에볼라 바이러스 - 경쟁 구도(2024년)

DelveInsight's, "Ebola Virus- Competitive landscape, 2024," report provides comprehensive insights about 18+ companies and 20+ drugs in Ebola Virus 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

Ebola Virus: Understanding

Ebola Virus: Overview

Ebola is a type of viral hemorrhagic fever caused by several species of viruses from the genus Ebolavirus. Symptoms of Ebola start out flu-like but can progress to severe vomiting, bleeding and neurological (brain and nerve) issues. Ebola can spread to people from bats, nonhuman primates and antelope. From there it can spread from human to human and cause outbreaks (where large numbers of people get infected around the same time). Outbreaks mostly happen in parts of Africa. Ebola virus disease is one of the diseases caused by ebolaviruses (specifically, Zaire ebolavirus) and known as "Ebola".EVD presents after an incubation period of 2 to 21 days, typically with sudden onset of fever, intense weakness, muscle pain, headache, and sore throat. This is followed by vomiting, diarrhea, rash, symptoms of impaired kidney and liver function, and in some cases, internal and external bleeding (e.g., oozing from gums, blood in stools). The progression of the disease varies among individuals, but severe cases often lead to multi-organ dysfunction and shock.

Ebola virus is zoonotic, with bats considered the most likely natural reservoir. Humans can acquire the virus through contact with infected animals such as fruit bats, primates, or antelope. Upon entry into the human body, the virus targets the immune system and various cell types, including macrophages and dendritic cells. It evades the immune response by inhibiting interferon production and rapidly replicates, causing widespread tissue necrosis and triggering a severe inflammatory response. This unchecked viral replication and immune dysregulation lead to the high fatality rate associated with EVD.

Diagnosing Ebola involves a combination of clinical assessment and laboratory tests. Initial diagnosis is based on the patient's history, symptoms, and potential exposure risks. Laboratory confirmation is achieved through polymerase chain reaction (PCR) tests, which detect viral RNA in blood samples. Additional tests include enzyme-linked immunosorbent assay (ELISA) to detect viral antigens or antibodies, and virus isolation techniques, although these require high-level biosafety laboratories.

Treatment for EVD is primarily supportive, aiming to maintain fluid and electrolyte balance, oxygen status, and blood pressure, and to treat any complicating infections. Antiviral treatments, such as remdesivir and monoclonal antibody therapies like Inmazeb (a cocktail of three monoclonal antibodies), have shown efficacy in clinical trials. Experimental vaccines, such as the rVSV-ZEBOV vaccine, have been deployed in outbreak settings to control the spread of the virus. Despite advances in treatment, early intervention and supportive care remain crucial for improving survival rates.

Report Highlights:

• In May 2024, RedHill announced the issue of a new Chinese patent Notice of Allowance covering opaganib as a therapy for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) from the Chinese National Intellectual Property Administration (CNIPA), valid through 2035.
• In November 2023, SK bioscience announced that it has signed an agreement that the company is partnering with Hilleman Laboratories Singapore to develop a low-cost, improved manufacturing process, second-generation Ebola-Zaire vaccine.
• In October 2023 RedHill Biopharma Ltd. announced that novel, twice daily, oral opaganib, delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease.

Ebola Virus: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Regeneron Pharmaceuticals

Regeneron Pharmaceuticals, founded in 1988 and headquartered in Tarrytown, New York, is a leading biotechnology company known for its innovative medicines and proprietary technology platforms. The company discovers, develops, manufactures, and markets medicines for the treatment of serious medical conditions, including eye diseases, asthma, cancer, and COVID-19. Key products include EYLEA, Dupixent, and REGEN-COV. Regeneron emphasizes scientific excellence, with significant investments in genetic research and technologies like VelociSuite.

Product Description: Inmazeb

Inmazeb, previously called REGN-EB3, was created using Regeneron's VelocImmune(R) platform and associated VelociSuite(R) technologies. The treatment consists of three monoclonal antibodies of similar structure, atoltivimab, maftivimab and odesivimab that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein. The three antibodies help neutralize the Ebola virus by blocking its ability to invade patients' and/or enlisting other immune cells to target infected cells and remove them from the body.

Inmazeb is administered as a single, weight-based intravenous infusion (50 mg atoltivimab, 50 mg maftivimab and 50 mg odesivimab per kg). Inmazeb was developed in collaboration and with federal funds from BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the HHS under ongoing USG Contract Nos. HHSO100201700016C and HHSO100201500013C.

Ebola Virus: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: INOVIO Pharmaceuticals

Cara Therapeutics is an early commercial-stage biopharmaceutical company leading a new treatment to improve the lives of patients suffering Ebola Virus. The corporate strategy is to leverage our first-in-class lead product, difelikefalin, to potentially treat pruritus across systemic, dermatologic, and neurologic disease categories. The company's strategic priorities are to launch and maximize the commercial potential of KORSUVA injection and to develop oral difelikefalin across all categories of pruritus, thus changing how pruritus is treated in clinical practice.

