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Covid-19 Nasal Vaccine Produces Antibodies, Cuts Viral Load

Nasal spray

(Wikimedia Commons)

3 Mar. 2022. Tests with lab animals show a vaccine given as a nasal spray produces high antibody volumes against SARS-CoV-2 infections and reduces viral loads. Results of tests by biotechnology companies Oragenics Inc. in Tampa, Florida and Inspirevax in Laval, Quebec with National Research Council of Canada, appear yesterday on the bioRxiv pre-publication server, and are not yet peer-reviewed.

Oragenics creates vaccines and treatments for infectious diseases, focusing recently on the Covid-19 pandemic, but also multi-drug resistant microorganisms. For Covid-19, the company is developing a next-generation vaccine called Terra CoV-2 with a synthetic protein technology licensed from National Institutes of Health and National Research Council of Canada. Oragenics says its platform enables design of new vaccines targeting the SARS-CoV-2 spike protein in six to eight weeks, making it possible to respond quickly to future variants.

The company enhances Terra CoV-2 with an adjuvant for stimulating more immune response in mucosal surfaces in the nose and lungs. That adjuvant, developed by Inspirevax — known until recently as Biodextris — is also licensed to Oragenics. The company envisions Terra CoV-2 as an easy-to-use booster vaccine to protect against Covid-19 after initial immunity wanes from today’s injected vaccines.

“Intranasally delivered SARS-CoV-2 vaccines,” says Oragenics executive chairman Frederick Telling in a company statement, “could provide increased protection in the nose and throat where viral entry occurs. This could lead to lower transmission of the virus compared to the currently available intramuscularly delivered vaccines as well as offering a needle-free delivery option.”

Higher antibody concentrations in vaccine recipients

A team from Oragenics, Inspirevax, and National Research Council tested immune responses of its Covid-19 nasal spray vaccine and protection against illness in lab mice and hamsters. Researchers gave two doses of vaccine or a placebo to mice, 21 days apart, with blood samples taken on days 21 and 35 after the first dose, as well as nasal swabs on day 35.

Blood samples show higher concentrations of immunoglobulin G and A antibodies in active vaccine than placebo recipients, which neutralize both the ancestral SARS-CoV-2 strain and beta variant, which prevents binding to receptor proteins in host cells. Nasal swab tests likewise show higher immunoglobulin A antibodies in mucous tissue among active vaccine recipients, compared to placebo.

The team then conducted a challenge test of the vaccine with hamsters that have a high susceptibility to Covid-19 infections. Animals received two doses of the nasal spray vaccine at either high or low levels, or a placebo, 21 days apart, with blood tests taken after 35 days. As with mice, hamsters receiving the active vaccine produce more neutralizing immunoglobulin G antibodies than placebo recipients after 35 days. Seven days later, the animals were exposed to SARS-CoV-2 viruses in ancestral, beta, and delta variant forms.

After five days, placebo recipient hamsters lose about 10 percent of their body weights, indicating development of illness, while vaccinated hamsters at both high and low dosage levels, experience no weight loss. Post-mortem analysis of the hamsters show no evidence of virus in nose or lung tissue retrieved from high- and low-dose vaccine recipients, while placebo recipients have high virus levels in nose and lung tissue. The authors do not report any indicators of adverse effects from the vaccine experienced by either mice or hamsters.

The authors believe the findings support continued development of the nasal spray vaccine. Oragenics says the results will be part of the company’s investigational new drug application with FDA, in effect a request to begin clinical trials.

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Human Intelligence Robot Maker Raises $58.5M in Early Funds

Human and robot hands

(Pete Linforth, Pixabay. https://pixabay.com/photos/connection-hand-human-robot-touch-3308188/)

2 Mar. 2022. A developer of robotics with human-like intelligence for general-purpose workplace applications is raising nearly $US 59 million in its first venture round. Sanctuary Cognitive Systems Corp. in Vancouver, British Columbia, Canada is a four year-old company creating general-purpose robotic systems for a range of industries to help solve labor shortages worldwide.

