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By Alan, on June 8th, 2023  (Maxpixel.net) 8 June 2023. A biological testing device company and industrial graphene manufacturer are collaborating on large-scale production of graphene biosensors for widespread use. Financial details of the partnership between Hememics Biotechnologies Inc. in Gaithersburg, Maryland and General Graphene Corp. in Knoxville, Tennessee are not disclosed.
Hememics Biotechnologies designs biological sensing devices using graphene, a material similar to graphite, but with a thickness of one atom, yet some 200 times stronger than steel, which also conducts heat and electricity, as well as absorbs light. Graphene consists of carbon atoms arrayed in an hexagonal honeycomb formation that can be combined with other elements to produce materials taking on graphene’s physical and electronic properties. A number of industries are using graphene in their products, including computer chips, display screens, antennas, energy storage, solar cells, and medical devices. The two British scientists that first isolated graphene received the 2010 Nobel Prize in physics.
Hememics Bio created a process based on research by its president and chief scientist David Ho that desiccates, or removes moisture from biological samples without altering their underlying natural structure. The company says this process makes it possible for sensing devices to read and analyze specimens faster and more accurately than before. Around this process, Hememics is developing a system with miniaturized bio-sensing chips, readers, analytics, and data transfer devices. That system, says the company can be used in handheld portable medical diagnostics, environmental sensing, and pathogen testing systems at the point of care and in the field.
Roll-to-roll manufacturing process
General Graphene is a manufacturer of graphene using an industrial-scale technology with chemical vapor deposition. The company says its process separates carbon from hydrocarbon gases that decompose at high temperature. The separated carbon then accumulates on a metallic foil, with graphene crystals forming and merging together as the foil moves through a roll-to-roll conveyor. General Graphene says this roll-to-roll process, similar to high-volume manufacturing methods for many products, produces high-quality graphene that can be fabricated into single- or multi-layer materials for refinement and use in other industries.
Hememics Bio says it has worked with General Graphene for nine months on developing graphene biosensors in large quantities for a variety of medical, environmental, military, and public safety applications. So far, says Hememics, the collaboration has produced and tested some 100,000 graphene biosensors, including devices that can detect dangerous poisons such as ricin and staphylococcal enterotoxin B or SEB, a bacterial toxin associated with food poisoning. Hememics says the tests show the graphene sensors can identify molecular and antigen evidence in ultra-low picomolar concentrations, and return results in five minutes.
The company says these graphene biosensors can be fabricated into diagnostics devices that detect multiple pathogens in a single blood or saliva sample, at levels 100 times more sensitive than lateral flow methods, such as paper test strips. “In the highly competitive world of diagnostics, speed and cost define whole product categories,” says Ho in a Hememics statement released through Cision. “At single-digit picomolar levels of detection, five-minute test times and non-clean-room manufacturing techniques, we broke through three significant barriers at once.”
The new collaboration with General Graphene is expected to expand the availability and use of graphene biosensors in portable and handheld medical devices, starting with results of the tests conducted by the two companies. “Feedback from these tests,” notes Hememics CEO John Warden, “will help a great deal in furthering products targeted for human trials.”
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By Alan, on June 7th, 2023  (Gerd Altmann, Pixabay. https://pixabay.com/illustrations/dna-analysis-research-7024975/) 7 June 2023. A developer of nanoscale lipid particles for delivering genomic therapies to specific cells and tissue, spun-off from academic labs, is raising $25 million in seed funds. Hopewell Therapeutics in Woburn, Mass. is based on research in the lab of biomedical and chemical engineering professor Qiaobing Xu at Tufts University, the company’s scientific founder and chief technology officer.
Hopewell Therapeutics seeks to provide an alternative to engineered or benign viruses for delivering gene therapies, as well as genome-editing treatments, and those with messenger RNA or mRNA and other nucleic acids. The two year-old enterprise is developing advances by Xu and colleagues at Tufts on harnessing nanoscale lipid or natural oil particles as therapy delivery mechanisms.
