Acute Graft-Versus-Host Disease - Pipeline Insight, 2024

This “Acute Graft-versus-Host Disease- Pipeline Insight, 2024” report provides comprehensive insights about 21+ companies and 23+ pipeline drugs in Acute Graft-versus-Host Disease 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

Acute Graft-versus-Host Disease: Understanding

Acute Graft-versus-Host Disease: Overview

Acute graft-versus-host disease (GVHD) is a common immune complication that can occur after allogeneic hematopoietic cell transplantation (alloHCT). Acute GVHD is a major health problem in these patients, and is associated with high morbidity and mortality. Acute GVHD is caused by the recognition and the destruction of the recipient tissues and organs by the donor immune effector cells. This condition usually occurs within the first 3 months after alloHCT, but later onset is possible. Targeted organs include the skin, the lower and upper gastrointestinal tract and the liver.

Clinically, the diagnosis is suspected when a recipient of HSCT develops any or all of the following signs or symptoms: dermatitis (skin rash), cutaneous blisters, and crampy abdominal pain with or without diarrhea, persistent nausea and vomiting, hepatitis (with elevation of bilirubin and/or liver enzymes). Typically, these symptoms occur before day 100 after the HSCT, but may occur later. Symptoms most frequently start with donor engraftment, but may happen later. Acute GVHD is a clinical diagnosis but, as many the symptoms of acute GVHD are non-specific, histologic confirmation, especially if the symptoms are atypical or involve just the liver or gut, may be extremely useful.

Acute GvHD is of two types:

a) Classic acute Graft Versus Host Disease: This type includes the development of maculopapular rashes on the body and is accompanied by nausea, vomiting, anorexia, profuse diarrhea, ileus or cholestatic hepatitis occurring within 100 days after transplant.

b) Persistent, recurrent or late-onset acute Graft Versus Host Disease: This type involves the development of features of classic acute GVHD beyond 100 days of transplant.

The pathophysiology of acute GVHD involves three phases: 1) damage to host tissues by inflammation from the preparative chemo- and/or radio-therapy regimen, 2) activation of donor-derived T cells triggered by recipient and donor antigen-presenting cells and inflammatory cytokines, with minor histocompatibility antigens playing a central role, and 3) activated donor T cells mediating cytotoxicity against target host cells through mechanisms like Fas-Fas ligand, perforin-granzyme B, and the production of cytokines such as TNF-α, which has been implicated in GVHD pathophysiology.

The management of acute graft-versus-host disease (GVHD) involves systemic steroids as the standard first-line treatment. For severe cases, various second-line options are available, including therapies like ATG, AAT, anti-TNF, MMF, anti-IL-2R, alemtuzumab, sirolimus, and others, which are now administered as third-line options. Standardizing assessment tools for disease severity, conducting detailed laboratory analyses, and identifying potential biomarkers are crucial steps in advancing GVHD management and developing targeted therapies.

"Acute Graft-versus-Host Disease- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Acute Graft-versus-Host Disease pipeline landscape is provided which includes the disease overview and Acute Graft-versus-Host Disease treatment guidelines. The assessment part of the report embraces, in depth Acute Graft-versus-Host Disease 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, Acute Graft-versus-Host Disease 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 Acute Graft-versus-Host Disease R&D. The therapies under development are focused on novel approaches to treat/improve Acute Graft-versus-Host Disease.

Acute Graft-versus-Host Disease Emerging Drugs Chapters

This segment of the Acute Graft-versus-Host Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II/III, 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.

Acute Graft-versus-Host Disease Emerging Drugs

MaaT013: MaaT Pharma

MaaT Pharma is developing MaaT013, which is made up of allogeneic, full-ecosystem pooled biotherapeutic intestinal microbiota manufactured in France, per the GMP requirements. It is an off-the-shelf, standardized, pooled-donor, high-richness microbiome biotherapeutic in enema formulation. The product is characterized by a high diversity and consistent richness of microbial species. MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal-predominant aGvHD. The drug is currently being evaluated under Phase III clinical trial for the treatment of Acute Graft-versus-Host Disease.

Lenzilumab: Humanigen

Lenzilumab is a proprietary Humaneered first-in-class monoclonal antibody that has been proven to neutralize GM-CSF, a cytokine of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome, or cytokine storm, associated with COVID-19 and other indications. Lenzilumab binds to and neutralizes GM-CSF, consequently improving outcomes for patients hospitalized with COVID-19. Humanigen believes that its GM-CSF neutralization has the potential to reduce the hyper-inflammatory cascade known as cytokine release syndrome common to chimeric antigen receptor T-cell (CAR-T) therapy and aGvHD. The drug is currently being evaluated under Phase II/III clinical trial for the treatment of Acute Graft-versus-Host Disease.

Apraglutide: Ironwood Pharmaceuticals

Apraglutide is an investigational new drug that is a next-generation, long-acting synthetic GLP-2 analog being developed for a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology, including short bowel syndrome with intestinal failure (SBS-IF) and Acute Graft-Versus-Host Disease (aGVHD). The drug is currently being evaluated under Phase II clinical trial for the treatment of Acute Graft-Versus-Host Disease (aGVHD).

Acute Graft-versus-Host Disease: Therapeutic Assessment

This segment of the report provides insights about the different Acute Graft-versus-Host Disease drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Acute Graft-versus-Host Disease

There are approx. 21+ key companies which are developing the therapies for Acute Graft-versus-Host Disease. The companies which have their Acute Graft-versus-Host Disease drug candidates in the most advanced stage, i.e. Phase III include, MaaT Pharma.

Phases

This report covers around 23+ 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

Acute Graft-versus-Host Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• Product Type

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

Acute Graft-versus-Host Disease: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Acute Graft-versus-Host Disease 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 Acute Graft-versus-Host Disease drugs.

Acute Graft-versus-Host Disease Report Insights

• Acute Graft-versus-Host Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Acute Graft-versus-Host Disease Report Assessment

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

Key Questions

Current Treatment Scenario and Emerging Therapies:

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

Key Players

• MaaT Pharma
• Medac
• CSL Behring
• Humanigen
• Ironwood Pharmaceuticals
• ReAlta Life Sciences
• Roche
• Incyte Corporation

Key Products

• MaaT013
• MC 0518
• Alpha-1 Antitrypsin
• Lenzilumab
• Apraglutide
• RLS-0071
• Obinutuzumab
• Itacitinib

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