This “Smallpox - Pipeline Insight, 2021,” report provides comprehensive insights about 4+ companies and 4+ pipeline drugs in Smallpox 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.
Smallpox is an acute contagious disease caused by the variola virus, a member of the orthopoxvirus family. It was one of the most devastating diseases known to humanity and caused millions of deaths before it was eradicated. Smallpox is a category A pathogen which are those organisms/biological agents that pose the highest risk to national security and public health because they can be easily disseminated or transmitted from person to person, result in high mortality rates and have the potential for major public health impact, might cause public panic and social disruption, and require special action for public health preparedness.
"Smallpox - Pipeline Insight, 2021" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Smallpox pipeline landscape is provided which includes the disease overview and Smallpox treatment guidelines. The assessment part of the report embraces, in depth Smallpox 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, Smallpox collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
The companies and academics are working to assess challenges and seek opportunities that could influence Smallpox R&D. The therapies under development are focused on novel approaches to treat/improve Smallpox.
This segment of the Smallpox 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.
Brincidofovir: Chimerix
Brincidofovir (BCV) is an oral antiviral being developed for the treatment of smallpox under the U.S. Food and Drug Administration's Animal Efficacy Rule, which allows for testing of investigational drugs in animal models to support effectiveness in diseases that are not ethical or feasible to study in humans. BCV is currently under review for approval at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) date of July 7, 2021. BCV is designed to improve treatment of viral infections by enhancing drug delivery to the intracellular site of viral replication. BCV effectively penetrates cells via its lipid conjugate, releasing the nucleotide analog cidofovir, which then acts to inhibit virus replication.
TNX-801: Tonix Pharmaceuticals Holding Corp
TNX-801 is a novel, live virus vaccine grown in cell culture.1 Tonix is developing TNX-801 as a potential smallpox preventing vaccine for widespread immunization and national stockpile. Though it shares structural characteristics with vaccinia-based vaccines, TNX-801 has unique properties that Tonix believes it may lower toxicity and offer potential safety advantages over existing vaccinia-based vaccines, which have been associated with adverse side effects such as myocarditis/pericarditis.
There are approx. 4+ key companies which are developing the therapies for Smallpox. The companies which have their Smallpox drug candidates in the most advanced stage, i.e. phase preregistration include, Chimerix.
The drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Smallpox therapeutic drugs key players involved in developing key drugs.
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Smallpox drugs.
Geography Covered
- Global coverage
Smallpox Understanding
Smallpox: Overview
Smallpox is an acute contagious disease caused by the variola virus, a member of the orthopoxvirus family. It was one of the most devastating diseases known to humanity and caused millions of deaths before it was eradicated. Smallpox is a category A pathogen which are those organisms/biological agents that pose the highest risk to national security and public health because they can be easily disseminated or transmitted from person to person, result in high mortality rates and have the potential for major public health impact, might cause public panic and social disruption, and require special action for public health preparedness.
"Smallpox - Pipeline Insight, 2021" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Smallpox pipeline landscape is provided which includes the disease overview and Smallpox treatment guidelines. The assessment part of the report embraces, in depth Smallpox 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, Smallpox 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 Smallpox R&D. The therapies under development are focused on novel approaches to treat/improve Smallpox.
Smallpox Emerging Drugs Chapters
This segment of the Smallpox 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.
Smallpox Emerging Drugs
Brincidofovir: Chimerix
Brincidofovir (BCV) is an oral antiviral being developed for the treatment of smallpox under the U.S. Food and Drug Administration's Animal Efficacy Rule, which allows for testing of investigational drugs in animal models to support effectiveness in diseases that are not ethical or feasible to study in humans. BCV is currently under review for approval at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) date of July 7, 2021. BCV is designed to improve treatment of viral infections by enhancing drug delivery to the intracellular site of viral replication. BCV effectively penetrates cells via its lipid conjugate, releasing the nucleotide analog cidofovir, which then acts to inhibit virus replication.
TNX-801: Tonix Pharmaceuticals Holding Corp
TNX-801 is a novel, live virus vaccine grown in cell culture.1 Tonix is developing TNX-801 as a potential smallpox preventing vaccine for widespread immunization and national stockpile. Though it shares structural characteristics with vaccinia-based vaccines, TNX-801 has unique properties that Tonix believes it may lower toxicity and offer potential safety advantages over existing vaccinia-based vaccines, which have been associated with adverse side effects such as myocarditis/pericarditis.
Smallpox: Therapeutic Assessment
This segment of the report provides insights about the different Smallpox drugs segregated based on following parameters that define the scope of the report, such as:
Major Players in Smallpox
There are approx. 4+ key companies which are developing the therapies for Smallpox. The companies which have their Smallpox drug candidates in the most advanced stage, i.e. phase preregistration include, Chimerix.
Phases
This report covers around 4+ 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
Smallpox 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
- intravitreal
- Subretinal
- 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.
Smallpox: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Smallpox 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 Smallpox drugs.
Smallpox Report Insights
- Smallpox Pipeline Analysis
- Therapeutic Assessment
- Unmet Needs
- Impact of Drugs
Smallpox 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 Smallpox drugs?
- How many Smallpox drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Smallpox?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Smallpox 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 Smallpox and their status?
- What are the key designations that have been granted to the emerging drugs?
Key Players
- Chimerix
- BioFactura
- Tonix Pharmaceuticals Holding Corp
- Bavarian Nordic A/S
- ViRAZE
- HK inno.N
Key Products
- Brincidofovir
- TNX-801
- TNX 1200
- MVA-BN® FREEZE-DRIED
- VIR002
- IN-B002
Table of Contents
IntroductionExecutive Summary
Smallpox: 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
Smallpox - Analytical Perspective
In-depth Commercial Assessment
- Smallpox companies’ collaborations, Licensing, Acquisition -Deal Value Trends
Smallpox Collaboration Deals
- Company-Company Collaborations (Licensing/Partnering) Analysis
- Company-University Collaborations (Licensing/Partnering) Analysis
Late Stage Products (Prergistration)
- Comparative Analysis
Brincidofovir: Chimerix
- Product Description
- Research and Development
- Product Development Activities
Preclinical and Discovery Stage Products
- Comparative Analysis
IN-B002: HK inno.N
- Product Description
- Research and Development
- Product Development Activities
Inactive Products
- Comparative Analysis
Smallpox Key Companies
Smallpox Key Products
Smallpox- Unmet Needs
Smallpox- Market Drivers and Barriers
Smallpox- Future Perspectives and Conclusion
Smallpox Analyst Views
Smallpox Key Companies
AppendixList of Tables
Table 1 Total Products for Smallpox
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 Smallpox
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:
- Chimerix
- BioFactura
- Tonix Pharmaceuticals Holding Corp
- Bavarian Nordic A/S
- ViRAZE
- HK inno.N