Xu’s lab studies the chemistry of lipids to alter their electrical charge and other properties to make deliveries with the particles safer, more accurate, and reliable. The lab notes that it maintains a library of lipid-like nanoparticles that are biodegradable, non-toxic, and designed to reach specific tissue and organs. Hopewell says it has an exclusive license from Tufts University to the Xu lab technology for a broad range of clinical and commercial applications.
Reach cells and tissue throughout the body
The company calls its process tissue-targeted lipid nanoparticles or ttLNPs. Xu says in a Hopewell Therapeutics statement released through Cision, “I began designing novel LNPs for genetic drug delivery during my post-doctoral work in the laboratory of Professor Robert Langer at MIT and carried it forward as I built my own research group at Tufts. We continue to innovate and expand our ttLNP platform, as we develop LNPs with the potential to bring next generation genomic medicines to patients with high unmet medical needs.”
Hopewell Therapeutics says its ttLNPs are designed to reach cells and tissue throughout the body, but outside the liver. In Feb. 2022, for example, Xu and colleagues published a paper in PNAS demonstrating delivery of mRNA with lipid-like nanoparticles to lab mice induced with the rare lung disease lymphangioleiomyomatosis or LAM that affects mainly women of child-bearing age. The researchers designed lipid nanoparticles that successfully delivered mRNA to correct for mutations in the tuberous sclerosis complex 2 or Tsc2 gene responsible for LAM. The authors note that most lipid nanoparticles today deliver genetic therapies to the liver and spleen.
The company’s first product, says CEO Louis Brenner, will deliver therapies for lung diseases, while also “exploring the potential of our ttLNP platform for patients with unmet needs in oncology, infectious diseases, rare genetic diseases, and neurological disorders.” The company says in addition to mRNA, its ttLNPs can also deliver small interfering RNA for gene-silencing therapies, DNA, gene-editing, and gene-writing treatments.
Hopewell Therapeutics is raising $25 million in seed funds from a group of venture investors that Hopewell says finances science-based start-ups: Mass Ave Capital, 5Y Capital, HIKE Capital, BOPU Capital, IMO Capital and WS Investments. The company says the funds are administered in a series of tranches, with most of the funds already delivered. According to Crunchbase, Hopewell already raised $8 million in Oct. 2021 and $7.1 million in Feb. 2022.
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By Alan, on June 6th, 2023  Vaccine patch system in use (Vaxxas Pty Ltd) 6 June 2023. Initial results from a clinical trial show a patch device delivering a Covid-19 vaccine is well tolerated by recipients and triggers a measurable immune response. Results of the trial were presented yesterday at the Biotechnology Innovation Organization or BIO annual meeting in Boston, by the vaccine technology company Vaxxas Pty. that developed the device.
Vaxxas — in Cambridge, Mass. and Brisbane, Australia — is creating an alternative method to conventional syringes for delivering vaccines, a single-use patch applied to the skin the company calls a high-density microarray patch, or HD-MAP. The plastic HD-MAP patch contains some 1,700 tiny projections, about 0.25 millimeters in length, with a vaccine coated on the tips. Vaxxas says the patch’s projections penetrate only the skin’s outer layer, enough to trigger a reaction from the immune system but without causing pain. That initial immune reaction, says the company, carries the vaccine from HD-MAP to the lymph nodes, where it induces a more general immune response. The vaccine-laden patch is delivered in a spring-fed single-use cylinder, pressed and held on the skin for two minutes.
In this case, the vaccine is HexaPro, designed to protect against the SARS-CoV-2 virus responsible Covid-19 infections and disease. Unlike most conventional Covid-19 vaccines, including those made with messenger RNA, HexaPro is made with a synthetic protein formulated to remain bioactive in ambient conditions, thus not needing constant refrigeration from production through administration. HexaPro is a product of molecular biology and engineering labs at University of Texas in Austin, licensed to Vaxxas.
