Toray Develops Biochip for High-Performance Multi-Item Allergy Testing
TheOne Medical Introduces OneVet Veterinary Endoscope, A Versatile and Portable Device to Keep Your Pet Healthy
Techcarer Is Introducing The AI and Endoscope Diagnostic System Designing Services At MEDICA 2021
Boehringer Ingelheim Expressed “Confidence in the Future” With Recording Positive Momentum in 2020 and Expanding R&D Investment
New Medical Ansats Will Be Equipped With Incubators For Saving Newborns
Intravacc’s Sabin Inactivated Polio vaccine (sIPV), out-licensed to LG Chem, receives WHO prequalification
iMediSync debuts iSyncWave, a dedicated device for neuropsychiatric disorders, at CES 2021
FDA Approves Liquid Biopsy NGS Companion Diagnostic Test for Multiple Cancers and Biomarkers
Cell ageing can be slowed by oxidants
KÄÄPÄ Biotech launches the new Nordic Mushrooms product line and signs a distribution agreement to North America
Samsung Biologics Opens Its First Overseas CDO R&D Center in San Francisco
On 29th, Samsung Biologics (CEO Tae-han Kim) held an online opening ceremony for its San Francisco Contract Development Organization(CDO) Research & Development (R&D) Center. Samsung Biologics established the center that implemented the headquarters' CDO R&D platform to focus on meeting the demand for contract development services in the western United States. Moreover, by realizing the 'one-stop service' of CRO-CDO-CMO, the company has set a goal to become the best company in each of them. "In San Francisco, the mecca of the biopharmaceutical industry, there are about 2,500 life science companies. Also, since San Francisco is advantageous in terms of connectivity with the headquarters to successfully construct the initial global CDO R&D center, we chose San Francisco as the first destination," said Tae-han Kim, CEO of Samsung Biologics. "After 2020, the next 10 years will be the period for global expansion to Boston, Europe, and China. Through this expansion, we will endeavor to maximize customer satisfaction in the entire process of research, development, and manufacturing (CRO/CDO/CMO) of new biopharmaceuticals." ▲ Tae-han Kim, CEO of Samsung Biologics ◆ Full-fledged global expansion to become a Next Door CDO partner Samsung Biologics' San Francisco CDO R&D Center has the same state-of-the-art CDO service platform as the one at the Incheon Songdo headquarters. It was opened on a minimal scale initially, and it will be expanded in accordance with the increasing demand of clients in the future. Through this center, the company announced to become a 'Next Door CDO Partner' that supports clients' drug development process through closer and faster communication with local Big Pharma and Biotech. As a result, Samsung Biologics has resolved the parallax and low geographic access concerns raised by some overseas clients. Samsung Biologics plans to additionally build CDO R&D centers in Boston, Europe, and China at the major bio clusters where potential clients are concentrated to strengthen accessibility further. "We plan to open CDO R&D centers in the eastern United States and Western Europe in 2021. China is relatively advantageous in terms of the parallax and geographical elements, so the headquarters in Songdo, Incheon will manage for the meantime. However, as potential clients are rapidly increasing, we still have a plan to establish the CDO R&D center in China in the future," said Kim. On the other hand, securing more than 60 order contracts within two years since entering 2018, Samsung Biologics' CDO business grows fast with revealing its prominence in the global market. The company has successfully received both FDA & EMA regulatory approvals. Besides, GI Innovation Inc.'s drug candidate, which was consigned from the cell line development stage to Samsung Biologics, was exported for 900 billion won ($793 million) to Jiangsu Simcere Pharmaceutical Co., Ltd. In particular, Samsung Biologics is putting a lot of efforts in the CDO business to secure speed and price competitiveness with the slogan 'Faster & Better'. It drastically shortened the time required from cell line development to raw material drug production to 6 months and final product production to 7 months. This is about twice as fast as the 12-month development period of the same category currently promoted by major global companies. ▲ Samsung Biologics presented its vision as a one-stop CDMO service partner. ◆ Killing three birds with CRO-CDO-CMO end-to-end service Samsung Biologics has been proliferating since it entered the bio-industry in 2010 with its biopharmaceutical CMO business. Currently, it has three large biopharmaceutical production facilities, with a total of 364,000 liters. The 4th factory is scheduled to be ready for GMP operation from the end of 2022, and when it goes into operation, Samsung Biologics will have a total production scale of 620,000 liters. Samsung Biologics is more than the world's largest production CMO. It announced a strategy to maximize customer satisfaction through 'end-to-end one-stop service' system ranging from CRO (contract research), CDO (contract development), and CMO (contract manufacturing. For this, in succession to the CDO market advance in 2018, the company recently expanded its business to CRO. It has set a goal to establish itself as the best global CRO company in 2030, starting with a CRO business that includes antibody production service. The 4th factory was designed as the final edition of a one-stop service available within one factory from cell line development to end-product manufacturing. Based on this one-stop service, Samsung Biologics plans to secure 50% of the CMO volume through the CDO business by 2030. "Samsung Biologics started from a mudflat in Songdo, but achieved the CMO champion in 2020. We aim to achieve the CDO global champion by 2022, starting with the first overseas CDO R&D center in San Francisco. In the case of CRO business, Samsung Biologics will expand new bio drugs and antibodies production in earnest, and challenge the CRO global champion by 2030," said Kim. "Through the one-stop service, biotech clients could develop, produce, and manufacture new bio drugs with better efficacy and quality at a lower cost. Ultimately, Samsung Biologics aims to contribute to improving human health and the quality of life."
