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Psychedelic Drug Shown to Relieve PTSD Brain Signals

Brain circuits

(NIH.gov)

20 Jan. 2023. A small clinical trial shows psychotherapy with the psychedelic drug MDMA generates brain signals that help relieve symptoms in people with post-traumatic stress disorder. Findings from the trial conducted by the MAPS Public Benefit Corporation appear in the 12 Jan. issue of the journal Frontiers in Psychiatry.

Post-traumatic stress disorder or PTSD is a chronic debilitating psychiatric disease marked by recurring flashbacks, dreams, and fearful episodes, often resulting from first-hand experiences with traumatic or dangerous experiences, such as military combat. When people with PTSD experience these symptoms, they often engage in behaviors to avoid triggering their fears and emotions, as well as loss of sleep, broken relationships with friends and family, and negative thoughts about themselves. PTSD is treated mainly with psychotherapy, although new drugs for the condition are also being developed.

Researchers from MAPS Public Benefit Corporation, a subsidiary of Multidisciplinary Association for Psychedelic Studies, a not-for-profit organization in San Jose, California, study the therapeutic effects of so-called mind-altering drugs for treating psychiatric disorders. One of those compounds is 3,4-methylenedioxy-methamphetamine or MDMA, more commonly known as ecstacy. MDMA is a synthetic chemical similar to stimulants, known to increase production in the brain of dopamine that increases energy and activity, and serotonin affecting mood, appetite, sleep, and hormones affecting trust and sexual arousal. MDMA also boosts norepinephrine in the brain, a chemical increasing heart rate and blood pressure, making MDMA potentially dangerous for people with heart conditions.

A team from MAPS Public Benefit Corporation, Medical University of South Carolina, and other institutions sought to learn more about the workings of MDMA in the brains of people with PTSD. The researchers cite several clinical studies showing benefits from MDMA for people with PTSD as part of their therapy. But in this study the team aims to discover more precise ways MDMA works in the brains of people with PTSD to gain those benefits. The researchers hypothesized MDMA would modify recruitment of signals in parts of the brain generating hyperactive fear responses, particularly the amygdala that regulates emotions such as fear and aggression, the hippocampus controlling memory, learning, emotion, and motivation, and insula affecting a wide range of sensory, affective, and cognitive functions.

Audio scripts with neutral and fear-arousing stories

To track these brain activities, the researchers used a technique called functional MRI, a type of magnetic resonance imaging that graphically displays blood oxygen levels in the brain in real time as an indicator of brain activity. For this clinical trial, the team recruited 10 participants in a larger clinical study testing MDMA dosage levels among participants with PTSD in psychotherapy sessions. Of the original 10 individuals, nine completed the trial, of which eight were military veterans and one civilian first-responder.

Participants were assessed for PTSD symptoms at the beginning of the study, then followed their prescribed treatments that included psychotherapy both with and without MDMA. During the sessions they heard six-minute audio scripts with neutral and fear-arousing stories during which they submitted to functional MRI brain scans, including a follow-up session after two months.

Results of the functional MRI scans show increased brain activity connecting the amygdala, hippocampus, and insula indicating better ability to process fears and emotions during the fear-arousing scripts heard by participants in MDMA-assisted psychotherapy. However, the scans show this brain activity occurring more on the left side of participants’ brains, not the entire brain. The researchers also found fewer differences between fear-arousing and neutral scripts among MDMA-assisted patients in signals to the cuneus in the brain that processes visual information. And, changes in brain signal connections among the amygdala, hippocampus, and insula in MDMA-assisted patients correlated with fewer reports of PTSD symptoms.

“These data add to our understanding of the biological rationale for using MDMA combined with therapy in the treatment of PTSD,” says MAPS Public Benefit Corporation CEO Amy Emerson in a company statement. “The results suggest that treatment with MDMA-assisted therapy may help reset the dysregulation in the brain caused by PTSD and that the effects are durable even two months after treatment.”

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Real-World Data Shown to Match Eye Disease Trial Results

Fundus photograph

Fundus photograph of a healthy right eye (OptometrusPrime, Wikimedia Commons)

19 Jan. 2023. Research findings show data in patients’ electronic health records can be collected and analyzed to replicate results from late-stage clinical trials of an eye disease biologic drug. Results of the study conducted by a team from Stanford University and life science and health analytics company Verana Health in San Francisco, appear in the 1 Jan. issue of the journal Ophthalmic Surgery, Lasers and Imaging or OSLI Retina.

