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Infographic – 100 Promising AI Companies

CB Insights AI 100

Click on image for full-size view (CB Insights)

21 May 2022. Artificial intelligence, or A.I., is underpinning more and more of our daily work and life in general. And A.I. algorithms are becoming a key part of a scientist’s toolkit for analytics, diagnostics, and drug discovery, as we report almost daily on Science & Enterprise. As a result, A.I. is attracting a good deal of business interest, seen in more new enterprises and investment money worldwide for applications across a range of industries and A.I. development tools.

The technology intelligence company CB Insights now compiles an annual list of new companies creating A.I. applications and tools, with the 2022 collection published this week. CB Insights uses a number of criteria to identify these 100 start-ups, including R&D activity, market potential, and technological novelty, with the list broken down into cross-industry applications, industry-specific applications, and development tools.

Of the three main categories, specific A.I. industry applications are the largest category, making up 43 of the 100 new companies in the CB Insights list. Nearly a quarter of those industry applications, 10 of 43, are in health care, including Insilico Medicine, based in Hong Kong. Science & Enterprise has reported several times on Insilico Medicine, which first began offering A.I. analytics as a service for drug discovery, and now discovers and develops its own treatments.

CB Insights says the 100 companies overall raised some $12 billion from 650 investors since 2017, with 39 of the companies still in seed or first-round venture financing. In the links below are Science & Enterprise stories describing venture funds created this year seeking to finance A.I. advances or applications.

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Addiction Therapy, VR Companies Partner on Veteran PTSD

Man in virtual reality headset

(PublicDomainPNG, Pixabay)

20 May 2022. A developer of addiction therapies and virtual reality software company are collaborating on help for veterans suffering from post-traumatic stress disorder. The partnership brings together BioCorRx Inc. in Anaheim, California that develops medications for people with alcohol and drug addictions, often combined with clinician-guided therapy programs, and 2B3D, a company in Newport Beach, California offering virtual and mixed-reality gaming experiences, but also software to assist with health care, including treatment for PTSD.

BioCorRx produces medication therapies through its pharmaceutical subsidiary for people with addictions to alcohol, opioids, and other drugs.The company’s lead program is a small pellet implanted under the skin, delivering the addiction therapy drug naltrexone continuously for three months. Naltrexone and other medications are available to help people with substance abuse disorders, but they often face a problem with compliance, since they require frequent dosing or administration in a clinic. The BioCorRx treatment is designed to overcome that problem. Last month, Science & Enterprise reported on the start of an early-stage clinical trial testing the drug, code-named BICX104.

A separate BioCorRx division offers the Beat Addiction Recovery Program that combines cognitive behavioral therapy with peer-group support, sometimes assisted with medications. Cognitive behavioral therapy seeks to highlight negative or false patterns of beliefs, then test and restructure them. By addressing these patterns, say therapists, individuals and their clinicians can develop healthier ways of thinking that replace negative beliefs.

VR, backed by blockchain

2B3D is an enterprise owned and operated by veterans that offers virtual, mixed, and augmented reality games, working in the “metaverse” that seeks to merge virtual and physical worlds. The company says its VR technology and experiences can be extended beyond games to endeavors where individuals interact through avatars in groups or communities to achieve work objectives, social goals, or health needs.

2B3D says interactions through its communities are based on blockchain, a system for capturing data about transactions in a networked ledger, but with data distributed among the various parties to the transactions. Data about a transaction are broken up into blocks, with each block connected in a chain. Each block is also time-stamped and encrypted with an algorithm giving it a unique identifier or fingerprint, also linked mathematically to the previous block in the chain. This linking of uniquely identified and encrypted blocks in the chain ensures the integrity of the data, as well as protects the data from hacking.

The company develops a VR experience called VRx providing virtual worlds for health communities and families to support therapy programs. To help veterans deal with PTSD, 2B3D provides VRx free to veterans, who interact with each other through game-style experiences. In the new collaboration, the companies aim to combine 2B3D’s VRx with BioCorRx medication and clinical programs. The companies cite data from 2017 showing veterans with substance abuse disorders are more than twice as likely to die from suicide than other veterans.