Sanctuary Cognitive Systems is developing robotic systems that it says are designed to perform a wide variety of human tasks in business. Most other robotics, says the company, are created to fulfill a specific set of tasks or activities. Sanctuary says its robotics use an intelligence that more resembles human functions, with a software framework covering several cognitive and sensory functions including memory, sight, sound, and touch.

When deployed, says the company, its human size and scale robotics can operate alongside humans, using artificial intelligence to observe and assess actions, and act on tasks. Sanctuary notes that its systems are operated and supervised by human workers, while the systems act on designated tasks and build their knowledge stores with algorithms for future work. The company says its systems are designed with the right combination of automated hardware and cognitive smarts to aid in performing a business’s work, and fill in for human workers when labor shortages occur.

Labor challenges outside the scope of most A.I. and robotics

“We are addressing a systemic problem across the global economy,” says Sanctuary co-founder and CEO Geordie Rose in a company statement. Rose adds, “With unfilled vacancies, workplace safety considerations, increasing employee turnover, worldwide aging populations, and declining workplace participation, one thing is clear: many labor-related challenges are outside the scope of current specialized A.I. and robotics technology.”

Sanctuary Cognitive Systems is raising $C 75.5 million ($US 58.5 million) in its first venture funding round. Taking part in the round are Bell Canada, Evok Innovations, Export Development Canada, Magna, SE Health, Verizon Ventures, and Workday Ventures. No lead financier for the round is identified.

Verizon Ventures in New York, the venture capital arm of Verizon Communications, is among the investors. “It’s not practical for most businesses,” says Verizon Ventures managing director Michelle McCarthy in a blog post, “to redesign factories to automate their entire operations or spend hundreds of thousands of dollars on a robotic arm that performs one simple function. Instead, implementing automation solutions that seamlessly plug into existing operations will be the realistic next step for most businesses adapting to the future of work.”

Another of Sanctuary’s first-round funders is Evok Innovations, also in Vancouver, a venture investor focusing on climate technologies and environmental outcomes. “Our investment in Sanctuary,” says Marty Reed, a partner at Evok Innovations in Sanctuary’s statement, “is in complete alignment with our mission at Evok Innovations to protect the environment and strengthen the economy. We believe that Sanctuary has the fastest, lowest-cost, and most commercially viable path to building human-like intelligence in machines.”

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Patent Board Rules for Broad Inst. in Crispr Case

Crispr graphic

(LJNovaScotia, Pixabay)

1 Mar. 2022. A U.S. patent appeals board ruled that the Broad Institute at Harvard and MIT is the discoverer of Crispr gene editing techniques in animal cells. A decision by the Patent Trial and Appeal Board in the U.S. Patent and Trademark Office says claims by University of California at Berkeley and University of Vienna, where researchers also made early Crispr discoveries, did not “provide sufficient, persuasive evidence” that Broad Institute inappropriately benefited from their work, called patent interference.

Crispr — clustered regularly interspaced short palindromic repeats — is a technique for editing genomes based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. The actual editing of genomes with Crispr in most cases uses an enzyme known as Crispr-associated protein 9 or Cas9. RNA molecules guide the editing enzymes to specific genes needing repair, making it possible to address root causes of many diseases, but also adjust traits in plant crops by removing or changing specific genes.

The patent appeals board decision is the latest step in a long-running dispute between Broad Institute, a genetics research center affiliated with Harvard University and MIT, and University of California in Berkeley with University of Vienna. Jennifer Doudna at Berkeley and Emmanuelle Charpentier, formerly at University of Vienna and now at Max Planck Institute for Infection Biology in Berlin, are credited with discovering the basic Crispr technique in 2012, for which they shared the 2020 Nobel Prize in Chemistry.

“Solve today’s real-world problems”

The dispute, and an earlier case also found in favor of Broad Institute, centers on application of Crispr to gene editing in cells with a nucleus called eukaryotes, found in more complex plants and animals. Broad says its labs developed techniques for using Crispr in eukaryotes separately from those used by Doudna and Charpentier, who experimented with prokaryotes, organisms without a cell nucleus, such as bacteria and other single-cell microorganisms. As reported by Science & Enterprise in Sept. 2018, a U.S. appeals court backed the Broad Institute’s original argument, and yesterday USPTO’s appeals board again sided with Broad Institute against renewed and similar claims by UC-Berkeley and Vienna.

