Stabilitech Recognised by WHO, seeks £6m funding to make oral SARS-COV-2 vaccine available by end of 2020
Stabilitech Biopharma, which is developing OraPro-COVID-19, an oral coronavirus vaccine, has been formally recognised on the international stage by the WHO as a vaccine developer, and seeks £6 million to fund clinical trials and manufacturing required to make the vaccine available by the end of 2020.
Bavarian Nordic has entered into an exclusive head of terms agreement to license AdaptVac’s proprietary capsid virus like particle (VLP)-based SARS-CoV-2 subunit vaccine technology, to help a European consortium, PREVENT-nCoV, move towards clinical proof of concept. Bavarian Nordic takes responsibility for clinical development and global commercialisation of the vaccine.
Researchers from the Human Cell Atlas Lung Biological Network, have identified two specific cell types in the nose as likely initial infection points for COVID-19 coronavirus, and cells in the eye and some other organs that also contain the viral-entry proteins. They also predict how a key entry protein is regulated with other immune system genes and reveals potential targets for the development of treatments to reduce transmission.
A new testing model from MedPharm supports pharmaceutical development programmes targeting coronavirus treatments, meaning companies can assess the therapeutic effectiveness of their anti-COVID-19 candidate compounds in nasal, airway (bronchial), and deep lung (alveolar) epithelia against members of the Coronaviridae family.
Nanoparticles developed by researchers from Galien Institute at Paris-Saclay University and the Federal University of Rio de Janeiro, made by conjugating squalene to adenosine and then encapsulating α-tocopherol, a natural antioxidant, have shown potential against the uncontrolled inflammatory processes associated with severe SARS-COV-2 infection.
Bioavanta-Bosti has developed of a 48-hour manufacturing process, using its Novochizol chitosan polysaccharide nanotechnology to encapsulate APIs – small molecules or biologics – for localised delivery and sustained release, to generate intra-pulmonary drug delivery formulations suitable for treating COVID-19 patients.
A novel inhaled formulation of the approved antihelminthic drug, niclosamide, is under development at the College of Pharmacy at The University of Texas at Austin for COVID-19. The compound was recently confirmed to exhibit antiviral efficacy in SARS-COV-2 infected cells and indeed was more potent compared with chloroquine, lopinavir and remdesivir, the group said.
Sensirion has launched a new flow sensor, SFM301, which has specifically been developed to be scaleable, and integrated easily into respiratory devices such as ventilators for the treatment of COVID-19 patients. The sensor is based on the company's CMOSens® technology, and can measure oxygen, and air.
Specialist respiratory drug product news publication OINDP News, has reported progress from several intranasal and inhaled COVID-19 vaccine development programmes, including from Altimmune, APEPTICO, a partnership between Neurimmune and Ethris, and a partnership between UW–Madison, FluGen and Bharat Biotech.
Martti Hedman, Chief Executive of Colorcon, has released a statement in which he confirmed that Colorcon is continuing its business activities, which had been categorised as essential and life sustaining by authorities around the world. He noted that Colorcon materials and coatings are used in some of the drugs that are being evaluated for use to treat COVID-19.
Roquette has identified its KLEPTOSE® hydroxypropyl beta-cyclodextrins (HPβCD) as potentially effective to help the joint efforts of the scientific and pharmaceutical communities working on treating and preventing new emerging viruses such as the coronavirus. HPβCD can effectively act as a safe, enabling excipient for solubility enhancement of antiviral drugs, stability improvement of therapeutic monoclonal antibodies, and as a vaccine adjuvant.
MedinCell investigating role of long-acting antivirals to break chain of SARS-COV-2 viral transmission
With evidence indicating that the established antiparasitic ivermectin can kill coronavirus in a laboratory setting in under 48 hours, MedinCell has published data showing that long-acting formulations of ivermectin can be designed with varying doses and durations with its BEPO® technology and is investigating whether a long-acting product could be effective in breaking the chain of viral transmission.
