COVID-19 Vaccines, Diagnostics and Therapies

Covid-19 Vaccines, Diagnostics and Therapies: COVID-19 is an infectious disease caused by the recently discovered coronavirus – SARS-CoV-2 or nCoV-2019. Geriatric population and people with underlying medical problems are more prone to develop serious illness. Currently, the disease is affecting 188 countries across the world with 5,103,278 infected individuals and 332,925 deaths so far. Further, the total cases of COVID-19 across India has crossed the 110,000 mark. To halt the spread of this malady, scientists and researchers are perpetually operating to find the potential treatments.

COVID-19 Current Diagnostics and Treatments

A COVID-19 diagnostic test is performed to determine the existence of the disease.

  • Traditional Diagnostics

The traditional diagnostics are classified into:

  1. Molecular Assays
  2. Immunoassays

These assays are further classified into:

Commercialized Manual Molecular Assay Kits

  • 1 copy (quantitative PCR) kits – 1 drop Inc.
  • COVID-19 (PCR- Real time) Kit – Edinburgh Genetics
  • Novel Coronavirus 2019-nCoV Kit – Shanghai GeneoDx Biotechnology

Commercialized Automated Molecular Assay Kits

  • SARS-CoV-2, RSV & Influenza panel – AusDiagnostics
  • COVID-19 Go Strips – Biomeme

All the PCR-based kits mentioned above identify the markers for COVID-19 in the genome.

Commercialized Manual/Automated Immunoassay Kits

  • COVID-19 Test Kit – Beijing Abace Biology
  • KT1032 Elisa Kit – Epitope Diagnostics
  • FIA COVID-19 (IgM/IgG) – GenBody, Inc. 

Commercialized Rapid Diagnostic Kits

  • COVID-19 (IgM/IgG) kit – AmonMed Biotechnology
  •  qSARS-COV-2 Rapid Test (IgG/IgM) – Cellex
  • SARS-CoV-2 IgM rapid test – SureBiotech

Some of the tests in-development are:

In- development Manual Molecular assay kits

  • REALQUALITY RQ-SARS-CoV-2 – AB ANALITICA
  • ampliCube Coronavirus SARS-CoV-2 – Mikrogen GmbH

In- development Automated Molecular assay kits

  • PANDAA qDx SARS-CoV-2 – Aldatu Biosciences
  • QPOC Nucleic Acid Testing – QuantuMDx

In- development Point of Care

  • COVID-19 (Rapid) NAT test – FemtoDx

In- development Immunoassay kits

  • Multiple Manual/Automated
  • Rapid Diagnostics

Recently Developed Diagnostics

  • Seegene has developed a COVID-19 test kit for identification of three COVID-19 specific target genes.
  • The US FDA has granted Emergency Use Authorization [EUA] to Roche’s cobas SARS-CoV-2 test.
  • Pune-based Mylab has received validation for its COVID-19 diagnostic test kits, also known as the RT-PCR test kit.
  • The US FDA has approved XpertXpress SARS-CoV-2 (Cepheid) foremergency use in hospitals and emergency rooms predominantly.
  • The US FDA has given emergency use authorization (EUA) to Abbott for its test – ID NOW COVID-19.  

Treatments under Evaluation

Company Drug Name   Recovered cases/ Results
AbbVie Kaletra Three confirmed recoveries.
Ascletis Pharmaceuticals Ganovo plus ritonavir and other combos Three confirmed recoveries.
Gilead Pharmeceuticals Remdesiver Showed no adverse events, Proved effective in certain cases.
Bayer Resochin Showed fairly good efficacy.
     
CytoDyn Leronlimab (PRO 140) Evaluated the drug in nine trials in 800 individuals.
Zhejiang Hisun Pharmaceutical Favilavir Evaluated for SARS-CoV2.
Genentech Acterma Trial registered for 94 patients

Pipeline Treatments & Vaccines

There are over 60 programs that are running on three main approaches:

  • Repurposed drugs
  • Antibodies
  • Vaccines

Repurposed drugs

Repurposed drugs are essentially medicines licensed for some indications but are being tested for use for novel diseases. Some of these drugs that are in the pipeline include:

  • Ganovo & Ritonavir therapy (combo) – Phase IV
  • Remdesivir and Actemra – Phase III
  • Leronlimab – Phase II
  • Chloroquine Phosphate (China/Japan) – Phase I
  • APN01 (China/Japan) – Phase I
  • Kaletra – Phase I

Vaccines

COVID-19 Vaccines in the pipeline include:

  • mRNA 1273 Vaccine – Phase I
  • Ad5-nCoV Vaccine – Phase I

Other Potential Drugs

Company Drug Mechanism/Type
Sanofi Kevzara (Sarilumab) mAb targeting IL-6 receptor
Innovation Pharma Brilacidin Defensin mimetic
Celularity & Sorrento Therapeutics CYNK-001 Cryopreserved Placenta-derived NK cell therapy
Regeneron Pharmaceuticals REGN-3048 & REGN-3051 Neutralizing mAbs
AIM ImmunoTech Inc. Ampligen (rintatolimod) An immunomodulator
Staidson Biopharma (Beijing) and InflaRx IFX-1 Anti – C5a mAb
Biocryst Galidesivir (BCX4430) Nucleoside RNA polymerase inhibitor
BioXyTran BXT-25 Anti-necrosis drug

Antibodies/Vaccines in Pre-Clinical Phase

Several companies including Sanofi, Johnson & Johnson and GlaxoSmithKline are developing therapies for COVID-19 that are currently conducting IND-enabling studies. Additionally, a few companies have also requested a fast track approval.

Covid-19 Vaccines under Collaborative Development

  • Arcturus Therapeutics and Duke University

Arcturus therapeutics has partnered with Duke University to develop vaccines that rely on engineering ribonucleic acid (RNA). Notably, the company intends to load the edited RNA virus in a liquid nanoparticle.

  • Erasmus MC and Utrecht University

Together with the Viroscience department and the Virology department of the Veterinary Medicine Faculty at Utrecht University a group of scientists have developed the first antibody that directly blocks the infection.

  • Vir Biotechnology, Inc and Alnylam Pharmaceuticals, Inc.

Vir Biotechnolosgy, Inc. and Alnylam pharmaceuticals, Inc. have expanded their current partnership to incorporate the development and commercialization of RNAi therapeutics that target SARS-CoV-2 virus.

  • Takis and Evvivax

The companies have entered into an agreement to develop a COVID-19 vaccine. The companies commit to use advanced vaccination technologies which will produce numerous antibodies to neutralize viruses.

  • GeoVax and BravoVax

The two organizations have collaborated for vaccine development using the former’s technology.

  • iBio and CC Pharming

The companies have joined hands for development of vaccine using the former’s technology.

  • Pipeline Diagnostics
  • Researchers at IIT Delhi have built an inexpensive probe free assay to detect COVID-19.
  • Everlywell, a US-based company, is also producing testing kits for sample collection of COVID-19.

Way Forward

With the growing scare of COVID-19 pandemic, many leading drug makers and budding startups have joined hands to quickly develop treatments that focus on the disease. The present treatment options are solely directed at assuaging the symptoms of the disease. Sagacious IP has additionally contributed to the current endeavor through its program for coronavirus research. Download our detailed guide on COVID-19 history, current and pipeline treatments as well as past/ongoing research patents.

-Harsha Agarwal (Life Sciences) and the Editorial Team

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