Verana Health collects and analyzes real-world health data from databases the company says represent some 90 million patients generated by de-identified records from 20,000 health care providers and medical associations in ophthalmology, neurology, and urology. The company says its analytical engine uses artificial intelligence to transform structured and unstructured data in electronic records to produce curated disease-specific data modules. Verana also provides its analytical software as a service to generate real-world medical evidence, assist in clinical trials, and manage data in medical registries.

In the study, a team from Stanford and Verana Health tested a data set from de-identified health records of patients with neovascular or so-called wet age-related macular degeneration or AMD, a common eye disease among older individuals where the retina deteriorates, leading to loss of visual acuity. The retina is a layer of light-sensitive tissue in the back of the eye, where images are focused and converted to electrical impulses sent through the optic nerve to the brain. With wet AMD, abnormal growth of blood vessels occur under the retina that bleed or leak, causing distortion in the retina’s structure.

In the previous decade, a number of new treatments for wet AMD emerged that control the abnormal development of blood vessels in the eye. These new drugs block a protein called vascular endothelial growth factor or VEGF that encourages blood vessel growth. Among the new drugs authorized by FDA to control VEGF for eye diseases are aflibercept, a biologic drug marketed as Eylea by Regeneron and ranibizumab, marketed as Lucentis by Genentech. Both drugs are injected periodically into the eyes.

Health data records from eye patient registry

Regeneron tested aflibercept in two late-stage clinical trials, first among wet AMD patients in the U.S. and Canada from 2007 to 2011, and in Europe, Asia, South America, and Australia from 2008 to 2011. In both trials, participants were randomly assigned to receive aflibercept , an experimental drug at the time, or a then-current treatment ranibizumab for comparison.

The Stanford/Verana Health team drew on health data of patients in the Intelligent Research in Sight or IRIS Registry maintained by American Academy of Ophthalmology. The researchers sought records of patients receiving injections of aflibercept or ranibizumab from Jan. 2013 through Dec. 2018. From that population, the team sought to match patients in the IRIS registry to eligibility and treatment conditions in the clinical trials.

Results show of the 90,900 patients with IRIS registry records meeting the clinical trial eligibility criteria, 4,457 or about five percent also matched the treatment group requirements. Of those patients meeting both eligibility and treatment group criteria, 90 percent maintained vision after one year. And, differences among the treatment groups — those taking aflibercept monthly or bi-monthly, or ranibizumab monthly — were not large enough for statistical reliability.

Even though the percentage of registry patients meeting both eligibility and treatment criteria was only five percent of the original cohort, the authors conclude this test of real-world data generates results replicating the endpoints in the original clinical trials. Plus, Verana Health believes these real-world data can support submissions to regulatory agencies, reducing time and cost of bringing new drugs and medical devices to market.

“This was a great pilot experiment to show that this type of analysis was possible,” says Stanford University ophthalmology professor and the paper’s senior author Theodore Leng in a Verana Health statement. “The next step is to determine whether we can replicate results in other trials and develop confidence in real-world data as a foundation from which we can scale.”

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QuickDNA Tests Meet International Lab Industry Standards

– Sponsored content –

DNA illustration

(Nogas1974, Wikimedia Commons)

19 Jan. 2023. For laboratory tests with enormous consequences to their subjects, it’s vital that the labs conducting the tests meet exacting standards for quality and reliability. For that purpose, the International Organization for Standardization or ISO in 2005 devised its standard 17025 for testing and calibration laboratories, published with the International Electrotechnical Commission or IEC.

ISO/IEC 17025, revised and updated since 2005, is designed to assure users of reliability of lab test results, along with sampling and calibration services. The standards apply to labs in government agencies, universities, and not-for-profit organizations, as well as private companies. The Covid-19 pandemic revealed the high public health need for reliability in lab tests, to detect and control the SARS-CoV-2 virus.

But lab test results can have enormous personal as well as public health consequences. An example of this type of test is one for DNA parentage, to determine family connections. Results of these tests can reveal familial links from DNA, often to answer sensitive paternity questions, where results can determine financial obligations or even criminal penalties.