Eight-fold higher antibody levels
The early-stage clinical trial enrolled 44 healthy adults at a clinic in Australia, age 18 to 50, already vaccinated against Covid-19. Participants received three applications of the device, randomly assigned for a partial or full dose or a placebo. Participants were assessed for SARS-CoV-2 antibody levels before the trial, then tracked at periodic intervals for 90 days. The study team is looking for mainly for any adverse reactions to the patch and vaccine, including skin irritations and swelling at the application site, as well as more serious adverse effects. The team is also measuring antibody concentrations in blood and saliva samples during that 90-day period. Science & Enterprise reported on the start of the trial in Nov. 2022.
At the BIO meeting, Vaxxas reported on the study’s findings after 28 days. The company says the HD-MAP patches are well tolerated by recipients with no serious adverse effects. In addition, an analysis of blood and saliva samples show vaccine recipients with an eight-fold higher concentration of relevant antibodies, on average, and also a greater antibody response among those receiving the higher vaccine dose.
“We believe,” says Vaxxas CEO David Hoey in company statement released through BusinessWire, “our patch-based delivery of a next generation spike protein has the potential to offer best-in-class protection against Covid-19 along with cost-effective distribution without the need for extensive refrigeration.”
In clinical studies so far, HD-MAP vaccines are administered by clinicians to provide for consistent conditions. However, as reported by Science & Enterprise in Mar. 2023, Vaxxas is also assessing the feasibility of self-administration by patients, with findings from a clinical trial showing vaccines applied by participants to their own arms with the device works as well in the skin as when administered by clinicians.
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By Alan, on June 5th, 2023  (Shutterbug75, Pixabay. https://pixabay.com/photos/camera-aperture-digital-camera-dslr-1239384/) 5 June 2023. A last-minute photography gig came up, so there will be no editorial post today on Science & Enterprise. We will resume our regular posting tomorrow.
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By Alan, on June 3rd, 2023  Click on image for full-size view (Statista) 3 June 2023. Science & Enterprise occasionally reports on new uses for virtual reality or augmented reality in business and medical systems, particularly when based on research evidence. Virtual reality or VR is a simulated three-dimensional sensory experience that replaces an individual’s real-world environment, while augmented reality or AR superimposes digital text, visual, or audio data in real time on a person’s real world experiences.
While applications of VR and AR technologies can seem compelling, the numbers of people actually using these systems remain relatively small. The business research company Statista released data yesterday from its Market Insights report on VR and AR showing some 98 million VR users and 23 million AR users worldwide. Those user numbers are expected to reach or exceed 120 million for VR in 2025 and 90 million for AR in 2026. By comparison, smartphone users today number in the billions.
VR games are currently, and by a wide margin, the top use of the technology and Meta, parent company of Facebook, has largely owned the VR gaming market up to now. But Apple is expected to announce a VR/AR headset at its worldwide developers conference that begins on Monday. Historically, Apple has shown it can dominate markets with dramatic advances in technology, such as iPod and iPhone.
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By Alan, on June 2nd, 2023  Mandrill, a primate species (Mhy, Pixabay. https://pixabay.com/photos/animal-mandrill-primate-species-396289/) 2 June 2023. A genomic systems company created an artificial intelligence algorithm from primate genomic data that identifies possible disease-causing mutations in humans. The data and analysis from the algorithm developed by Illumina Inc. in San Diego and academic researchers are published in today’s special issue of the journal Science (paid subscription required) with additional reports on primate evolution in the companion journal Science Advances.
An international research team organized by Illumina, a maker of high-throughput genomic sequencing systems, seeks to broaden the focus of most large-scale genome analytics that focus on human genetics, which often suffer from a preponderance of data on Europeans. This lack of diversity, say the authors, limits the effectiveness of genomic analysis, noting that only about one-tenth of one percent (0.1%) of the more than 70 million possible human protein-altering genomic variations in clinical databases are annotated, with the rest of unknown or uncertain importance.
Humans are part of the primate order that includes species ranging from small lemurs to gorillas and orangutans. For this study, the researchers took a different approach to analyzing human genomics by broadening the scope to the entire primate order. The authors note that human and non-human primates share a largely common genome with near-perfect amino acid sequences among the species. The team hypothesized that genomic variants common to human and non-human primates are unlikely to cause disease, since they survived natural selection in their evolutionary past stretching back tens of millions of years.
