Pharma COVID Roundup: News from GSK, Apple, Google, Fujifilm
The latest on potential COVID-19 treatments, vaccines, and diagnostics with news from GSK, Apple, Google, Fujifilm, Inovio, and CanSino Biologics, and Covis Pharma.
News from GSK, Apple, Google and Fujifilm
GSK, Mammoth Biosciences To Develop COVID-19 CRISPR-Based Test
GSK Consumer Healthcare and Mammoth Biosciences, a San Francisco-based developer of a CRISPR-based disease detection platform, have formed a collaboration to develop a disposable, rapid, and handheld test to detect active SARS-CoV-2, the virus that causes COVID-19.
The collaboration will use Mammoth Biosciences’ CRISPR-based DETECTR platform that can identify and signal the presence of viral RNA strands obtained through a nasal swab. The companies say the test will use the proprietary DETECTR platform, which has demonstrated the system’s potential to deliver diagnostic results for SARS-CoV-2 in a handheld format.
The companies say the test has the potential to deliver point-of-use results in less than 20 minutes and will not require a laboratory setting. It will be a disposable and easily distributable diagnostic which, subject to regulatory review, will be available first in a clinical setting and ultimately by consumers at home.
Mammoth and GSK Consumer Healthcare have begun work on the COVID-19 test and say they are aiming to have a device submitted for review by the US Food and Drug Administration for emergency use authorization (EUA) before the end of 2020. The test will then be made available to US healthcare facilities that diagnose or treat COVID-19, and are eligible to use EUA-approved tests, with the goal of having it subsequently available over-the-counter to consumers. Following the development of a COVID test, both companies say they intend to explore how they can use the DETECTR technology platform to develop other types of diagnostics for consumer use.
Source: Mammoth Biosciences
Apple, Google Partner to Enable a Contact Testing App for COVID-19
Apple and Google have partnered to build Exposure Notifications, a digital technology to tell someone they may have been exposed to COVID-19. Exposure Notifications will enable apps created by public health agencies to work cross both Android phones and iPhones.
In a joint statement from Apple and Google, the companies say they have worked together over the last several weeks (as reported on May 20, 2020) by reaching out to public health officials, scientists, privacy groups and government leaders to get their input and guidance.
Starting May 20, 2020, the Exposure Notifications technology is available to public health agencies on both iOS and Android. Exposure Notifications is not an app, public health agencies will incorporate the application programming interface into their own apps that people install. Each user gets to decide whether or not to opt-in to Exposure Notifications; the system does not collect or use location from the device; and if a person is diagnosed with COVID-19, it is up to him/her whether or not to report that in the public health app.
Apple and Google announced the partnership between their companies on April 10, 2020 to develop opt-in contact tracing technology for COVID-19. Contact tracing is used by public health officials to contact, test, treat and advise people who may have been exposed to an affected person.
Fujifilm Begins Research for AI-based Technology for COVID-19
Fujifilm Corporation is commencing a research study to develop artificial intelligence (AI)-based technology to aid in the diagnosis and treatment assessment of patients with COVID-19-induced pneumonia.
The technology will be used to quantify the lesions of interstitial pneumonia, pulmonary inflammation and fibrosis that result in the hardening of the lungs. The research project, co-developed with Kyoto University, will begin with local medical institutions in Japan treating COVID-19 patients, starting with the Kanagawa Cardiovascular and Respiratory Center in Yokohama, Japan.
Fujifilm’s CT quantification technology for interstitial pneumonia used AI-based software that examines CT images of the bronchi, blood vessels, and lungs and automatically carries out categorization and measurement to quantify lesions of interstitial pneumonia.
Fujifilm began collaborating with Kyoto University in the spring of 2018 and applied Fujifilm’s AI technology to categorize and quantify lesions of interstitial pneumonia to case data held by Kyoto University.
Fujifilm says it will apply this CT quantification technology for interstitial pneumonia to develop the technology that helps evaluate the progress of patients with COVID-19-induced pneumonia and determine the effectiveness of treatments. In addition, the company says the technology is expected to contribute to accelerating the development and evaluation of drug candidates for treating pneumonia induced by COVID-19.
Source: Fujifilm Corporation
Google’s Verily Launches COVID-19 Research Project
Verily, the life sciences arm of Alphabet, the parent company of Google, has launched Baseline COVID-19 Research Project, through Verily’s Project Baseline, to advance the scientific understanding of COVID-19. Participants who choose to join will have access to relevant clinical studies and research activities, which may include scientific research and testing of new tools or interventions.
The first initiative, Baseline Antibody Research, is a serology study offered to individuals who have received COVID-19 nasal swab testing through the Baseline COVID-19 Testing Program. This program, initially starting in the Bay Area of San Francisco, is focused on the human immune response to infection. The company says public health authorities will likely rely on serology testing to estimate national infection rates and to determine whether or not antibodies confer protection against the virus. The Baseline Antibody Research will be used to support assessment of variability across different COVID-19 testing methods to support ongoing containment efforts.
