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By Alan, on December 8th, 2023  Killer T-cells surround a cancer cell (NICHD, Flickr) 8 Dec. 2023. The developer of an experimental immunotherapy delivering nanoscale payloads to treat pancreatic cancer says the treatment received fast-track status from the Food and Drug Administration. The biotechnology company EnGeneIC in Sydney, Australia is developer of cancer therapies delivered directly to tumor cells, guided by synthetic antibodies that it says avoid toxicity to healthy tissue.
The EnGeneIC technology packages cancer-killing treatments, either conventional chemotherapies or synthetic interfering RNA, as glycolipid or carbohydrate/natural oil particles about 400 nanometers across; one nanometer equals one billionth of a meter. The company says its EnGeneIC dream vectors or EDVs can concentrate up to one million molecules of the cancer-killing drugs, much higher concentrations than given systemically to patients, making them more potent in destroying tumors. EnGeneIC says at 400 nanometers, EDVs are too large to pass through blood vessel linings in healthy tissue, but will escape through in leaky blood vessels in microenvironments, the supportive mass of cells and blood vessels surrounding tumors.
The company says its EDVs are guided to tumors by synthetic antibodies designed to target epidermal growth factor receptor proteins, overexpressed on cell surfaces in the vast majority of solid tumors. Once on the cell surface, says EnGeneIC, the nanoscale therapy payloads are ingested through the cell membrane, then broken-down inside the cell, releasing their cancer-killing contents, thus minimizing toxicity elsewhere. In addition, says the company, the presence of EDVs creates a microenvironment more receptive to immune responses, with a preclinical study showing a greater production of dendritic, macrophage, natural killer, and tumor-specific T-cells that can prolong remission times.
EnGeneIC is testing its EDVs in a clinical trial among patients with advanced pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer that begins in the lining of the ducts carrying enzymes from the pancreas. Pancreatic cancer in many cases is difficult to diagnose in its early stages, making treatments more problematic once detected in later stages. The early- and mid-stage trial is enrolling up to 40 patients in Australia with advanced pancreatic ductal adenocarcinoma or PDAC expressing epidermal growth factor receptor proteins. The study team is looking for safety indicators, such as adverse effects from the treatments to determine safe dose levels, as well as anti-cancer activity, immune responses, and survival times. The trial has no control or comparison group.
Six months vs. two months average survival time
Initial results of the trial, published last month in the journal Clinical Cancer Research, report on 25 enrolled patients, of which seven patients dropped out due to the rapid advance of their disease, and one withdrew consent. The study team reports that before the withdrawal of these participants, 19 of the 25 reported mild to moderate adverse effects, which were resolved within hours, but showed no other safety-related concerns. Patients also exhibited minimal to no toxicities from the treatments.
Moreover, eight of the 17 patients completing the trial survived more than six months, compared to historical average survival times of two months. In addition, say the authors, 80 percent of patients receiving EDV treatments maintained their body weights or gained weight, compared to the severe weight loss seen in most pancreatic cancer patients.
FDA awards fast-track status to experimental drugs for serious unmet medical conditions exhibiting superior effectiveness, fewer adverse effects, reduced toxicities, or meeting key public health priorities. Treatments with fast-track status gain more frequent meetings and written communications with FDA staff, and are eligible for expedited or rolling (stage-by-stage) reviews.
In an EnGeneIC statement released through Globe Newswire, the company says fast-track status from FDA will help expedite clinical trials of EDVs for pancreatic cancer patients in the U.S. Co-founder and CEO Himanshu Brahmbhatt notes, “We are committed to expeditiously advancing our clinical program for PDAC patients and others with low survival cancers. These are the patients who need it most.”
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By Alan, on December 7th, 2023  (NIH.gov) 7 Dec. 2023. A developer of treatments for brain disorders and researchers at Stanford University aim to harness ultrasound to deliver drugs in nanoscale particles to precise regions of the brain. The collaboration brings together Cordance Medical in Mountain View, California with radiologist Raag Airan and neuroscientst Nolan Williams, members of the Stanford Medicine faculty.