Injectable hydrogel could someday lead to more effective vaccines
Vaccines have curtailed the spread of several infectious diseases, such as smallpox, polio and measles. However, vaccines against some diseases, including HIV-1, influenza and malaria, don’t work very well, and one reason could be the timing of antigen and adjuvant presentation to the immune system. Now, researchers reporting in ACS Central Science developed an injectable hydrogel that allows sustained release of vaccine components, increasing the potency, quality and duration of immune responses in mice. To confer resistance to infectious diseases, vaccines display parts of a pathogen –– known as antigens –– to cells of the immune system, which develop antibodies against these molecules. If a vaccinated person later becomes infected with the same pathogen, their immune system can quickly deploy antibodies to destroy the invader. Vaccines usually contain an additional component, called an adjuvant, that helps stimulate the immune system. In natural infections, the body is typically exposed to antigens for 2-3 weeks, compared with only 1-2 days for vaccines. Eric Appel and colleagues wondered whether they could develop an injectable hydrogel that would slowly release vaccine components over a longer period of time, more similar to what the body is used to, which might boost the immune response. The researchers developed a polymer-nanoparticle hydrogel that could be mixed with vaccine components. When injected under the skin of mice, the material formed a localized area of inflammation that attracted certain types of immune cells, while slowly releasing the antigen and adjuvant over a period of several days. As a result, the mice injected with the hydrogel produced more antibodies over a longer period of time than mice treated with a traditional vaccine. Importantly, the antibodies produced by the hydrogel-vaccine-treated mice had about 1,000-fold higher affinity for the antigen than those made by mice receiving the standard immunization. Although the new system still needs to be tested to see if it improves vaccine protection from specific diseases, this study demonstrates a simple, effective vaccine delivery platform that enhances the potency and duration of antibody-mediated immunity in mice, the researchers say.
Delivering proteins to testes could someday treat male infertility
According to the Mayo Clinic, about 15% of couples are infertile, and male infertility plays a role in over one-third of these cases. Often, problems with sperm development are to blame. Now, researchers reporting in ACS Nano have found a way to deliver a protein important for sperm cell production directly to mouse testicles, where it restored normal sperm development and allowed previously infertile mice to father pups. Male infertility often happens because of a lack of sperm in the semen, which can result from damage to the blood-testis barrier (BTB). This barrier protects reproductive cells from harmful toxicants and drugs, and a protein called PIN1 is important for its function. Mice genetically engineered to lack PIN1 are infertile, with small testes, depleted sperm stem cells and a low sperm count. Although scientists have considered gene therapies to treat male infertility, these procedures are risky because they could cause unwanted genetic changes in reproductive cells that might be passed onto offspring. Hyun-Mo Ryoo and colleagues wanted to develop a system to deliver proteins (such as PIN1) instead of genes to the testes, but first they had to find a way to get proteins through the complex tubes of the testicles and into cells. The researchers developed a delivery system called Fibroplex, which consisted of spherical nanoparticles made of silk fibroin and a coating of lipids. They loaded PIN1 into Fibroplex, and showed that the particles appeared safe and didn’t show signs of toxicity or testicular damage in mice. When the team injected the PIN1-loaded Fibroplex into the testes of young mice with PIN1 deletions, the treatment restored nearly normal PIN1 levels and sperm stem cell numbers and repaired the BTB. Treated mice had normal testicular weight and size and about 50% of the sperm count of wild-type mice. Until about 5 months after treatment, when the protein degraded, the PIN1-Fibroplex-treated mice fathered a similar number of pups as wild-type mice, whereas untreated mice with PIN1 deletions remained infertile. This is the first demonstration of direct delivery of proteins into the testis to treat male infertility, the researchers say.
Pharming receives Orphan Drug Designation for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)
Pharming Group N.V. (Euronext Amsterdam: PHARM) today announced that the European Commission has granted orphan drug designation for leniolisib for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS), based on a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicine Agency (EMA). Leniolisib was previously granted Orphan Drug Designation by the US Food and Drug Administration (FDA) in January 2018 for “the treatment of Activated PI3Kδ Syndrome (APDS) or p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency (PASLI)”. The European Commission orphan drug designation provides certain regulatory procedural and financial incentives including, but not limited to, product market exclusivity for ten years in the EU following regulatory approval. To qualify, an investigational drug must be intended to treat a life-threatening or chronically debilitating condition that affects fewer than five in 10,000 people in the EU, and where the treatment provides a significant benefit to those affected by the condition or no satisfactory treatment is available. Sijmen de Vries, Chief Executive Officer of Pharming, commented: “We are pleased to have received orphan drug designation from the European Commission, an important milestone in the development of leniolisib for the treatment for APDS, an ultra-rare and debilitating disease. With no currently approved treatment, leniolisib has the potential to address a significant unmet need for patients with APDS. Leniolisib is currently being studied in a registration-enabling Phase II/III trial and remains, subject to regulatory approval, on track to launch in H2 2022.” What is Activated Phosphoinositide 3-kinase Delta Syndrome (APDS)? Activated phosphoinositide 3-kinase-delta (PI3Kδ) syndrome (APDS) is caused by mutations in the gene PIK3CD (Type 1 APDS) or PIK3R1 (Type 2 APDS) that activate PI3Kδ. Synonyms for Type 1 and Type 2 APDS are PASLI-CD and PASLI-R1, respectively. PASLI is the acronym for p110δ-activating mutation causing senescent T cells, lymphadenopathy, and immunodeficiency. APDS is defined as an ultra-rare, genetic, primary immunodeficiency disease characterized by increased susceptibility to recurrent and/or severe bacterial and viral infections, chronic benign lymphoproliferation, and/or autoimmune disease. The APDS incidence rate around the world is currently estimated to be 1-2 per million. The diagnosis of APDS is made by sequencing the genes PIK3CD and/or PIK3R1 in patients with a compatible phenotype, i.e., immunodeficiency and lymphoproliferation of unknown origin. Beginning in childhood, people with APDS develop recurrent infections, particularly in the lungs, sinuses, and ears. Over time, recurrent respiratory tract infections can lead to a condition called bronchiectasis, which damages the passages leading from the windpipe to the lungs (bronchi) and can cause breathing problems. People with APDS may also have chronic active viral infections, commonly Epstein-Barr virus or cytomegalovirus infections. Sufferers also frequently develop lymphomas and other cancers. Another possible feature of APDS is abnormal clumping of white blood cells. These clumps can lead to enlarged lymph nodes (lymphadenopathy), or the white blood cells can build up to form solid masses (nodular lymphoid hyperplasia), usually in the moist lining of the airways or intestines. While lymphadenopathy and nodular lymphoid hyperplasia are noncancerous (benign), APDS also increases the risk of developing a form of cancer called B-cell lymphoma.
