COVID-19 Vaccine Development

Dynavax and Medigen Announce Partnership for a Novel Adjuvanted COVID-19 Vaccine Candidate

On 23rd July 2020, Dynavax Technologies, a biopharmaceutical company focused on developing and commercialising novel vaccines, and Medigen Vaccine Biologics, a biopharmaceutical company focusing on the development and production of vaccines and biologics, announced their collaboration to develop an adjuvanted vaccine candidate to protect against COVID-19. The collaboration is evaluating the combination of Medigen’s stable prefusion form of the SARS-CoV2 recombinant spike protein with Dynavax’s advanced adjuvant CpG 1018™, the adjuvant contained in Dynavax’s U.S. FDA-approved adult hepatitis B vaccine. Preclinical studies demonstrated that the vaccine candidate generated strong immune responses in experimental animals.
Charles Chen, Chief Executive Officer of Medigen stated: “The COVID-19 pandemic is straining healthcare systems across the globe, making a safe, effective and affordable vaccine an important tool in combatting the disease and protecting patients, especially for low and middle-income countries (LMICs). In preclinical testing, the combination of Dynavax’s proven adjuvant with our recombinant spike protein vaccine candidate generated strong virus neutralizing antibody responses and cellular immunity. These results support advancing evaluation of the combination into Phase 1 human testing, which we expect to begin in September of this year.”
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UK Government Acquires COVID-19 Vaccine Manufacturing Centre

The UK government has agreed to acquire a manufacturing site in Essex, which was built to make fish medicine, so that it can be converted to produce a COVID-19 vaccine. The purchase will enable an existing facility, owned by the aquaculture firm Benchmark Holdings, which specialises in fish health and genetics, to be repurposed into a fully licensed human vaccine manufacturing centre.
The site which is located in Essex will be converted into the Cell and Gene Therapy Catapult Manufacturing Innovation Centre and is scheduled to open in December 2021. The UK government had already invested £93m in a state-of-the-art manufacturing innovation centre near Oxford which will have capacity to produce millions of doses of a vaccine each month.
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Oxford University’s COVID-19 Vaccine Shows Promising Efficacy Results

On 20th July 2020, interim results of COVID-19 vaccine being developed by Oxford University and AstraZeneca were published in the medical journal the Lancet. Data showed that the vaccine caused side effects, including fever, headaches, muscle aches, and injection site reactions, in about 60% of patients. All of the side effects were deemed mild or moderate, and all resolved themselves over the course of the study. The experimental vaccine produced a dual immune response in people aged 18 to 55.
Dr Adrian Hill, director of the Jenner Institute at Oxford University stated: “We are seeing good immune response in almost everybody,” said “What this vaccine does particularly well is trigger both arms of the immune system.”
The vaccine is in phase II/III trial in the UK and has recently gone into phase III trials in South Africa and Brazil, it will be made available on a “not-for-profit basis for the duration of the coronavirus pandemic”.
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UK Government Signs Deal with BioNTech/Pfizer and Valneva for COVID-19 Vaccines

On 20th July 2020, the UK government securing access to 90 million doses of two experimental COVID-19 vaccines being developed by a partnership of BioNTech, Pfizer and Valneva. The deals are in addition to those already agreed for experimental vaccines being developed by Oxford University, AstraZeneca and Imperial College London. In a separate deal with AstraZeneca, it has also secured access to one million doses of a treatment containing COVID-19-neutralising antibodies to protect those who cannot receive vaccines such as cancer and immunocompromised patients.
Business Secretary Alok Sharma stated: “This new partnership with some of the world’s foremost pharmaceutical and vaccine companies will ensure the U.K. has the best chance possible of securing a vaccine that protects those most at risk”.
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Johnson & Johnson (J&J) in Discussion with Japan, Gates Foundation For COVID-19 Vaccine

On 16th July 2020, it was announced that J&J is in discussions with the Government of Japan, as well as the Bill and Melinda Gates Foundation, regarding allocations of its COVID-19 vaccine candidate as it prepares to initiate human trials. These discussions will help J&J determine pricing for its vaccine, which the U.S. drugmaker intends to sell on a not-for-profit basis during the pandemic.
The company had already agreed to prioritise an allocation to the United States (US) as part of its funding agreement with the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA). The Bill and Melinda Gates Foundation would focus on allocating any vaccine it acquired to developing countries.
J&J’s Chief Financial Officer Joseph Wolk stated:” Nothing has been finalized yet. We continue to have those discussions. People from the countries and the organizations we mentioned want to lock in a certain minimum level of capacity that they would get.”
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Novartis Launches Not-for-profit Portfolio of Medicines for Symptomatic Treatment of COVID-19