While Broad Institute won its case with the patent appeals board, its comments on the case yesterday appear to call for a truce with UC-Berkeley and Vienna rather than continued fighting. “A complex patent and licensing landscape threatens innovation,” says the statement, “The best thing, for the entire field, is for the parties to reach a resolution and for the field to focus on using Crispr technology to solve today’s real-world problems.” The institute says it “has pressed for a joint licensing strategy, or patent pools, for more than eight years … with the hope of ensuring open, equitable, and streamlined access to these transformative tools.”

A UC-Berkeley statement says the university is “disappointed” by the appeals board decision and believes the board “made a number of errors.” The statement also notes UC-Berkeley and Vienna “has more than 40 issued U.S. patents that were not involved in this interference and that cover various guide formats of Crispr-Cas9 genome editing systems with applications in all environments, including eukaryotic cells.” The university adds it has patents for Crispr-Cas9 in 30 other countries.

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Remote Work Is Good And Bad News For Cities

– Contributed content –

Chicago River

(A. Kotok)

1 Mar. 2022. The US is going back to normal. Restaurants are packed, stadiums are sold out, and rockstars are hosting concerts once more. For all intents and purposes, things look very similar to how they did in 2019, with the addition of a few face masks dotted around here and there.

But when it comes to returning to the office, it’s a different story. Workers just aren’t playing ball. The idea of waking up, showering, getting dressed and then commuting through busy traffic is unappealing after more than two years of staying in.

This new reality is creating an opinion among many that the days of the conventional office are numbered. Giant downtown skyscrapers could be a thing of the past if workers successfully negotiate remote work.

The implications of this on cities are tremendous. Most modern infrastructure is designed to ferry workers from the peripheries of cities to the core. Land prices in central locations have been sky-high, historically, because businesses want the best spots at the center of the transport network. Rents in Manhattan, for example, are astronomical.

But with the move to remote working, that will change. We’re never going to go back to the number of in-office person days that we had before the pandemic. That’s simply not going to happen.

Many people will work from home

Over the coming decade, American workers will spend around 25 percent of their time working from home. In the context of the pandemic, that doesn’t sound like a great deal, but before the arrival of COVID-19, the figure was just five percent.

You can make an argument that SARS-CoV-2 accelerated a trend that was already in place, but it has done so so rapidly that comparisons are almost moot. Experts predicted, based on current trends, that we might hit 25 percent of workers at home by 2050 or 2060.

COVID-19 has created a culture shift. While spending time at home, workers question what the point of going to the office actually was. Business leaders praise the proverbial “chat by the water filter” because of its ability to spur communication and innovation, but employees know that there’s not much in it for them. They would rather avoid spending hours in traffic every morning, and pressing their suits on the weekend instead of having fun.

Office occupancy rates

Commentators might have expected a plunge in office space usage, but data suggest that demand is only down around 1 percent since 2019. The real figures might actually be flat.

That’s because firms still need office space, and they haven’t quite figured out yet how to rent buildings effectively. While there are new office rental companies entering the market, offering on-demand space, uptake is, as yet, marginal.

What’s more, most companies are not able to make the move to a fully remote working model. There are genuine business reasons for having people in the office. Furthermore, workers don’t want total isolation. For many, hybrid working, going in one or two days a week, is a good compromise.

It’s a mess

Corporations are, in general, doing quite well dealing with the current remote working setup. They’re looking to team management tips to improve how they interact with peripheral staff in the office, keeping productivity reasonably high.

Cities, though, are starting to suffer. Strangely, it’s not the lack of office demand that’s the problem, but the lack of worker demand. With fewer people in the office, there are fewer lunchtime shopping trips, coffee breaks, meals out, subway trips and bus rides. Following on from this, city officials are collecting fewer taxes.