With Deep Learning Algorithms, Standard CT Technology Produces Spectral Images
Bioimaging technologies are the eyes that allow doctors to see inside the body in order to diagnose, treat, and monitor disease. Ge Wang, an endowed professor of biomedical engineering at Rensselaer Polytechnic Institute, has received significant recognition for devoting his research to coupling those imaging technologies with artificial intelligence in order to improve physicians’ “vision.” In research published today in Patterns, a team of engineers led by Wang demonstrated how a deep learning algorithm can be applied to a conventional computerized tomography (CT) scan in order to produce images that would typically require a higher level of imaging technology known as dual-energy CT. Wenxiang Cong, a research scientist at Rensselaer, is first author on this paper. Wang and Cong were also joined by coauthors from Shanghai First-Imaging Tech, and researchers from GE Research. “We hope that this technique will help extract more information from a regular single-spectrum X-ray CT scan, make it more quantitative, and improve diagnosis,” said Wang, who is also the director of the Biomedical Imaging Center within the Center for Biotechnology and Interdisciplinary Studies (CBIS) at Rensselaer. Conventional CT scans produce images that show the shape of tissues within the body, but they don’t give doctors sufficient information about the composition of those tissues. Even with iodine and other contrast agents, which are used to help doctors differentiate between soft tissue and vasculature, it’s hard to distinguish between subtle structures. A higher-level technology called dual-energy CT gathers two datasets in order to produce images that reveal both tissue shape and information about tissue composition. However, this imaging approach often requires a higher dose of radiation and is more expensive due to needed additional hardware. “With traditional CT, you take a grayscale image, but with dual-energy CT you take an image with two colors,” Wang said. “With deep learning, we try to use the standard machine to do the job of dual-energy CT imaging.” In this research, Wang and his team demonstrated how their neural network was able to produce those more complex images using single-spectrum CT data. The researchers used images produced by dual-energy CT to train their model and found that it was able to produce high-quality approximations with a relative error of less than 2%. “Professor Wang and his team’s expertise in bioimaging is giving physicians and surgeons ‘new eyes’ in diagnosing and treating disease,” said Deepak Vashishth, director of CBIS. “This research effort is a prime example of the partnership needed to personalize and solve persistent human health challenges.”
Wearable Circuits Sintered at Room Temperature Directly on the Skin Surface for Health Monitoring
Wearable electronics are getting smaller, more comfortable and increasingly capable of interfacing with the human body. To achieve a truly seamless integration, electronics could someday be printed directly on people’s skin. As a step toward this goal, researchers reporting in ACS Applied Materials & Interfaces have safely placed wearable circuits directly onto the surface of human skin to monitor health indicators, such as temperature, blood oxygen, heart rate and blood pressure. The latest generation of wearable electronics for health monitoring combines soft on-body sensors with flexible printed circuit boards (FPCBs) for signal readout and wireless transmission to health care workers. However, before the sensor is attached to the body, it must be printed or lithographed onto a carrier material, which can involve sophisticated fabrication approaches. To simplify the process and improve the performance of the devices, Peng He, Weiwei Zhao, Huanyu Cheng and colleagues wanted to develop a room-temperature method to sinter metal nanoparticles onto paper or fabric for FPCBs and directly onto human skin for on-body sensors. Sintering –– the process of fusing metal or other particles together –– usually requires heat, which wouldn’t be suitable for attaching circuits directly to skin. The researchers designed an electronic health monitoring system that consisted of sensor circuits printed directly on the back of a human hand, as well as a paper-based FPCB attached to the inside of a shirt sleeve. To make the FPCB part of the system, the researchers coated a piece of paper with a novel sintering aid and used an inkjet printer with silver nanoparticle ink to print circuits onto the coating. As solvent evaporated from the ink, the silver nanoparticles sintered at room temperature to form circuits. A commercially available chip was added to wirelessly transmit the data, and the resulting FPCB was attached to a volunteer’s sleeve. The team used the same process to sinter circuits on the volunteer’s hand, except printing was done with a polymer stamp. As a proof of concept, the researchers made a full electronic health monitoring system that sensed temperature, humidity, blood oxygen, heart rate, blood pressure and electrophysiological signals and analyzed its performance. The signals obtained by these sensors were comparable to or better than those measured by conventional commercial devices. The authors acknowledge funding from The Pennsylvania State University, the National Science Foundation, the Shenzhen Science and Technology Program, the Bureau of Industry and Information Technology of Shenzhen and the National Natural Science Foundation of China.
Conductive Hydrogel for Photothermal-Responsive Stretchable Artificial Nerve and Coalescing with Damaged Peripheral Nerve
Injuries to peripheral nerves –– tissues that transmit bioelectrical signals from the brain to the rest of the body –– often result in chronic pain, neurologic disorders, paralysis or disability. Now, researchers have developed a stretchable conductive hydrogel that could someday be used to repair these types of nerves when there’s damage. They report their results in ACS Nano. Injuries in which a peripheral nerve has been completely severed, such as a deep cut from an accident, are difficult to treat. A common strategy, called autologous nerve transplantation, involves removing a section of peripheral nerve from elsewhere in the body and sewing it onto the ends of the severed one. However, the surgery does not always restore function, and multiple follow-up surgeries are sometimes needed. Artificial nerve grafts, in combination with supporting cells, have also been used, but it often takes a long time for nerves to fully recover. Qun-Dong Shen, Chang-Chun Wang, Ze-Zhang Zhu and colleagues wanted to develop an effective, fast-acting treatment that could replace autologous nerve transplantation. For this purpose, they decided to explore conducting hydrogels –– water-swollen, biocompatible polymers that can transmit bioelectrical signals. The researchers prepared a tough but stretchable conductive hydrogel containing polyaniline and polyacrylamide. The crosslinked polymer had a 3D microporous network that, once implanted, allowed nerve cells to enter and adhere, helping restore lost tissue. The team showed that the material could conduct bioelectrical signals through a damaged sciatic nerve removed from a toad. Then, they implanted the hydrogel into rats with sciatic nerve injuries. Two weeks later, the rats’ nerves recovered their bioelectrical properties, and their walking improved compared with untreated rats. Because the electricity-conducting properties of the material improve with irradiation by near-infrared light, which can penetrate tissues, it could be possible to further enhance nerve conduction and recovery in this way, the researchers say. The authors acknowledge funding from the National Key Research and Development Program of China, the National Natural Science Foundation of China, the Program for Changjiang Scholars and Innovative Research Team in University, and Program B for Outstanding Ph.D. Candidate of Nanjing University.