“PTSD changes brain chemistry in much the same way substance abuse and addiction do,” says Tom Welch, executive vice-president of BioCorRx in a company statement. “Often, these disorders form at the same time and feed off one another.” Rob Bell, CEO and founder of 2B3D, adds “Our virtual reality solution for PTSD will be available to all veterans, but for those who suffer from drug or alcohol addiction, there’s only so much we can do with virtual reality alone.”

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Venture Investor Funds Cell Therapy Targeting Tech

SomaCode team

Oliver Dodd, left, and Soufiane Aboulhouda, leading the SomaCode project (Wyss Institute, Harvard University)

19 May 2022. A venture capital company is funding biomedical engineering research to improve the reach and targeting of cell therapies to more diseases. The project is part of Northpond Labs, a joint undertaking of Northpond Ventures in Cambridge, Massachusetts, providing $12 million for five years to support researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University developing biomedical technologies with commercial promise.

The Wyss Institute project known as SomaCode seeks to solve a continuing problem with cell therapies, increasing the reach of these treatments to more organs and tissue in the body. As of last year, says Wyss Institute, cell therapies approved so far by FDA address blood-related cancers, such as leukemia and lymphoma, due largely to the relative ease of injected cells in reaching diseased cells in blood. Reaching diseased cells in solid organs and tissues, however, is a more complex problem, which SomaCode is taking on.

SomaCode is an initiative from the lab of George Church, professor of genetics at Harvard Medical School and a core faculty member at Wyss Institute. Doctoral candidates Soufiane Aboulhouda and Oliver Dodd lead the project that adapts high throughput genomic analysis to identify molecular signatures acting as unique indicators of specific diseases. For many diseases, those signals are generated by inflammation, associated with specific regions in the body. In some diseases, however, inflammation signals can change, making it more difficult for the immune system to find precise locations of diseased cells.

Second Northpond Labs project

Wyss Institute says SomaCode addresses this problem by genetically modifying immune-system cells to add in better targeting properties. The modified cells are collected in a pool of cells, which the researchers test for addressing specific disease targets. By repeating this process, says Wyss Institute, the SomaCode team can find cellular alterations that reliably reach diseased cells, and produce engineered cells with gene editing techniques like Crispr that work as therapies.

Northpond Labs began in 2020 as a vehicle for Northpond Ventures to support emerging biomedical technologies developed at Wyss Institute addressing important unmet needs, and with high commercial potential. SomaCode is the second technology supported by Northpond Labs. The first funded project is called eRNA, creating a more efficient and inexpensive manufacturing process for synthetic RNA oligonucleotides, short RNA sequences used in therapeutics and genome editing.

Both SomaCode and eRNA are validation projects at Wyss Institute. Validation projects have proven their concept and meet predefined technical, product development and intellectual property criteria for commercialization. Researchers on validation projects add in technical features and properties that build a stronger case for commercialization, and reduce risks to potential investors.

Aboulhouda notes in a Wyss Institute statement that the Northpond funding “allows us to significantly accelerate this exciting research,” and that the team looks forward “to work with and learn from the incredible interdisciplinary team at Northpond.” Michael Rubin, Northpond Ventures’ founder and CEO adds, “The SomaCode project team really impressed us with their systematic approach to addressing a therapeutic challenge, supported by milestone-driven deliverables and entrepreneurial drive.”

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Precision Antibacterial Company Raises $35M in New Funds

E. coli bacteria

E. coli bacteria (Agricultural Research Service, USDA)

18 May 2022. A biotechnology company creating targeted antibacterial and microbiome treatments aided by gene editing is raising $35 million in new venture funds. Locus Biosciences Inc. is a developer of antibiotics using synthetic biology and the gene editing technology Crispr to treat bacterial infections, as well as treatments for other diseases influenced by bacterial activity.