DNA, short for deoxyribonucleic acid, is made of two linked strands of amino acids, with the sequence of those amino acids making up an individual’s genetic code. Much of a person’s genetic code is passed down from parents, where high degrees of similarity in DNA sequences indicate family connections. Most tests use minimal or non-invasive biological speciments such as blood sample or saliva swab, although in some cases hair, gum, or used toothbrushes can be used.

The company QuickDNA offers its DNA Parentage Test to answer questions of family connections, and says its labs are certified compliant with ISO/IEC 17025 standards. The company says it returns results in 72 hours and keeps the findings confidential. QuickDNA also offers DNA tests for prenatal parentage, as well as ancestry and animal breed determination.

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Biotech, Academic Lab Partner on Microbiome-Safe Products

Spray bottle

(Public Domain Pictures, Pixabay)

18 Jan. 2023. A biotechnology company creating products for gut health and a university immunology lab are evaluating cleaning products for potential damage to human protective tissues. The initiative brings together Seed Health Inc. in Los Angeles and the Swiss Institute of Allergy and Asthma Research, part of University of Zurich in Switzerland.

Seed Health is a developer of therapies and consumer products based on the microbiome, communities of bacteria in the gut, skin, and elsewhere in the body. Research into the microbiome reveals connections between the state of these microbial communities and a wide range of health conditions, beginning with the gastrointestinal system, but extending to the skin, metabolic, immune, and nervous systems as well. Seed Health also makes consumer probiotics for gut, skin, brain, and oral health, as well as digital health tools and probiotics for honeybee protection. A separate subsidiary develops biologics for vaginal and reproductive health.

For this project, Seed Health is partnering with immunologist Cezmi Akdis, director of the Swiss Institute of Allergy and Asthma Research that uses the acronym SIAF. Akdis and colleagues study the effects from increasing use of chemicals found in common consumer products such as preservatives, emulsifiers, and micro-plastics that over time damage the epithelial or thin tissue layers that protect skin and mucosal membranes from infections, toxins, pollutants, and allergens in the environment. Akdis hypothesizes in a paper published in Nature Reviews Immunology that degradation of these epithelial layers contributes to the steep rise in allergies and autoimmune diseases, particularly in urban and industrial regions.

Increased cell death and inflammation in gut tissue

In Dec. 2022, researchers led by Akdis tested common dishwasher detergents and rinse agents on microfluidic chip devices with tissue organoids emulating gut functions, and found these compounds, particularly with higher levels of alcohol rinse agents, are toxic to epithelial barriers in the gut. An analysis of these effects shows increased cell death and inflammation in gut tissue. In addition, dishes washed with professional cleaning compounds have residues of cell- and epithelial tissue-damaging compounds. One of the study’s co-authors is Raja Dhir, co-founder and co-CEO of Seed Health.

The Seed Health/SIAF collaboration is screening some 200 compounds using a microfluidic system similar to that used in the published research, starting with effects on adult scalp, face, and body skin, as well as infant skin. The project plans to extend the analysis to epithelial tissue in the gut, respiratory tract, and mucous membranes in the vagina and mouth.

“A defective epithelial barrier,” says Akdis in a Seed Health statement released through Cision, “can facilitate the entry of allergens and induce an inflammatory response that can initiate or aggravate many chronic inflammatory diseases. This makes the need to further evaluate the health hazards of these barrier-damaging compounds, and the search for safer alternatives, all the more urgent.”

“Until this point,” adds Dhir, “we’ve lacked the technology and methods to establish the toxicity threshold of compounds in everyday products, resulting in population exposure in excess. Our platform uniquely combines host and microbial immunology to reimagine the future of products in the built environment.”

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Trial to Assess At-Home Asthma Lung Function Tests

Adult inhaler user

(NIAID, Flickr. https://flic.kr/p/LyQUUT)

17 Jan. 2023. A clinical trial is set to begin that compares monitoring of lung functions in people with asthma using portable ultrasound and mobile app at home to conventional tests in a clinic. The trial is conducted by digital health technology company Koneksa in New York evaluating spirometry, a common technique for testing lung capacity, for monitoring patients’ asthma treatments at home.

Koneksa is a seven year-old company that develops software for measuring biomarkers or health indicators from digital data, particularly for clinical trials in partnerships with drug makers. Among the company’s lead products is a system for measuring lung function data with a portable ultrasound spirometer device and app designed for the iPhone. A spirometer measures a person’s lung capacity, specifically amount of air forced from the lungs in one second, called forced expiratory volume in one second or FEV1. This measure is considered the gold standard of lung function measurements and in most cases require patients to visit a clinic for spirometry tests.

