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PRAK 03202

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Drug Profile

PRAK 03202

Alternative Names: Coronavirus vaccine - Akers Biosciences/Premas Biotech; PRAK-03202; PRAK3202

Latest Information Update: 28 Apr 2024

At a glance

  • Originator Premas Biotech
  • Class Peptide vaccines; Virus-like particle vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 28 Apr 2024 No recent reports of development identified for research development in COVID-2019-infections in USA (IM)
  • 27 Aug 2020 Premas Biotech announces intention to submit IND application to the US FDA and Drugs Controller General of India for COVID-2019 infections
  • 27 Aug 2020 Adverse events and pharmacodynamics data from preclinical trials in COVID-19 infections released by Premas Biotech

Development Overview

Introduction

PRAK 03202 is a peptide vaccine being developed by Akers Biosciences under a license from Premas Biotech for the treatment of COVID-2019 infections using Premas’ genetically engineered S. cerevisiae platform, D-Crypt™.The vaccine candidate is based on the three COVID-19 proteins namely; spike, envelope and membrane. Preclinical trial is ongoing in India and early research is underway in the US.

D-CryptTm platform has capability to express 30 proteins of similar profile to those in the structure of COVID-19 and the technology platform is highly scalable with a robust process.

As at April 2024, no recent reports of development had been identified for research development in COVID-2019-infections in USA (IM).

Company Agreements

In March 2020, Akers Biosciencesenters into a licensing agreement with Premas Biotech, under which Akers will in-license a novel coronavirus vaccine candidate under development by Premas using Premas’ genetically engineered S. cerevisiae platform, D-Crypt™, and partner with Premas to ultimately seek the US FDA approval. Under the terms of the agreement, Akers is acquiring Cystron Biotech LLC for a $US1 million upfront payment, 6 22 756 shares of common stock or common stock equivalents and a royalty on net sales. In addition, Akers shall make additional payments of cash and stock to the sellers of Cystron Biotech LLC upon the achievement of certain milestones, along with a change of control. Akers is also required to make certain cash payments to Premas upon the achievement of additional milestones. [1]

Key Development Milestones

In August 2020, Akers Biosciences and Premas Biotech released the positive proof of concept results from preclinical studies [2] .

In July 2020, Akers Biosciences announced the initiation of preclinical studies in animals for its COVID-2019 vaccine in India, in collaboration with Premas Biotech. The company also completed the manufacturing process for the virus like particle vaccine candidate, including three antigens from SARS-CoV-2 virus. The preclinical study intends to evaluate safety and immune response of vaccine in mice. The company also reported that Premas is in communication with the regulatory authorities of India and the US for development of vaccine [3] .

In May 2020, Akers Biosciences successfully completed its vaccine prototype based on the transmission electron microscopic (TEM) images of the recombinant virus like particle (VLP) assembled in yeast. At this time, the company also established manufacturing protocol and commenced large-scale production studies for the vaccine candidate [4] .

Drug Properties & Chemical Synopsis

  • Route of administration IM
  • Formulation unspecified
  • Class Peptide vaccines, Virus-like particle vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7 (Vaccines)

Development Status

Summary Table

Download Data (CSV)
Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Preclinical India IM / unspecified Premas Biotech 07 Jul 2020
COVID 2019 infections - - No development reported (Research) USA IM / unspecified Premas Biotech 28 Apr 2024

Commercial Information

Involved Organisations

Organisation Involvement Countries
Premas Biotech Originator India
Premas Biotech Owner India
Akers Biosciences Licensee USA

Scientific Summary

Adverse Events

In proof-of-concept preclinical studies, PRAK 03202 was well tolerated and safe at all doses, in mice that received the intramuscular injection. No adverse events were reported [2] .

Pharmacodynamics

In proof-of-concept preclinical studies, PRAK 03202 showed a robust immune response against the three SARS-Cov2 antigens, S, E, and M. PRAK 03202 elicited neutralizing antibody titers levels in all the dose cohorts starting from 5 microgram to 20 microgram dose regimens. After three doses in mice, all the groups' cohorts showed binding antibody levels similar to convalescent patients’ levels [2] .

Future Events

Expected Date Event Type Description Updated
31 Aug 2020 Trial Update Akers Biosciences plans preclinical trials for COVID-19 infections in summer 2020 [4] 09 Jul 2020

Development History

Event Date Update Type Comment
28 Apr 2024 Phase Change - No development reported No recent reports of development identified for research development in COVID-2019-infections in USA (IM) Updated 28 Apr 2024
27 Aug 2020 Regulatory Status Premas Biotech announces intention to submit IND application to the US FDA and Drugs Controller General of India for COVID-2019 infections [2] Updated 31 Aug 2020
27 Aug 2020 Scientific Update Adverse events and pharmacodynamics data from preclinical trials in COVID-19 infections released by Premas Biotech [2] Updated 31 Aug 2020
07 Jul 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in India (IM) Updated 09 Jul 2020
14 May 2020 Trial Update Akers Biosciences plans preclinical trials for COVID-19 infections in summer 2020 [4] Updated 09 Jul 2020
14 May 2020 Regulatory Status Akers Biosciences intends to have discussions with the regulatory authorities of India and USA [4] Updated 20 May 2020
24 Mar 2020 Licensing Status Akers Biosciences enters into a licensing agreement with Premas Biotech for the coronavirus Vaccine [1] Updated 02 Apr 2020
24 Mar 2020 Phase Change Early research in COVID-2019 infections in USA, India (IM) [1] Updated 02 Apr 2020

References

  1. Akers Biosciences Acquires Licenses to Coronavirus Vaccine Candidate from Premas Biotech.

    Media Release

  2. Akers Biosciences and Premas Biotech Announce SARS CoV-2 Positive Proof of Concept Results.

    Media Release

  3. Akers Biosciences and Premas Biotech Announce Initiation of Animal Studies.

    Media Release

  4. Akers Biosciences and Premas Biotech Announce Successful Completion of Vaccine Prototype & Obtained First Images of VLP.

    Media Release
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