On 16th July 2020, Novartis announced a new initiative to help patients in low-income and lower-middle-income countries access affordable medicines to treat the major symptoms of COVID-19 in the absence of a vaccine or treatment.
The COVID-19 portfolio by Novartis includes 15 medicines from its Sandoz unit for treating gastro-intestinal illness, acute respiratory symptoms, pneumonia and septic shock. Some of the medicines in the portfolio are Amoxicillin, Colchicine, Heparin, Dexamethasone, Pantoprazole and Salbutamol. the drugs were selected based on their clinical relevance and availability in order to meet global demand.
Sandoz CEO Richard Saynor stated: This initiative builds on our earlier global commitment to keep prices stable for a basket of essential drugs used to treating COVID-19 patients. The COVID-19 Response Portfolio for low-income and lower-middle-income countries is designed to support governments in treating COVID-19 symptoms before they lead to complications in patients.”
Dr Lutz Hegemann, Chief Operating Officer for Global Health at Novartis stated: “Access to medicine can be a challenge for patients in low- and lower-middle-income countries and the situation has worsened during COVID-19. With our COVID-19 portfolio, we wish to help address the additional healthcare demands of the pandemic in the countries we are targeting”.
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GSK and Medicago Partner for Development of COVID-19 Candidate Vaccine

On 7th July 2020, GlaxoSmithKline (GSK) and Medicago announced a collaboration to develop and evaluate a COVID-19 candidate vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. CoVLPs mimic the structure of the virus responsible, allowing them to be recognised by the immune system. Use of an adjuvant can be of particular importance in a pandemic situation as it may boost the immune response and reduce the amount of antigen required per dose, allowing more vaccine doses to be produced.
Preclinical results of the vaccine showed a high level of neutralising antibodies following a single dose when administered with adjuvant, Phase I clinical testing is scheduled to begin mid-July to assess the safety and immunogenicity of three different dose levels of antigen combined with GSK’s pandemic adjuvant and in parallel with an adjuvant from another company. The companies will use Medicago’s plant-based production platform to manufacture the vaccine antigen, this technology relies on a plant as bioreactors to produce the S-spike protein which self-assemble into VLPs for use in the CoVLP vaccine candidate. It is highly scalable and can support the production of large amounts of vaccine in a significantly shortened timeline.
Dr Thomas Breuer, Chief Medical Officer, GSK Vaccines, stated: “This agreement paves the way for an innovative vaccine option combining a scalable plant-based antigen technology with an adjuvant which has pandemic dose sparing capability. If successful, it will be a meaningful contributor in the fight against COVID-19. We strongly believe that multiple vaccines are needed, including post-pandemic vaccines. This plant-based technology also shows promise beyond COVID-19 and has the potential to help prevent other infectious diseases.”
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COVID-19 Research and Therapeutic Development

Merck Partners with IRBM for Development of Peptides Against COVID-19

On 21st July 2020, Merck (tradename of Merck & Co.) and IRBM, a global Contract Research Organization announced a research collaboration to identify and develop novel peptide therapeutics active against different strains of coronavirus, including SARS-CoV-2. The parties will work on hit to lead optimisation and preclinical drug development to rapidly advance selected candidates towards the clinic.
IRBM is involved in peptide drug development, including target validation, initial hit identification and the development of a clinical candidate, established in 2010 as a spin-off from MSD. As part of the collaboration with Merck, IRBM will leverage its previous SARS research to potentially identify and develop a treatment for SARS-CoV-2 and other future coronavirus strains
IRBM CSO Carlo Toniatti stated: “With this new outbreak of coronavirus, it makes sense for MSD and IRBM to join forces in this crucial area and work together on a treatment for this devastating pandemic as well as possible future pandemics.”
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Tonix Pharmaceuticals to Develop Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