In the Koneksa respiratory system, data from the portable spirometer are sent via Bluetooth to a mobile iPhone app that forwards the data to the cloud for analysis with algorithms. Koneska says the system can be used to assess FEV1 in patients with other respiratory diseases, such as Covid-19 and COPD, as well as asthma. The company is partnering with biopharmaceutical company Regeneron, a developer of monoclonal antibody treatments for Covid-19, on validating remote FEV1 measurements.

Testing LABA with inhaled corticosteroids

Patients receiving treatment for chronic asthma need to visit their physician or clinic periodically for a spirometer test to assess their progress. Koneska says its system is designed to conduct the test a home, enabling more frequent tests of lung function, as well as reduced time and cost to the patient. In Oct. 2020 a Koneska team published results of a pilot test with asthma patients that found a high correlation between FEV1 measurements of patients using an at-home spirometer and conventional spirometry in a clinic.

The new clinical trial, says Koneska, is evaluating the remote spirometry system among patients with moderate asthma taking inhaled corticosteroids, supplemented with long-acting beta-agonist or LABA therapy. LABA treatments are used only when inhaled corticosteroids are not sufficient to relax tightened muscles in the airways, and need close monitoring due to safety concerns. The study is not yet listed on ClinicalTrials.gov, the U.S. government registry.

Koneska says the the ability of its remote spirometry system to capture data more frequently makes it possible to enroll a smaller number of patients than usual in the trial. “More frequent at-home mobile spirometry measurements,” says Koneska chief medical officer John Wagner in a company statement released through BusinessWire, “are expected to be more sensitive and accurate and may provide earlier detection of treatment effect in a smaller sample size when compared with in-clinic spirometry.” Wagner adds the study will “evaluate whether digital biomarkers derived from remote monitoring with a smart device and mobile spirometer can provide additional information correlated to symptom scores in asthma.”

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Nasal Spray Vaccine Shown to Stop Gonorrhea Infections

Neisseria gonorrhoeae bacteria

Neisseria gonorrhoeae bacteria (CDC.gov)

16 Jan. 2023. A vaccine against gonorrhea given as a nasal spray is shown to generate protective immune responses in lab mice of both sexes, and in females similar to an intravaginal vaccine. Findings from the preclinical study are reported in the 22 Dec. 2022 issue of the journal mSphere, published by American Society of Microbiology, testing a vaccine developed by companies in the Netherlands and U.S.

Gonorrhea is a common sexually-transmitted disease among teens and young adults. While drugs are available to treat gonorrhea, Neisseria gonorrhoeae bacteria responsible for the disease are becoming more resistant to current treatments, making the disease more difficult to treat. Centers for Disease Control and Prevention says in 2020 nearly 678,000 cases of gonorrhea were reported in the U.S.

The experimental vaccine tested in the study, code-named Avacc 11, is made by biotechnology company Intravacc B.V. in Bilthoven, the Netherlands, working with another biotech, Therapyx Inc., in Buffalo, New York. Avacc 11 is made with the Intravacc technology called outer-membrane vesicles or OMVs, which in nature are circular particles containing antigens released by gram-negative bacteria, responsible for many infectious diseases. The company says it creates synthetic OMVs with added properties for invoking a precise immune response, lower toxicity, and increased yield, including those designed for nasal sprays to generate an immune response in mucous membranes.

For Avacc 11, Intravacc is partnering with Therapyx, commercializing a technology licensed from Brown University on protein micronization and encapsulation. The company’s process, called Exstam, formulates therapeutic proteins into microscale particles encapsulated in biodegradable polymers for longer shelf life and greater stability. One of the company’s lead products is an encapsulated form of immune cytokine or enzyme interleukin-12 that Therapyx says can be given as an oral drug, inhaled, or delivered to mucous membranes.

Developed under an NIAID contract

As reported in Science & Enterprise in Oct. 2022, Intravacc received a $14.6 million contract from National Institute of Allergy and Infectious Diseases or NIAID to develop a nasal spray vaccine against gonorrhea. Intravacc is partnering with Therapyx on development of the vaccine that delivers OMVs and interleukin-12 micro-particles to protect against Neisseria gonorrhoeae bacteria infections.