Biochip instead of animal testing
New active ingredients require new tests. For ethical, economic and scientific reasons, animal experimentations are increasingly being replaced by biochips. Human cells from different organs are placed on the chips and supplied with nutrient solution via small channels. In this way, blood circulation and metabolic functions of the human body are simulated. Monitoring after the addition of active substances such as drugs, cosmetics or chemicals allows conclusions to be drawn about the reactions and processes in the human body. The continuous supply of the cells with liquid nutrient medium is a great challenge, as even small variations influence the test results. The LiquiDoS dosing system by HNP Mikrosysteme contains a highly precise, low-shear micro annular gear pump (mzr pump), which is ideally suited for filling the biochip. Volume flows from 1.5 µl/min to 72 ml/min as well as dosing volumes from 0.25 µl are gently realized with the LiquiDoS. In addition to the micropump, LiquiDoS contains a filter, a shut-off valve and the mzr-Touch Control. The graphical user interface facilitates the handling of the system by direct input of dosing quantity and dosing duration. Furthermore, the mzr-Touch Control enables simple programming, fast switching between manual and automated dosing tasks as well as reproducible results. HNP Mikrosysteme GmbH, located in Germany, develops, manufactures and markets pumps and systems worldwide which deliver small amounts of liquids fast and accurately. Beside several applications in plant engineering, chemical processing and pharmaceutical processing, mzr-pumps are used in the field of life science and analytical instrumentation.
AlzeCure gets abstract on the NeuroRestore platform against Alzheimer's accepted for poster presentation at CTAD
AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops a broad portfolio of drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, today announced that the company has received a second abstract approved for poster presentation at the annual Alzheimer's conference CTAD, Clinical Trials in Alzheimer's Disease, which this year will be held completely digitally on November 4-7. The abstract titled ACD856, a novel cognitive enhancer targeting neurotrophin signaling for the treatment of Alzheimer’s Disease shows that AlzeCure’s leading drug candidate, ACD856, in the company's NeuroRestore platform has the potential for widespread use of various types of cognitive memory disorders. The abstract is based on the results that led to the selection of a drug candidate and the recent completion of a successful clinical microdose study; a work carried out in collaboration with Professor Bengt Winblad and Professor Maria Eriksdotter at Karolinska Institutet, as well as Pontus Forsell, Johan Sandin and Gunnar Nordvall at AlzeCure. ”It is very satisfactory that we have now received two abstracts approved for presentation at this leading Alzheimer's conference. The results we have seen, and which are summarized in this abstract, show the possibilities with our main candidate ACD856 and support further clinical studies. I am very much looking forward to our upcoming clinical studies with the candidate, which we expect to be able to start before the end of the year", said Martin Jönsson, CEO of AlzeCure Pharma AB. The abstract and the poster will be available to registered participants online on CTAD's website from November 4, 2020.
FDA Approves Nivolumab and Ipilimumab for Unresectable Malignant Pleural Mesothelioma
On October 2, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) as first-line treatment for adult patients with unresectable malignant pleural mesothelioma. Efficacy was investigated in CHECKMATE-743 (NCT02899299), a randomized, open-label trial in patients with unresectable malignant pleural mesothelioma and no prior anticancer therapy. Patients were randomized to receive either nivolumab and ipilimumab for up to 2 years (n=303) or 6 cycles of combination chemotherapy with cisplatin or carboplatin plus pemetrexed (n=302). The trial demonstrated a statistically significant improvement in overall survival (OS) for patients treated with nivolumab plus ipilimumab compared with those who received chemotherapy. Median OS was 18.1 months (95% CI: 16.8, 21.5) versus 14.1 months (95% CI: 12.5, 16.2) (HR 0.74; 95% CI: 0.61, 0.89; p=0.002). Median progression-free survival per blinded independent central review (BICR) was 6.8 months (95% CI: 5.6, 7.4) in the nivolumab plus ipilimumab arm and 7.2 months (95% CI: 6.9, 8.1) in the chemotherapy arm (HR 1.0; 95% CI 0.82, 1.21). Confirmed overall response rate per BICR was 40% (95% CI: 34, 45) and 43% (95% CI 37, 49) in the nivolumab plus ipilimumab and chemotherapy arms, respectively. Median response duration was 11.0 months in the nivolumab plus ipilimumab arm and 6.7 months in the chemotherapy arm. The most common adverse reactions (incidence ≥ 20%) in patients receiving the combination of nivolumab plus ipilimumab in CHECKMATE-743 were fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritus. The recommended doses for unresectable malignant pleural mesothelioma are nivolumab 360 mg every 3 weeks and ipilimumab 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression.