This reality explains why city politicians and officials are so keen on people returning to the office. Some have suggested awarding companies that insist on full-time office-based working with tax benefits or bonuses.

Of course, a lot of the political reactions involve short-term thinking. While demand for downtown services will recede, it will increase out of town. Cities may become more distributed and less prone to congestion by breaking into self-contained and sufficient communities.

According to some commentators, Wednesday on New York’s subway system is going to feel more like Sunday. The volume of people is now much lower than it was before. Local authorities, therefore, may feel the pressure to raise ticket prices to cover their fixed cost, making transportation to work even more unsustainable, fueling a vicious cycle of decline.

In summary, Americans aren’t keen on going back to the office. It’s not about avoiding disease – that risk has largely receded. Instead, it’s just a behavioral and cultural shift, but one that will have a profound impact on how cities organize themselves.

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Trial Assessing AI-Aided Blood Test for Early Stage Cancer

Blood vials

(Ahmad Ardity, Pixabay)

28 Feb. 2022. A clinical trial is underway enrolling people with and without cancer to evaluate blood samples analyzed with artificial intelligence to detect early-stage cancer. Freenome Holdings Inc. in South San Francisco sponsors the trial to assess a diagnostic process that the company says uses multiple analytical techniques to detect multiple types of cancer.

Freenome aims to improve cancer diagnostics, making it possible to discover cancer earlier in the progress of the disease, when individuals have more treatment and prevention options. Many current screening methods, says the company, use simplified models to understand cancer, a dynamic, complex disease. In addition, says Freenome, physicians need to know more about the disease than just its presence or absence in the patient.

The company’s technology applies genomics, machine learning, and other computational techniques to analyze ordinary blood draws. Many liquid biopsies using blood samples, says Freenome, focus on a few genetic mutations suspected of causing a person’s cancer. Freenome says its process analyzes a wider range of molecular indicators in blood, looking for evidence of immune-system or metabolic changes, as well as DNA from cells emitted by a tumor. The company says its analytics identify signals and biomarkers not only detecting the presence of cancer, but also providing a more detailed picture of the condition for oncologists to prescribe precise treatments earlier in the disease.

Tested with colorectal and pancreatic cancer

Freenome published results from earlier studies of its diagnostic process on two forms of solid tumor cancer. In Jan. 2020, the company reported findings from a clinical trial that analyzed blood and stool samples from individuals tested for colorectal cancer, or CRC. The study team matched participants already diagnosed for CRC with average-risk individuals undergoing routine screening. Results, reported to a meeting of American Society of Clinical Oncology, show high true-positive sensitivity and true-negative specificity, both 94 percent, for early-stage CRC. The findings also show the Freenome test is more sensitive than other current tests analyzing blood and stool samples.

As reported by Science & Enterprise in Sept. 2021, another study shows the Freenome technology reveals individuals in early stages of pancreatic cancer, a form of cancer usually difficult to detect until its later stages. The study analyzed blood samples from 75 individuals with pancreatic ductal adenocarcinoma, or PDAC, the most common form of pancreatic cancer, tested with the Freenome process and the CA19-9 biomarker test used mainly to monitor disease progression. The combination of Freenome and CA19-9 tests produced an overall sensitivity of 93 percent, with 82 percent for early (stage 2) cases and 100 percent for late-stage cases, and an overall specificity of 96 percent.

The new case-control clinical trial is enrolling 5,400 participants in the U.S. age 30 and older, and like the CRC study, matching persons with cancer to healthy individuals, and taking blood samples for 12 months. Analytics from the blood samples are expected to show biomarkers and other indicators for specific cancer types or combinations of cancers. Freenome says more than 100 sites will conduct the study, but so far, only five locations are listed. The company titled the study Vallania after the mother of a Freenome scientist who died of pancreatic cancer.

“It’s been our plan from the beginning to extend our platform’s capabilities to include additional cancers beyond CRC,” says Freenome CEO Mike Nolan in a company statement released through Cision. Nolan adds, “The Vallania study is a key step in achieving that goal.”