Cordance Medical is a five year-old biotechnology company creating non-invasive devices for diagnosing and treating brain diseases. The company’s technology uses ultrasound to help drug treatments cross the blood-brain barrier, a collection of tightly packed cells lining blood vessels in the brain preventing foreign substances from entering the brain. Those foreign substances include most drugs, making it more difficult to treat brain disorders, including cancer and neurodegenerative diseases such as dementia and Parkinson’s disease. The blood-brain barrier also limits cells from brain tumors from entering the general blood stream, preventing the growing use of liquid biopsy blood tests to detect brain cancers.
Cordance Medical devices use ultrasound, a form of targeted sound waves, focused on precise areas of the brain to gently stretch blood vessels in those regions, allowing drugs to pass in or circulating tumor cells to pass out. Low-frequency ultrasound waves, says the company, create micro-scale bubbles that vibrate in the blood stream expanding blood vessels to allow drug molecules or circulating tumor cells to pass through. Patients wear a Cordance helmet-like headgear that concentrates the ultrasound waves on regions of the brain previously identified through MRI or CT scans. In October 2023, the company’s NeuroAccess device to enable liquid biopsies received a Breakthrough Device designation from the Food and Drug Administration.
Delivery with ultrasound to cerebrospinal fluid
In the collaboration with Stanford medical school, Cordance Medical is joining with researchers Raag Airan and Nolan Williams to study targeted drug delivery with nanoscale drug particles activated by ultrasound. Airan’s lab investigates precise drug delivery to the brain with both drug nanoparticles and ultrasound, with research published last year demonstrating the group’s techniques in lab rats delivering drugs to cerebrospinal fluid with ultrasound. Williams is part of Stanford’s Brain Stimulation Lab that studies neurostimulation as a psycho-pharmalogical process for treating neurological and psychiatric disorders.
The collaboration with the Stanford neuroscientists seeks to adapt Cordance Medical’s NeuroAcess device for releasing drug-loaded nanoparticles with ultrasound in precisely targeted brain locations. The company says this “uncaging” capability goes beyond the technology’s original blood-brain barrier objectives, to treat a range of neurological and psychiatric disorders, while minimizing adverse effects.
Ryan Dittamore, CEO of Cordance Medical, says in a company statement that the agreement is “a critical step forward in the field of precision neuropsychiatry.” Dittamore adds, “Our NeuroAccess platform, when paired with Dr. Airan’s novel nanoparticles, has the potential to revolutionize patient care by providing more precise control of neural activity.” The agreement, says the company, includes a first-in-human clinical trial in patients with chronic pain, testing a nanoparticle formulation of the drug ketamine.
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By Alan, on December 6th, 2023  Natural killer cell (NIAID, Flickr. https://flic.kr/p/Lnh5i1) 6 Dec. 2023. A developer of treatments for cancer and autoimmune disorders from stem cells says FDA cleared its request to start a clinical trial of its therapy for systemic lupus erythematosus. Century Therapeutics, a biotechnology company in Philadelphia, says the Food and Drug Administration authorized a study of its experimental drug code-named CNTY-101, already in an early-stage trial for B-cell lymphoma, a blood-related cancer.
Systemic lupus erythematosus or SLE is the most common form of the chronic autoimmune disease lupus. An autoimmune disorder occurs when the immune system attacks healthy cells or tissue rather than an invading pathogen. In the case of SLE, connective tissue like joints or skin are affected, with symptoms like arthritis pain or skin rash, but also hair loss, sores, swollen glands, fatigue, and inflammation of linings of the heart or lungs. The disease can also lead to kidney damage, heart disease, and breathing difficulties. SLE is a complex disease, with no known single cause, but believed to be a combination of genetic and environmental triggers.
Century Therapeutics is a five year-old company spun-off from labs at Massachusetts General Hospital in Boston and Stanford University in Palo Alto, California. Immunologist Marcela Maus at Mass. General and Harvard Medical School, one of the company’s scientific founders, studies the biology and engineering of T-cells in the immune system as cancer therapies, while cell biologist Hiromitsu Nakauchi at Stanford medical school, also a scientific founder, investigates clinical applications of stem cells. Century Therapeutics licenses technology for stem cell transformation and production from Fujifilm Cellular Dynamics in Tokyo. Science & Enterprise reported in July 2019 on the company’s raising of $250 million in its first venture round.