Locus Bio, a seven year-old enterprise in Morrisville, North Carolina, says it engineers viruses called bacteriophages, or phages, natural enemies of bacteria that infect and replicate inside bacteria, where the viruses produce lysin enzymes. These enzymes then break down the walls of bacterial cells, destroying the bacteria. The company says it combines high-throughput drug discovery processes with artificial intelligence to find phages with the needed properties to combat specific bacteria, then designs a collection of phages for each target.

In addition, says Locus Bio, its technology uses the gene-editing technique Crispr to destroy bacteria targeted by engineered phages. Crispr — short for clustered, regularly interspaced short palindromic repeats — edits the genomes of organisms with bacterial defense mechanisms using RNA to identify and monitor precise locations in DNA. In most gene editing cases, Crispr uses enzymes like Cas9 that cut DNA at precise locations. Locus Bio, however, says it replaces Cas9 with the enzyme Cas3, which shreds DNA beyond repair, killing bacterial cells.

Evidence of lower E. coli levels

The company’s lead product, code-named LBP-EC01, is a treatment for urinary tract infections or UTIs caused by e. coli bacteria. UTIs occur most often among women, in the bladder and urethra. If left untreated, these infections can spread to the kidneys or beyond with serious consequences. National Kidney Foundation says urinary tract infections are responsible for some 10 million doctor visits a year in the U.S., with at least 1 in 5 women likely to have an infection in her lifetime.

Locus Bio conducted an early-stage clinical trial of LBP-EC01, completed last year, which the company says met all of its safety objectives and shows evidence of lower E. coli levels in the bladders of UTI patients. Science & Enterprise reported on the start of the trial in Jan. 2020. Locus Bio says it has other products in its pipeline in preclinical development that address diseases of the microbiome, communities of bacteria and other microbes in the body, many of which are essential to good health.

The company is raising $35 million in its second venture funding round with investors that include Artis Ventures, Tencent Holdings, Viking Global Investors, Johnson and Johnson Innovation, and Discovery Innovations. Locus Bio is collaborating with Janssen Pharmaceuticals, a division of Johnson & Johnson, in developing LBP-EC01. The new financing includes a convertible note that converts a previous loan to equity. According to Crunchbase, Locus Bio raised $93.7 million in earlier rounds.

The company says in a statement it plans to apply the new funds to a mid- and late-stage clinical trial of LBP-EC01 and preclinical work on microbiome diseases, as well as further develop its manufacturing facilities. Locus Bio says its manufacturing plant is a self-contained facility for making viral therapeutics, which the company wants to enhance for producing solid-dose oral drugs.

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Disclosure: the author owns shares in Johnson & Johnson

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Companies Partner on Implanted Diabetes Beta Cell Device

Diabetes blood glucose test

(Amanda Mills, CDC.gov)

17 May 2022. A company developing implants that release cell therapies is collaborating with a producer of regenerative stem cells to dispense insulin for people with diabetes. The deal calls for Evotec SE in Hamburg, Germany to take an €20 million ($CN 27 million, $US 21 million) equity stake in Sernova Corp., in London, Ontario, Canada.

Sernova Corp. is a medical device enterprise creating implanted systems releasing long-term cell therapies that function, in effect, as replacement organs. The company’s technology platform is its cell pouch, a biocompatible device implanted in the body containing cells that generate therapeutic proteins. Sernova says the cell pouch is made of natural tissue, with cylindrical chambers that microencapsulate cells within the pouch to reduce immune rejection, although immune-protective medications are still required.

For people with diabetes, the cell pouch is implanted in the abdominal wall, containing islet or beta cells in the pancreas that produce insulin. An early- and mid-stage clinical trial assessing the system’s safety among individuals with type 1 diabetes is underway at University of Chicago, but also tracking efficacy indicators such as blood glucose levels and hypoglycemic events. Sernova is adapting its cell pouch technology as well for hemophilia A, where individuals do not produce clotting factor 8 to prevent excessive bleeding.