New approach to airborne disinfection uses food-coloring dyes
The COVID-19 pandemic has shed new light on the needs for improved disinfection methods, both for individuals and facilities. Purdue University innovators have developed an airborne disinfection method – using food-coloring dyes – to be applied to the entire body and rooms for sterilization purposes and lowering the risk of infection. The Purdue team’s disinfection method uses edible materials. The Purdue team presented the technology in July during a COVID-19 virtual conference sponsored by the National Council of Entrepreneurial Tech Transfer. “Most of the antiviral and antibacterial sprays used for airborne antiviral and antibacterial disinfectants, such as aerosolized hydrogen peroxide, ozone and deep ultraviolet illumination, are a biohazard risk to humans,” said Young Kim, an associate professor of biomedical engineering at Purdue. “Additionally, disinfectants containing titanium dioxide and noble metal nanoparticles pose carcinogenic and cytotoxicity risks.” Kim also said new methods are needed since transmission of pathogens (viruses and bacteria) often occurs in the air and infection with pathogens is transmitted by an airborne route. The Purdue method might also help in medical settings, where healthcare workers typically are exposed to the disease-causing agents when they take off their personal protective equipment. The Purdue airborne antiviral phototherapy technique uses small aerosols FDA-approved food coloring dyes to mitigate the risks of airborne transmissions of pathogens. This is referred to as Photodynamic Airborne Cleaner (PAC). “We have demonstrated with our novel solution how visible light activation of several FDA-approved food coloring dyes generate singlet oxygen, which can be used to kill airborne pathogens,” Kim said. “In the medical community, it is well known that singlet oxygen is effective to inactivate viruses. We are developing a scalable aerosol generation system for the dyes, allowing uniform fog-like dispersion lingering in the air to minimize wetting and surface staining. In addition, as health care workers are often infected when removing PPE, this technology can be installed in a confined chamber for health care professionals to change PPE in hospital settings.” The novel photoreactive arrangement can be used in rooms where many people are present at risk of airborne pathogen exposure. The innovators are working with the Purdue Research Foundation Office of Technology Commercialization to license this patented technology.
Vico Therapeutics raises $31 million in Series A financing round to advance therapies for rare central nervous system diseases
Vico Therapeutics, a Leiden, the Netherlands, based biotech company focusing on the development of RNA modulating therapies for rare neurological disorders, today announced that it has raised $31 million (€27 million) in a Series A financing round. Vico will use this funding to further advance its late preclinical stage Antisense OligoNucleotides (AON) lead platform for the development of therapies for different forms of Spinocerebellar Ataxia (SCA) and Huntington Disease (HD) into first-in-human clinical trials in late 2021. Its early discovery RNA editing platform is directed towards RETT syndrome. The financing was led by Life Science Partners (LSP), co-led by Kurma Partners, and supported by Pontifax, Droia Genetic Disease, Polaris Partners and Pureos Bioventures and Idinvest Partners. Vico’s lead asset is an investigational AON therapy targeting expanded (CAG) trinucleotide repeats that translate into abnormally long and toxic polyglutamine (polyQ) stretches in proteins that cause a series of neurodegenerative polyQ disorders like Spinocerebellar Ataxia type 1 (SCA1), type 3 (SCA3) and Huntington’s disease (HD). It has been demonstrated to preferentially reduce the levels of mutant polyQ compared to wildtype proteins. This was confirmed in several established mouse models for SCA1, SCA3 and Huntington Disease, with a long-term and widespread distribution of the compound throughout the central nervous system. Based on these encouraging data combined with the broad applicability of the lead compound to multiple different brain disorders with high unmet medical need, Vico is advancing this program towards a first-in-human trial expected in late 2021. Luc Dochez, Founder and Chairman of Vico Therapeutics, stated: "This Series A funding will allow us to advance our lead program into the clinic and continue to build our capabilities as a leader in the development of novel therapies for serious CNS disorders. We see tremendous potential to advance the field and apply the breadth of our antisense oligonucleotide (AON) expertise to address severe neurological disorders. We are looking forward to accelerating the development of our platform technologies around AON technology and RNA-modulation/editing to bring best-in-class therapies to patients. The Vico team built this company around a unique synergy between state-of-the-art molecular biology, AON chemistry laboratories and industry experience in successfully developing drugs based on AON technology." Martijn Kleijwegt, managing partner at LSP, lead investor and board member, added: "Vico is building a leading team and has a cutting-edge infrastructure to engineer best-in-class therapies for severe neurological conditions and accelerate their advancement into human clinical trials. A major strength of Vico’s approach is the broad applicability to different polyQ diseases and the selectivity for mutant proteins."
Intravacc and Celonic to Develop and Produce a Novel COVID-19 Vaccine
Intravacc, a global leader in translational research and development of viral and bacterial vaccines, and Celonic Group, a premium biopharmaceutical contract development and manufacturing organization (CDMO), specialized in development and production of Advanced Therapy Medicinal Products (ATMP) and mammalian cell lines expressed bio-therapeutics, today announced that they have signed a research agreement to further design, develop and produce a Covid-19 vaccine based on an immunogenic Spike (S) protein of SARS-CoV-2 combined with Intravacc’s prorietary Outer Membrane Vesicle (OMV) technology. In the beginning of March this year Intravacc started working on the development of four candidate coronavirus vaccines based on three proprietary technologies: Vero cell, OMV and iBoost. For this specific joint vaccine development, Intravacc combines its safe and immunogenic OMV delivery platform with S-proteins expressed by Celonic Group’s industry-leading CHOvolution® mammalian cell expression sytem, in order to generate a highly effective and balanced B and T cell response against SARS-CoV-2. Swiss based Celonic Group will construct cell lines producing the S-protein in high quantities and develop a GMP production process. Preclinical studies will start shortly to select the best candidate protein for the vaccine. The collaboration aims to accelerate development of Intravacc’s COVID-19 OMV protein vaccine, which is expected to enter clinical testing in 2021. Dr. Jan Groen, Intravacc’s Chief Executive Officer of Intravcc said: “Several studies have shown that OMVs have the ability to enhance the immune response and can be relatively easy formulated with target specific peptides and proteins. This, combined with the fact they can be quickly scaled-up for manufacturing, makes it an ideal suited platform under the current circumstances where quantity and speed are critical” Dr. Konstantin Matentzoglu, Chief Executive Officer of Celonic, adds: “At Celonic, we are thrilled to join hands with Intravacc in the fight against this worldwide pandemic. The novel vaccine has the potential to prevent morbidity and mortality of COVID-19. Together, we have an opportunity to make a difference in the lives of patients at this time of great need.”
