatix a pioneering molecular diagnostics company, announced today that the Defense Advanced Research Projects Agency (DARPA) has awarded the company up to $1.1 million for further development of a rapid diagnostic that reads the immune system to predict severe respiratory failure risk in COVID-19 patients. The diagnostic is being developed to help physicians make better hospital admission and resourcing decisions for COVID-19 patients at hospital presentation.
The Inflammatix approach – known as host-response diagnostics – rapidly reads the immune system using multiple mRNA biomarkers and a machine learning algorithm. The company is developing other host-response diagnostic tests that identify the presence and type of infection (viral or bacterial), in addition to predicting the risk of severe disease, to enable physicians to make more informed decisions for patients with acute infection and sepsis.
“We are grateful that DARPA has recognized the promise of our host-response approach to benefit COVID-19 patients and caregivers, and we look forward to accelerating development and availability of our CoVerityTM COVID-19 Severity Test as a result of this agreement,” said Inflammatix CEO and Cofounder Tim Sweeney, MD, PhD. “The 5-mRNA classifier for CoVerity was developed on a training set of more than 20 clinical studies and we intend to translate it into a rapid assay that can be used as a clinical tool to help triage patients after diagnosis with COVID-19. Improved triage has the potential to reduce morbidity and mortality while enabling hospitals to allocate resources more effectively.”
The company’s host-response diagnostic approach for predicting COVID-19 severity risk was shown to be superior to clinical biomarkers, including IL-6, in a new study presented last week at the 2020 European Society of Clinical Microbiology and Infection Diseases (ESCMID) Conference on Coronavirus Disease (ECCVID).
“While major progress has been made in developing rapid platforms to diagnose SARS-CoV-2 infection, predicting severity in COVID-19 patients remains an unmet medical need,” said Evangelos J. Giamarellos-Bourboulis, MD, Professor of Internal Medicine and Infectious Diseases at ATTIKON University General Hospital in Athens, Greece, Chairman of the European Sepsis Alliance, President of the European Shock Society, and lead investigator for the study. “In this study, the host-response approach demonstrated very high accuracy for identifying severe disease in COVID-19 patients and outperformed clinical markers for risk stratification. Existing tools have shown limited accuracy in enabling us to confidently identify high-risk patients early who need close monitoring or discharge non-severe patients to recover at home.”
In this prospective study of 97 patients with PCR-confirmed SARS-CoV-2 pneumonia and blood drawn on the day of admission at ATTIKON University General Hospital in Athens, Greece, CoVerity demonstrated an area under the receiver operating characteristic curve (AUROC) of 0.88 (95% CI 0.81-0.95) for identifying patients who developed respiratory failure or died, independent of age, while IL-6 had an AUROC of 0.73 (95% CI 0.62 – 0.85). The new classifier had the highest accuracy among all single biomarkers tested, including IL-6, procalcitonin, C-reactive protein, lactate, and SuPAR.
This agreement is part of DARPA’s efforts to develop platform technologies that can be deployed safely and rapidly to provide the U.S. population with near-immediate protection against emerging infectious diseases and engineered biological weapons, even in cases when the pathogen or infectious agent is unknown.
About Inflammatix
Inflammatix is a molecular diagnostics company that is reimagining diagnostics by reading the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Future tests will be developed to run on the company’s sample-to-answer isothermal instrument platform, MyrnaTM, in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company is funded by leading medical technology investors including Khosla Ventures, Northpond Ventures, the Stanford StartX Fund, Think.Health Ventures and OSF Ventures. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).
Media Contacts
For Inflammatix:
Mariesa Kemble
[email protected]
608.850.4745
Apr 29, 2020
Model Demonstrated Cost Effectiveness in Test Use on Patients Suspected of Acute Respiratory Tract Infections in American Emergency Department Setting
Burlingame, Calif., April 29, 2020 — Inflammatix, a pioneering molecular diagnostics company delivering precision medicine at the point of care, announced the publication of a health economic model that shows use of the company’s HostDxTM Sepsis test in patients suspected of acute respiratory tract infections (ARTI) in Emergency Departments is cost-effective versus standard-of-care. The study was published today in The Journal of Health Economics and Outcomes Research. The model informs hospital clinicians of the potential clinical and economic benefits of widespread adoption of the HostDx Sepsis test.
“Despite best intentions, current practices for evaluating patients suspected for acute respiratory tract infections are insufficient. Many patients without bacterial infections are overtreated with unnecessary antibiotics and extended hospital stays, while some patients with infections are missed, leading to dire clinical outcomes. This study shows that Inflammatix’s HostDx Sepsis test for the diagnosis of acute infections and sepsis could allow for improved patient outcomes and substantial health system savings” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix.