As an intermediate step, researchers from the two companies first tested the formulation as an intravaginal vaccine with female mice. Results show the intravaginal vaccine generates antibodies in the female mice blood, saliva, and vaginal fluids. Likewise, lymph nodes in the mice produce more interferon-gamma, another immune system cytokine. When formulated as a nasal spray, Avacc 11 produces similar antibody responses in female and male mice tested, when compared to a placebo of empty micro-particles.

A challenge test of the vaccine, where inoculated female mice are exposed to gonorrhea-causing bacteria shows Avacc 11 protects against infection when given as either a nasal spray or intravaginal form. The authors say that protection extends to a variety of Neisseria gonorrhoeae strains. The researchers also refined the Avacc 11 formulation to remove potentially toxic compounds generated by Neisseria gonorrhoeae OMVs, as well as the membrane protein Rmp that blocks antibodies.

“This intranasal gonococcal vaccine,” says Intravacc CEO Jan Groen in a company statement, “is more suitable to fight gonorrhea infections, which are becoming increasingly resistant to antibiotic treatments.” According to a funding document from NIAID, the company plans to continue safety and efficacy testing in lab animals, as well as prepare for an investigational new drug application, in effect a request to begin clinical trials, with the Food and Drug Administration.

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Infographic – 2022 Biotech Venture Funding Weakens

Chart: Venture investments total by year for biotech and pharma companies

(National Venture Capital Association and Pitchbook)

14 Jan. 2022. Venture funds for new U.S. biotechnology and pharmaceutical companies declined from historical highs in 2022, but a closer look reveals even more signs of financial tightening. Data on the fourth quarter and full-year venture capital financing in the U.S. were reported this week by National Venture Capital Association or NVCA and investment market research company Pitchbook (registration required).

NVCA and Pitchbook found total year investments for U.S. biotech and pharma start-ups totaled $30.7 billion in 2022, down from the $39 billion invested in 2021, but still higher than the $29.6 billion total for 2020, and previous years going back to 2012. Likewise the number of venture investment transactions for this sector declined to 1,054 in 2022, from 1,415 in 2021, another historical high mark, and roughly in line with deal totals in 2020 and 2019.

Investment dollars for U.S. angel and seed-stage biotech and pharma start-ups, those in the earliest stages, remained at about 25 percent during 2022, about the same as the previous two years. Since 2019, the proportion of venture investing in this sector for late-stage start-ups, third rounds called series C or later, grew to 40 percent of all investment dollars. Caught in the squeeze are companies raising series A and B venture rounds, which now make up about a third of all investment dollars, down from about 40 percent in 2021. In addition, the median deal size in this sector barely rose to $9.8 billion in 2022, from $9.7 billion in 2021, after rising steadily each year since 2019.

As we noted last week in our review of global trends, annual totals for venture investing in U.S. companies indicates 2021 may be an anomaly of loosening credit from responses by governments to the Covid-19 pandemic, according to NVCA and Pitchbook analysts. As inflation took hold in 2022, say the analysts, credit tightened making money less available for venture investors and others. As a result, according to the new data, total venture funding and deals for U.S. tech start-ups declined in each quarter of 2022. These progressive declines suggest the tight financial environment will continue into 2023.

A bright spot in the U.S. investment world is the continued increase in new venture capital for investing. Venture capital companies in the U.S. report raising $162.6 billion in 2022, a record total and a gain from the $154.1 billion raised in 2021. However, the number of U.S. venture investors declined in 2022 to 769 from 1,270 in 2021 and 869 in 2020.

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Environmental Biomarker Start-Up Gains $16M in Early Funds

Human body hair sample

Human body hair sample (Daniel Souza, Wikimedia Commons. https://commons.wikimedia.org/wiki/File:Human_body_hair_with_pulp.jpg)

13 Jan. 2023. A new company developing diagnostics for neurological and other disorders based on environmental exposures is raising $16 million in venture funds. Linus Biotechnology Inc. in New York, founded in 2020 and led by researchers at Mount Sinai medical school, is based on studies of the exposome that probes effects of environmental factors to identify precise indicators of disease.