SITA Selects Basis Technology to Power Contact Tracing of Infections Crossing Borders
Basis Technology announced that SITA — a software provider that is owned by 400 members of the air transport industry — has selected Rosette name matching for its contact tracing solution. Governments will be able to open borders and keep track of who came in contact with confirmed cases of COVID-19 while traveling. SITA’s Intelligence and Targeting system lets a contact tracer find out whether any person newly diagnosed with COVID-19 travelled in the past 30 days. Displaying airplane seating charts to contact tracers, SITA identifies potentially exposed airline crews and passengers by quickly pinpointing travelers who booked tickets with, or sat in proximity to, a person diagnosed with COVID-19. Within minutes, contact tracers can notify those people via phone or email obtained from travel records. The European CDC states, "The availability of passenger locator data, particularly for airline passengers, is extremely important for the success and effectiveness of contact tracing operations for communicable diseases." The ECDC estimates up to seven hours of contact tracing are required for each case. This tool is designed to drastically reduce that time, enabling governments to reopen borders with the confidence that new cases can be quickly contained. “We integrated Rosette name matching from Basis Technology into our SITA Intelligence and Targeting border management system a few years ago. It gave us better results out of the box and was quicker to deploy with a lower cost of ownership,” said Ricardo Letosa, Senior Product Manager at SITA. “There was no question we would use Rosette for contact tracing as well because you don’t check into a hospital with your passport number. When you have no common identifiers between health and travel records besides name and date of birth, you have to go with the best name matching you can get, and for SITA that is Rosette from Basis Technology.” “We are thrilled to be part of SITA’s response to COVID-19. The airline industry has been hit hard, and we hope this software will help world governments reopen their borders and make air travelers feel safe again,” said Carl Hoffman, CEO of Basis Technology. “Contact tracing is an important tool to contain the spread of COVID-19 as countries reopen. It is vital that we give the contact tracers every possible tool to be successful.”
Three Stages to COVID-19 Brain Damage Identified by Top Neurologists in Journal of Alzheimer Disease Paper
The Journal of Alzheimer’s Disease has just published a paper with a comprehensive review of the COVID-19’s effect on the nervous system which classifies brain damage caused by COVID-19 into three stages. One of the authors, nationally-recognized neurologist Dr. Majid Fotuhi, MD, PhD, who is the medical director of NeuroGrow Brain Fitness Center in Northern Virginia and an affiliate staff at Johns Hopkins Medicine, encourages the adoption of this three-stage classification, calls for more research on COVID's long-term effects on the brain, and stresses the need for patients to receive a brain MRI before leaving the hospital. “We are learning that a significant number of hospitalized COVID-19 patients have various degrees of brain impairment. As a medical community, we need to monitor these patients over time as some of them may develop cognitive decline, attention deficit, brain fog, or Alzheimer’s disease in the future. There is a lot we can do to promote brain healing in COVID-19 patients, but first we must understand the nature and severity of their neurological deficits. At the patient level, getting a baseline MRI before leaving the hospital is imperative so that we have a starting point to evaluate and treat them,” explained Fotuhi. In the just published paper, Dr. Fotuhi and his colleagues warn about neurological issues in patients who suffer from COVID-19, including stroke, seizures, confusion, dizziness, paralysis, and/or coma. Already, two dozen case reports are revealing the impact of COVID-19 on the brains of patients. In fact, one study from Wuhan, China, showed that 45% of patients with severe COVID-19 illness experience marked neurological deficits. Another study from France showed 84% of ICU patients with COVID-19 have positive abnormalities on their neurological examination, and that 15% of patients who leave the ICU have residual “dysexecutive function,” which involves poor attention and difficulty with decision-making and controlling behavior. The paper proposes the adoption of a three stage “NeuroCovid” classification scheme to provide a basis from which to build on future hypotheses and investigations regarding SARS-Cov2 and the nervous system. These stages include: • NeuroCovid Stage I: The virus damage is limited to epithelial cells of nose and mouth and the main symptoms include transient loss of smell and taste. • NeuroCovid Stage II: The virus triggers a flood of inflammation, called cytokine storm, which begins in the lungs and travels in the blood vessels throughout all body organs. This cytokine storm leads to the formation of blood clots which cause small or large strokes in the brain. • NeuroCovid Stage III: An explosive level of cytokine storm damages the blood brain barrier, the protective insulation layer in blood vessels of the brain. As a result, blood content, inflammatory markers, and virus particles invade the brain and patients develop seizures, confusion, coma, or encephalopathy. Fotuhi points out that many patients with COVID-19 may have no noticeable neurological symptoms at first; but in some cases, patients may present with neurological symptoms even before they have fever, cough, or shortness of breath. In addition to having an MRI while at the hospital, he stresses that patients will need to be monitored in a few months after their hospitalization. “Our experience with previous forms of coronaviruses suggest that in the long-term patients may develop depression, insomnia, Parkinson’s disease, memory loss, or accelerated aging in the brain,” elaborated Fotuhi. “For those recovering from COVID-19, I recommend regular exercise, eating a heart healthy diet, reducing stress, and improving sleep; these are critical ways patients can rejuvenate their brain and minimize having poor outcomes in the future.” These interventions, along with targeted brain training and neurofeedback therapy, are the main features of Dr. Fotuhi’s 12-week Brain Fitness Program. As published in the Journal of Prevention of Alzheimer’s Disease (2016), 84% of elderly with cognitive impairment who complete this brain rehabilitation program gain improvements in their brain function and many of them experience growth in the parts of their brain for learning and memory. These findings were similar for patients who gained recovery from their persistent post-concussion syndrome. The program will now be tailored for patients suffering from post-COVID neurological issues. A Harvard- and Johns Hopkins-trained neurologist and neuroscientist, Dr. Fotuhi is widely regarded as an authority in the field of memory, Alzheimer’s Disease, concussion treatment, ADHD, and increasing brain vitality at any age.
