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
Injectable hydrogel could someday lead to more effective vaccines
Delivering proteins to testes could someday treat male infertility
Pharming receives Orphan Drug Designation for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)
With Deep Learning Algorithms, Standard CT Technology Produces Spectral Images
Wearable Circuits Sintered at Room Temperature Directly on the Skin Surface for Health Monitoring
Conductive Hydrogel for Photothermal-Responsive Stretchable Artificial Nerve and Coalescing with Damaged Peripheral Nerve
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.”
American Association for Cancer Research (AACR) Reveals Relationship Between COVID-19 and Cancer
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. ▲ Anti-tumor treatment within 14 days after confirmation of COVID-19 and consolidation in CT scan showed significant results in the hazard ratio (HR). (Image provided: Tongji Hospital) To begin with, Prof. Li Zhang of Tongji Medical College, Wuhan, China, gave a presentation about <The experience of treating patients with cancer during the COVID-19 pandemic in China>. Tongji Medical College collected data on cancer patients from 3 hospitals in Wuhan from January 13 to February 26, 2020, and conducted both univariate and multivariate analysis on severe patients for risk factors. In addition, 124 cancer patients who had undergone immune checkpoint inhibitors (ICI), and their families were followed up to find out the infection rate and clinical results. She stated, “Of the cancer patients, 28 were infected with COVID-19, the median age was 65, and the male gender was 60.7% (17pts). 25% (7pts) were lung cancer, and 28.6% (8pts) were considered to be infected through hospital-associated transmission. 53.6% (15pts) had severe events with the mortality rate of 28.6%. Aggressive presentations and negative outcomes could be seen in cancer patients with COVID-19.” Also, “As a result of chest CT, 75% (21pts) had ground-glass opacity, and 46.3% (13pts) had consolidation. The patients with patchy consolidation showed a higher risk of developing into severe events. Moreover, since anti-tumor treatment that progressed within 14 days after confirmation of COVID-19 significantly increased the proportion of severe events, it is recommended to actively perform COVID-19 tests on cancer patients who have undergone anti-tumor treatment.” Prof. Li Zhang explained about the attempt to find out where there is a relationship between ICI and COVID-19. “Only one of the 124 cancer patients who had undergone ICI therapy was confirmed to have COVID-19, so it was difficult to get meaningful evidence of showing the relationship between ICI therapy and COVID-19 within limited data.” Meanwhile, Prof. Marina C. Garassino of Fondazione IRCCS Istituto Nazionale dei Tumori, Prof. Fabrice Barlesi of Gustave Roussy Cancer Campus Grand Paris, Dr. Carlos Gomez-Martin of Octubre University Hospital, Dr. Paolo A. Ascierto of Istituto Nazionale Tumori IRCCS Fondazione Pascale, Dr. Louis P. Voigt of Memorial Sloan Kettering Cancer Center, and Prof. Hongbing Cai of Zhongnan Hospital of Wuhan University also gave presentations about the relationship between COVID-19 and cancer patients conducted at each center, hospital or research institute. The contents of the main presentations will be uploaded on Acrofan in follow-up articles.
POSTECH Developed Smart Contact Lens for Diabetes Monitoring and Diabetic Retinopathy Therapy
Diabetes is called an "immortal disease" as it is never completely removed with any treatment of modern medical science once it develops. But what if you could control the secretion of insulin just by wearing contact lenses? Recently, POSTECH (Pohang University of Science and Technology) research team developed a wireless smart contact lens technology that can diagnose diabetes by wearing contact lenses and can even treat diabetic retinopathy by itself. The smart contact lens can diagnose and treat diabetes by controlling drug release with electrical signals. It is made of biocompatible polymers and incorporates biosensors, drug delivery systems, and data communication systems. The research team confirmed that the sugar concentration in tears analyzed by the smart contact lens in the diabetic rabbit model is consistent with the blood sugar analyzed by the conventional glucose meter and that the drug in the smart contact lens can be used to treat diabetic retinopathy. In recent years, by utilizing such smart contact lens-based technology, researches are being conducted to broaden the scope of use as an electronic drug system that can treat mental disorders by electrical stimulation. Mental disorders include depression and brain diseases such as Alzheimer's and Parkinson's disease. The research team expects that smart contact lenses for self-controlled treatment, along with real-time bio-analysis, will be developed and quickly applied to wearable healthcare-related industries. The findings were published in the world-wide journal, Science Advances.
Cumulative Quantities of Osang Healthcare COVID-19 Test Kit Exceeded 10 Million
Osang Healthcare, a South Korean manufacturer and distributor of medical devices, announced that after receiving approval from the FDA on March 18, the cumulative order quantities of COVID-19 test kits had surpassed 10 million. All orders received so far will be shipped later this month. The company has provided COVID-19 test kits to more than 30 countries, including the United States, Brazil, Russia, Italy, Romania, Morocco, Kuwait, and Argentina. In order to export the test kit, it is required to pass the strict technical requirements offered by the FDA in each country. Among them, the U.S. FDA has the highest entry barrier. However, on April 18, the company announced that it obtained emergency use authorization (EUA) by the U.S. FDA on its COVID-19 test kit, GeneFinder™ COVID-19 Plus RealAMPKit. Compared to other EUA-approved products, it has been approved as a universal kit that almost all equipment can use. Thus, the company was able to supply test kits across the United States. "The process of obtaining emergency use authorization, which demands strict technical requirements, had never been easy. I am so proud and happy to be approved by the U.S. FDA for emergency use for the first time in Korea. This is because all employees, such as the dedicated team research center and quality team, worked together in a unified way based on the technology accumulated in the field of diagnostic equipment for 20 years," said Lee Dong-Hyun, CEO of Osang Healthcare. Meanwhile, unlike the competitors that can detect two genes, Osang Healthcare's test kit can identify all three target genes (E, RdRp, N), making the test results highly accurate. Also, as the reagents are user-friendly and efficient, It is highly regarded as a suitable product for mass inspection.