Tiziana Life Sciences has developed a handheld inhaler that will allow the rapid delivery of TZLS-501, its drug to treat inflammation of the lung in COVID-19. The company believes TZLS-501 (anti-IL6R) combined with this newly introduced inhalation technology may rapidly inhibit inflammation in lungs and in combination with intravenous administration may deplete circulating levels of IL-6 and potentially halt progression of COVID-19-mediated lung damage and death.
Theravance Biopharma is advancing TD-0903, a lung-selective nebulised Janus kinase inhibitor (JAKi) into clinical development to assess its utility in preventing the cytokine storm associated with acute lung injury (ALI) in patients hospitalised COVID-19 patients. The goal is the prevention of disease progression to ARDS.
BIOHAVEN GIVEN FDA GO-AHEAD TO BEGIN PHASE II TRIAL OF INTRANASAL VAZEGEPANT IN COVID-19 LUNG INFLAMMATION
Biohaven is to initiate a Phase II trial within weeks of intranasal vazegepant, its third-generation, high-affinity, selective small molecule CGRP receptor antagonist, in pulmonary complications of COVID-19 disease. The clinical trial will assess the potential benefits of CGRP receptor-blockade in mitigating an excessive immune response which in some cases can be fatal in COVID-19.
CALL FOR HELP IN THE FIGHT AGAINST COVID-19! BUSINESSES UNITE TO SUPPLY 15,000 FACE VISORS A DAY TO NHS
A growing group of businesses is urgently calling for more companies to join its initiative to put in place an end-to-end supply chain for desperately needed protective face visors for NHS and other workers in the fight against COVID-19. The group aims to achieve volumes of approx. 15,000 units/day.
Leading device design consultancies Cambridge Consultants, PA Consulting, Sagentia, Team Consulting and TTP , with industrial assistance from MetLase, have joined forces to answer the UK government's call for the rapid development and manufacture of vital ventilators for patients suffering with severe symptoms of COVID-19.
Canadian biotech company IMV has made impressively rapid, solid progress on the development of a vaccine candidate against the novel coronavirus, using its lipid-based vaccine delivery platform, DPX. New developments in just two weeks include, include: initiation of peptide candidate manufacturing, cGMP scale-up plans, preclinical models/assays; and Phase I clinical trial design completed, with discussions with Health Canada already underway also.
In its COVID-19 announcement, Ximedica has confirmed that its manufacturing facility remains open under the “essential service” classification and that is focusing on US national efforts to help address the challenges surrounding ventilator and PPE supplies. It also highlighted its core strength in engineering, with more than 200 engineers who have established several highly effective means of remote collaboration.
Oramed Pharmaceuticals Highlights Potential Suitability of its Platform Technology for COVID-19 Vaccine
The US FDA has granted “Expanded Access Emergency Use” to Vero Biotech immediately to use its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL DS, in the treatment of cardiopulmonary symptoms associated with COVID-19. The agency recently approved GENOSYL (NO) gas, for inhalation for the treatment of persistent pulmonary hypertension of the newborn.
N4 demonstrating utility of Nuvec® vaccine delivery system in COVID-19 vaccines using COVID-19 DNA plasmid
Springboard is now offering: design reviews / risk assessments of COVID-19 related medical devices at no charge; answering ad hoc requests for advice on devices relevant to COVID-19 at no charge; device development expertise, including a willingness to tackle short term projects on a not-for profit basis; submission of services to the UK Gov call for businesses to help make NHS ventilators.
The world, and our industry with it, has entered an unfamiliar and difficult period. I would like to take this opportunity to update you on how ONdrugDelivery can and will continue to provide its services uninterrupted, and tell you about some specific initiatives we're launching to help our readers, authors and clients across the global industry.
Pion has offered its analytical services
pro bono to assist in the development of vaccines and therapeutics for use in the fight against COVID-19. Its Scissor SubCutaneous Injection Site Simulator assays "simulate the stress conditions and environmental transitions of a biopharmaceutical drug when injected SC".
John Cahill, Director, Senior Consultant, Quality & Compliance, PharmaLex Ireland, provides an update on the status of several COVID-19 vaccine and therapeutic development programmes, emphasising the considerable efforts being made by industry, regulatory agencies and others, to accelerate development in what is normally, due to the need for stringent regulation, a notoriously slow-moving sector.