Chronic lymphocytic leukemia - Pipeline Insight, 2021

DelveInsight’s, “Chronic lymphocytic leukemia – Pipeline Insight, 2021,” report provides comprehensive insights about 60+ companies and 60+ pipeline drugs in Chronic lymphocytic leukemia 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

Chronic lymphocytic leukemia Understanding
Chronic lymphocytic leukemia: Overview
Chronic lymphocytic leukemia (also called CLL) is a cancer of the blood and bone marrow that usually gets worse slowly. CLL is one of the most common types of leukemia in adults. It often occurs during or after middle age; it rarely occurs in children. In the beginning, CLL does not cause any signs or symptoms and may be found during a routine blood test. Later, signs and symptoms may occur. Some of the major symptoms include: Painless swelling of the lymph nodes in the neck, underarm, stomach, or groin, Weakness or feeling tired, Pain or a feeling of fullness below the ribs, Fever and infection, Easy bruising or bleeding. CLL happens when there are changes in the genetic material (DNA) in bone marrow cells. The cause of these genetic changes is unknown, so it's hard to predict who might get CLL. There are a few factors that might raise the risk. CLL diagnosis is made via; Physical exam and health history, differential complete blood count, Lactate dehydrogenase testing, blood chemistry studies, Beta-2-microglobulin testing, and several others. Chemoimmunotherapy using anti-CD20 monoclonal antibodies has thus become the standard treatment for most patients with chronic lymphocytic leukaemia, irrespective of age. Idelalisib in combination with rituximab or the anti-CD20 monoclonal antibody ofatumumab is recommended for patients with TP53 aberration who are not suitable for alternative first-line treatment options.

""Chronic lymphocytic leukemia - Pipeline Insight, 2021"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Chronic lymphocytic leukemia pipeline landscape is provided which includes the disease overview and Chronic lymphocytic leukemia treatment guidelines. The assessment part of the report embraces, in depth Chronic lymphocytic leukemia 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, Chronic lymphocytic leukemia 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 Chronic lymphocytic leukemia R&D. The therapies under development are focused on novel approaches to treat/improve Chronic lymphocytic leukemia.

Chronic lymphocytic leukemia Emerging Drugs Chapters
This segment of the Chronic lymphocytic leukemia 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.
Chronic lymphocytic leukemia Emerging Drugs
• Ublituximab: TG Therapeutics
Ublituximab (TG-1101) is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions (including antibody-dependent cellular cytotoxicity [ADCC] and complement dependent cytotoxicity [CDC]), leading to destruction of the cell. The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with UKONIQ® (umbralisib), the Company’s once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022.

• LOXO305: Loxo Oncology
Pirtobrutinib is an investigational, oral, highly-selective non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. Pirtobrutinib was designed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turnover rate, preserve activity in the presence of the C481 acquired resistance mutations, and avoid off-target kinases that have complicated the development of both covalent and investigational non-covalent BTK inhibitors. The drug is currently being evaluated in Phase III stage of development for the treatment of chronic lymphocytic leukemia.

• Cirmtuzumab: Oncternal Therapeutics
Cirmtuzumab is a first-in-class humanized monoclonal antibody that binds with high affinity to a biologically important epitope on ROR1 (Receptor-tyrosine kinase-like Orphan Receptor 1). ROR1 is a type 1 transmembrane protein, essential for fetal development, that is expressed on the plasma membrane with an extracellular domain that is essential for ligand binding and signal transduction. Cirmtuzumab binds to many different types of cancer cells, but does not recognize most normal adult tissues. Cirmtuzumab was developed at the University of California in San Diego based on the pioneering scientific research of Thomas Kipps, MD, Ph.D., and his colleagues at the Moores Cancer Center. Oncternal holds an exclusive worldwide license to develop and commercialize antibodies recognizing ROR1. The development of cirmtuzumab has been supported by the California Institute for Regenerative Medicine (CIRM), in recognition of the role of ROR1 conferring stem cell-like properties to the cancer cells that express it. A Phase II clinical trial is evaluating Cirmtuzumab to treat CLL.

• Olaptesed pegol: NOXXON Pharma
NOX-A12 (olaptesed pegol) is currently under Phase II stage of development as a combination therapy in multiple oncology indications. NOX-A12 targets CXCL12 (C-X-C Chemokine Ligand 12), a key chemokine (signaling) protein. NOX-A12 is designed to fight solid tumors by modulating the tumor microenvironment in two distinct ways: Break tumor protection enabling anti-cancer immune cells, such as killer T-cells, to enter the tumor with the aim of unleashing the full potential of immuno-oncology approaches, such as immune checkpoint inhibitors and Block tumor repair through preventing the attraction of ‘repair cells’ to the tumors obstructing tumor re-growth following radiotherapy.
Further product details are provided in the report……..

Chronic lymphocytic leukemia: Therapeutic Assessment
This segment of the report provides insights about the different Chronic lymphocytic leukemia drugs segregated based on following parameters that define the scope of the report, such as:
• Major Players in Chronic lymphocytic leukemia
There are approx. 60+ key companies which are developing the therapies for Chronic lymphocytic leukemia. The companies which have their Chronic lymphocytic leukemia drug candidates in the most advanced stage, i.e. Preregistration include, TG Therapeutics.
• Phases
DelveInsight’s report covers around 60+ 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
Chronic lymphocytic leukemia 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
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Chronic lymphocytic leukemia: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chronic lymphocytic leukemia 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 Chronic lymphocytic leukemia drugs.

Chronic lymphocytic leukemia Report Insights
• Chronic lymphocytic leukemia Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Please Note: Due to the brevity and/or nature of the content posted, there is no table of contents available for this report.

Executive Summary
Chronic lymphocytic leukemia: 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 (Phase III)
• Comparative Analysis
Ublituximab: TG Therapeutics
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
• Comparative Analysis
Cirmtuzumab: Oncternal Therapeutics
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Early stage products (Phase I)
• Comparative Analysis
NX-2127: Nurix
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
• Comparative Analysis
Chronic lymphocytic leukemia Key Companies
Chronic lymphocytic leukemia Key Products
Chronic lymphocytic leukemia- Unmet Needs
Chronic lymphocytic leukemia- Market Drivers and Barriers
Chronic lymphocytic leukemia- Future Perspectives and Conclusion
Chronic lymphocytic leukemia Analyst Views
Chronic lymphocytic leukemia Key Companies
Table 1 Total Products for Chronic lymphocytic leukemia
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 Products
Figure 1 Total Products for Chronic lymphocytic leukemia
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

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