Gene edits to evade immune detection
CNTY-101, Century Therapeutics’ lead product, is made from off-the-shelf induced pluripotent stem cells, also known as adult stem cells, transformed into natural killer cells in the immune system. The company says it uses the genomic editing technique Crispr, short for clustered regularly interspaced short palindromic repeats, to edit the genes in stem cells to target their therapeutic effects, as well as evade detection from the immune system called Allo-Evasion, allowing the therapies to work. CNTY-101 is being tested in an early-stage clinical trial at two sites among patients with B-cell non-Hodgkin’s lymphoma, begun earlier this year, looking mainly for safety and tolerated dosage, but also clinical responses to the treatments.
Century Therapeutics says FDA cleared its investigational new drug or IND application for a similar early-stage clinical trial testing CNTY-101 among patients with SLE. The new trial, says the company, will investigate the treatment’s safety and tolerability in participants, as well as chemical activity in the body and any clinical responses. Century Therapeutics expects the study to begin in the first half of 2024, with initial results by the end of the year.
“We believe the unique profile of CNTY-101,” says Century Therapeutics CEO Brent Pfeiffenberger in a company statement, “which incorporates multiple precision edits including our Allo-Evasion technology, positions it as an off-the-shelf allogeneic treatment option that could meaningfully improve outcomes for patients with SLE for whom existing therapies fall short.”
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By Alan, on December 4th, 2023  DNA Card (Biomemory, Cision) 4 Dec. 2023. A company developing DNA into a feasible method for large-scale data storage unveiled a credit card-sized device using DNA for off-line data storage. Biomemory, a two year-old biotechnology company in Paris, now offers its DNA Card that the company says can hold 1 kilobyte or 1,000 characters of text, as a practical demonstration of its technology.
The company says DNA data storage makes it possible to store digital data at one million times more density than current media, such as solid-state drives or magnetic tape, to meet a rapidly growing need for reliable data storage. And, says Biomemory, DNA offers a much more durable medium for data storage than current technologies, as evidenced by the ability to retrieve and decode DNA from fossils of extinct animals unearthed after many thousands of years. In addition, the company says its process is environmentally friendly and remains stable at ambient temperatures, without an external energy source, and emits no carbon dioxide.
Science & Enterprise reported on Biomemory in Nov. 2022, when the company raised €5 million in seed funds. At the time, researchers from Biomemory had recently posted a manuscript describing the company’s process called DNA Drive that uses an algorithm to encode binary data into DNA sequences. Biomemory creates synthetic DNA reflecting those sequences for assembly into bacterial DNA plasmids, where the encoded DNA sequences are amplified and extracted for storage. When needed, the company’s algorithm decodes the stored DNA sequences back into binary data.
DNA extracted and decoded
The DNA Card, says Biomemory, uses this process to create a chip in the card that stores data specified by the user in synthetic DNA. Individuals send the company one kilobyte of data for encoding into DNA, equivalent to a short paragraph of text, that Biomemory returns to the individual encoded into DNA on two identical cards. The company then asks the recipient to send one of the cards to its partner Eurofins Genomics that provides genomic sequencing services. Eurofins Genomics extracts the DNA from the customer’s card, sequences the DNA, and returns the text to the user for comparison with the original. Biomemory charges a fee of €1,000 ($US 1,080) for the service.
While the amount of data on a DNA Card is limited, Biomemory says it’s still a major advance in DNA data storage. “After years of talk about the potential of molecular computing,” says Biomemory CEO Erfane Arwani in a company statement released through Cision, “we are incredibly proud to bring the first DNA data storage product to market, that not only pushes the boundaries of innovation but also aligns with our commitment to environmental sustainability and efficiency.”
The company says it’s scaling up the process to met the constantly expanding storage needs of data centers. By 2026, says Biomemory, the company plans to unveils its Biomemory Prime service for storing 100 petabytes of data. One petabyte is equivalent to 1,024 terabytes, with one terabyte equaling some 1 trillion bytes of data.