On 16th July 2020, Tonix Pharmaceuticals a clinical-stage biopharmaceutical company, announced that it had entered into a research collaboration and option agreement with Columbia University focused on studying the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. The partnership will focus on T cell and antibody responses to SARS-CoV-2, the virus that causes COVID-19 at the cellular level including human monoclonal antibodies and anti-idiotypes. The technology is designed to fill in important gaps in understanding the detailed immune responses to COVID-19, and to provide a foundation upon which to target vaccines and therapeutics to appropriate individuals by precision medicine.
Columbia University researchers Dr Ilya Trakht and Dr Sergei Rudchenko will lead the project. Trakht’s team will investigate T-cell and antibody responses using different techniques, including at the cellular level via stimulation of T-cells in-vitro with SARS-CoV-2 antigens and the production of fully human monoclonal antibodies against the virus. The aim of the project is to enable the isolation and characterisation of therapeutic, fully human monoclonal antibodies to the virus.
Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, stated, “We expect that more than one COVID-19 vaccine will ultimately be approved by the Food and Drug Administration (FDA), and a challenge for future research will be to determine which vaccine is appropriate for each individual. Data from this collaboration will provide a roadmap and tools to potentially guide these recommendations. This work may also guide the selection of appropriate individuals for COVID-19 vaccine trials, such as for Tonix’s TNX-1800, based on a live replicating vector platform, which is designed to confer durable T cell immunity. It is also possible that new COVID-19 vaccines can designed which will be tailored to individuals by precision medicine. We are excited to work with our collaborators at Columbia University on these precision medicine technologies and also to potentially develop new monoclonal antibody therapeutics.”
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COVID-19 Drug Testing Platform Launched by UK Universities

On 7th July 2020, The University of Liverpool, Liverpool School of Tropical Medicine and Southampton Clinical Trials Unit have announced the launch of an innovative COVID-19 drug testing platform called “AGILE” in order to accelerate the development of the most promising therapies. AGILE developed by Infectious Diseases clinicians, clinical and pre-clinical pharmacologists, clinical trials specialists and statisticians, is a platform that can test new drugs for COVID-19 and identify compounds which could be game changers in the battle against COVID-19.
AGILE is a “proof of confidence engine” that can treat COVID-19 patients for the first time with promising drugs that have been developed in laboratories around the world. The trial is conducted at the Royal Liverpool University Hospital Clinical Research Unit, where treatment is carefully monitored throughout by an independent committee to ensure that it is safe to continue, and the first evidence about the effectiveness of the drug for treatment of COVID-19 is accumulated to determine if it should be fast-tracked into large-scale trials.
Professor Saye Khoo, Chief Investigator on AGILE at the University of Liverpool, stated: “In the ongoing COVID-19 pandemic, we need to find innovative ways to identify safe and effective treatments as soon as possible. The AGILE platform bridges the gap between pre-clinical drug discovery and large-scale testing, rapidly identifying drugs that have the best chance of success.”
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Regeneron Initiates Phase III COVID-19 Prevention Trial in Collaboration with NIAID

On 6th July 2020, Regeneron Pharmaceuticals, Inc. announced the initiation of late-stage clinical trials evaluating REGN-COV2, an investigational double antibody cocktail for the treatment and prevention of COVID-19. A Phase III trial will evaluate REGN-COV2’s ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient and is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19. They selected the two most potent, non-competing and virus-neutralizing antibodies to create REGN-COV2 and have scaled up this dual-antibody cocktail for clinical use.
This follows a positive review from the Independent Data Monitoring Committee of REGN-COV2 Phase I safety results in an initial cohort of 30 hospitalised and non-hospitalised patients with COVID-19.The Phase III prevention trial is being conducted at approximately 100 sites and is expected to enrol 2,000 patients in the US; the trial will assess SARS-CoV-2 infection status.
George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron stated: “We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic. We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an anti-viral antibody cocktail that could be available much sooner than a vaccine.”
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Sanofi and Regeneron Terminate Kevzara® (sarilumab) Phase III U.S. trial in COVID-19 Patients

On 2nd July 2020, Sanofi and Regeneron Pharmaceutical announced that the U.S. Phase III trial of Kevzara® (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone (placebo).
In the primary analysis group, adverse events were experienced by 80% of Kevzara patients and 77% of placebo patients. Serious adverse events that occurred in at least 3% of patients and more frequently among Kevzara patients were multi-organ dysfunction syndrome (6% Kevzara, 5% placebo) and hypotension (4% Kevzara, 3% placebo). Based on the results, the US-based trial has been stopped, including in a second cohort of patients who received a higher dose of Kevzara (800mg). Detailed results are to be submitted to a peer-reviewed publication later this year. A separate Sanofi-led trial outside of the U.S. in hospitalized patients with severe and critical COVID-19 using a different dosing regimen is ongoing.
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Issue Number: PN2007

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