Product Description: INO 4201

INO-4201 is a DNA vaccine targeting Zaire Ebola virus (ZEBOV) glycoprotein (GP), designed to prevent ZEBOV infection. INO-4201 encodes for a synthetic consensus antigen that encompasses ZEBOV genetic variability from various outbreak strains to broaden immune coverage for divergent ZEBOV virus variants. INO-4201 was evaluated in a 46-participant randomized, placebo-controlled Phase 1b trial to assess its safety, tolerability, and immunogenicity in healthy adult participants who previously received a single injection of Ervebo, a vaccine approved by the U.S. Food and Drug Administration for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. The participants were dosed with 1 mg of INO-4201 injected intradermally followed by electroporation using INOVIO's investigational proprietary smart device, CELLECTRA(R). Currently, the drug is in the Phase I stage of its development for the treatment of Ebola Virus.

2. Company Overview: Auro Vaccines

Auro Vaccines LLC is a clinical-stage vaccine development company pioneering a major evolutionary step in the design and development of preventive and therapeutic vaccines for infectious diseases. The novel approach is based on a proprietary technology platform that allows us to quantitatively and qualitatively tailor effective immune responses to specific targets. The Prime/Boost System of Vaccines (PBS Vax(TM)) platform provides the ability to "tune" the immune response to whatever is required for a specific target and disease context. The exceptional flexibility of this platform overcomes the shortcomings of current DNA and classic prophylactic vaccines, enabling us to address targets of high unmet medical need.

Product Description: Ebola virus vaccine

The company utilizes VesiculoVax(TM)-vectored vaccines for emerging infectious disease indications where the rapid induction of neutralizing antibodies is needed to protect against the viruses causing hemorrhagic fevers (Ebola, Marburg, Lassa, CCHFV). The Auro Vaccines' prototype VesiculoVax(TM) vector (vesicular stomatitis virus, VSV) has demonstrated single dose protection of monkeys against lethal challenge with Ebola and Marburg viruses. A VesiculoVax(TM) VSV vectored HIV vaccine and a VesiculoVax(TM) VSV vectored Ebola vaccine have both completed phase I clinical evaluation demonstrating safety, 100% vaccine take, and immunogenicity across a range of doses. A series of immunologically distinct VesiculoVax(TM) vectors have been developed to the point that they have demonstrated protective efficacy in animal models of lethal disease caused by VEE, EEE, and WEE viruses. The drug has recently completed Phase I clinical trial for the treatment of patients with Ebola Virus.

3. Company Overview: RedHill Biopharma Ltd.

RedHill Biopharma Ltd. is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. Founded in 2009 and headquartered in Tel Aviv, Israel, and operates globally, with a significant presence in the United States. The company specializes in developing treatments for various GI conditions, including Crohn's disease, ulcerative colitis, irritable bowel syndrome (IBS), and H. pylori infection. RedHill has been actively involved in developing treatments for various infectious diseases, including COVID-19. It has pursued strategic acquisitions and partnerships to expand its product pipeline and commercial capabilities, particularly in the U.S. market. The company invests heavily in R&D to bring innovative therapies to market. Its R&D efforts are centered around leveraging its expertise in GI and infectious diseases.

Product Description: Opaganib

Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential diseases, including gastrointestinal acute radiation syndrome (GI-ARS), COVID-19, other viruses as part of pandemic preparedness, and cholangiocarcinoma (bile duct cancer). Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury(R), Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study. The drug is currently in Preclinical stage of development for the treatment of patients with Ebola Virus.

Ebola Virus Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Ebola Virus 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.

• Ebola Virus Competitive Landscape

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

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

Key Players

• Auro Vaccines
• INOVIO Pharmaceuticals
• RedHill Biopharma Ltd.
• Emergent BioSolutions
• Arisan Therapeutics
• TFF Pharmaceuticals
• China Immunotech

Key Products

• Ebola virus vaccine
• INO 4201
• Opaganib
• RHB-107
• Pan - Ebola
• ARN 75092
• Research Programme: Viral vaccines
• EBV TCR T cell therapy

Table of Contents

Introduction

Executive Summary

Ebola Virus: Overview

• Introduction
• Classification
• Risk factors
• Diagnosis
• Treatment

Ebola Virus-Analytical Perspective: In-depth Commercial Assessment

• Ebola Virus Collaboration Analysis by Companies

Competitive Landscape

• Comparative Assessment of Companies (by therapy, development stage, and technology)

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

Ebola Virus: Company and Product Profiles (Marketed Therapies)

Regeneron Pharmaceuticals

• Company Overview

Inmazeb

• Product Description
• Research and Development Activities
• Product Developmental Activities

Ebola Virus: Company and Product Profiles (Pipeline Therapies)

Late Stage Products (Phase III)

• Comparative Analysis

Company Name

• Company Overview

Drug Name

• Product Description
• Research and Development Activities
• Product Developmental Activities

Mid Stage Products (Phase II)

• Comparative Analysis

Company Name

• Company Overview

Drug Name

• Product Description
• Research and Development Activities
• Product Developmental Activities

Early Stage Products (Phase I)

• Comparative Analysis

INOVIO Pharmaceuticals

• Company Overview

INO 4201

• Product Description
• Research and Development Activities
• Product Developmental Activities

Preclinical and Discovery Stage Products

• Comparative Analysis

RedHill Biopharma Ltd.

• Company Overview

Opaganib

• Product Description
• Research and Development Activities
• Product Developmental Activities

Inactive Products

• Comparative Analysis

Ebola Virus- Unmet needs

Ebola Virus- Market drivers and barriers