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Drug repurposing in SARS-CoV-2 / COVID-19: preventing the maladaptive immune response leading to critical disease requiring ICU care.

Plenge Gen

You can download a pdf copy of the blog here.) Repurposing of approved therapies is the fastest way to impact patients today, as these medicines have regulatory approval to enable investigator-initiated trials and have a manufacturing process to ensure drug supply. The blog is long, so I will start with an executive summary.

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Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

The Pharma Data

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. Source link.

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Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine Candidate

The Pharma Data

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

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Keeping tabs on Covid-19: Thermo Fisher Scientific antibody test is granted the CE Mark Certification and pharma cargo companies prepare for temperature-controlled vaccine delivery

The Pharma Data

The University of Oxford has regularly appeared in our updates since July 2020, as its team of researchers leads an ongoing clinical trial for the Covid-19 vaccine. More recently, the university has released news of its collaboration with Thermo Fisher Scientific as it looks to discover an immune Covid-19 response pre- and post-vaccination.

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ImaginAb Announces License and Supply Agreement with Pfizer for CD8 ImmunoPET Technology

The Pharma Data

Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing costs and helping new therapies to advance to market faster, which ultimately will improve treatment and care of cancer patients. View original content to download multimedia: [link].

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Keeping tabs on Covid-19: UK firm tests oral delivery of Covid-19 vaccine and Novavax aims to distribute 51 million vaccines to Australia

The Pharma Data

Pending ImmunityBio’s discussions with the US Food and Drug Administration , the oral vaccine will enter Phase 1 trials as a prime and boost, and will be explored as an option to provide healthcare providers with a boost to subcutaneous vaccinations. Download this exclusive report here.

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Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

The Pharma Data

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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