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By Alan, on December 1st, 2023  (Manolo Franco, Pixabay) 1 Dec. 2023. A collaboration between biotechnology and dairy products businesses seeks to identify peptides in milk to form into dietary supplements for people with mood disorders. Financial and intellectual property details of the agreement between the biotechnology enterprise Lactocore Group and food products company Ingredia Dairy Experts SA were not disclosed.
Lactocore Group is a five year-old company in Boston and Berlin discovering therapeutic peptides, short chains of amino acids, for mental health and metabolic conditions in humans, farm animals, and pets. The company says it uses computational techniques to screen and identify peptides in milk with potential as therapies, followed by further behavioral screening with Zebrafish models and preclinical development in lab cultures and animals. The Lactocore technology is based on research in physiology, biochemistry, and molecular biology by the company’s founders at Moscow State University and elsewhere in Europe. In Aug. 2023, the company joined the Biolabs business accelerator in Heidelberg, Germany.
The company focuses on peptides because of their record of safety and tolerability, since they readily break down into amino acids that are easy to absorb. The lead product at Lactocore is a peptide code-named LCGA-17m16 to address anxiety and depression. The company says LCGA-17m16 limits the alpha 2 delta or a2d protein that acts on gamma-aminobutyric acid or GABA receptors in the brain. GABA receptors are nervous system activity inhibitors, kept in balance with excitatory proteins in healthy individuals. Several psychiatric disorders, including anxiety and depression, are associated with low GABA concentrations in the brain.
Extracts functional proteins and other bioactive ingredients
In Aug. 2021, Lactocore co-founder and CEO Anton Malyshev and colleagues in Russia and the U.S. reported in the journal Frontiers in Neuroscience on discovery and tests with lab mice of LCGA-17 peptide. The authors say the screening process shows LCGA-17 has a high affinity for a2d proteins and GABA receptors, and lab tests show the peptide binds with rodent brain cells comparable to leading psychiatric drugs. In further tests, lab mice induced with anxiety and depression, then given LCGA-17 peptides, are able to complete exercises indicating little anxious or depressive behavior.
The collaboration with Ingredia aims to develop food supplements enriched with therapeutic peptides to help relieve mood disorders in humans and animals. Ingredia, based in Arras in northern France, is a dairy cooperative that also extracts and markets ingredients from milk, including functional proteins and other bioactive ingredients. In their project, Lactocore and Ingredia are investigating peptides derived from cow milk after hydrolysis or chemical reactions in water. The team plans to screen the hydrolyzates with mass spectrometry, a process to identify the results at a fine level of granularity to isolate specific peptides for further development.
The project expects to begin in Jan. 2024. “Peptides have vast and diverse physiological effects in humans and animals,” says Malyshev in a Lactocore statement released through Cision. Malyshev adds, “This long-term partnership with Ingredia, an industry leader in the European segment of functional ingredients, marks a significant expansion in our research domain.” Future collaborations between the companies are expected to focus on peptides for metabolic conditions, Lactocore’s other therapeutic area.
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By Alan, on November 30th, 2023  Embrace2 smart watch (Andres Babic, Empatica Inc.) 30 Nov. 2023. A developer of medical monitoring systems with data from wearable devices will soon start asking individuals with epilepsy to offer data for an algorithm that predicts seizures. Empatica Inc. in Boston today announced the study that aims to capture evidence from people with epilepsy in the general population, for an algorithm demonstrated earlier with a few participants.
Empatica designs and markets wearable devices for research, clinical trials, and monitoring health conditions. One of its devices is a smart watch called Embrace2 for people with epilepsy that detects possible convulsive seizures, including during sleep. Epilepsy is a neurological condition affecting more than one percent of the U.S. population causing recurring seizures. Those seizures can range from brief loss of awareness to muscular twitching or shaking and loss of consciousness called convulsions. The Empatica seizure-detector watch, cleared by FDA, detects changes in electrical activity on the skin, and connects wirelessly to a phone app that alerts parents or caregivers of a seizure, as well as another diary-style app that shows patterns of seizures.
