COVID-19 Vaccine Development

Moderna COVID-19 Vaccine Has Neutralising Activity Against Emerging Virus Variants

On 25th January 2021, Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced results from in vitro neutralisation studies of sera from individuals vaccinated with Moderna COVID-19 Vaccine showing activity against emerging strains of SARS-CoV-2. Vaccination with the Moderna vaccine produced neutralising titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and South Africa, respectively. The study showed no significant impact on neutralising titers against the B.1.1.7 variant relative to prior variants. A six-fold reduction in neutralising titers was observed with the B.1.351 variant relative to prior variants however neutralizing titer levels with B.1.351 remain above levels that are expected to be protective. This study was conducted in collaboration with the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

The two-dose regimen of the Moderna COVID-19 vaccine at the 100-µg dose is expected to be protective against emerging strains detected to date. The company will test an additional booster dose of its vaccine to study the ability to further increase neutralising titers against emerging strains beyond the existing primary vaccination series and is advancing an emerging variant booster candidate (mRNA-1273.351) against the B.1.351 variant first identified in the Republic of South Africa. The Company is advancing mRNA-1273.351 into preclinical studies and a Phase I study in the US to evaluate the immunological benefit of boosting with strain-specific spike proteins.

Stéphane Bancel, Chief Executive Officer of Moderna stated: “As we seek to defeat the COVID-19 virus, which has created a worldwide pandemic, we believe it is imperative to be proactive as the virus evolves. We are encouraged by this new data, which reinforce our confidence that the Moderna COVID-19 Vaccine should be protective against these newly detected variants. Out of an abundance of caution and leveraging the flexibility of our mRNA platform, we are advancing an emerging variant booster candidate against the variant first identified in the Republic of South Africa into the clinic to determine if it will be more effective to boost titers against this and potentially future variants.”

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In Vitro Study Shows Pfizer-BioNTech Vaccine is Effective Against Other COVID-19 Variants

On 8th January 2021, Pfizer and BioNTech announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB) that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralise SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains. The results were published on the preprint server bioRxiv, available here.

The virus variants from the United Kingdom and South Africa have multiple mutations in their spike or S glycoproteins, which are key targets of virus neutralising antibodies. These variants share the N501Y mutation, which is located in the receptor-binding site of the spike protein and results in the virus’ spike protein binding more tightly to its receptor. To determine if sera of people who had received the Pfizer-BioNTech COVID-19 vaccine could neutralize SARS-CoV-2 with the N501Y mutation, a virus with this substitution was generated in UTMB’s laboratory. The sera of 20 participants from the previously reported Phase III trial neutralised the virus with the mutation as well as neutralised virus without the mutation.

While the virus tested did not include the full set of spike mutations found on the UK or South African variants, neutralisation of virus with the N501Y mutation by the Pfizer- BioNTech vaccine-elicited human sera is consistent with preserved neutralisation of a panel of 15 pseudoviruses bearing spikes with other mutations found in circulating SARS-CoV-2 strains. This indicates that the key N501Y mutation, which is found in the emerging U.K and South Africa variants, does not create resistance to the Pfizer-BioNTech vaccine induced immune responses.

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Bayer and CureVac Partner for COVID-19 Vaccine Development

On 7th January 2021, Bayer announced a collaboration with CureVac, a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA). As part of their partnership, Bayer will support the further development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate CVnCoV. Bayer will also provide expertise and established infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information, supply chain performance.

Stefan Oelrich, Member of the Board of Management, Bayer AG and President of the Bayer’s Pharmaceuticals Division stated: “The need for vaccines against COVID-19 is enormous. We are therefore pleased to be able to provide significant support to CureVac, a leader in mRNA technology, in advancing the further development and supply of its COVID-19 vaccine candidate. We are highly committed to making our capabilities and networks available to help end this pandemic.”

CureVac will be the Marketing Authorisation holder, while Bayer will support CureVac with country operations within the European Union and selected additional markets. Bayer holds further options to become Marketing Authorization Holder in other markets outside of Europe.