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Infographic – We Stand with Ukraine

Ukraine graphic

(Muhammad Syafrani, Pixabay. https://pixabay.com/illustrations/state-international-flag-text-2727717/)

26 Feb. 2022. No need to say more.

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Clinical Trial Set for AI-Driven Lung Fibrosis Drug

lung illustration

(Kai Stachowiak, Pixabay)

25 Feb. 2022. A clinical trial is set to begin testing the safety and chemical activity of a drug candidate for lung fibrosis, discovered and refined with artificial intelligence. Insilico Medicine in Hong Kong says the early-stage or phase 1 trial testing Insilico’s experimental treatment known as ISM001-055 will enroll 80 healthy volunteers in New Zealand.

INS018_055 is Insilico’s first therapy designed entirely with the company’s A.I.-based drug discovery platform, also offered as a service to drug developers. As reported by Science & Enterprise a year ago, the company uses deep learning, a form of machine learning that finds underlying patterns in relationships, and builds those relationships into knowledge bases. Insilico says it then applies an A.I. technique called a generative adversarial network using two sets of algorithms that test each other while learning the underlying patterns. Those repeated rounds test the authenticity of new data generated by the model, eventually producing optimized data points.

Insilico combines these techniques in its deep learning target discovery system called PandaOmics that analyzes gene, transcription, protein, and clinical data sets. The company says it focused this technology to discover a new treatment for idiopathic pulmonary fibrosis, or IPF, a progressive lung disease usually affecting people between the ages of 50 and 70. The disorder results in fibrosis or scar tissue building up in the lungs, limiting the ability of lungs to transfer oxygen to the blood stream. The scarring of lung tissue increases over time, often leading to other serious lung conditions, including lung cancer and blood clots. Most patients die within five years after diagnosis.

Discovery and preclinical in 18 months

Insilico then called on its Chemistry42 system for drug molecule design. The company says Chemistry42 builds molecules from scratch, creating and testing chemical structures that meet the target’s properties and binding characteristics. The system also responds to needs for specified drug properties, such as molecule complexity or shape, metabolic stability, and solubility.

For Insilico’s IPF target, the system needed to design a safe oral drug meeting specifications for availability in the body, selectivity, and stability, resulting in a small molecule drug candidate first code-named INS018_055, now called ISM001-055. The company reported preclinical tests in lab animals showed no toxic effects after 14 days, as well as less fibrosis and improved lung functions. The entire drug discovery and preclinical development process, says Insilico, took 18 months.

“Modern deep learning technologies,” says Insilico Medicine founder and CEO Alex Zhavoronkov in a company statement released through Cision, “enable us to perform target identification using longitudinal biological data from healthy subjects and make inferences into a variety of diseases. This was the guiding principle for our anti-fibrotic program starting with identifying targets that may play a role in both aging and disease.”

Insilico says it already conducted a preliminary micro-dose assessment of ISM001-055 safety with a small group of human testers. The new clinical trial will enroll 80 healthy adults in Christchurch, New Zealand divided into 10 groups. Five groups of participants will take a single varying dose of ISM001-055 or a placebo, while another five groups will take multiple varying doses of the drug, or a placebo, all for 10 days.  The study team will track participants for 12 months looking primarily for signs of adverse effects. The team is also tracking chemical activity in the body, responses of various organs and functions, and T-cell responses in the immune system.

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Digital Neuroscience Companies Partner on AR/AI Diagnostics

Brain circuits illustration

(HypnoArt, Pixabay)

24 Feb. 2022. Two companies creating digital technologies for neurological conditions are collaborating on augmented reality and artificial intelligence in diagnostics. Financial and intellectual property details of the agreement between Altoida Inc. in Washington, D.C. and Click Therapeutics Inc. in New York are not disclosed.

Altoida develops assessments of cognitive performance to reveal indicators of brain health, packaged as smartphone and tablet apps. The company’s process uses exercises with immersive augmented reality games to portray daily life activities. The company says individuals’ responses to these exercises are scored for cognitive and motor skill indicators, with the collection of exercises taking only 10 minutes. The exercises are designed to measure cognitive and functional abilities, with A.I. algorithms used to correlate results to clinical and real-world indicators of brain health.