Until recently, forecasting rather than detecting the onset of seizures required capturing data with an electroencephalogram or EEG that requires wearing a helmet-like device with electrodes attached to the scalp. In Nov. 2021, a team from the Mayo Clinic and other institutions reported on an algorithm that processes data captured from a clinical-grade Empatica watch. This device detects changes in several physiological indicators in addition to electrical activity on the skin. The team developed a recurrent neural network, a machine-learning algorithm that processes data in sequence over time, which accurately predicted seizures in five of six subjects with epilepsy.
Physiological and lifestyle indicators, and seizure experiences
The new initiative seeks to validate the earlier proof-of-concept findings, as well as further develop the algorithm with data and experiences from the general population of people with epilepsy. The study expects to capture data from participating individuals with an Empatica watch and app, measuring several physiological and lifestyle indicators, along with their seizure experiences. Empatica expects to begin enrolling participants in Jan. 2024, but interested individuals can pre-register on the company web site.
“Seizure forecasting has long been among the most-requested features for people with epilepsy,” says Rosalind Picard, Empatica co-founder and chief scientist in a company statement released through BusinessWire. Picard adds, “Patients with epilepsy understand the toll that uncertainty around seizures takes and we hope that this study will help give them better control over their life, reducing stress and perhaps also enabling early interventions that ultimately reduce or prevent seizures from happening.”
Empatica is spun-off from the Media Lab at Massachusetts Institute of Technology, where Picard is director of affective computing research. Science & Enterprise reported most recently on the company in Nov. 2022, when FDA cleared Empatica’s continuous patient monitoring system that collects real-time data on four digital health indicators for home patient care.
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By Alan, on November 29th, 2023  (Bruno Aguirre, Unsplash. https://unsplash.com/photos/couple-sitting-on-the-bench-uLMEcr1O-1I) 29 Nov. 2023. A new challenge competition from XPrize calls for proactive and accessible health care solutions for improving the quality of life among older people worldwide. The XPrize Healthspan challenge, announced today at the Global Healthspan Summit in Riyadh, Saudi Arabia, expects to award up to $101 million to the winning entry, with pre-registration and public comment periods now open.
The XPrize Healthspan competition aims to close the gap between longer lifespans and the quality of life experienced by people as they age. While global life expectancy has increased in recent years, people in their later years are experience more chronic disease and disability, adding misery to their lives and trillions of dollars in health care costs for medical care. XPrize cites data showing the percentage of people worldwide age 60 and older is expected to double to 22 percent by 2050, creating an urgent need for healthier aging solutions.
The challenge is asking participants to design and develop treatments that restore muscle, brain, and immune functions lost to degradation from aging, in either a single therapeutic or combination of therapies. Proposed therapeutics should restore at least 10 years of functionality to older individuals, with an eventual goal of 20 years. The competition runs for seven years to 2030, to allow for development and clinical trials, but with intermediate milestone assessments and awards in 2025 and 2026.
XPrize is using a challenge to break through obstacles in health care innovation, such as arbitrary organizational or discipline silos, regulatory barriers, long development timetables particularly for clinical trials, lack of personalized options, and disparities in accessing new technologies. The competition organizers expect participating teams to propose solutions reflecting advances in health care science and technology from multiple fields.
Prize amounts scaled to longer restoration of functions
“By targeting aging with a single or combination of therapeutic treatments,” says founder and executive chairman Peter Diamandis in an XPrize statement, “it may be possible to restore function lost to age-related degradation of multiple organ systems.” Diamandis adds, “Converging exponential technologies such as A.I., epigenetics, gene therapy, cellular medicine, and sensors are allowing us to understand why we age. It’s time to revolutionize the way we age. Working across all sectors, we can democratize health and create a future where healthy aging is accessible for everyone and full of potential.”
XPrize plans to award prizes of $61 million to a team that develops one or more treatments restoring muscular, cognitive, and immune functions of 10 years, with a $71 million prize for restoring those functions to 15 years, and $81 million for a 20-year functional restoration. Winning teams are expected to deliver their proposed solutions in a year or less. Forty semi-finalists are expected to divide $10 million in prizes in 2025, with another $10 million in milestone prizes awarded to 10 finalists in 2026-27.
One of the challenge sponsors is Solve FSHD, a venture philanthropy and advocacy organization for facioscapulohumeral muscular dystrophy or FSHD, a type of muscular dystrophy with progressive muscle degeneration and weakness, but no cure. Solve FSHD is offering a separate $10 million bonus award, in parallel with the main competition, for treatments that improve muscle functions in people with the disease for at least 10 years.
