For your information this will be the last monthly issue of Pharma News. Going forward we will have weekly news summaries published on our website and LinkedIn.

COVID-19 Vaccine Development

Sanofi and GSK Begin Phase II COVID-19 Vaccine Candidate Study

On 23rd February 2021, Sanofi, and GlaxoSmithKline (GSK) announced the initiation of a Phase II dose-finding study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. The trial is a randomised, double-blind, multi-centre dose finding study conducted in adults aged 18 years of age and older to evaluate the safety, reactogenicity, and immunogenicity of two injections given 21 days apart.

Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur stated: “Over the past few weeks, our teams have worked to refine the antigen formulation of our recombinant-protein vaccine, based on learnings from our initial Phase 1/2 study. We are confident that our vaccine candidate has strong potential, and we are very encouraged by the latest preclinical data. This new Phase 2 study will enable us to identify the final vaccine formulation for adults of all ages. We have demonstrated our commitment to focusing efforts and capabilities towards the global fight against the pandemic, and this new study takes us a step closer to achieving our primary goal of developing a COVID-19 vaccine with a good efficacy and safety profile.”

Roger Connor, President of GSK Vaccines added: “We are pleased to be starting this new Phase 2 study. The world needs multiple vaccines, and we are confident that combining our proven pandemic adjuvant system with this improved antigen formulation will have significant potential as the pandemic evolves. We look forward to further progressing this vaccine candidate to Phase 3 in Q2 2021 if this Phase 2 study is successful.”

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Novavax Completes Subject Enrolment in COVID-19 Vaccine Trial

On 23rd February 2021, Novavax, a biotechnology company developing next-generation vaccines for serious infectious diseases, announced the completion of enrolment for PREVENT-19, a Phase III study in the United States and Mexico to evaluate the efficacy, safety, and immunogenicity of the company’s COVID-19 vaccine. The randomised, placebo-controlled, observer-blinded study will analyse the efficacy, safety, and immunogenicity of NVX-CoV2373 with Matrix-M versus placebo. It has enrolled 30,000 adult participants across 118 sites in the US and Mexico, trial sites were chosen in high transmission rate areas to expedite the accumulation of positive cases that could demonstrate efficacy.

Gregory M. Glenn, President of Research and Development, Novavax stated: “The full enrolment of PREVENT-19 is another important step in building a body of evidence to demonstrate that NVX-CoV2373 will be safe and effective across diverse, representative populations. We thank the thousands of volunteers and individuals, including our partners at NIH, the COVID-19 Prevention Network, and trial sites in the U.S. and Mexico, who enabled rapid recruitment and enrolment in the trial, which we believe is a critical aspect to building vaccine trust and uptake across the globe.”

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Russia Grants Approval to Third COVID-19 Vaccine

On 21st February 2021, Russian Prime Minister Mikhail Mishustin announced that the country has approved a third COVID-19 vaccine for domestic use. Produced by the Chumakov Centre, CoviVac is a whole-virion vaccine, which derives from inactivated coronavirus. It is transported and stored at 2-8°C and administered as two doses given 14 days apart, tested for safety on 200 individuals aged 18 to 60 years of age.

Previously Russia had approved two COVID-19 vaccines, Gamaleya Institute-developed Sputnik V vaccine and a vaccine developed by the Vector Institute in Novosibirsk.

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Pfizer and BioNTech Begin COVID-19 Vaccine Trial in Pregnant Women

On 18th February 2021, Pfizer and BioNTech announced that the first participants have been dosed in a Phase II/III study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in preventing COVID-19 in healthy pregnant women 18 years of age and older.

The randomised, placebo-controlled, observer-blind study will analyse the safety, tolerability, and immunogenicity of two doses of the vaccine or placebo given 21 days apart. It will enrol around 4,000 healthy pregnant women who will receive the vaccine from 24 to 34 weeks of gestation. The subjects will be part of the study for about seven to ten months, depending on whether randomised to receive the vaccine or placebo. The trial will also evaluate safety in infants of vaccinated pregnant women and the transfer of potentially protective antibody to them.

William Gruber, Senior Vice President of Vaccine Clinical Research and Development Pfizer stated “We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations. Pregnant women have an increased risk of complications and developing severe COVID-19, which is why it is critical that we develop a vaccine that is safe and effective for this population. We are deeply thankful to the volunteers who are enrolling in the trial, and site investigators who are leading this work.”

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Altimmune Gets FDA Nod to Start Clinical Trials for COVID-19 Vaccine

On 17th February 2021, Altimmune, a clinical-stage biopharmaceutical company, announced that the US. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application for its Phase I clinical trial of AdCOVID, a novel, single-dose, intranasal COVID-19 vaccine candidate. Altimmune expects to commence patient enrollment in the Phase I clinical trial in the coming week.

A single-dose vaccine candidate, AdCOVID is designed to trigger a broad immune response including systemic immunity (neutralising antibody), as well as local immunity in the nasal cavity and respiratory tract. The trial will analyse the safety and immunogenicity of AdCOVID in up to 180 healthy adult participants aged 18 to 55 years. Subjects will receive AdCOVID at one of three dose levels administered as a nasal spray.

Vipin K. Garg, President and Chief Executive Officer of Altimmune stated: ”We believe deployment of intranasal vaccines like AdCOVID will be essential to a successful global response to the pandemic. FDA clearance of the IND marks an important step in developing a safe and effective vaccine designed to stimulate mucosal as well as systemic immunity following intranasal administration. Developing vaccines that can effectively prevent transmission is a growing imperative to block the spread of disease and combat the emergence of new variants. We look forward to the data from this trial in the coming weeks.”