A recent study of 148 individuals, divided between 58 healthy persons and 90 in various stages of Alzheimer’s disease, evaluated Altoida’s digital measures against today’s clinical assessment questionnaires. Altoida conducted the study with the Innovative Medicines Initiative, and findings posted on the medRxiv pre-publication server in November 2021 are not yet peer-reviewed. Results show Altoida’s augmented reality test scores correlate with clinical questionnaire assessments, and better differentiate between Alzheimer’s disease stages than conventional questionnaires.

Develop more sensitive measures of cognition

Click Therapeutics creates software for treating neurological conditions based on artificial intelligence and data science. The company’s software pipeline includes therapies for disorders such as major depression and schizophrenia, as well as treatments for smoking cessation, insomnia, migraine, and other pain. Click Therapeutics’ Clickoteen product for smoking cessation is now on the market, with eight other software therapies currently in clinical trials.

The deal calls for the companies to collaborate on developing more sensitive measures of cognition, particularly for Click Therapeutics to use in its clinical trials of central nervous system or CNS disorders. “Through this partnership,” says Altoida CEO Travis Bond in a company statement released through BusinessWire, “Altoida and Click Therapeutics will be the first to scale the development of cognitive biomarkers using augmented reality across a number of CNS clinical trials to give patients insight into their brain health and provide a better and earlier understanding of how cognition affects CNS disorders.”

“Partnering with Altoida,” notes Shaheen Lakhan, chief medical officer at Click Therapeutics, “allows us to leverage their AI-driven augmented reality technology to help us better understand baseline measures of cognition and how it affects patient outcomes.” Lakhan adds, “Altoida’s proprietary digital cognitive assessment uses augmented reality to simulate real-world activities of daily living, which can be completed on a smartphone or tablet under 10 minutes, which we believe will accelerate insights into individual’s patterns of disease.”

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NIH Small Biz Grant Supports Uterine Health Diagnostic

Women silhouettes

(Pixabay: https://pixabay.com/vectors/women-silhouettes-girl-woman-4918254/)

23 Feb. 2022. A women’s health diagnostics developer is receiving funds for a non-invasive test analyzing menstrual fluids to detect the uterine disorder endometriosis. National Institute of Child Health and Development or NICHD, part of National Institutes of Health, is awarding $1.5 million to NextGen Jane in Oakland, California to confirm and refine genomic indicators in menstrual fluid for the test.

Endometriosis occurs when tissue resembling the lining of the uterus grows outside the uterus. According to WomensHealth.gov, endometriosis affects 11 percent of women in the U.S. between the age of 15 and 44. The disorder, says the agency, occurs more often among women in their 30s and 40s, making it difficult to become pregnant. Other symptoms are menstrual cramps and other pain, bleeding between menstrual periods, and digestive problems. Pelvic exams, ultrasound, or MRI imaging can help detect endometriosis, but laparoscopic surgery is needed to confirm the diagnosis.

NextGen Jane says that despite laparoscopic surgery, endometriosis reoccurs in half of women with the condition. Moreover, says the company, the time between onset of the disease and diagnosis averages 10 years. As a result, says NextGen Jane, there’s an unmet need for a safe, quick, and easy-to-use diagnostic test for endometriosis.

The company is developing what it calls a smart tampon system to collect and test menstrual fluids, to provide a yes or no answer to women who think they may have endometriosis. The at-home device, as envisioned by NextGen Jane, will collect menstrual fluids for rapid measurement of blood volume and biomarker analysis to return a yes/no signal for the disorder.

Develop big-data analytic tools

Earlier, NextGen Jane received a grant of nearly $268,000 from NICHD to verify the feasibility of detecting multiple RNA biomarkers in menstrual fluids with a smart tampon device. The new award provides funds over two years to confirm the preliminary analysis of RNA biomarkers in menstrual fluid, with a sample of 72 women diagnosed either with or without endometriosis. The grant also supports gathering RNA sequencing and other data from some 300 women before and after undergoing laparoscopic surgery for endometriosis, to validate true-positive sensitivity and true-negative specificity of those biomarkers.