Linus Bio is commercializing technology developed by Mount Sinai researchers who study biomarkers for autism spectrum disorder, a set of related neurological conditions affecting the ability to communicate, learn, and interact socially. Symptoms of these disorders can appear in childhood and affect daily functioning, with repetitive and stereotyped patterns of behavior. According to Centers for Disease Control and Prevention, 1 in 44 children are identified with autism spectrum disorder, occurring across all races, ethnic groups, and social classes, and in four times as many boys than girls.

Diagnosis of autism or these related conditions is based largely on behavioral observations. Research by Manish Arora, professor of environmental medicine and dentistry at Mount Sinai, indicates that the extent of prenatal and early life exposure to certain chemicals and nutrients can affect a child’s development and life-long health in a dynamic way. Among their studies, Arora and colleagues found twin children with higher levels of certain metals in their baby teeth, like lead, and lower amounts of zinc and manganese, were more likely to be diagnosed with autism than their matched twins with normal levels of these metals.

Breakthrough device designation

In 2020, Arora with Mount Sinai colleagues Christine Austin and Paul Curtin — professors of environmental science and data science respectively — licensed their process and founded Linus Bio. The company technology takes non-invasive tissue samples, such as hair, and probes the samples with lasers that the company says keeps molecules intact for analysis. The laser probe, says the company, is combined with with robotics and deep computational techniques to identify biomarkers or indicators of disorders matched to phenotypes or traits. Linus Bio says the tests can be repeated over time to track changes in a condition, as well as early detection.

The company’s first test, called StranDx, is a diagnostic aid currently for autism spectrum disorder. StranDx uses a single strand of hair from infants through adults up to age 21. In Dec. 2021, StranDx received a breakthrough device designation from the Food and Drug Administration for medical devices that provide more effective diagnosis or treatment of debilitating diseases. A breakthrough device developer is given more access to FDA experts during pre-market review, as well as prioritized review of the device. The company says StranDx also received a CE mark, clearing the device for marketing in Europe.

Linus Bio says autism spectrum disorder is just the first condition to test for exposome factors, since early detection is considered crucial, with tests in development or planning for a wider range of diseases. “We chose to focus on autism first for many considerations,” says CEO Arora in a company statement, “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.”

Linus Bio’s first venture round is raising $16 million led by health care investor GreatPoint Ventures and technology investor Bow Capital, both in San Francisco. Taking part in the round are Divergent Investments and a number of individual investors. According to Crunchbase, Linus Bio raised some $17.5 million in earlier financing.

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CEPI Assessing Advanced RNA Nanoparticle Vaccine

Zika virus

Transmission electron microscopic image of Zika virus, a type of flavivirus (CDC.gov)

12 Jan. 2023. An international health organization is evaluating a new type of vaccine made with biodegradable RNA nanoparticles to help head off future viral pandemics. The Coalition for Epidemic Preparedness Innovations, or CEPI, is funding creation and testing of an RNA vaccine by Tiba Biotech LLC in Cambridge, Massachusetts that offers a different RNA vaccine process first developed at MIT.

Early RNA vaccines protecting against viral diseases including Covid-19 use synthetic messenger RNA or mRNA delivered inside nanoscale lipid particles. While the vaccines are largely effective in preventing disease they can also cause adverse side effects, such as soreness from inflammation or fever in some recipients. Most current RNA vaccines also require refrigeration or freezing for storage and delivery, the so-called cold chain, which adds to costs for health authorities and limits their use in lower-resource regions.

As a result, CEPI issued last year a proposal call for advances in RNA vaccines, including “RNA platform technologies based on potentially high-impact innovations offering substantial advantages over existing mRNA technologies.” For developers of these technologies, CEPI offers to support research on discovery and preclinical proof-of-concept studies.

RNA vaccines without the need for lipid nanoparticles

Tiba Biotech was formed in 2018 to commercialize advances in RNA vaccine technology discovered in the lab of bioengineering professor Daniel Anderson at MIT. A team led by Jasdave Chahal, then a postdoctoral researcher in Anderson’s lab, published findings in July 2016 — reported by Science & Enterprise — showing vaccines made with mRNA molecules formulated into nanoscale dendrimer particles. Dendrimers are star-shaped symmetrical molecules with many desirable properties for vaccines, including stability, solubility, and low toxicity. The researchers found they could quickly produce mRNA dendrimer vaccines that produce antibody and T-cell responses protecting lab animals against Ebola, influenza, and other deadly viruses.

