BK Virus Infection Clinical Trials Review: An Update on Emerging Therapies and Treatment

DelveInsight Business Research LLP
·8 min read

The surge in BK Virus Infection cases spurs treatment opportunities, and many prominent players such as AlloVir, Amplyx Pharmaceuticals, SL VAXiGEN, Hybridize Therapeutics, and others come forward to develop BK Virus Infection therapies.

Los Angeles, USA , March 08, 2021 (GLOBE NEWSWIRE) -- BK Virus Infection Clinical Trials Review: An Update on Emerging Therapies and Treatment


The surge in BK Virus Infection cases spurs treatment opportunities, and many prominent players such as AlloVir, Amplyx Pharmaceuticals, SL VAXiGEN, Hybridize Therapeutics, and others come forward to develop BK Virus Infection therapies.


DelveInsight’s “BK Virus (BKV) Infection Pipeline Insight'' report provides comprehensive insights about ...4+ companies and ...4+ pipeline drugs in the BK Virus Infection pipeline landscapes. It comprises BKV Infection pipeline drug profiles, including clinical and non-clinical stage products. It also includes the BK Virus Infection therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive BKV Infection pipeline products.


Some of the crucial features of the BK Virus Infection Pipeline Report

  • The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation, and EMA has offered PRIority MEdicines (PRIME) and Orphan Drug (ODD) designations to Viralym-M.

  • The companies such as AlloVir, Amplyx Pharmaceuticals, SL VAXiGEN, Hybridize Therapeutics, and many others are developing therapies to improve BK Virus Infection treatment scenario.

  • BK Virus Infection pipeline assets such as ALVR-105, MAU868, SL-V10, HYB-BKV, and others are in different developmental stages to treat BKV Infection.

  • The BK Virus Infection pipeline has HYB-BKV (Hybridize Therapeutics) in pre-clinical stage of development, while SL-V10 (SL VAXiGEN) and MAU868 (Amplyx Pharmaceuticals) in phase I and Phase II of clinical development respectively.

  • Teriflunomide by Sanofi Genzyme is in the preclinical stage of development for the treatment of Human polyomavirus infections.


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BK is a circular, double-stranded DNA virus from the polyomavirus family, including the JC virus and SV40. BK virus is one of 13 known polyomaviruses.


Antibodies to BKV are available in around 80 to 90 percent of adults globally, indicating previous infection or exposure to the virus. Initial infection with BKV is mostly asymptomatic or associated with a mild flu-like illness. After primary infection, BK Virus Infection continues to be inactive or latent in the kidney and bladder. A weakened immune system may lead to BKV reactivation and cause severe disease. In patients who have had kidney transplants, BK Virus Infection can result in transplanted kidney loss. In the absence of effective treatment, decreasing immunosuppression is recommended; but, reducing the immunosuppression can result in acute organ rejection. BKV reactivation in the bladder can lead to hemorrhagic cystitis. Severe cases need bladder irrigation, clot evacuation, blood transfusion, stenting, and nephrostomy.


There are presently no approved treatments for renal nephropathy or hemorrhagic cystitis caused by BK Virus Infection. The backbone of treatment for BK virus nephropathy is to lower the immunosuppression, as there is currently no particular antiviral for the BK virus. Clearance of BK viremia can be a sign of nephropathy resolution.


BKV Pipeline Drugs

  • Viralym-M by AlloVir

ALVR 105 is a human leukocyte antigen (HLA) matched multi-virus-specific T cell candidate, also known as Viralym-M, developed by AlloVir.


Viralym-M is designed to function an essential role in linking immunity between conditioning and reconstitution of their immune systems. Reinstituting immunity during this time of critical immune compromise, Viralym-M may substantially decrease or prohibit virus-associated morbidity and mortality and dramatically enhance patient results. Viralym-M has the potential to transform care for transplant patients fundamentally, as well as people who are at high risk for opportunistic viral infections by decreasing or preventing disease morbidity and dramatically improving.


Research and Development
Phase III
NCT04390113: AlloVir commenced a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the treatment of patients with Virus-Associated Hemorrhagic Cystitis after Allogeneic Hematopoietic Cell Transplant (HCT) in January 2020.