Help people with type 1 and type 2 diabetes

Evotec discovers and develops a wide range of therapies covering metabolic diseases, oncology, neuroscience, pain, inflammation, and infectious diseases. The company works largely through collaborations with drug companies, medical device developers, and research labs providing drug discovery services. One of Evotec’s programs offers induced pluripotent stem cells, or iPSCs, adult cells derived from patients for transformation into functioning cells, as a service for discovering regenerative treatments. The company says it operates multiple iPSC lines that can produce cells in industrial quantities. Evotec says it first partnered with Harvard University’s Stem Cell Institute to develop the service, and later employed by several other drug companies and labs.

Under their agreement, Sernova is incorporating Evotec’s iPSCs that transform into pancreatic beta cells into its cell pouch for people with diabetes. The companies expect their collaboration will result in a cell pouch implant that can help people with both type 1 and type 2 diabetes dependent on regular insulin releases. The goal, say the companies, is to develop an implanted therapy for diabetes that produces an unlimited amount of insulin.

In the deal, Sernova gains access to Evotec’s iPSCs through an option to license the technology to develop treatments for type 1 and type 2 diabetes. Also under the agreement, Evotec is making an immediate €15 million equity investment in Sernova, with another €5 million investment planned for later.

“Together we will progress a highly differentiated first-in-class beta cell therapy into clinical development,” says Cord Dohrmann, chief scientist at Evotec in a statement, “with the common goal to bring a truly transformative therapy to insulin-dependent diabetic patients. The synergies of Evotec’s and Sernova’s technologies puts Sernova in position to become the world’s leader in beta cell replacement therapy.”

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Trial Shows Gene Therapy Results with Sickle Cell Disease

Sickle cells illustration

Sickle cells illustration (Open Stax College, wikimedia commons, https://commons.wikimedia.org/wiki/File:1911_Sickle_Cells.jpg)

16 May 2022. Early results from a clinical trial show an experimental gene transfer therapy largely reduces painful events from sickle cell disease for one to two years. Findings from the trial sponsored by the therapy’s developer Aruvant Sciences are scheduled for delivery today at a meeting of American Society of Gene and Cell Therapy in Washington, D.C.

Sickle cell disease is a genetic blood disorder where hemoglobin, a protein in blood that delivers oxygen to cells in the body, causes blood cells to become crescent or sickle shaped instead of their normal round form. The abnormal shape causes blood cells to break down, become less flexible, and accumulate in tiny blood vessels, leading to anemia and periodic painful episodes. Sickle cell disease is prevalent worldwide, and affects some 100,000 people in the U.S., including about 1 in 500 people of African descent, and 1 in 1,000 to 1,400 people of Hispanic descent.

Aruvant Sciences is a four year-old biotechnology enterprise in New York developing gene therapies for rare diseases, beginning with the blood disorders sickle cell disease and beta-thalassemia where people produce lower levels of hemoglobin in their blood. The company is part of collection of businesses created by Roivant Sciences in Basel, Switzerland to develop biomedical technologies. Roivant calls the individual companies “vants” with each of the companies focusing on a particular disease or technology type. Science & Enterprise reported on formation of Aruvant Sciences in Nov. 2018.

Lower chemotherapy doses

The clinical trial is evaluating Aruvant Sciences’ lead product code-named ARU-1801 that uses benign lentiviruses to deliver a modified healthy fetal hemoglobin gene to a patient’s own blood-forming stem cells. In this case, a sample of the patient’s stem cells are extracted from bone marrow, then cultured and transformed into healthy blood-forming cells with functioning genes producing fetal hemoglobin, and infused back into the patient. This process was first developed by Punam Malik, a hematologist at Cincinnati Children’s Hospital studying gene therapies for blood disorders, and licensed to Aruvant Sciences.

The early- and mid-stage trial, led by Malik, is enrolling 10 adults with severe sickle cell disease, or SCD, in the U.S. and Jamaica. Participants first receive a form of chemotherapy to reduce immune-system interference with the ARU-1801 infusions. The company says it uses lower doses of chemotherapy to reduce chances of adverse effects. The study team tracks participants for two years looking mainly for severe or life-threatening adverse effects from the gene therapy, as well as efficacy indicators, such as fetal hemoglobin measures and number of painful episodes from sickle cells blocking blood vessels, called vaso-occlusive events. The study has no control or comparison group.