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EMA Grants Approval to Moderna’s COVID-19 Vaccine

On 6th January 2021, the European Medicines Agency (EMA) granted conditional marketing authorisation for Moderna’s COVID-19 Vaccine in people from 18 years of age. EMA’s human medicines committee (CHMP) has assessed the data on the quality, safety and efficacy of the vaccine and recommended, by consensus, a formal conditional marketing authorisation be granted by the European Commission. The vaccine is given as two injections into the arm, 28 days apart, the most common side effects were usually mild or moderate.

Emer Cooke, Executive Director of EMA stated: “This vaccine provides us with another tool to overcome the current emergency. It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.”

EMA’s approval is based on a trial data that showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine compared with people who received dummy injections, and 90.9% efficacy in participants at risk of severe COVID-19.

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COVID-19 Research and Therapeutic Development

Adamis Pharmaceuticals Submits IND application to FDA for Tempol

On 20th January 2021, Adamis Pharmaceuticals Corporation announced the submission of an Investigational New Drug (IND) to the US Food and Drug Administration (FDA) for the investigational use of Tempol for the treatment of COVID-19. The submission of the IND to FDA followed a meeting with FDA in which the FDA gave specific recommendations on Chemistry, Manufacturing and Controls (CMC) and Clinical aspects to be included in the IND.

Tempol has demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. It has been shown to decrease proinflammatory cytokines (cytokine storm), and through its potent antioxidant activity has been shown to decrease the harmful effects of reactive oxygen species (ROS). Tempol has also been shown to decrease platelet aggregation, which is observed in many COVID-19 patients.

Dr Dennis J. Carlo, President and CEO of Adamis stated: “We believe that Tempol could play a pivotal role not only in the treatment of COVID-19 but actually in preventing hospitalisation. With new mutations occurring in the virus, it is apparent there is an ongoing need for new therapies. The South African and other variants could very well evade the protection of antibody treatments and also bring up concerns about the efficacy of the current COVID-19 vaccines. Mutations can possibly render these vaccines less potent and could require them to be updated as with influenza vaccines.”

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Verona Pharma Completes Enrolment in Pilot Study of potential COVID-19 inhaler

On 14th January 2021, Verona Pharma, a clinical-stage biopharmaceutical company focused on respiratory diseases, announced it has completed enrolment in its pilot clinical study evaluating the efficacy and safety of ensifentrine delivered via pressurized metered-dose inhaler (pMDI) formulation in US patients hospitalised with COVID-19.

Ensifentrine is a first-in-class product candidate with both bronchodilator and anti-inflammatory activities in one compound. Clinical data from studies of ensifentrine in the treatment of other respiratory diseases have shown ensifentrine improved lung function, reduced inflammation in the lungs and reduced symptoms of cough and sputum production. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 people.

David Zaccardelli, President and CEO of Verona Pharma, said: “Completing enrolment of the pilot study in COVID-19 is an important milestone and we are on track to report top-line results in the second quarter of 2021. We are pleased vaccines are now approved for the prevention of COVID-19; however, a significant unmet need remains for effective treatments for symptomatic patients. We believe ensifentrine, with its novel mechanism of action, could help to improve COVID-19 patient outcomes.”

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Imperial College’s Trial Shows Arthritis Drugs Could Reduce Mortality in COVID-19 Patients

Imperial College London has reported that the REMAP-CAP trial of two arthritis drugs, tocilizumab and sarilumab may reduce mortality in COVID-19 patients who need support in an intensive care unit (ICU). The REMAP-CAP trial evaluates the effect of treatments on a combination of survival and length of time patients need support in an ICU.

The study design randomises patients to multiple combinations of treatments, enabling researchers to evaluate different treatments for COVID-19, including antivirals, drugs which modulate the immune response, and therapies that modulate or support other vital aspects of the body’s response to the virus.

Deputy Chief Medical Officer Professor Jonathan Van-Tam said: “This is a significant step forward for increasing survival of patients in intensive care with COVID-19. The data shows that tocilizumab, and likely sarilumab, speed up and improve the odds of recovery in intensive care, which is crucial for helping to relieve pressure on intensive care and hospitals and saving lives.”