Identify more than 4 million unclassified variants
More than 100 researchers led by Kyle Farh, Illumina’s vice president for A.I., obtained whole-genome data from 809 individual cases representing 233 primate species. From those primate genomes, the team identified 4.3 million common missense variants, mutations where a single base pair of amino acids is different from the usual base pair in that sequence, which can alter the corresponding protein in the species. The researchers note that common missense variants between humans and at least one other primate are annotated in 98.7 percent of entries classified as benign in the ClinVar database of genomic variations linked to disease. And the authors note that as a result of their analysis, ClinVar can now identify more than 4 million previously unclassified missense variants as benign, a 50-fold increase.
Yet the vast majority of missense variants in the human genome remain unclassified. To help clarify their status, Farh and colleagues built an algorithm called Primate AI-3D, based on a convolutional neural network that combines image analysis with machine learning. The researchers trained the algorithm on 3-D protein structure images from AlphaFold, an A.I. system that builds protein structures from amino acid sequences. The team also designed the algorithm to separate variants common to all primates from matched controls, and predict human disease-causing probabilities.
The researchers tested and validated Primate AI-3D against 15 other machine-learning algorithms on four disease databases, to distinguish between benign and disease-causing genomic variations, in six different clinical benchmarks, with authors noting that Primate AI-3D outperformed them all. In the UK Biobank, a database with correlated genomic and health data on a half-million U.K. residents, the algorithm found many people considered healthy, particularly those of non-European origin, are at increased risk of common diseases.
“What we find,” says Fahr in an Illumina news feature, “is that 97 percent of otherwise healthy people in the general population carried highly actionable variants for clinically relevant conditions.” Fahr adds,”Up to now we’ve learned that you need genome sequencing if you have a rare disease or cancer. But actually it looks like every healthy person in the population has highly impactful variants in our genomes that are clinically relevant and are important to be informed about.”
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By Alan, on June 1st, 2023  (Radu Marcusu, Unsplash) 1 June 2023. A clinical trial is underway testing an experimental therapy for peanut allergy that its developer says trains the immune system without using peanut proteins. The study is sponsored by Aravax Pty. Ltd. in Melbourne, Australia that designed a treatment for adjusting immune-system responses in people with peanut allergies before immune cells react directly to allergens in peanuts.
Aravax is a biotechnology enterprise whose sole business is peanut allergy therapies. The company’s technology is based on immunology research at Monash University in Melbourne seeking alternatives to most other peanut allergy treatments that train the immune system to accept allergy-inducing proteins in peanuts. The therapies work with small escalating doses of peanut proteins to desensitize reactive immune-system cells and limit or stop release of histamines that cause inflammatory responses. Those responses can range from mild itching to life-threatening anaphylaxis.
Aravax says the technology in its lead product code-named PVX108 targets T-cells that regulate and balance reactions by other immune system cells responding directly to allergens, in this case allergy-inducing peanut proteins. The company says it uses peptides, short chains of amino acids, that interact with T-cells to adjust their normally reactive responses to offending allergens. When people with peanut allergies are exposed to a series of these peptide treatments, says Aravax, their immune systems learn to accept peanuts, but without using peanut proteins that can cause adverse effects in some cases.
Changes in peanut-specific indicators
The company tested PVX108 in an early-stage clinical trial with adults having peanut allergies. The study exposed participants to escalating doses of PVX108 or a placebo over 16 weeks, with the study team looking primarily for adverse effects. A follow-up study tracked participants over 18 months taking blood samples for changes in biomarkers or molecular indicators of changes in their immune systems. Aravax says the trial shows PVX108 is safe and well-tolerated, including among participants with asthma, and after one year induces changes in peanut-specific cellular and antibody indicators.