Results presented today report on four participants in the trial, age 19 to 34, receiving ARU-1801, and followed for 12 to 24 months. Researchers say participants experienced temporary low white blood cell and platelet cell counts for a median period of seven days, but otherwise no serious adverse effects from the chemotherapy or ARU-1801 treatment. In addition, two participants report no painful episodes in the 12 to 18 months following treatment, while two others report 80 and 93 percent fewer events in the 24 months after receiving ARU-1801.

“The data demonstrate,” says Malik in an Aruvant Sciences statement, “that the ARU-1801 gene therapy may not only be able to reduce severe vaso-occlusive events, but also reduce days in the hospital for SCD patients, which could provide a clinically meaningful benefit for patients and help reduce health care costs.”

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Infographic – Synthetic Opioids Driving Overdose Deaths

Chart: Opioid overdose deaths

Click on image for full-size view (Statista)

14 May 2022. While Covid-19 may grab health headlines in the U.S., the opioid epidemic is not going away, and shifting from prescription to synthetic compounds. Data from the Centers for Disease Control and Prevention, and presented in chart form this week by the business research company Statista, show overdose deaths from synthetic opioids accelerating in the U.S.

Provisional data from CDC show for 2021, drug overdose deaths of any kind reached 103,600, exceeding the 100,000 marker for the first time. And those numbers are rising each year, from nearly 68,000 in 2018 to more than 71,000 in 2019, and about 92,500 in 2020. Those numbers include both intentional overdose deaths, such as suicides and homicides, as well as accidental or unintended overdose deaths, with overdose deaths among men far exceeding those for women.

Further data breakdowns from CDC’s National Center for Health Statistics, displayed in Statista’s chart, show sharply rising numbers of overdose deaths from synthetic opioids, rather than prescription drugs or heroin. Fentanyl and other synthetic opioids account for nearly 18 deaths in 100,000 people in the U.S. in 2020, increasing dramatically since 2015. At the same time, the rate of prescription opioid overdose deaths remains relatively stable at about 5 per 100,000 population, and the rate of heroin overdose deaths dropping slightly to about 4 per 100,000.

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Early Trial Data Show Crispr Cancer Therapy Response

Crispr genome edits illustration

(NIH.gov)

13 May 2022. Initial results from a clinical trial show non-Hodgkin lymphoma patients receiving low doses of gene-edited T-cells achieve a clinical response, but with some adverse effects. Caribou Biosciences Inc. in Berkeley, California, reported the results of its experimental therapy code-named CB-010, which the company plans to present next month at a meeting of the European Hematology Association in Vienna, Austria.

Caribou Biosciences uses the gene-editing technology Crispr to create engineered immune-system cells as cancer therapies. The gene editing technology Crispr, short for clustered regularly interspaced short palindromic repeats, is derived from bacterial defense mechanisms using RNA to identify and target precise locations in DNA for editing. One of the company’s founders is Jennifer Doudna, professor of chemistry and biology at University of California in Berkeley, a co-recipient of the 2020 Nobel Prize in chemistry and scientific adviser to the company.

CB-010 is designed with Caribou Bio’s technology known as chRDNAs, pronounced “Chardonnays,” providing more precise DNA targeting than earlier forms of Crispr. The company says chRDNAs use more than RNA alone to find targeted genes, which makes possible more complex editing of T-cells and natural killer cells in the immune system. Caribou says for CB-010 it takes donated T-cells from healthy volunteers, then makes three types of edits in the cells’ genome, inserting chimeric antigen receptors or CARs that target genes coding for original T-cell receptors. Plus, the edits remove checkpoint proteins called PD-1 inhibiting immune responses to cancer, and target the CD19 protein, a characteristic indicator of B-cells found on the cell surface.

