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BPI 002

Drug Profile

BPI 002

Alternative Names: BPI-002

Latest Information Update: 18 Mar 2020

At a glance

  • Originator BeyondSpring Pharmaceuticals
  • Class Antineoplastics; Immunotherapies; Small molecules
  • Mechanism of Action Cytotoxic T-lymphocyte antigen 4 inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preclinical Colorectal cancer; COVID 2019 infections

Most Recent Events

  • 13 Mar 2020 BeyondSpring submits provisional U.S. patent application for BPI 002, for methods of treating viral infections, including COVID-2019 infections
  • 13 Mar 2020 Preclinical trials in COVID-2019 infections in USA (PO)
  • 03 Apr 2018 BeyondSpring plans a phase I trial for Cancer in 2019

Development Overview

Introduction

BPI 002 is an oral, small-molecule, cytotoxic T-lymphocyte antigen 4 inhibitor (CTLA4 inhibitor), being developed by BeyondSpring as an immuno-oncology agent for the treatment of colon cancer and COVID-2019 infections. Preclinical development is underway in the US.

Key Development Milestones

In March 2020, BeyondSpring reported that BPI 002 can activate the adaptive immune system, including CD4+ helper T cells and CD8+ cytotoxic T cells, to directly attack and kill virally infected cells, including RNA virus, such as those causing COVID-2019. BPI 002 can also potentially function as an adjuvant to provide improved long-term humoral (B-cell dependent) protection against future viral infection, when combined with a vaccine.The company also mentioned that the drug has the potential to directly attack and kill RNA virus without precipitating thereby limiting toxicities [1] .

In preclinical studies in immune competent colon cancer animal model, BPI 002 was synergistic to checkpoint inhibitors [2] .

Patent Information

In March 2020, BeyondSpring reported that the company has submitted provisional U.S. patent application for its pipeline asset BPI-002, for methods of treating viral infections, including COVID-2019 inections, when administered alone or in combination with a vaccine [1] .

As at March 2017, BeyondSpring Pharma owned four pending international patent applications filed under the PCT, which the company planned to file nationally in the US and in other jurisdictions directed to compositions containing BPI 002 and methods of using BPI 002 [2] .

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation unspecified
  • Class Antineoplastics, Immunotherapies, Small molecules
  • Target Cytotoxic T-lymphocyte antigen 4
  • Mechanism of Action Cytotoxic T-lymphocyte antigen 4 inhibitors
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

    L01 (Antineoplastic Agents)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

    L1 (Antineoplastics)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Preclinical USA PO / unspecified BeyondSpring Pharmaceuticals 13 Mar 2020
Colorectal cancer - - Preclinical USA PO / unspecified BeyondSpring Pharmaceuticals 08 Mar 2017

Commercial Information

Involved Organisations

Organisation Involvement Countries
BeyondSpring Pharmaceuticals Originator USA
BeyondSpring Pharmaceuticals Owner USA

Future Events

Expected Date Event Type Description Updated
31 Mar 2019 Trial Update BeyondSpring plans a phase I trial for Cancer in 2019 (3245089) [3] 05 Apr 2018
28 Oct 2017 Regulatory Status BeyondSpring intends to file an IND application for Cancer [4] 14 Jun 2017

Development History

Event Date Update Type Comment
13 Mar 2020 Patent Information BeyondSpring submits provisional U.S. patent application for BPI 002, for methods of treating viral infections, including COVID-2019 infections [1] Updated 18 Mar 2020
13 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (PO) [1] Updated 18 Mar 2020
03 Apr 2018 Trial Update BeyondSpring plans a phase I trial for Cancer in 2019 [2] [3] Updated 05 Apr 2018
28 Apr 2017 Regulatory Status BeyondSpring intends to file an IND application for Cancer [4] Updated 14 Jun 2017
08 Mar 2017 Patent Information BeyondSpring Pharma has pending patents for BPI 002 in USA and other jurisdictions [2] Updated 14 Jun 2017
08 Mar 2017 Phase Change - Preclinical Preclinical trials in Colorectal cancer in USA (PO) [2] Updated 29 May 2017

References

  1. BeyondSpring Files for Patent Protection on BPI-002 for the Treatment of Viral Infections Including COVID-19.

    Media Release
  2. BeyondSpring Provides Operational Update and Fourth-Quarter and Full-Year 2017 Financial Results.

    Media Release
  3. BeyondSpring Provides Quarterly Operational Update and Full Year 2016 Results.

    Media Release
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