COVID-19 NEWS

Stabilitech Recognised by WHO, seeks £6m funding to make oral SARS-COV-2 vaccine available by end of 2020

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.

Telemedicine gains acceptance amid the COVID-19 pandemic

Telemedicine gains acceptance amid the COVID-19 pandemic

Noble highlights how telemedicine is poised to become a mainstream alternative to the traditional in-person methods of care delivery, with the COVID-19 pandemic easing barriers to acceptance and introducing patients to the safety and convenience of telehealth technology.

RedHill’s US IND Approved for Opaganib SARS-COV-2 trial; positive results from Israeli trial

RedHill’s US IND Approved for Opaganib SARS-COV-2 trial; positive results from Israeli trial

RedHill Biopharma has received US FDA of its IND for a Phase IIa clinical trial of opaganib (Yeliva^®, ABC294640) in 40 hospitalised SARS-COV-2 patients, and has reported positive preliminary results from a trial of the product in six patients in Israel.

BAVARIAN NORDIC ENTERS AGREEMENT WITH ADAPTVAC TO ADVANCE COVID-19 VACCINE

BAVARIAN NORDIC ENTERS AGREEMENT WITH ADAPTVAC TO ADVANCE COVID-19 VACCINE

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.

KEY NOSE CELLS IDENTIFIED AS LIKELY COVID-19 VIRUS ENTRY POINTS

KEY NOSE CELLS IDENTIFIED AS LIKELY COVID-19 VIRUS ENTRY POINTS

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.

ARTES USING METAVAX<sup>®</sup> AND SplitCore VLP PLATFORM FOR SARS-CoV-2 vaccine

ARTES USING METAVAX^® AND SplitCore VLP PLATFORM FOR SARS-CoV-2 vaccine

ARTES Biotechnology has begun development of SARS-CoV-2 vaccine candidates based on its virus-like particle (VLP)-based platform technologies METAVAX^® and SplitCore.

MedPharm Develops Model to Support Coronavirus Pharmaceutical Development

MedPharm Develops Model to Support Coronavirus Pharmaceutical Development

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.

Squalene-based nanoparticles for the treatment of uncontrolled inflammatory processes

Squalene-based nanoparticles for the treatment of uncontrolled inflammatory processes

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.

Chitosan nanoparticles suitable for aerosol treatment of Covid-19 patients

Chitosan nanoparticles suitable for aerosol treatment of Covid-19 patients

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.

ANSYS simulations to help provide insights in fight against COVID-19

ANSYS simulations to help provide insights in fight against COVID-19

ANSYS, Inc, has posted sample clips of various simulations on its webpage, for others to use to gain insights in the fight against COVID-19. The simulations, which can be viewed here, offer various insights on aspects.

NanoPass Sharing Microneedle Device with Pharma Partners for COVID-19 Vaccine

NanoPass Sharing Microneedle Device with Pharma Partners for COVID-19 Vaccine

NanoPass is sharing its proprietary MicronJet microneedle device with vaccine and immunotherapy companies to help in the efforts to develop a safe, effective and affordable vaccine against SARS-COV-2, novel coronavirus.

Pulmonary Delivery Could Make Niclosamide Effective Against COVID-19

Pulmonary Delivery Could Make Niclosamide Effective Against COVID-19

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.

New Sensor Solution for Ventilators

New Sensor Solution for Ventilators

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.

Inhaled and nasal Covid-19 vaccine progress

Inhaled and nasal Covid-19 vaccine progress

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.

Message from Colorcon CEO Martti Hedman

Message from Colorcon CEO Martti Hedman

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.

Combating Coronavirus: Cyclodextrins in Treatment & Prevention

Combating Coronavirus: Cyclodextrins in Treatment & Prevention

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

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.

INHALER FOR DIRECT PULMONARY DELIVERY OF ANTI-IL-6 MAB IN COVID-19

INHALER FOR DIRECT PULMONARY DELIVERY OF ANTI-IL-6 MAB IN COVID-19

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 ADVANCES TO CLINICAL TRIALS WITH TD-0903 IN COVID-19 ACUTE LUNG INJURY

THERAVANCE ADVANCES TO CLINICAL TRIALS WITH TD-0903 IN COVID-19 ACUTE LUNG INJURY

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 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

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.

