Anti-CD38 antibody - Pipeline Insight, 2024

This “Anti-CD38 antibody- Pipeline Insight, 2024” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Anti-CD38 antibody 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

Anti-CD38 antibody: Understanding

Anti-CD38 antibody: Overview

CD38 is a membrane-bound protein first identified by monoclonal antibody typing of lymphocytes and thus thought of as a lymphocyte-specific antigen. CD38 was discovered in 1980 by E.L Reinherz and S. Schlossman, and is a type II transmembrane glycoprotein. CD38 plays a role in regulation of migration, receptor-mediated adhesion by interaction with CD31 or hyaluronic acid, and signaling events. Consistently, its expression in lymphocytes shows stage-related variations and ligation by agonistic antibodies against CD38 can trigger a wide range of responses in various types of blood cells. It is present not only on cell surfaces but also in various intracellular organelles, including the nucleus. The human CD38 antigen is a 46 kilodalton (kDa) type II transmembrane glycoprotein with a short N-terminal cytoplasmic tail and a long extracellular domain.CD38 can be internalized and shed and it also exists in a 39 kDa soluble form in biological fluids. The gene encoding CD38 is on Chromosome. It is present in hematopoietic cells (its distribution seems to depend on the activation and differentiation of the cell) and can be expressed also in various tissues. It is also expressed on regulatory T cells, regulatory B cells, and myeloid-derived suppressor cells with a high surface expression associated with compromised immune surveillance for malignancies. CD38 is present in most of the circulating T- and B-cells are CD38-, and activated B- and T-cells, it is also present on monocytes, natural killer cells, dendritic cells, and plasma cells. Anti-CD38 antibodies exert their therapeutic effects via direct effector mechanisms on MM cells (i.e., CD38 enzymatic inhibition, direct induction of apoptosis) and through Fc-dependent immune mechanisms, including antibody-dependent cellular cytotoxicity (ADCC), complement-directed cytotoxicity (CDC), and antibody-directed cellular phagocytosis (ADCP). Anti-CD38 monoclonal antibodies exert their toxic activity against cells expressing CD38, such as plasma cells, through several mechanisms, such as complement-dependent cytotoxicity, antibody dependent cellular cytotoxicity, and antibody dependent cellular phagocytosis. Plasma cells have very high CD38 expression and play an important role in the pathogenesis of antibody-mediated autoimmune diseases through antibody production. Anti-CD38 antibodies are currently also being evaluated in smoldering Multiple Myeloma and also in other disease conditions.

Anti-CD38 antibody- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Anti-CD38 antibody pipeline landscape is provided which includes the disease overview and Anti-CD38 antibody treatment guidelines. The assessment part of the report embraces, in depth Anti-CD38 antibody 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, Anti-CD38 antibody 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 Anti-CD38 antibody R&D. The therapies under development are focused on novel approaches to treat/improve Anti-CD38 antibody.

Anti-CD38 antibody Emerging Drugs Chapters

This segment of the Anti-CD38 antibody 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.

Anti-CD38 antibody Emerging Drugs

Felzartamab: I-MAB Biopharma Felzartamab (TJ202/MOR202) is an investigational human monoclonal antibody derived from MorphoSys' Hu CAL® antibody technology. The antibody is directed against CD38 on the surface of multiple myeloma cells, which has been characterized as one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. According to its suggested mode of action, the antibody recruits cells of the body's immune system to kill the tumor through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The antibody does not involve complement dependent cytotoxicity, or CDC, an additional immune mechanism involved in tumor cell killing. Scientific research suggests that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Currently, the drug is in the Phase III stage of its development for the treatment ofMultiplemyeloma.

TAK-079: Takeda TAK-079 is a high-affinity antibody against a specific molecule called CD38, which is found in abundance on the surface of malignant myeloma cells and at low levels on the surface of normal immune cells, including activated natural killer (NK) cells, T- and B-cells, among others. TAK-079 binds with great affinity to myeloma cells in the bone marrow and other organs. It is hoped that this binding will induce the cells to activate mechanisms that will initiate programmed celldeath.

Currently, the drug is in the Phase II stage of its development for the treatment of Idiopathic thrombocytopenic purpura, and Myasthenia gravis. The drug is also being evaluated for Systemic lupus erythematosus, Multiple myeloma and IgA nephropathy.

STI 6129: Sorrento Therapeutics STI 6129 is a CD38 Antibody-Drug Conjugate (ADC) with covalently bound duostatin tubulin inhibitors (Duostatin 5) using a proprietary site-specific C-LOCK™ chemical linker designed to reduce the premature systemic release of duostatin and avoid the potential for toxicity, particular ocular toxicity, seen with other ADCs, especially first-generation products. STI-6129 has demonstrated an improved therapeutic index in animal models, as compared to traditional non-selective conjugates. STI-6129 has the potential for being a first-line treatment for amyloidosis as well as second line in those patients who have developed daratumumab resistance, an anti-CD38 mAb alone. STI-6129 binds to different epitopes than daratumumab and the addition of the targeted delivery of the duostatin can potentially manage those patients who have become refractory to such treatments. STI-6129 utilizes several technology platforms that are under development by Sorrento Therapeutics, including a CD38 specific antibody identified from its fully human G-MAB™ antibody library, its proprietary drug payload Duostatin 5 and its site-specific C-LOCK conjugation technology. Currently, the drug is in the Phase I/II stage of its development for the treatment of Multiple Myeloma.

CID-103: CASI Pharmaceuticals CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that recognizes a unique epitope on CD38. It was engineered to have strong activity against CD38 malignant cells and to reduce certain safety issues observed with existing treatments. Preclinical data of CID-103 demonstrates enhanced activity against a broad array of malignancies which express CD38 and demonstrates a better preclinical safety profile when compared to other CD38 mAbs. These attributes offer the potential for accelerated development and regulatory review, including rapid advancement into earlier lines of therapy. Currently, the drug is in the Phase I stage of its development for the treatment of patients with multiple myeloma.

Anti-CD38 antibody: Therapeutic Assessment

This segment of the report provides insights about the different Anti-CD38 antibody drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Anti-CD38 antibody

There are approx. 15+ key companies which are developing the therapies for Anti-CD38 antibody. The companies which have their Anti-CD38 antibody drug candidates in the most advanced stage, i.e. phase III include, I-MAB Biopharma.

Phases

This report covers around 15+ 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

Anti-CD38 antibody pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

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

Anti-CD38 antibody: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Anti-CD38 antibody 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 Anti-CD38 antibody drugs.

Anti-CD38 antibody Report Insights

• Anti-CD38 antibody Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Anti-CD38 antibody 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 Anti-CD38 antibody drugs?
• How many Anti-CD38 antibody drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Anti-CD38 antibody?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Anti-CD38 antibody 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 Anti-CD38 antibody and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Sorrento Therapeutics
• I-MAB Biopharma
• Takeda
• Hangzhou Sumgen Biotech
• Wuhan YZY Biopharma Co., Ltd.
• Biomunex Pharmaceuticals

Key Products

• SG 301
• Felzartamab
• TAK-573
• STI 6129
• Y 150
• BMX-101

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