Monkeypox - Competitive Landscape, 2024

DelveInsight's, "Monkeypox - Competitive landscape, 2024," report provides comprehensive insights about 8+ companies and 10+ drugs in Monkeypox Competitive landscape. It 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

Monkeypox: Understanding

Monkeypox: Overview

Mpox, formerly known as monkeypox, is a viral disease caused by the monkeypox virus, which belongs to the Orthopoxvirus genus. Initially endemic to Central and West Africa, it has spread globally since 2022, with cases reported in the United States and Europe. Transmission occurs through close contact with infected individuals or animals, with symptoms typically appearing 3 to 17 days after exposure and lasting 2 to 4 weeks. Common symptoms include a painful rash that progresses from red bumps to blisters, along with fever, chills, and swollen lymph nodes. Two main clades of the virus exist: Clade I, generally associated with more severe disease, and Clade II, which drove the recent outbreak. Although there is no specific treatment, smallpox vaccination offers some protection, and public health measures are essential to limit the spread of the disease.

Initial signs often include fever, muscle aches, sore throat, and swollen lymph nodes, followed by the development of a distinctive rash. This rash usually starts as flat spots that evolve into painful blisters filled with fluid, which eventually crust over and heal, lasting around 2 to 4 weeks. Lesions can appear on various parts of the body, including the face, palms, soles, and genitals. Other common symptoms may include headaches, fatigue, back pain, and chills. While many cases are mild and resolve without treatment, some individuals-especially those with weakened immune systems-may experience more severe illness.

The pathophysiology of mpox (monkeypox) involves several stages, beginning with viral entry through respiratory or dermal routes. The virus primarily targets epithelial cells in the respiratory tract or keratinocytes in the skin. After an incubation period of 6 to 13 days, it replicates at the entry site and spreads to regional lymph nodes, leading to primary viremia as it enters the bloodstream. During secondary viremia, the virus disseminates to organs such as the spleen, liver, and skin, causing widespread lesions. The immune response, involving both humoral and cellular components, works to control viral replication and establish immunity. In severe cases, histopathology reveals significant tissue damage, including necrosis and inflammatory infiltrates in lymphoid tissues and the respiratory system.

The diagnosis of mpox involves a combination of clinical evaluation and laboratory testing, with polymerase chain reaction (PCR) tests being the most reliable method, typically conducted on samples from skin lesions, blisters, or scabs. Blood samples may also be taken to detect the presence of the virus or antibodies. Treatment is largely supportive, as most cases are mild and resolve within 2 to 4 weeks. Although there is no specific antiviral treatment, antivirals like tecovirimat may be prescribed for severe cases. Symptom management includes pain relief, maintaining hydration, and isolating until all lesions heal to prevent further transmission.

Report Highlights:

• In September 2024, TC BioPharm announced that it intends to begin Proof of Concept preclinical studies for its lead therapeutic TCB 008, for treatment in monkey pox.
• In September 2024, Tonix Pharmaceuticals Announced that it's Single Dose Mpox Vaccine Candidate TNX-801 aligns with WHO's Newly Issued Preferred Target Product Profile for Mpox Vaccines in Global Health Emergency.
• In August 2024, The US National Institutes of Health (NIH) unit, the National Institute of Allergy and Infectious Diseases (NIAID), had released initial results from the PALM 007 clinical trial of SIGA technologies tecovirimat in treating monkeypox virus (Mpox).
• In August 2024, Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) had approved the supplemental Biologics License Application (sBLA) for the expansion of the indication for ACAM2000, (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection. The approval is based on previously available human safety data and data from a well-controlled animal study in which ACAM2000 vaccine was shown to be effective in protecting against mpox virus exposure.
• In August 2024, Bavarian Nordic A/S had submitted clinical data to the European Medicines Agency (EMA) to support the extension of the IMVANEX (MVA-BN) smallpox and mpox vaccine indication to include adolescents 12 to 17 years of age.