Chahal and colleagues went on to found Tiba Biotech and now serves as the company’s chief scientist. Tiba Biotech says its process can design synthetic biodegradable RNA nanoparticles without the need for encasing the RNA in lipids. As a result, says the company, its process can deliver higher doses of RNA for vaccines, as well as cancer treatments and gene therapies. In addition, says Tiba, the larger capacity of its nanoparticles can carry more complex deliveries, such as multiple antigens and Crispr gene editing payloads.

For CEPI, Tiba Biotech is creating a vaccine to protect against Japanese encephalitis virus, a disease caused by a flavivirus, a virus family causing a number of vector-borne diseases resulting in recent epidemics including dengue, West Nile, yellow fever, and Zika. CEPI is providing $2 million to Tiba to design, develop, and test in preclinical studies a vaccine protecting against Japanese encephalitis virus or JEV. The goal of the project is to assess the vaccine’s potential for eventually producing less costly and more efficient vaccines with fewer adverse effects. If successful, say CEPI and Tiba, the project could be extended to develop vaccines against other known viruses, as well as prepare for vaccines against as yet unknown pathogens with pandemic potential.

Richard Hatchett, CEO of CEPI notes in a statement, “mRNA vaccines have been a game changer for the global pandemic response, but there is scope to substantially improve the technology to make it more effective and accessible when responding to future outbreaks.” Christian Mandl, Tiba Bioech co-founder and interim chief scientific officer adds, “This initial focus on JEV is just the start to developing, expanding, and enhancing RNA vaccine rapid-response capabilities against known and unknown threats.”

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Audio Digital Biomarkers Start-Up Raises $3.7M in Seed Funds

MD with stethoscope

(George Hodan, Public Domain Pictures)

11 Jan. 2023. A new company developing techniques to analyze internal physiological sounds captured by stethoscopes as health indicators is raising $3.7 million in seed funds. Lapsi Health in Amsterdam and Helsinki says it’s creating devices and software to identify digital biomarkers with big-data analytics of audio derived from stethoscopes.

The company’s technology is based on auscultation, the common and non-invasive practice by physicians of listening with a stethoscope to sounds made by a patient’s heart, lungs, blood vessels, and gastrointestinal organs. With auscultation, a physician can uncover noticeable problems in heart rhythms, heart valve problems, difficulties breathing in one or both lungs, as well as abnormal activity in the intestines. Auscultation can also reveal turbulence or low intensity of blood flow. From those initial indicators with a stethoscope, physicians can then follow-up with more precise and conclusive tests.

Lapsi Health is developing technology that aims to capture the sounds heard through stethoscopes as digital audio that can be analyzed with computational tools to reveal details of an individual’s health. These so-called digital biomarkers, says the company, can then be built into point-of-care medical devices, or sent electronically to monitor patients remotely and in telemedicine encounters between clinicians and patients. In addition, says Lapsi Health, auscultation analytics can be combined with digital therapeutics to directly address diseases.

European tech competition award

“Data driven decisions,” says Lapsi Health co-founder and chief medical officer Diana van Stijn in a company statement released through Cision, “are the next step to improving health care, patient empowerment, clinical intelligence, and to make clinical research more democratized. These are the ideals that inspired us to create Lapsi Health.”

After the company’s formation in July 2021, Lapsi Health began incubation at Health Incubator Helsinki that provides facilities for research-based health care start-ups as well as mentoring, advisory services, and networking opportunities. In March 2022, according to Crunchbase, the company raised $640,000 in pre-seed funds, followed in June by a $1.1 million Eurostars award, a European technology grant competition. And in September, says the company, Lapsi Health was accepted into the the TechLeap accelerator for technology start-ups in the Netherlands.

Lapsi Health has so far not revealed specifics of its technology portfolio, but the company says it developed its first prototype early last year. Since then, notes co-founder and CEO Jhonatan Bringas Dimitriades, “we released four generations of prototypes and two native applications. We have been able to validate our technology and showcase it in several venues worldwide and to several medical leaders.”

In its seed funding round, Lapsi Health is raising $3.7 million led by Modi Ventures in Houston that backs early-stage companies adapting artificial intelligence and medical technology developers. Taking part in the round are current investors Vendash and Bolwork, and new investor BeKey, a software company. Lapsi Health says it plans to use the proceeds to continue developing its technology and prepare for certification with the Food and Drug Administration, to enter the U.S. market.

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