Four of five achieve complete response

The early-stage clinical trial is enrolling 50 patients with relapsed or stubborn, non-responsive cases of B-cell non-Hodgkin lymphoma, a cancer of lymph tissue in the immune system, a more common form of non-Hodgkin lymphoma in adults. Participants first are given chemotherapy to remove regulatory T-cells and similar immune cells that could compete with the treatments. The first trial participants are then given escalating doses of CB-010 to find the optimum dosage, and check for adverse effects. The study team is also assessing clinical responses to the treatments. Science & Enterprise reported on the start of the trial in July 2021.

By the 23 Feb. 2022 cut-off date, says Caribou Bio, five of the first six participants in the trial receiving a lower dose of engineered CAR T-cells in CB-010, completed the 28-day post-treatment evaluation period. All of these five individuals, says the company, experienced at least some clinical response to the treatments, with four participants reporting a complete response, indicating disappearance of cancer cells. Those complete responses continued for at least three months at the cut-off date, with one participant experiencing a complete response for six months following treatment.

The company says three of the six participants treated with CB-010 experienced problems from low red-, white, or platelet blood cell counts, or low levels of immunoglobulin antibodies that required medical attention. And one participant reported mild to moderate cytokine and immune effector cell release syndromes that required treatment, with that individual later among the complete clinical responses. No participants experienced graft versus host disease, immune system reactions that reject donated cells.

Caribou Bio says the safety and efficacy results so far support continuing the trial at a higher dose for patients.”CB-010 is the first allogeneic anti-CD19 CAR T-cell therapy in the clinic with a PD-1 knock-out,” says Rachel Haurwitz, Caribou’s president and CEO in a company statement, “a genome-editing strategy designed to limit premature CAR T-cell exhaustion, potentially leading to better tumor debulking and an improved therapeutic index through sustained anti-tumor activity.” Haurwitz adds that the results “represent important steps toward validating our chRDNA genome-editing platform as well as our plans for future development of CB-010 and our broader pipeline.”

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Roche, Global Fund to Build Local Diagnostic Processes

Transporting HIV tests

Transporting HIV tests samples in Nigeria (Anthony Abu, USIAID.gov, Flickr)

12 May 2022. The medical products company Roche is partnering with the Global Fund to develop systems and processes for disease diagnostics in low-resource regions. While the collaboration is expected to last five years, financial and intellectual property terms of the partnership were not disclosed.

Roche is a global developer of drugs and diagnostics based in Basel, Switzerland. In 2014, the company established its global access initiative to expand testing for HIV-AIDS in low-resource regions of the world, in support of the United Nations efforts to combat AIDS. Since then, Roche expanded its global-access program to include tests for tuberculosis, hepatitis B and C, human papillomavirus, and most recently SARS-CoV-2 viruses. Roche says it designed the program to support sustainable local solutions connecting supply chains to point-of-care delivery. The company says its efforts focus on diagnostics and lab testing networks to build capacity and strengthen local health care delivery.

The Global Fund — full name: The Global Fund to Fight AIDS, Tuberculosis, and Malaria — says it raises and allocates more that $4 billion a year to fight these infectious diseases in low-and middle-income countries. The group estimates about 2 billion people are infected with tuberculosis worldwide, with 37 million people living with HIV, of which 6 million are undiagnosed. In addition, says the Global Fund, the Covid-19 pandemic has interrupted HIV and tuberculosis health programs, citing data showing HIV tests declining 22 percent and 100,000 more deaths from tuberculosis occurring in low-resource countries since 2020.

Build more capacity at the local level

The Global Fund, based in Geneva, says it works with individual country governments and civil societies to devise effective interventions addressing HIV-AIDS, tuberculosis, and malaria at the local level. The group says in 2019 to 2021, it allocated about three-quarters of its funds (74%) to Sub-Saharan Africa and 16 percent to the Asia-Pacific region, with the remaining 10 percent divided between Latin America, North Africa, Middle East, Eastern Europe, and Central Asia.