Preliminary XPrize Healthspan challenge guidelines are now available for download, with pre-registration and public comments taken through June 2024. Final guidelines and full registration is expected to begin in July 2024.
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By Alan, on November 28th, 2023  Lung x-ray (Toubibe, Pixabay. https://pixabay.com/photos/x-ray-image-roentgen-thorax-568241/ 28 Nov. 2023. A developer of messenger RNA therapies for respiratory and rare diseases says it received clearance to begin a clinical trial in the U.K. for an inhaled treatment for viral lung conditions. Ethris GmbH in Munich, Germany says the Medicines and Healthcare Regulatory Agency or MHRA in the U.K. authorized a clinical trial of the company’s experimental drug code-named ETH47.
Ethris is a biotechnology company that creates therapies with synthetic messenger ribonucleic acid or mRNA, a single-stranded nucleic acid that carries instructions for making proteins from genetic codes in DNA to the nucleus of cells. In its natural state, says Ethris, mRNA is unstable in the body and can cause immune reactions. As a result, the company devised a technology for stabilized non-immunogenic mRNA, or SNIM-RNA, that it says overcomes these obstacles. Ethris says its mRNA treatments can be given repeatedly to patients to enable sustained production of therapeutic proteins in the body, or replace missing proteins.
SNIM-RNA therapies, says the company, are delivered with lipid or natural oil nanoscale particles that can cross cell membranes. Ethris says its lipid nanoparticle process makes it possible to administer mRNA treatments with aerosols to the upper and lower respiratory system. The company says it also can produce its treatments in freeze-dried form, which along with aerosol formulations, remain usable at room temperatures.
Proteins with immune defense against viruses
ETH47 is Ethris’s lead product, designed to treat viral infections in the respiratory tract. The company says ETH47 can be formulated as a nasal spray or given with an inhaler directly to the lungs. Ethris says ETH47 delivers mRNA with instructions to generate type 3 interferons, proteins providing an immune defense against viruses. Once in respiratory mucous membrane cells, says the company, ETH47 induces an innate immune response to stop viral entry and replication. Because ETH47 is designed to work independently of specific viruses, says Ethris, it can address a range of viral infections, including those triggering attacks from asthma.
The early-stage clinical trial authorized by MHRA is expected to enroll healthy participants for testing ETH47, and begin in December 2023. No further details about the study were disclosed.
“The trial start will be our first program to enter the clinic,” says Ethris CEO Carsten Rudolph in a company statement, adding this phase of ETH47’s development “brings us a step closer to providing innovative solutions that address the unmet need of respiratory viral infections, especially for the vulnerable population or patients with an underlying respiratory disease e.g., asthma or COPD.”
The company’s other programs are developing drugs for rare diseases with inhaled therapies, injections, and implanted treatments, as well as vaccines. In Sept. 2023, researchers at Ethris published a study in Nature Biomedical Engineering with colleagues from DIOSynVax in Cambridge, U.K. demonstrating in lab mice a vaccine protecting against a broad range of sarbecoviruses that include the zoonotic viruses responsible for Covid-19 infections and other pandemics.
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By Alan, on November 27th, 2023  High-density micro-array patch applied to the upper arm (Vaxxas) 27 Nov. 2023. A vaccine delivered with a patch device is shown in a clinical trial to generate neutralizing antibodies against measles and rubella similar to conventional injections. Results of the trial, conducted among healthy adult volunteers in Australia and reported on 17 Nov. 2023 in the journal MDPI Vaccines, also show the patch-delivered vaccine is safe and well tolerated.
Measles is a highly contagious viral disease causing skin rash, coughing, and sneezing, but largely controlled in some parts of the world through widespread childhood vaccination. Where vaccinations are not readily available, often in lower-resource regions, measles is still a threat to children, and according to the the Measles and Rubella Partnership, claimed 128,000 lives in 2021. Rubella, sometimes called German measles, is a milder form of the disease, but can lead to birth defects among pregnant women, including children with congenital rubella syndrome, a disease causing multiple birth defects.
