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Human Immunodeficiency Virus (Hiv 1) Infection - Pipeline Insight, 2021

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    Clinical Trials

  • 60 Pages
  • September 2021
  • Region: Global
  • DelveInsight
  • ID: 5262014
This “Human Immunodeficiency Virus (HIV 1) Infection - Pipeline Insight, 2021,” report provides comprehensive insights about 20+ companies and 20+ pipeline drugs in Human Immunodeficiency Virus (HIV 1) Infection pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

  • Global coverage

Human Immunodeficiency Virus (HIV 1) Infection Understanding

Human Immunodeficiency Virus (HIV 1) Infection: Overview


HIV-1 is the most common type of Human Immunodeficiency Virus. It attacks the body's immune system. The virus destroys CD4 cells. CD4 cells help the body to fight infections. HIV-1 can severely damage immune system and lead to Acquired Immune Deficiency Syndrome (AIDS). Infection with HIV type 1 (HIV-1) typically occurs across mucosal surfaces or by direct inoculation. The virus first encounters dendritic cells (DCs), which subsequently facilitate spread of HIV-1 to CD4+ T lymphocytes. Human Immunodeficiency virus 1 is transmitted in bodily fluids that include: blood, semen, vaginal and rectal fluids, breast milk. Traditional approaches for treating HIV-1 infection have focused on the use of antiretroviral agents, alone and in combination. Antiretroviral monotherapy with nucleoside analogues such as AZT has resulted in some clinical benefit in delaying the onset of HIV-related disease, although the clinical benefit as well as the ability to raise CD4 count and lower viral load has been temporary. Therapy with combinations of antiretroviral nucleoside analogs has had a more pronounced effect on suppressing viral load and raising peripheral CD4 counts in infected persons. Therefore, combining therapeutic modalities designed to restore immune function with those aimed at suppressing viral replication may prove to be the most effective method of treating HIV-1 infection.

"Human Immunodeficiency Virus (HIV 1) Infection - Pipeline Insight, 2021" report by the publisher outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Human Immunodeficiency Virus (HIV 1) Infection pipeline landscape is provided which includes the disease overview and Human Immunodeficiency Virus (HIV 1) Infection treatment guidelines. The assessment part of the report embraces, in depth Human Immunodeficiency Virus (HIV 1) Infection commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Human Immunodeficiency Virus (HIV 1) Infection collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Human Immunodeficiency Virus (HIV 1) Infection R&D. The therapies under development are focused on novel approaches to treat/improve Human Immunodeficiency Virus (HIV 1) Infection.

Human Immunodeficiency Virus (HIV 1) Infection Emerging Drugs Chapters


This segment of the Human Immunodeficiency Virus (HIV 1) Infection report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Human Immunodeficiency Virus (HIV 1) Infection Emerging Drugs


Lenacapavir: Gilead Sciences


Lenacapavir is a potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. Lenacapavir's multi-stage mechanism of action is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting therapy options for people living with or at risk for HIV-1. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes. The company recently announced that the marketing authorization application for lenacapavir and is now under evaluation by EMA. In June 2021, New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.

UB421: United BioPharma


UB-421 is an experimental HIV antibody, under development in phase III by United Biomedical, Inc. (UBI), headquartered in Hauppauge, New York, U.S. for use in the treatment of HIV-1 infection. By blocking the CDR2 domain of the CD4 receptor of the virus, it prevents initial viral attachment to the host T cell and entry into the host immune cell via a competitive inhibition mechanism.

Islatravir (MK-8591): Merck Sharp & Dohme


Islatravir (formerly MK-8591) is Merck's investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) that exhibits both translocation inhibition (which prevents nucleotide binding and incorporation to the DNA chain, resulting in immediate chain termination) and delayed chain termination (which prevents nucleotide incorporation even in the event of translocation). Islatravir is currently being evaluated for the treatment of HIV-1 infection in combination with other antiretrovirals, including the ILLUMINATE clinical trials program for oral, once-daily treatment. Islatravir is also being studied for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a single agent across a variety of formulations, including the IMPOWER clinical trials evaluating an oral once-monthly regimen. In 2012, Merck licensed islatravir (4'-ethynyl-2-fluoro-2'-deoxyadenosine or EFdA) from the Yamasa Corporation based in Choshi, Japan. In March 2021, Gilead and Merck Announce Agreement to Jointly Develop and Commercialize Long-Acting, Investigational Treatment Combinations of Lenacapavir and Islatravir in HIV.

PRO140: CytoDyn Inc.