DEVICE DESIGN CONSULTANCIES JOIN FORCES, STEP-UP TO THE COVID-19 VENTILATOR CHALLENGE

DEVICE DESIGN CONSULTANCIES JOIN FORCES, STEP-UP TO THE COVID-19 VENTILATOR CHALLENGE

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.

Development of IMV’s DPX-COVID-19 Vaccine Progresses Apace

Development of IMV’s DPX-COVID-19 Vaccine Progresses Apace

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.

Aquavit Developing Microchannel Drug Delivery Device / Novel Compositions for Vaccine Against COVID-19

Aquavit Developing Microchannel Drug Delivery Device / Novel Compositions for Vaccine Against COVID-19

Aquavit Pharmaceuticals is applying its AQUAGOLD® microchannel drug delivery device in the development of a self-administered dermal vaccine against COVID-19 caused by the SARS-CoV-2 coronavirus.

How the current pandemic will shape healthcare innovation for the next decade

How the current pandemic will shape healthcare innovation for the next decade

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

Oramed Pharmaceuticals Highlights Potential Suitability of its Platform Technology for COVID-19 Vaccine

In a letter to shareholders issued as an update relating to COVID-19, Oramed Pharmaceuticals has highlighted the suitability of its platform technology for protein-based vaccines, including potentially a vaccine against COVID-19, and the potential for partnerships for such a project.

EUROFINS CDMO Launches “Direct To Patient” Service for Continuity of Treatment for Customers’ Clinical Trial Patients

EUROFINS CDMO Launches “Direct To Patient” Service for Continuity of Treatment for Customers’ Clinical Trial Patients

CDMO Eurofins has launched a Direct to Patient service to assure the continued supply of treatments to its customers' clinical trial patients.

Stabilitech to have oral coronavirus vaccine ready for preclinical evaluation in 3 months

Stabilitech to have oral coronavirus vaccine ready for preclinical evaluation in 3 months

UK biopharma company Stabilitech is developing OraPro-COVID-19, applying its OraPro technology with the aim of developing a viral vector with six weeks, and having a capsule ready for animal testing within 12 weeks.

TEQ proud to support ‘Essential Business’ activity with European sourcing of high-quality medical packaging

TEQ proud to support ‘Essential Business’ activity with European sourcing of high-quality medical packaging

TEQ is proud to continue delivering a range of medical packaging solutions for customers working […]

Vero Biotech gets okay for expanded access to its Genosyl DS iNO system to treat COVID-19 patients

Vero Biotech gets okay for expanded access to its Genosyl DS iNO system to treat COVID-19 patients

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<sup>®</sup> vaccine delivery system in COVID-19 vaccines using COVID-19 DNA plasmid

N4 demonstrating utility of Nuvec^® vaccine delivery system in COVID-19 vaccines using COVID-19 DNA plasmid

N4 Pharma has initiated a proof of concept project using a Covid-19 DNA plasmid to demonstrate the utility of its Nuvec® silica nanoparticle vaccine delivery system for potential collaboration partners developing Covid-19 DNA or RNA vaccines.

Springboard offers medical device expertise to tackle COVID-19

Springboard offers medical device expertise to tackle COVID-19

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.

UPDATE AND NEWS FROM ONDRUGDELIVERY’S PUBLISHER IN RESPONSE TO COVID-19

UPDATE AND NEWS FROM ONDRUGDELIVERY’S PUBLISHER IN RESPONSE TO COVID-19

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 Offers Its Analytical Services Pro Bono if used in the fight against COVID-19

Pion Offers Its Analytical Services Pro Bono if used in the fight against COVID-19

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".

COVID-19, what’s left to be said and done?…well, everything!

COVID-19, what’s left to be said and done?…well, everything!

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.

Ampio to Study Nebulised Ampion Anti-Inflammatory Biologic in COVID-19 Patients

Ampio to Study Nebulised Ampion Anti-Inflammatory Biologic in COVID-19 Patients

Ampio Pharmaceuticals is preparing an expanded access US FDA protocol to study potential benefit of nebulised treatment with Ampion in COVID-19-induced acute respiratory distress syndrome (ARDS), an immediately life-threatening condition.