The new trial is a mid-stage study enrolling 90 children and adolescents, age 4 to 17, in Australia with peanut allergies. Participants are randomly assigned to receive one dose of PVX108 or a placebo every four weeks as an injection under the skin for one year, with low and higher doses tested among younger children. All participants are given supervised peanut challenges before and after treatment, and are tracked for up to 74 weeks.
The study team is looking mainly at the maximum amount of peanut protein participants can tolerate after treatments with PVX108 at week 46, compared to the beginning of the trial. The researchers are also monitoring participants for adverse effects from the treatments, particularly severe effects, and several other health indicators. The company says it plans to expand the trial to sites in the U.S. by the end of the year.
Aravax’s chief scientist Sara Prickett, one of the original academic researchers behind the company’s technology, is speaking about PVX108 at the European Academy of Allergy and Clinical Immunology Congress in Hamburg, Germany later this month. Prickett says in a company statement released through Cision, she expects to talk about the “progress being made at Aravax to tackle peanut allergies, an issue that affects millions of people globally.” She adds, “I’ve seen the impact that peanut allergies not only have on patients, but also families.”
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By Alan, on May 31st, 2023  E. coli bacteria (Volunteer7, Wikimedia Commons. https://commons.wikimedia.org/wiki/File:102125192_ecoli.jpg) 31 May 2023. A clinical trial shows an oral therapy with engineered viruses delivers precise gene-edited payloads to reduce E. coli communities in the gut with no serious adverse effects. Initial findings from the trial were released today on the web site of Snipr Biome ApS in Copenhagen, Denmark, developer of the experimental drug code-named Snipr001, and are not yet peer-reviewed.
Snipr Biome is a biotechnology enterprise that designs gene-edited treatments for infections in the microbiome, communities of bacteria and other microorganisms in the gut and elsewhere in the body. The company’s process employs the genome editing technique Crispr, short for clustered regularly interspaced short palindromic repeats. Crispr is based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA.
Snipr Biome says its process delivers DNA sequences edited with Crispr and Cas editing enzymes, which code for therapeutic peptides, short strings of amino acids, to kill harmful gut bacteria and prevent infections, while sparing beneficial microbes. The company’s delivery mechanisms are either engineered bacteriophages, or phages, natural viral adversaries of bacteria, or bacterial conjugation, where genetic materials are transferred from one bacterium to another through direct contact.
Developed for high-risk cancer patients
In this case, Snipr Biome designs Snipr001, its lead product, with four engineered phages to deliver edited DNA to kill harmful strains of Escherichia coli or E. coli bacteria in the gut. The company says it developed Snipr001 for patients with blood-related cancers like leukemia or lymphoma at high risk of infection, by destroying harmful and antibiotic-resistant E. coli in the gut before reaching the blood stream. The usual treatments, says Snipr Biome, are broad spectrum antibiotics such as fluoroquinolone that are already used excessively, contributing further to the global problem of antibiotic-resistant microbes.
The early-stage clinical trial enrolled 36 healthy adult volunteers, randomized two-to-one to receive one of three Snipr001 dose levels or a placebo, once a day for seven days. The study team looked mainly for adverse effects from the treatments, for up to 35 days after the seven-day treatment regimen. The researchers also tracked participants for another 152 days, for any lingering adverse effects. And the team took fecal samples from participants before, during, and after giving Snipr001, to gauge gut E. coli levels in participants as well as the feasibility of collecting these data. Science & Enterprise reported on the start of the trial in Apr. 2022.
Snipr Biome says participants report only mild to moderate adverse effects from Snipr001 treatments, with no serious adverse effects nor any withdrawals from the trial. The company does not specify the adverse effects experienced by participants. Snipr Biome also reports evidence of Snipr001 in fecal samples taken from participants, as well as lower E. coli levels in the samples of Snipr001 recipients. However, the company does not report any numerical data.
Christian Grøndahl, CEO and co-founder of Snipr Biome says in a company statement that the study provides “clinical validation for this innovative treatment.” Grøndahl adds, “With the combined killing effects of bacteriophages and Crispr-Cas technology, Snipr001 has demonstrated the ability to target and eliminate antibiotic-resistant E. coli strains in the gut, providing a safe alternative to traditional treatments that do not work against antibiotic-resistant strains, while sparing the rest of the gut microbiome.”