AACR Led Global Cooperation to Resolve Questions About Relationship Between Cancer Patients and COVID-19
(Image from: AACR) Due to COVID-19, the American Cancer Society (AACR) decided to hold annual meetings online. AACR Virtual Annual Meeting 2020 takes place on two separate occasions, April 27-28 and June 22-24. On the first day, the 27th, there were mainly presentations on current or completed bio-clinical trials. On the 28th, the meeting was started with the plenary session on the subject of <COVID-19 and Cancer>, followed by symposiums and general meetings on new drugs and treatments under development. The virtual plenary session <COVID-19 and Cancer>, which was held at 9 AM EDT, consisted of 7 presentations. In each presentation, the status of COVID-19 and various statistics on cancer patients in major countries and cities around the world, such as Wuhan, Milan, Paris, Madrid, Naples, and New York, were revealed, and their views and opinions were also shared. The following are the six presentations presented after Prof. Li Zhang of Tongji Medical College in the first order, <The experience of treating patients with cancer during the COVID-19 pandemic in China>. Marina Chiara Garassino, MD, from Istituto Nazionale dei Tumori in Milan, gave a presentation about <TERAVOLT: First results of a global collaboration to address the impact of COVID-19 in patients with thoracic malignancies>. TERAVOLT researched 200 patients with COVID-19 and thoracic cancers from 8 countries. As a feature of the findings, the mortality rate was 34.6%, and most of the deaths were due to COVID-19, not cancer. The most frequent complications were pneumonia and acute respiratory distress syndrome (ARDS), and she emphasized that many patients were not offered of ICU admissions mainly due to the shortages and institutional rules. “Tumor type and cancer therapy did not impact survival. Even at multivariate analysis, no factors were associated with risk of death. As the cancer diagnosis patients with thoracic malignancies are less likely to be admitted to the intensive care unit, they are at increased risk of prolonged hospitalization and mortality from COVID-19 infection,” Garassino stated. “Our study has several limitations such as short follow-up and selected population, but TERAVOLT will continue to collect data and to provide data in order to identify characteristics associated to a severe COVID-19 able to help societies to create guidelines tailored on individual risk.” Fabrice Barlesi, MD, PhD, from Gustave Roussy Cancer Campus Grand Paris gave a presentation with a theme of <Outcome of cancer patients infected with COVID-19, including toxicity of cancer treatments>. The research in this presentation was conducted on a total of 7,251 cancer patients managed by Gustave Roussy from March 14 to April 15. As of April 20, 95 (69.3%), 20 (14.6%), and 22 (16.1%) pts were discharged, had died, or were still hospitalized, respectively. Moreover, clinical deterioration occurred in 34 (24.8%) who were associated with hematological underlying disease, CRP at diagnosis of COVID19 or the use of cytotoxic chemotherapy. “Globally, the rate of the SARS-CoV-2 infection in our cancer patients’ population does not seem to be higher compared to the global population. We have not found evidence that COVID19 is more lethal or aggressive in cancer patients that underwent usual SARS-Cov-2 treatment,” Barlesi stated. “Special attention has to be given to frail patients with ECOG>1, hematological diseases, or advanced disease treated with cytotoxic chemotherapy within the last 3 months. We believe that adequate testing and protective measures will justify an optimal management of the cancer patients’ underlying tumor.” Carlos Gomez-Martin, MD, PhD, from University Hospital 12 de Octubre in Madrid, Spain, presented about <Adapting oncologic practice to COVID19 outbreak: From outpatient triage to risk assessment for specific treatment in Madrid, Spain>. From March 9 to April 19, a total of 287 cancer patients were screened, and approximately 26% were confirmed. Data on the first 63 patients were shared through the presentation. More than 80% of patients had metastatic diseases, and 40% had lung-related cancer. The mortality rate was about 25% (16), and lung-related cancer, neutropenia, and acute respiratory distress syndrome were the major risk factors. It was also noted that positive results such as 9 out of 15 patients survived as a result of using the Tocilizumab treatment. “For all patients admitted routine blood test and Chest Xr or CT of the lungs performed previously to been transferred to Ward. Specifics and separate wards for suspected, confirmed and negative coronavirus patients were prepared. Also, all chemo Treatments were reconsidered based on objectives, life expectancy, and type of therapy and clinical status of every patient,” stated Gomez-Martin. “COVID-19 treatment must be multidisciplinary and it should include specific antiviral therapy, supportive treatment, close monitoring of inflammatory parameters, and appropriate use of anticoagulants given the risk of thromboembolic complications in this disease.” Paolo A. Ascierto, MD, from the Istituto Nazionale Tumori IRCCS Fondazione Pascale in Naples, Italy, gave a presentation of <Experience in using oncology drugs in patients with COVID-19>. In the institution to which Ascierto belongs, only two out of 400 patients were confirmed as COVID-19, and all succeeded in receiving a negative test within 10 days using Tocilizumab therapy. Tocilizumab is an anti-IL-6 drug and is known to be effective in patients with cytokine release syndrome. It was also explained that the COVID-19 related acute respiratory stress syndrome is caused by excessive cytokine production. “To keep safe both patients and healthy workers is the most important rule. In our daily practice we adopted a specific policy about the conduct of our clinical managements of melanoma patients, in order to minimize the risk of any potential exposure. We are prioritizing patients, according to the kind of treatment and the stage of disease,” stated Ascierto. “In Italy we started on 19th of March a phase II study (NCT04317092) which enrolled 330 patients in 24 hours, with the ability of tocilizumab to reduce the one-month mortality rate as main endpoint. Besides, we are also conducting clinical study on another anti-IL-6 drug, Sarilumab.” Louis P. Voigt, MD, from Memorial Sloan Kettering Cancer Center in New York gave a presentation about <Flattening the curve but widening disparities>. He first introduced the status of COVID-19 impact on New York State. As of April 22, when fatality was categorized as race/ethnicity, Hispanic (34%) and Black (28%) patients more than 60%. Out of 15,740, the total number of deaths, 14,018 had at least one comorbidity. Hypertension (9,028) was the highest, and the cancer was 1,154. “The proportion of Black and Hispanic was also high in non-hospitalized, non-fatal hospitalized cases, compared to White and Asians. Higher incidence of cancer, higher cancer-related mortality, higher incidence of COVID-19, and higher COVID-19 were related mortality in African American population. But we need to be more careful, because the reality is more complex. We need more time and data,” Voigt stated. “Pandemic create perfect conditions for suboptimal care or deviation from standard care with major impact on the most vulnerable patients. This is because healthcare systems become overwhelmed during pandemic, and decisions are sometimes driven by fear and emotions rather than evolving facts. The most vulnerable among us can fall out of the safety net if we do not pay attention. We need to create more robust safety net.” Last but not least, Hongbing Cai, MD, from Zhongnan Hospital of Wuhan University presented with a theme of <Patients with cancer appear more vulnerable to SARS-COV-2>. Zhongnan Hospital conducted a multi-center study including 105 cancer patients and 536 age-matched non-cancer patients confirmed with COVID-19. According to the study, COVID-19 patients with cancer had higher risks in all severe outcomes. Patients with hematological cancer, lung cancer, or with metastatic cancer (stage IV) had the highest frequency of severe events. In addition, patients who received surgery had higher risks of having severe events, while patients with only radiotherapy did not demonstrate significant differences in severe events when compared to patients without cancer. “These findings indicate that cancer patients appear more vulnerable to SARS-COV-2 outbreak. Since this is the first large cohort study on this topic, our report will provide the much-needed information that will benefit global cancer patients. As such, we believe it is extremely important that our study be disseminated widely to alert clinicians and patients,” stated Cai. “Self-protective isolation, strict in-hospital infection control, and appropriate online medical services are recommended. On top of that, individualized treatment plans need to be developed based on the tumor types and stages of patients by clinicians.”