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Lifearc Funds COVID-19 Screening Hub at the University of Glasgow

On 6th January 2021, it was announced that the University of Glasgow’s Centre for Virus Research (CVR) is set to establish a COVID-19 drug screening and resistance hub in Scotland. The COVID-19 Drug-Screening and Resistance Hub (CRUSH) project will be in partnership with LifeArc and the University of Dundee Drug Discovery Unit.

Work in the facility will include studies to investigate promising drug candidates for COVID-19 treatment, alongside the integration of drug screening with the early identification of any possible drug and immune-resistant virus variants, to accelerate the investigation process.

Professor Massimo Palmarini, Director of the CVR, said: “The establishment of CRUSH is an exciting development for the CVR, and we are delighted to be partnering with LifeArc on this initiative. Whilst CRUSH activities will initially focus on the COVID-19 pandemic, the CVR and the CRUSH facility are well positioned to rapidly respond to future viral outbreaks, delivering innovation to address public health crises caused by high consequence viruses. We look forward to working with academic and industry partners to develop CRUSH as a national facility.”

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Other Pharma Industry News

Roche’s Faricimab hits Primary Endpoint in AMD studies

On 25th January 2021, Roche announced positive topline results from two identically designed global phase III studies, TENAYA and LUCERNE, evaluating its investigational bispecific antibody, faricimab, in patients with neovascular or age-related macular degeneration (nAMD). Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight weeks.

Nearly half of the people in both studies were treated with faricimab every 16 weeks during the first year. This is the first time this level of durability has been achieved in a phase III study of an injectable eye medicine for nAMD. Neovascular AMD affects around 20 million people globally and is the leading cause of blindness in those aged 60 and older.

Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development stated: “These results show the potential of faricimab as a new class of medicine that could extend time between treatments for people living with neovascular age-related macular degeneration. We have now seen positive and consistent results in four phase III studies for faricimab across both neovascular age-related macular degeneration and diabetic macular edema. We look forward to submitting this data to global regulatory authorities, with the aim of bringing this promising treatment option to patients as soon as possible.”

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FDA Accepts Priority Review of Merck’s Investigational Pneumococcal Vaccine

On 12th January 2021, Merck announced that the FDA are conducting a priority review of the Biologics License Application (BLA) for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease in adults 18 years of age and older. The EMA is also reviewing an application for licensure of V114 in adults.

The BLA and priority review designation were supported by results from Phase II and Phase III clinical studies in a variety of adult populations, including healthy adults and those at increased risk. Additional studies in the BLA support the potential use of V114 in various real-world clinical settings, including in co-administration with the quadrivalent influenza vaccine and as part of a sequential administration with PNEUMOVAX 23, and demonstrate equivalent performance among consecutive lots of V114.

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories stated: “Building on our nearly 40 years of experience with PNEUMOVAX® 23, Pneumococcal Vaccine Polyvalent, we have developed V114 as another potentially important option to help protect more adults from invasive pneumococcal disease, especially those who are at increased risk. We look forward to working with the FDA during the review of this application.”

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Merck Acquires Germany-based AmpTec

On 7th January 2021, Merck announced the acquisition of mRNA contract development and manufacturing organisation (CDMO) AmpTec. The agreement strengthens Merck’s capabilities to develop and manufacture mRNA for its customers for use in vaccines, treatments and diagnostics applicable in COVID-19 and many other diseases.

Stefan Oschmann, Chairman of the Executive Board and CEO of Merck stated: “The success of mRNA-based vaccines for COVID-19 lays the path to accelerate the development of these therapeutics for many other diseases. By combining AmpTec’s PCR-based mRNA technology with Merck’s extensive expertise in lipids manufacturing, we are able to provide a truly differentiated and integrated offering across the mRNA value chain, which will significantly decrease supply chain complexity and enhance speed-to-market.”

In addition to the mRNA technology capabilities, AmpTec has a diagnostics expertise that focuses on producing customized long RNAs and DNAs for in vitro diagnostics. It will complement Merck’s diagnostics business, which specialises in providing critical raw materials, components and services for in vitro diagnostics manufacturers.

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Issue Number: PN2101

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