The publication described a cost impact model comparing the cost of standard of care versus the use of HostDx Sepsis in two hypothetical arms with 1000 patients presenting with symptoms of ARTI in the Emergency Department of an average US hospital. Compared to standard of care, on average, the HostDx Sepsis test arm showed a 0.80 day reduction in hospital ward length of stay (a 36.7% decrease), 1.49 reduction in days of antibiotic treatment (a 29.5% decrease), and a 1.67% decrease in 30-day mortality rate (a 13.64% decrease). Average cost savings were estimated at $1,974 per patient tested and nearly $2 million for the 1000-patient cohort (before considering the price of the HostDx Sepsis test, which has not yet been established).
For each scenario, standard of care and HostDx Sepsis, costs of treatment, hospitalizations, medications and outpatient visits were considered. HostDx Sepsis produces three scores for each patient: the likelihood of a bacterial infection; the likelihood of a viral infection; and risk stratification score. The HostDx Sepsis arm assumed the application of the test’s performance previously published in prospective clinical validation studies in the journals Science Translational Medicine1 and Nature Communications2,3. These included area under the receiver operating curve (AUROC) of 0.85 for the detection of a bacterial infection, 0.90 for the detection of a viral infection and 0.88 for predicting 30-day mortality (risk stratification).
“The ability to interrogate and understand how the immune system reacts to infection is more important than ever given the current COVID-19 pandemic. Whether it’s COVID-19, influenza, or bacterial infections, physicians need the ability to rapidly identify the presence, type, and severity of infection in a timely manner. Tests with robust performance characteristics that are generalizable are key to improving outcomes and reducing healthcare costs,” continued Sweeney.
Sepsis leads to 270,000 deaths4 in the US and $27B in Medicare costs5 annually. Inflammatix’s HostDx Sepsis test uses proprietary machine learning algorithms that incorporate the expression of multiple immune genes (host response) to identify the presence of bacterial or viral infections and to determine if a patient has or is likely to develop sepsis. Inflammatix’s simple-to-use, sample-to-answer HostDx system is designed to produce results at or near the point of care in 30 minutes or less. The company plans to advance its HostDx tests through commercial launch in Europe and submission to the United States Food and Drug Administration in 2021.
In January 2020, Inflammatix announced it had received $32 million in Series C financing. Prior to that, in November 2019, the company announced a cost-sharing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, to further develop its HostDx tests. The agreement is worth up to $72 million based on achieving certain milestones.*
Citation
Schneider JE, Romanowsky J, Schuetz P, Stojanovic I, Cheng HK, Liesenfeld O, et al. Cost impact model of a novel multi-mRNA host response assay for diagnosis and risk assessment of acute respiratory tract infections and sepsis in the emergency department. JHEOR. 2020;7(1):24-34. doi:10.36469/jheor.2020.12637
About Inflammatix
Inflammatix is a molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infection and sepsis, where its HostDx™ tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, Grey Sky Venture Partners and the Stanford-StartX Fund. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).
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Media Contact:
Jonathan Romanowsky
[email protected]
(650) 219-2141
Apr 16, 2020
Burlingame, Calif., April 16, 2020 — Inflammatix, a pioneering molecular diagnostics company delivering precision medicine at the point of care, today announced the appointment of João Fonseca, Ph.D., as Chief Technology Officer. Dr. Fonseca will oversee Inflammatix’s molecular assay development and engineering teams as the company advances its rapid tests for acute infections, sepsis, and COVID-19 risk stratification.
“João is an exceptional scientist and executive with a successful track record for building breakthrough diagnostics products, particularly at the point of care,” said Tim Sweeney, Ph.D., cofounder and chief executive officer of Inflammatix. “He will play a critical role in bringing our novel tests to the clinic where they will help physicians take the guesswork out of determining which patients with infections need antibiotics, as well as which are likely to have or develop sepsis. He will also oversee our COVID-19 product development portfolio.”
Dr. Fonseca comes to Inflammatix with extensive credentials in science and medical technology. Since 2006, he has served as founder, CEO and chief scientific officer of biosurfit, a Lisbon, Portugal-based company whose blood tests utilize proprietary technology to diagnose multiple conditions at the point of care. The company’s tests are broadly available throughout Europe. Prior to biosurfit, Dr. Fonseca was a professor in physics and experimental physics at the Technical University of Lisbon and a researcher at the University of Lisbon. He also founded a non-profit organization that works with patients and researchers to advance novel cancer treatments and research. Dr. Fonseca has authored multiple publications in top peer-reviewed journals, is the author of 22 patents and has received numerous awards, including “Entrepreneur of the Year” by the Portuguese Young Entrepreneur Association.
“I’m excited to join Inflammatix in their mission of harnessing the immune system to tackle some of the world’s most pressing public health challenges, including antibiotic resistance and sepsis,” said Dr. Fonseca. “I look forward to helping the company deliver its rapid molecular tests into hospitals and clinics where they can benefit patients and to helping the company build a robust pipeline in additional clinical indications.”
About Inflammatix
Inflammatix is a molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infection and sepsis, where its HostDx™ tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, Grey Sky Venture Partners and the Stanford-StartX Fund. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).
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Media Contact:
Jonathan Romanowsky
[email protected]
(650) 219-2141