In their collaboration, the Roche global access program and Global Fund plan to build more capacity for HIV and tuberculosis testing at the local level to deliver diagnostics results and better manage medical waste. To meet these goals, the partners expect to develop more effective processes for collection, transporting, and testing patient specimen samples, as well as returning results in time for meaningful interventions.

As part of this program, Roche and the Global Fund say they will address challenges including access to roads, workforce capacity, IT systems, and network infrastructure needed to perform and deliver results for HIV and tuberculosis tests. In addition, the project expects to produce new solutions for medical waste and used testing instruments, to reduce their environmental and economic burdens on local communities. The partners plan to work with government health ministries on implementing new technologies and knowledge transfer in two or three pilot projects, then scale up the program to 10 countries over five years.

“Getting people to test for HIV and TB,” says Global Fund executive director Peter Sands in a Roche statement, “is fundamental to containing transmission and enrolling people on treatment, which are crucial steps to saving lives and ending these diseases as public health threats.” Thomas Schinecker, CEO of Roche Diagnostics adds, “Connecting our experts with critical local stakeholders, we are aiming to help build sustainable solutions that could be scaled across countries.”

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Trial Set for Ingested Colon Cancer Detection Capsule

Detect cancer scrabble

(Marco Verch, Flickr)

11 May 2022. A clinical trial is set to begin assessing an electronic capsule designed to detect and transmit images from the gut to detect early cancer-causing polyps. The study is conducted by the Mayo Clinic in Rochester, Minnesota, and sponsored by Check-Cap Ltd., developer of the system, in Isfiya, Israel.

Check-Cap cites data estimating 1.9 million worldwide cases of colorectal cancer and 935,000 deaths each year, with 150,000 of those cases and 53,000 deaths in the U.S. At the same time, says the company, screening rates for colorectal cancer are low, since colonoscopies, the procedure to screen for the disease, requires extensive preparations to empty the colon, sedation of many patients, and an invasive endoscope. As a result, benign polyps in the colon in many asymptomatic individuals are going undetected, yet could be removed if identified before becoming tumors.

The Check-Cap system, called C-Scan, uses a capsule, small enough to be swallowed, containing a tiny X-ray emitting device and an image contrast agent.  The image contrast agent mixes with colon tissue, which gives off photons or light particles, read by X-ray detectors in the capsule. The close proximity of the capsule to the colon wall allows for low X-ray doses. At the same time, photons given off from the colon interact with electrons in the tissue, changing their direction and energy in measurable ways, a process called Compton scattering.

The capsule captures both sets of photons, and transmits the data to three collection units worn on the torso, where they’re relayed to a workstation. The company’s algorithms and software then process the data and prepare 3-D images of the colon interior surface for physicians, highlighting suspicious regions. Check-Cap says the C-Scan system is not intended to replace colonoscopies, but serves as a preliminary screening step. A positive C-Scan response, says the company, should be followed by a colonoscopy.

Two-part clinical trial

“Detecting precancerous polyps is needed to effectively prevent colorectal cancer,” says Check-Cap CEO Alex Ovadia in a company statement. Ovadia adds, “We believe Check-Cap has the potential to reach those who are deterred by colonoscopy and to help improve colon cancer screening through a patient-friendly solution without the need of bowel cleaning, sedation, and fasting.”

In an early-stage clinical study, reported by Science & Enterprise in Dec. 2019, 45 participants swallowed the C-Scan capsule, then had a colonoscopy to compare results. None of the participants completing the study reported any more than mild adverse effects, and later published results of the trial show the system with a true-positive sensitivity of 78 percent and true-negative specificity of 90 percent.

The new clinical trial is enrolling 952 healthy participants, age 50 to 75, at up to 15 sites in the U.S. In the first part of the study, some 200 participants will test the C-Scan system to help calibrate the device and analytics for average risk of colorectal cancer. In the second part of the trial, remaining participants will use the C-Scan system and receive a colonoscopy to detect precancerous polyps, with a sample size large enough to generate statistically reliable data for FDA’s decision-making needs.

The company expects to complete the calibration part of the trial, and begin the main data-gathering portion, in the fourth quarter of 2022.

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