Leronlimab (Pro 140) is a humanized monoclonal antibody targeted against the CCR5 receptor found on T lymphocytes of the human immune system. In pre-clinical studies, Leronlimab has demonstrated the ability to mimic CCR5 deficiency by binding to CCR5 receptors, thereby preventing HIV from interacting with its primary co-receptor. CytoDyn has successfully completed a Phase III pivotal trial with Leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients meeting its primary endpoint.

Human Immunodeficiency Virus (HIV 1) Infection: Therapeutic Assessment


This segment of the report provides insights about the different Human Immunodeficiency Virus (HIV 1) Infection drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Human Immunodeficiency Virus (HIV 1) Infection


There are approx. 20+ key companies which are developing the therapies for Human Immunodeficiency Virus (HIV 1) Infection. The companies which have their Human Immunodeficiency Virus (HIV 1) Infection drug candidates in the most advanced stage, i.e. Preregistration include, Gilead sciences.

Phases


This report covers around 20+ products under different phases of clinical development like

  • Late stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • Route of Administration

Human Immunodeficiency Virus (HIV 1) Infection pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Oral
  • Parenteral
  • Intravenous
  • Subcutaneous
  • Topical.
  • Molecule Type

Products have been categorized under various Molecule types such as

  • Monoclonal Antibody
  • Peptides
  • Polymer
  • Small molecule
  • Gene therapy
  • Product Type

The drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Human Immunodeficiency Virus (HIV 1) Infection: Pipeline Development Activities


The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Human Immunodeficiency Virus (HIV 1) Infection therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities


The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Human Immunodeficiency Virus (HIV 1) Infection drugs.

Human Immunodeficiency Virus (HIV 1) Infection Report Insights

  • Human Immunodeficiency Virus (HIV 1) Infection Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Human Immunodeficiency Virus (HIV 1) Infection Report Assessment

  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions Answered


Current Treatment Scenario and Emerging Therapies:
  • How many companies are developing Human Immunodeficiency Virus (HIV 1) Infection drugs?
  • How many Human Immunodeficiency Virus (HIV 1) Infection drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Human Immunodeficiency Virus (HIV 1) Infection?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Human Immunodeficiency Virus (HIV 1) Infection therapeutics?
  • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Human Immunodeficiency Virus (HIV 1) Infection and their status?
  • What are the key designations that have been granted to the emerging drugs?


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Table of Contents

Introduction

Executive Summary

Human Immunodeficiency Virus (HIV 1) Infection: Overview
  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management

Pipeline Therapeutics
  • Comparative Analysis

Therapeutic Assessment
  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type

Late Stage Products (Preregistration)
  • Comparative Analysis

Lenacapavir: Gilead Sciences
  • Product Description
  • Research and Development
  • Product Development Activities

Mid Stage Products (Phase II)
  • Comparative Analysis

Triptorelin: Immune System Regulation
  • Product Description
  • Research and Development
  • Product Development Activities

Early stage products (Phase I/II)
  • Comparative Analysis

Cal-1: CSL Behring
  • Product Description
  • Research and Development
  • Product Development Activities

Inactive Products
  • Comparative Analysis

Human Immunodeficiency Virus (HIV 1) Infection Key Companies

Human Immunodeficiency Virus (HIV 1) Infection Key Products

Human Immunodeficiency Virus (HIV 1) Infection- Unmet Needs

Human Immunodeficiency Virus (HIV 1) Infection- Market Drivers and Barriers

Human Immunodeficiency Virus (HIV 1) Infection- Future Perspectives and Conclusion

Human Immunodeficiency Virus (HIV 1) Infection Analyst Views

Human Immunodeficiency Virus (HIV 1) Infection Key Companies

AppendixList of Tables
Table 1 Total Products for Human Immunodeficiency Virus (HIV 1) Infection
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive ProductsList of Figures
Figure 1 Total Products for Human Immunodeficiency Virus (HIV 1) Infection
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Merck Sharp & Dohme Corp.
  • United Biopharma
  • Gilead sciences
  • CytoDyn
  • GalaxoSmithKline
  • Frontier Biotechnologies
  • Immune System Regulation
  • CSL Behring
  • Inovio Pharmaceuticals
  • Taimed Biologics
  • Oncovir, Inc
  • Theravectys S.A.
  • Novartis
  • Aelix Therapeutics
  • MacroGenics
  • Viriom
  • Jiangsu HengRui Medicine Co., Ltd.
  • Sanofi
  • AbbVie
  • Vir Biotechnology