Monkeypox: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Bavarian Nordic

Bavarian Nordic is a fully integrated biotechnology company specializing in the development, manufacturing, and commercialization of innovative vaccines. The company is recognized globally for its expertise in smallpox and mpox (monkeypox) vaccines, which are crucial for public health preparedness and have been supplied to various governments. In addition to these, Bavarian Nordic has a robust portfolio of vaccines for travelers and endemic diseases, aiming to protect and save lives through advanced vaccine technologies. The company's mission focuses on enhancing global health security by addressing infectious diseases and maintaining a strong commitment to innovation in vaccine development.

Product Description: Modified vaccinia Ankara

MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only mpox vaccine approved in the US and Switzerland (marketed as JYNNEOS), Canada (marketed as IMVAMUNE), and the EU/EEA and United Kingdom (marketed as IMVANEX). Originally developed in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN had been indicated for use in the general adult population (18 years and older) in individuals considered at risk for smallpox or mpox. During the 2022-2023 mpox outbreak, the vaccine was granted an Emergency Use Authorization by the US FDA for both pre- and post-exposure use in adolescents.

Monkeypox: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Moderna Therapeutics

Moderna Therapeutics is a biotechnology company pioneering mRNA-based therapies and vaccines. Founded in 2010 and headquartered in Cambridge, Massachusetts, Moderna leverages messenger RNA (mRNA) technology to develop treatments for a wide range of diseases, including infectious diseases, cancer, and rare genetic disorders. The company gained global recognition for its rapid development of the COVID-19 vaccine, mRNA-1273, during the pandemic. Moderna's mRNA platform allows for quick adaptation to new viral variants and has broad applications in both therapeutic and prophylactic solutions, with a robust pipeline addressing oncology, cardiovascular, and autoimmune diseases.

Product Description: mRNA-1769

mRNA-1769 is an mRNA-based vaccine being developed by Moderna Therapeutics for the prevention of monkeypox and smallpox infections. As an RNA vaccine, it works by delivering genetic instructions to cells, prompting them to produce viral proteins that trigger an immune response. This response helps the body recognize and combat the viruses more effectively, reducing their replication and infectivity. Administered via the intramuscular route, mRNA-1769 functions as an immunostimulant, enhancing the body's natural defense mechanisms to prevent infection from both monkeypox and smallpox. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of monkeypox.

2. Company Overview: BioNTech

BioNTech is a next-generation immunotherapy company at the forefront of developing novel treatments for cancer and other serious diseases. Leveraging a wide range of computational discovery tools and therapeutic platforms, the company rapidly advances innovative biopharmaceuticals. Its oncology pipeline features a diverse array of product candidates, including individualized and off-the-shelf mRNA-based therapies, CAR T cell therapies, bispecific immune checkpoint modulators, targeted cancer antibodies, ADCs, and small molecules. BioNTech is also a leader in mRNA vaccine development, applying its expertise to create vaccines for various infectious diseases. With robust in-house manufacturing capabilities and strong collaborations with global pharmaceutical companies like Pfizer, Genentech, Sanofi, and Regeneron, BioNTech continues to drive advancements in immunotherapy and vaccine development.

Product Description: BNT166a

BNT166a is an mRNA-based vaccine candidate developed by BioNTech, designed to target surface antigens expressed in the two infectious forms of the monkeypox virus (MPXV). These antigens trigger an immune response that helps the body combat virus replication and reduce infectivity. As an RNA vaccine, BNT166a delivers genetic instructions to cells, prompting them to produce specific viral proteins that stimulate the immune system to recognize and fight the virus more effectively. This immunostimulant mechanism aids in enhancing the body's ability to neutralize the MPXV, potentially preventing or mitigating infection. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of monkeypox virus.

Monkeypox Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Monkeypox Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Monkeypox Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Monkeypox Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Monkeypox drugs?
• How many Monkeypox drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Monkeypox?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Monkeypox 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 Monkeypox and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• Bavarian Nordic
• BioNTech
• Moderna Therapeutics
• Tonix Pharmaceuticals
• Emergent BioSolutions

Key Products

• Modified vaccinia Ankara
• BNT166a
• mRNA-1769
• TNX-801
• ACAM2000