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By Alan, on May 30th, 2023  Colorized scanning electron micrograph of a T lymphocyte. (NIAID) 30 May 2023. A clinical trial has begun testing a treatment for solid tumor cancers using engineered T-cells with proteins to attack specific tumor cells, but also avoid healthy cells. The study is conducted by A2 Biotherapeutics Inc. in Agoura Hills, California, assessing the safety of its experimental therapy code-named A2B530 in patients with colorectal, pancreatic, and non-small cell lung cancers.
A2 Biotherapeutics is a five year-old company that says its biotechnology process is designed to overcome a shortcoming in many of today’s cancer immunotherapies, namely imprecise targeting of cancer cells. While these cancer treatments use altered T-cells from the immune system to seek out tumor cells expressing characteristic antigen molecules, says the company, those same antigens are also found on some healthy cells. As a result, many of today’s immunotherapies can cause off-target toxic effects.
To meet this problem, A2 Bio says its technology, called Tmod, modifies a cancer patient’s T-cells with chimeric antigen receptor proteins, or CAR T-cells like other immunotherapies, but takes the process further. Its cancer treatments include activator protein molecules targeting precise antigens of the patient’s tumor, but also a blocker protein that stops the activator from attacking healthy cells. The blocker looks for expression of a certain human leukocyte antigen or HLA protein on the cell surface indicating a healthy state, from a characteristic genomic pattern called heterozygosity.
Patients first screened in associated trial
A2 Bio says A2B530, the therapy candidate tested in the clinical trial, uses CAR T-cells with an activator protein that seeks out tumor cells expressing the characteristic carcinoembryonic antigen, and the blocker protein looking for HLA-A*02 proteins on cells indicating a healthy state. Thus A2B530 attacks only cells displaying the carcinoembryonic antigen, but also without an HLA-A*02 protein, indicating tumor cells, and sparing healthy cells.
The early- and mid-stage clinical trial is enrolling 160 participants in the U.S. with colorectal, pancreatic and non-small cell lung cancers considered non-treatable with surgery, locally advanced, or metastatic, and expressing the carcinoembryonic antigen. Participants are first screened in an associated clinical trial for loss of HLA proteins on tumor cells, with T-cells harvested from those patients meeting those criteria, and personalized A2B530 treatments manufactured for each patient. A2 Bio collaborated with Tempus Labs in Chicago that uses artificial intelligence algorithms to develop companion diagnostics for this screening system.
Trial participants are preconditioned with chemotherapy to remove their existing T-cells, followed by infusion of the treatments, and the company says the first A2B530 dose in the trial was administered. The study team is looking initially for adverse effects, such as overreaction by the immune system called cytokine release syndrome or toxicity to nerve cells at different A2B530 dosage levels. Participants are also tracked for two years on their response rates to the treatments. In addition, the study team is testing participants for the persistence of A2B530 as well as cytokine levels in blood samples over two years.
“Tmod CAR T,” notes A2 Bio’s chief medical officer William Go in a company statement, “is designed to address the fundamental challenge of selectivity in solid tumor targeted therapy: to avoid on-target, off-tumor dose-limiting toxicity.” Company CEO Scott Foraker adds, “This is the first medicine of an innovative pipeline that leverages the selectivity provided by the blocker to provide potentially safer and more efficacious therapeutics for cancer patients.”
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By Alan, on May 29th, 2023  Memorial Day 2010, at the Vietnam War Memorial in Washington, D.C. (A. Kotok) 29 May 2023. It’s Memorial Day today in the U.S., a day to honor those who gave their lives in the service of this country. We’ll resume our editorial posting tomorrow.
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Welcome to Science & Enterprise Science and Enterprise is an online news service begun in 2010, created for researchers and business people interested in taking scientific knowledge to the marketplace.
On the site’s posts published six days a week, you find research discoveries destined to become new products and services, as well as news about finance, intellectual property, regulations, and employment.
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