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Jassen’s COVID-19 Vaccine Conditional Marketing Authorisation Received by EMA

On 16th February 2021, the European Medicines Agency (EMA) announced receipt of an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V.

The data supporting the application will be assessed by EMA’s human medicines committee (CHMP) under an accelerated timetable and they should have an opinion in the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust.

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Rolling Review of CureVac’s COVID-19 Vaccine

On 12th February 2021, the EMA announced that CHMP had started a rolling review of CVnCoV, the COVID‑19 vaccine being developed by CureVac AG. The initiation of the review was a result of the data from laboratory studies and early clinical studies in adults. These studies suggested that the vaccine triggered the production of antibodies and immune cells that target SARS-CoV-2. The rolling review will continue until enough supporting data is available for a formal marketing authorisation application.

CureVac is currently conducting human trials to assess the vaccine’s safety, immunogenicity, and effectiveness against COVID-19. EMA will evaluate data from these and other clinical trials as they become available.

EMA will assess the vaccine’s compliance with the usual standards for effectiveness, safety, and pharmaceutical quality.

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COVID-19 Research and Therapeutic Development

Study Shows Correlation Between Temperature and COVID-19 Transmission

On 18th February 2021, Akers Biosciences and its proposed merger partner MyMD Pharmaceuticals, a clinical stage pharmaceutical company committed to extending healthy lifespan by focusing on developing two therapeutic platforms, announced a new study published in PLOS ONE, which shows that rising temperatures during spring and summer months are associated with slower rates of COVID-19 transmission, which is consistent with the seasonal respiratory virus’ behaviour.

The study looked to determine the relationship between COVID-19 transmission rates and rising local temperatures, was conducted among 50 representative Northern Hemisphere countries that meet specific criteria, such as having sufficient COVID-19 cases and meteorological data for analysis. The results concluded that boreal summer months are associated with slower rates of transmission, showing a highly significant and correlation relationship between temperature and the rate of increase in COVID-19.

Aam Kaplin, Chief Scientific Officer of MyMD Pharmaceuticals stated “The present findings of this research suggest that, like other seasonal viruses, SARS-CoV-2 could prove to be extremely difficult to contain over time, unless there is a concerted and collaborative global effort to work to end this pandemic. There is a continuing need to develop more effective therapeutics to treat COVID-19 in the coming months until eradication takes place on a global level, and we continue to look at leading institutions as partners for our upcoming Phase II trial of MyMD-1 in Covid.”

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EU to Launch HERA Incubator to Address the Emerging Threat of COVID-19 Variants

On 17th February 2021, The European Commission (EC) issued communication for the proposed launch of a European bio-defence preparedness programme called “HERA Incubator” to address the emerging threat of coronavirus variants.  Plans include important new research investments, mobilising an additional €30 million from Horizon 2020 to be complemented by a further €120 million from Horizon Europe.

The programme will provide the means to detect and counter further coronavirus mutations and help ensure access to effective vaccines when a new virus or variant has emerged. Horizon 2020 funding will support the rapid establishment of a new EU-wide vaccine trial network called VACCELERATE and boost capacities to track and analyse virus variants and to share data by reinforcing the European COVID-19 Data Platform and other existing research infrastructure projects and networks. Horizon Europe funding will complement this action by providing further support for open data sharing, cohort studies, and for vaccine trials.

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Other Pharma Industry News

Lilly and Rigel Enter Partnership to Develop RIPK1 Inhibitors for Treatment of Immunological and Neurodegenerative Diseases

On 18th February 2021, Eli Lilly and Company and Rigel Pharmaceuticals announced a global exclusive license agreement and strategic collaboration to co-develop and commercialise Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. R552 completed Phase I clinical trials and is entering Phase II clinical trials this year. RIPK1 is a critical signalling protein implicated in a broad range of key inflammatory cellular processes including necroptosis, a type of regulated cell death, and cytokine production.

As part of the agreement, Lilly will also lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system (CNS) diseases. Rigel is also conducting pre-clinical activities with its lead CNS penetrant RIPK1 inhibitor candidates.

Ajay Nirula, vice president of immunology at Lilly stated:” At Lilly, our immunology strategy is focused on the pursuit of novel targets that have the potential to develop into best-in-class medicines for patients with autoimmune conditions. RIPK1 inhibitors are a promising approach, and R552 is an exciting addition to our immunology pipeline. We look forward to working with Rigel to advance its clinical development.”

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FDA Approves First in the World Implant for the Treatment of Rare Bone Disease

On 17th February 2021, the FDA announced the approval of Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use, it is the first in the world and the first-of-its-kind implant to replace the talus for the treatment of avascular necrosis (AVN) of the ankle joint, a serious and progressive condition that causes the death of bone tissue as a result of a lack of blood supply to the area. The implant provides an alternative to other surgical interventions commonly used in late-stage AVN that may disable the motion of the ankle joint.

Raquel Peat director of the FDA’s Centre for Devices and Radiological Health’s Office of Orthopaedic Devices stated: “Avascular necrosis of the ankle, while a rare condition, is a serious and potentially debilitating one that causes pain and can lead to inhibited motion of the ankle joint, and in some cases, removal of part of the leg. Today’s action provides patients with a treatment option that could potentially reduce pain, retain the range of motion of their joint and improve quality of life.”

The Patient Specific Talus Spacer 3D printed implant is made for each patient individually, modelled from computed tomography imaging, and is fitted to a patient’s specific anatomy. The FDA reviewed data for the Patient Specific Talus Spacer through the humanitarian device exemption (HDE) process. Data supporting the safety and benefit of the implant included results from 31 patients and 32 talus replacement surgeries with the implant.

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Issue Number: PN2102