Alongside antibody research, the COVID-19 Research Project will focus on the outcomes of those affected by COVID-19. Beyond clinical study opportunities, research activities may also include scientific surveys on mental health, lifestyle, and other issues. Members of the Project Baseline will be able to access opportunities and choose to take part in whatever research interests them through an online member portal.
The COVID-19 Research Project joins a growing number of efforts by Project Baseline and Verily specifically to combat COVID-19. In March 2020, Project Baseline joined with California to deliver community-based testing to high-risk individuals, supported by the Baseline Platform, which was designed to enable decentralized access, electronic screening, and return of results.
Since the launch of the California-based testing, the program has begun to scale nationwide, partnering with Rite Aid to power testing sites across eight additional states. Verily has also introduced the COVID-19 Pathfinder, a set of digital tools for hospitals and health systems to connect patients with up-to-date health information on-demand.
News from Inovio, Cansion Biologics and Covis Pharma
Inovio’s Preclinical Results on COVID-19 DNA Vaccine INO-4800
Inovio, a Plymouth Meeting, Pennsylvania biopharmaceutical companyy developing immunotherapies for infectious diseases and cancer, has published the preclinical study data for IN0-4800, its COVID-19 DNA vaccine.
The company reports that preclinical study demonstrates robust neutralizing antibody and T cell immune responses against SARS-CoV-2, the virus that causes COVID-19. The study was published in the peer-reviewed journal, Nature Communications.
INO-4800 targets the surface antigen spike protein of SARS-CoV-2 virus. The studies demonstrated that vaccination with INO-4800 generated robust binding and neutralizing antibody as well as T cell responses in mice and guinea pigs. The authors demonstrated virus neutralizing activity using three separate neutralization assays testing the vaccine’s ability to generate antibodies which can block virus infection by: (1) an assay using live SARS-CoV-2 viruses; (2) an assay using a pseudo-virus assay, where another virus displays the SARS-CoV-2 Spike protein; and, (3) a novel high-throughput surrogate neutralization assay measuring the ability of INO-4800-induced antibodies to block SARS-CoV-2 Spike binding to the host ACE2 receptor.
Study authors also detected these antibodies in the lungs of the vaccinated animals which could be important in providing protection from SARS-CoV-2. In addition, high levels of spike-specific T cell responses were observed with INO-4800 vaccination, which could be important in mediating protection from the virus infection.
CanSino, Precision NanoSystems to Co-Develop COVID-19 RNA-LNP Vaccine
CanSino Biologics, a Tianjin, China-based company focusing on vaccine research, production and commercialization, and Precision NanoSystems (PNI), a Vancouver, Canada-based company focused on technologies for nanomedicines, have entered into a co-development agreement to develop a mRNA lipid nanoparticle (mRNA-LNP) vaccine against COVID-19.
Under the agreement, the companies will use PNI’s proprietary RNA vaccine platform, consisting of a lipid nanoparticle delivery system and the company proprietary manufacturing technology, to advance a COVID-19 mRNA-LNP vaccine candidate toward human clinical testing and pursuant to regulatory approvals, commercialization in different regions. PNI will be responsible for the development of the mRNA-LNP vaccine, and CanSino Biologics will be responsible for pre-clinical testing, human clinical trials, regulatory approval and commercialization. CanSino Biologics has rights to commercialize the vaccine product in Asia, except Japan, with PNI retaining rights for rest of the world. The agreement includes undisclosed payments and royalties.
CanSino Biologics is developing a recombinant novel coronavirus vaccine (adenovirus Type 5 vector) candidate (Ad5-nCoV), which is being co-developed with the Beijing Institute of Biotechnology, and which is currently in Phase II clinical trials in China. CanSinoBIO recently announced a collaboration with the National Research Council of Canada to initiate clinical testing of the Ad5-nCoV vaccine candidate in Canada. In parallel to clinical development of Ad5-nCoV, CanSinoBIO says it wants to join efforts with PNI to develop and commercialize a mRNA-LNP based vaccine.
Source: Precision NanoSystems
Covis Pharma Initiates Phase III Trial of COVID-19 Inhaler Treatment
Covis Pharma, a Luxembourg-based specialty pharmaceutical company, has initiated a Phase III clinical study to assess its asthma drug, Alvesco (ciclesonide), against COVID-19. The study is being initiated after US Food and Drug Administration approval of the company’s investigational new drug filing for Alvesco for the treatment of COVID-19.
The Phase III study is a multicenter, randomized, double-blind, placebo-controlled study of Alvesco, a metered-dose inhaler, in non-hospitalized individuals with COVID-19 aged 12 and above. The study will enroll 400 patients at multiple clinical trial sites across the US. The company says early results of the Phase III clinical study are expected to be released in late-August/early-September 2020.
Alvesco is a glucocorticoid indicated for the long-term treatment of asthma as maintenance therapy in adults and adolescents 12 years of age and older in the US and over six years of age in Canada. It is currently under evaluation in clinical trials for the treatment of COVID-19 Australia, Japan, South Korea, Sweden, the UK, and now the US.
Covis says it is working to make the appropriate supply of Alvesco available for these clinical investigations by supporting research efforts and donating Alvesco inhalers.
Source: Covis Pharma