AbClon Succeeds in Discovering Novel Antibody Drug Candidate for COVID-19
AbClon, a Korean antibody drug company, stated that it has confirmed the neutralizing capacity to effectively inhibit the infection of COVID-19 from a novel antibody drug candidate discovered from the company's own human antibody library. AbClon has achieved the spike protein of SARS-CoV-2 (COVID-19) and, in particular, several antibodies and affibodies that specifically bind to the receptor-binding domain (RBD) and has applied for patents. The receptor-binding domain is a site that directly binds to human receptors. Among the 20 candidates discovered from the COVID-19 virus neutralizing capacity test conducted by the Korea University Medical Center, AbClone first selected one novel drug candidate that can most effectively neutralize coronavirus and inhibit target cell infection. And the company is now intensively developing the candidate. The coronavirus is RNA-based and is known to easily cause strain. It has already been reported that at least three strains have occurred, and is expected to increase in the future. AbClon is also developing an affibody or AffiMab-type double-antibody using affibodies in order to cope with the coronavirus strains and realize the therapeutic effect applicable to a wide range of patients.
Seegene Received Emergency Use Authorization (EUA) by USFDA For COVID-19 Test Kit
Seegene, a Korean company specialized in molecular diagnostics, announced on the 22nd that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Allplex™ 2019-nCoV Assay. Seegene's coronavirus test kit, Allplex™ 2019-nCoV Assay is used worldwide for COVID-19 screening. Since Allplex™ 2019-nCoV Assay can detect all three target genes (E, RdRp, N), it is not only highly accurate, but also can test with only one tube, so it can efficiently perform a large number of tests. Immediately after the occurrence of COVID-19 in China, Seegene quickly began to develop COVID-19 diagnostic reagents using its own AI reagent development system. Seegene's diagnostic reagent technology and automated testing systems have played a pivotal role in effectively controlling the COVID-19 situation in Korea. Seegene Medical Foundation, the affiliated company of Seegene and the largest inspection agency in Korea, can test up to 15,000 COVID-19 tests a day based on the automated testing system. Seegene's testing system has become a global standard for COVID-19 diagnosis and is currently used in more than 60 countries, mainly Italy, Spain, France, and Germany. Having secured an extensive global network and established an excellent reputation through a variety of reagent products, Seegene has been able to quickly apply COVID-19 tests through dedicated testing equipment installed in various places, and it is still generating a great demand from all over the world.
Regarding an approval for the interim order of “TORAYMYXIN” to treat COVID-19 patients in Canada
Toray Industries, Inc. and Toray Medical Co., Ltd. announced that Canadian Authority, Health Canada has issued an Interim Order for use of an endotoxin adsorption cartridge, TORAYMYXIN® to treat patients with the novel coronavirus (“COVID-19”). COVID-19, the novel coronavirus (SARS-CoV-2) is an infectious disease that causes organ dysfunction including respiratory failure with worsening disease conditions. As the COVID-19 pandemic accelerates,“Interim order respecting the Importation and sale of medical devices for use in relation to COVID-19” has been established by Health Canada. Toray has possessed the Canadian Import License for TORAYMYXIN® to treat patients with septic shock since its approval in 2003 (License Number: 63404). In addition to the current indications, Toray applied for the authorization of the interim order for TORAYMYXIN® to treat COVID-19 patients, and was granted expanded indications for use on April 17 as follows. Expanded indications for the interim order When TORAYMYXIN is used for COVID-19 patients, indications are as follows: Acute respiratory failure in the absence of cardiac failure or fluid overload Having diffuse alveolar damage (DAD) (HRCT findings) PaO2/FiO2 =< 300 mmHg
Osang Healthcare Received Emergency Use Authorization (EUA) by USFDA For COVID-19 Test Kit
Osang Healthcare, a subsidiary of OsangJaiel, announced that it obtained emergency use authorization (EUA) by the US Food and Drug Administration (FDA) on its COVID-19 test kit, GeneFinder™ COVID-19 Plus RealAMPKit. Osang Healthcare is a South Korean manufacturer and distributor of medical devices. As the excellence of Korean test kits became known, competition around the world is fierce to secure Korean test kits. Currently, more than 100 countries have imported Korean COVID-19 test kits. With this FDA's EUA approval of Osang Healthcare, it is expected that the proportion of test kits in exports will increase significantly. Osang Healthcare has begun negotiations to export to the US market in earnest through this EUA approval. Currently, specific discussions are underway for large-scale export contracts related to the supply of COVID-19 test kits to various channels in the United States. Recently, the company has signed large-scale export contracts with Brazil, Russia, Italy, Romania, Morocco, Argentina, and the Federal Emergency Management Agency (FEMA). Besides, it is currently responding to export inquiries from over 70 countries around the world, and the produced quantity is shipped every week. The company stated, "We already have expanded the production capacity so that there is no problem in supplying test kits in preparation for additional large-scale orders from the United States, South America, Europe, and the Middle East."