Vaxxas, a biotechnology company in Cambridge, Mass. and Brisbane, Australia, is developing a patch-applicator device as an alternative delivery vehicle for vaccines. The Vaxxas device uses high-density microscale needles on a small patch, with the needles about 0.25 millimeters in length that do not cause pain, delivered in a single-use spring-loaded applicator. The company says the needles are coated with the vaccine and penetrate to only the outer skin layers, enough to alert the immune system that carries the vaccine to lymph nodes for invoking a general immune response. And Vaxxas says vaccines on the patch can be stored at ambient temperatures without refrigeration.
Science & Enterprise reported on clinical trials of the Vaxxas patch with a Covid-19 vaccine, showing the vaccine delivered with the device is well-tolerated and generates an immune response similar to conventional injections. The company is also testing the patch with a commercial influenza vaccine, and developing another device to deliver a typhoid vaccine. Results from a separate trial support the feasibility of individuals self-administering vaccines with a micro-needle patch, without the supervision of a clinician.
Comparable antibody production rates as injections
In the new early-stage trial, Vaxxas enrolled 63 healthy adult volunteers in Australia to test the patch device with a vaccine against measles and rubella. Participants were randomly assigned to received a patch with either a high or low dose of the vaccine, a placebo patch, or an approved measles-rubella vaccine given with an injection under the skin. After 28 days, the authors report that compared to the beginning of the trial, low-dose vaccine patches generated neutralizing antibodies against measles and rubella at about the same rate (38%) as the conventional vaccine (36%), and twice the rate of the high-dose patches, 19 to 25 percent. The authors say previous vaccination or exposure to measles and rubella created a higher baseline for comparison.
Other findings show patch vaccine recipients displayed at most mild to moderate adverse effects. And the vaccines in the devices were still considered usable even after transported for three days at 40 degrees C or 104 degrees F.
“Measles and rubella remain significant health concerns in many parts of the world,” says Vaxxas CEO David Hoey in a company statement released through BusinessWire, “and we look forward to moving this product forward to later stage clinical trials.” Among the later stage trials, says the company, is an early- and mid-stage study in The Gambia in west Africa among children not yet vaccinated for measles or rubella.
Vaxxas is following a similar strategy for its vaccine patch device as Micron Biomedical Inc., developer of a peel-and-stick patch for vaccines. Science & Enterprise reported in May 2023 on that company’s clinical trial in The Gambia showing its patch vaccine for measles and rubella generated comparable immune responses as conventional injections.
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By Alan, on November 25th, 2023  Click on image for full-size view (CB Insights) 25 Nov. 2023. With all the headlines generated by artificial intelligence these days, one would expect investors would show as much enthusiasm for the technology. According to CB Insights, however, venture investments in A.I. are declining each quarter in 2023, with the number of venture deals reaching a low level not seen since 2017.
In its report issued earlier this month (registration required), technology intelligence company CB Insights says venture investments in A.I. worldwide declined to $8.3 billion in the third quarter of 2023, down from $9.4 billion in the second quarter and $$15.2 billion in Q1. In addition, the number of venture investment transactions in A.I. in the third quarter fell to 501, which CB Insights says is the fewest number of deals for a three-month period since 2017.
In an historical context, the CB Insights report looks less discouraging. The $8.3 billion raised by A.I. start-ups in Q3 2023 is comparable to quarterly investment totals worldwide in pre-pandemic 2019, with the average deal size rising in the third quarter to $26.3 million, from $19.6 million in Q2, and down slightly from $29.3 million in Q1. The median deal size — the half-way mark of smallest to largest transactions — so far this year, however, fell to $4 million by the third quarter, from $4.5 million in 2022 and $5.5 million in 2021.
CB Insights also notes that U.S.-based A.I. start-ups raised $5.8 billion, 70 percent of all venture dollars in the third quarter of 2023, in 236 of the 501 deals. Among the top A.I. investment recipients in Q3 was Generate:Biomedicines in Somerville, Mass. that raised $273 million in its third venture round during September. Earlier this month, Science & Enterprise reported on a demonstration of that company’s generative A.I. technology applied to design of therapeutic proteins, published in the journal Nature.
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