The study aims to assess Viralym-M, an allogeneic, off-the-shelf multi-virus-specific T cell therapy, which focuses on six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6, and JC virus. The study hypothesis is to administer Viralym-M to patients with virus-associated HC will show superiority for the time to resolution of HC as compared to patients when treated with placebo. The primary hypothesis will be evaluated in patients with BK virus viruria to show superiority over placebo in this population (BK Intent-to-Treat [ITT] population). A supplementary analysis will be carried out in all patients with any virus-associated HC (cytomegalovirus [CMV], human herpesvirus 6 [HHV-6], Epstein-Barr virus [EBV], JC virus [JCV], and/or adenovirus [AdV]) to assess the efficacy in this broader population (ITT Population). The study is anticipated to be finished by August 2022.


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Scope of BKV Infection Pipeline Drug Insight

  • Coverage: Global

  • Major Players: 4+ Key Players

  • Prominent Players: AlloVir, Amplyx Pharmaceuticals, SL VAXiGEN, Hybridize Therapeutics, and many others.

  • Key Drugs Profiles: 4+ Products

  • Phases:

    • BKV Infection Therapies Late-stage (Phase III)

    • BK Virus Infection Therapies (Phase II)

    • BKV Infection Therapies (Phase I)

    • BK Virus Infection Therapies Pre-clinical stage and Discovery candidates

    • Discontinued and Inactive candidates

  • Targets:

    • Protease

    • Immune System

    • Multiple Kinase

  • Route of Administration:

    • Intramuscular

    • Intravenous

    • Oral

    • Subcutaneous

  • Mechanism of Action:

    • Immunostimulants

    • Antisense oligonucleotides

    • Antibody-dependent cell cytotoxicity; Immunomodulators

    • Immunologic cytotoxicity; T lymphocyte replacements

  • Molecule type:

    • Monoclonal antibodies

    • Stem Cell Therapy

    • DNA Vaccines

  • Product Type

    • Monotherapy

    • Combination

Key Questions regarding Current BK Virus Infection Treatment Landscape and Emerging Therapies Answered in the Pipeline Report

  • What are the current options for BK Virus Infection treatment?

  • How many companies are developing therapies for the treatment of BK Virus Infection?

  • How many are BK Virus Infection emerging therapies in the early-stage, mid-stage, and late stages of development to treat BK Virus Infection?

  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and significant licensing activities that will impact the BK Virus Infection market?

  • Which are the dormant and discontinued products and the reasons for the same?

  • What is the unmet need for current therapies for the treatment of BK Virus Infection?

  • What are the current novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing BK Virus Infection therapies?

  • What are the key designations that have been granted for the emerging therapies for BK Virus Infection?

  • How many patents are granted and pending for the emerging therapies for the treatment of BK Virus Infection?

Table of Contents

1

BK Virus Infection Report Introduction

2

BK Virus Infection Executive Summary

3

BK Virus Infection Overview

4

BK Virus Infection Analytical Perspective In-depth Commercial Assessment

5

BK Virus Infection Pipeline Therapeutics

6

BK Virus Infection Late Stage Products (Phase III)

6.1

ALVR-105: AlloVir

7

BK Virus Infection Mid Stage Products (Phase II)

7.1

MAU868: Amplyx Pharmaceuticals

8

BK Virus Infection Early Stage Products (Phase I)

8.1

SL-V10: SL VAXiGEN

9

BK Virus Infection Pre-clinical Products and Discovery Stage Products

9.1

HYB-BKV: Hybridize Therapeutics

10

BK Virus Infection Therapeutic Assessment

11

BK Virus Infection Inactive Products

12

Company-University Collaborations (Licensing/Partnering) Analysis

13

BK Virus Infection Key Companies

14

BK Virus Infection Key Products

15

BK Virus Infection Unmet Needs

16

BK Virus Infection Market Drivers and Barriers

17

BK Virus Infection Future Perspectives and Conclusion

18

BK Virus Infection Analyst Views

19

Appendix

20

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