AM Medical Creates Timely Virtual Forum Where Medicine and Technology Meet to Transform Lives, Featuring Presentation on Community Response to COVID-1
Technology experts and clinicians who are incorporating additive manufacturing (a.k.a. 3D printing) to improve patient care will gather virtually to accelerate innovation at the AM Medical Virtual Summit on Wednesday, May 27, 2020, hosted by the American Society of Mechanical Engineers (ASME). Registration is FREE, thanks to sponsor support. With a fresh approach to networking, learning and advancing the industry, ASME designed this virtual experience to set the stage for meaningful connections and productive meetings. From virtually anywhere, participants can gain insights from thought leaders at keynotes, participate in lunch and learns, spend time at their choice of 20 sessions in three different tracks – medical device manufacturing, tissue biofabrication, and specific considerations for clinicians– or explore what’s new from a growing list of vendors in the virtual exhibit hall. The AM Medical Virtual Summit is the only immersive event focused on 3D-printed medical applications that unites innovators who are changing the healthcare landscape. The virtual event features presentations on the medical AM/3D printing community’s response to COVID-19, quality systems for manufacturing, collaborations and resources in additive manufacturing, 3D printing for point-of-care, and 3D biofabrication. Keynote panelists include top medical 3D printing leaders from Johnson & Johnson, Mayo Clinic, Medtronic, Stryker, the U.S. Food and Drug Administration (FDA), and more. Other programming features such as the InnoZone Theatre and virtual networking lounge encourage discussion and co-creation. “At Johnson & Johnson, we are using 3D Printing technology to innovate at every touchpoint with patient specific, on-demand solutions that promise to transform the standard-of-care and to help more people access treatments globally,” says Sam Onukuri, head of the company’s 3D printing innovation and customer solutions, and a panelist in the “Medical AM/3DP Community Response to COVID-19” presentation at 10 a.m. EDT on May 27. Children with birth defects, soldiers with cranial injuries, conjoined twins, cancer patients and many others have been helped by 3D printing innovations. The value to individual patients is immeasurable. Every day, physicians including Dr. Juan Carlos Fernandez-Miranda of Stanford University and many others are using additive manufacturing technologies to improve patient care. Fernandez-Miranda and his team used 3D modeling and virtual reality to plan a recent life-saving surgery to remove a brain tumor from a two-year-old boy. He is a panelist in the AM Medical Virtual Summit breakout session, “Multi-disciplinary Approach Needed for Point-of-Care 3D Printing,” at 2 p.m. EDT on May 27. Meanwhile, as these inspiring stories about individual patients make headlines, 3D printing technology also is being used to more efficiently mass produce medical and dental devices, to create complex structures, and to produce innovative designs not possible with other existing technology. Nearly 150 medical devices that have been cleared by the FDA are produced using additive manufacturing, compared with just a handful of medical devices that are patient-matched with 3D printing at the point of care. The total value of AM machines, materials, software and services for medical applications is projected to reach $2.2 billion by 2024, according to a recent report from Global Market Insights. However, achieving this growth potential requires collaboration between the manufacturing and medical communities to enable technology application. “Now more than ever, there is an incredible demand for advanced healthcare solutions that impact patient care and operational efficiency. The COVID-19 pandemic has underscored the need,” says ASME President Richard Laudenat. “The 3D printing industry has demonstrated how quickly it can respond to augment the medical supply chain. We are fueling more collaborations that will unlock future growth opportunities and improvements for patient care. There’s potential for exceptional applications to become accessible to more patients as device manufacturers harness the technology for production on a larger scale.” Sponsors and exhibitors in the AM Medical Virtual Summit include industry leaders such as 3D Systems, B9 Creations, CAD BLU, EOS, Formlabs, GE Additive, Marvel Medtech, MasterGraphics, NCS Technologies, Nota3D, Protolabs, Trumpf, Xometry, and Zeiss. “Transformational technologies deserve new approaches,” says Debbie Holton, ASME’s managing director of industry events. “We’re excited to offer attendees a comprehensive look at 3D technologies with real-world applications that impact all of us. Our innovative event design engages experts and newcomers from all fields to drive technology forward. This conversation will continue beyond the May event as ASME rolls out a series of AM Virtual Summit events and presents a hybrid in-person and virtual event this October in Minneapolis.”