“To overcome a significant barrier in helping women with endometriosis,” says NextGen Jane co-founder and CEO Ridhi Tariyal in a company statement released through BusinessWire, it is critical to increase disease awareness through convenient at-home testing.” Tariyal adds, “This competitive NIH grant helps NextGen Jane take the next steps in developing the big-data analytic tools needed to establish the molecular signature of this novel non-invasive diagnostic for patients in obstetrics and gynecological care and for women who want greater control of their own health.”

NextGen Jane is also participating in a study with Baylor College of Medicine in Houston to identify genomic signatures for endometriosis onset and remission. The study is part of a project to identify inflammatory pathways that could lead to precision medicine treatments for endometriosis harnessing the body’s own mechanisms against the disorder.

The award is a Small Business Innovation Research or SBIR grant made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. SBIR grants fund work by research companies in the U.S., and in most cases are made in two parts: a first phase to determine technical and commercial feasibility, and a second phase to develop and test a working prototype or prepare for clinical trials.

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Precision Meds Continue Gaining FDA Approvals

Digital DNA

(Pete Linforth, Pixabay. https://pixabay.com/illustrations/dna-life-biotechnology-evolution-4068826/)

22 Feb. 2022. Food and Drug Administration approved 17 new medications in 2021 addressing genetic targets, according to data from a precision medicine advocacy group. The annual report of the Personalized Medicine Coalition in Washington, D.C. indicates both the number and percentage of new precision treatments approved by FDA in 2021 are similar but down slightly from 2020.

Precision or personalized medicines are prescribed by physicians to meet a patient’s molecular make-up, based on results of diagnostics, and the individual’s medical history. The Personalized Medicine Coalition’s annual report says FDA approved 17 new drugs and biologics meeting this definition in 2021, making up 35 percent of all new therapies last year. In 2020, FDA approved 20 new precision drugs and biologics, comprising 39 percent of all new treatments. Since 2015, precision medications account for 25 to 42 percent of all new drugs or biologics approved each year by FDA.

Seven of the 17 new precision drugs and biologics approved by FDA are cancer therapies, mainly for treating non-small cell lung cancer, but also bile duct and uterine cancer, and chronic myeloid leukemia. Each of these therapies addresses specific biomarkers, molecular indicators revealed through genetic testing. In addition, the report notes approval of two cell therapies approved by FDA last year to treat blood related cancers, large B-cell lymphoma and multiple myeloma. In both cases, patients’ T-cells are genetically altered, then re-infused as therapeutics.

New or expanded precision medicine diagnostics

FDA approved another seven new precision drugs or biologics to treat rare or inherited diseases indicated by specific biomarkers, according to the report. The approved medications treat Duchenne muscular dystrophy, Pompe disease, Von Hippel-Lindrau disease, progressive familial intrahepatic cholestasis, myasthenia gravis, heterozygous familial hypercholesterolemia, and molybdenum cofactor deficiency. Three other approved precision therapies address HIV, and severe cases of itching (pruritis) and blood-vessel inflammation (vasculitis).

The PMC report points out related FDA actions in 2021 authorizing diagnostic tests for precision therapies. The group says the agency cleared or broadened the scope of nine companion diagnostics for precision drugs. The report also highlights recognition for the Oncology Knowledge Base at Memorial Sloan Kettering Cancer Center in New York, as one of FDA’s human genetic variant databases that document evidence of links between genetic variations and diseases or conditions.

PMC president Edward Abrahams says in an organization statement the findings show “personalized medicines have accounted for more than a quarter of newly approved drugs for each of the last seven years and for more than a third of the drugs approved since 2017, not to mention the approval of new or expanded indications for a countless number of paradigm-shifting diagnostic tests,” adding that the report “leaves no question that the era of personalized medicine is upon us, presenting both opportunities and challenges for patients and health systems.”

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