Multiple Myeloma - Pipeline Insight, 2024

This “Multiple Myeloma- Pipeline Insight, 2024” report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Multiple Myeloma 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

Multiple Myeloma: Understanding

Multiple Myeloma: Overview

Multiple myeloma (MM) is a clonal plasma cell proliferative disorder characterized by the abnormal increase of monoclonal immunoglobulins. Unchecked, the excess production of these plasma cells can ultimately lead to specific end-organ damage. Most commonly, this is seen when at least one of the following clinical manifestations are present: hypercalcemia, renal dysfunction, anemia, or bone pain accompanied by lytic lesions.

Symptoms
The specific symptoms, age of onset, and rate of progression of multiple myeloma varies from patient to patient. Some affected individuals will not exhibit any symptoms (asymptomatic). Multiple myeloma may progress to cause life-threatening complications. The most common symptom associated with multiple myeloma is bone pain, usually of the lower back or ribs. Another possible sign of multiple myeloma is an elevated level of calcium in the blood, a condition called hypercalcemia.

Causes
The exact cause of multiple myeloma is not known. Symptoms occur as a result of a process that is initiated by the abnormal multiplication of plasma cells in bone marrow. Scientists suspect there may be a variety of causes that may include environmental factors (e.g., the effects of exposure to radiation), genetic abnormalities, and/or additional factors that may play varying contributing roles. Exposure to dioxin has been associated with an increased risk of myeloma.

Diagnosis
A diagnosis of multiple myeloma is made based upon a thorough clinical evaluation, a detailed patient history, and a variety of specialized tests. Such tests may include removal and microscopic examination of small samples of bone marrow (biopsy or aspiration), blood tests to detect low levels of red and white blood cells, and various x-ray techniques including magnetic resonance imaging (MRI), computed tomography (CT), and positron emission tomography (PET) scanning that may reveal characteristic changes to bones. A test that uses electric currents to sort proteins in the blood or urine (electrophoresis) may be used to detect elevated levels of M-proteins. An immunoglobulin free light chain assay of blood is considered a standard of evaluation.

Treatment
The treatment of multiple myeloma usually involves chemotherapy to reduce the numbers of abnormal plasma cells, drugs to help fight infection (e.g., antibiotics), and medications to reduce pain (analgesic drugs). Additional treatment may include the use of high energy x-rays (radiation therapy) to destroy cancer cells and reduce bone masses that may develop. The use of new biologic drugs may also be recommended. If affected individuals experience involvement of the kidneys, fluids may need to be administered to avoid dehydration. Stem-cell transplantation along with high-dose chemotherapy is regularly used for the treatment of multiple myeloma.

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

Multiple Myeloma Emerging Drugs Chapters

This segment of the Multiple Myeloma 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.

Multiple Myeloma Emerging Drugs

Zevorcabtagene Autoleucel: Carsgen Therapeutics Zevorcabtagene Autoleucel (Zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product candidate against B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma (R/R MM). In October 2022, China National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) and has granted the priority review for zevor-cel. Zevor-cel is expected to be approved by the NMPA for the treatment of R/R MM at the end of 2023 or the beginning of 2024. In January 2023, CARsgen and Huadong Medicine entered into a collaboration agreement for the commercialization of CARsgen's lead drug candidate, zevor-cel, in mainland China. Since reaching the agreement, teams from CARsgen and Huadong Medicine have been working together closely to implement this collaboration and prepare for the approval and commercialization of zevor-cel in China.

Descartes 08: Cartesian Therapeutics Descartes-08 is an autologous BCMA-targeting RNA-modified CAR T-cell therapy. Descartes-08 is engineered by m RNA transfection to express anti-BCMA CAR for a defined length of time. Descartes-08 express anti-BCMA CAR for 1 week, limiting risk of uncontrolled proliferation; produce inflammatory cytokines in response to myeloma target cells; and are highly cytolytic against myeloma cells regardless of presence of myeloma-protecting bone marrow stromal cells, exogenous a proliferation-inducing ligand, or drug resistance including IMiDs. The magnitude of cytolysis correlates with anti-BCMA CAR expression duration, indicating a temporal limit in activity. In early-stage clinical studies, Descartes-08 has been safe and well-tolerated in patients with MG and multiple myeloma. Currently, the drug is in the Phase II stage of its development for the treatment of MultipleMyeloma.

GC012F: Gracell Biotechnology Shanghai Co., Ltd.GC012F is Gracell's Fas TCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer and autoimmune disease treatment by driving fast, deep and durable responses with improved safety profile. GC012F is currently being evaluated in clinical studies in multiple hematological cancers as well as autoimmune diseases, and has demonstrated a consistently strong efficacy and safety profile. Gracell has initiated a Phase 1b/2 trial evaluating GC012F for the treatment of relapsed/refractory multiple myeloma in the United States and a Phase 1/2 clinical trial in China is to be commencedimminently.

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 Multiple Myeloma.

STI-1492: Sorrento Therapeutics STI-1492 is a therapeutic candidate developed by Sorrento Therapeutics for the treatment of relapsed or refractory multiple myeloma. It is an allogeneic, off-the-shelf therapy that involves the administration of Anti-CD38 A2 Dimeric Antigen Receptor T (DAR-T) cells through a single intravenous infusion. The therapy is currently being evaluated in a phase 1b, open-label, dose-escalation study involving subjects with relapsed or refractory multiple myeloma. CD38 is a transmembrane glycoprotein present on various immune cells and hematologic malignancies, and its expression has been associated with poor prognosis. Currently, the drug is in the Phase I stage of its development for the treatment of Multiple Myeloma.

Multiple Myeloma: Therapeutic Assessment

This segment of the report provides insights about the different Multiple Myeloma drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Multiple Myeloma

• There are approx. 75+ key companies which are developing the therapies for Multiple Myeloma. The companies which have their Multiple Myeloma drug candidates in the most advanced stage, i.e. Registered include, Carsgen Therapeutics.

Phases

This report covers around 80+ 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

Multiple Myeloma 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

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

Multiple Myeloma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Multiple Myeloma 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 Multiple Myeloma drugs.

Multiple Myeloma Report Insights

• Multiple Myeloma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• CASI Pharmaceuticals
• Carsgen Therapeutics
• Cartesian Therapeutics
• Gracell Biotechnology Shanghai Co., Ltd.
• Sorrento Therapeutics
• TeneoOne
• Karyopharma Therapeutics
• Arcellx
• Poseida Therapeutics
• Ichnos Sciences
• Nerviano Medical Sciences
• Bristol Myers Squib
• Ascentage Pharma
• Ionis Pharmaceuticals
• Chongqing Precision Biotech Co., Ltd.
• CRISPR Therapeutics
• AstraZeneca
• IGM Biosciences
• Novartis
• GlaxoSmithKline
• Innovent Biologics
• Keymed Biociences
• Starton Therapeutics
• Takeda
• Fate Therapeutics
• Gilead Sciences
• Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
• Janssen Pharmaceutical
• Nanjing IASO Biotechnology Co., Ltd.
• GPCR Therapeutics
• Chimerix

Key Products

• CID-103
• Zevorcabtagene Autoleucel
• Descartes 08
• GC012F
• STI-1492
• TNB-383B
• Selexinor
• CART-ddBCMA
• P-BCMA-ALLO1 CAR-T cells
• ISB 1342
• NMS-03597812
• CC-95266
• APG-2575
• ION251
• C-4-29 Cells
• CTX120
• AZD0305
• IGM-2644
• PHE885
• Belantamab mafodotin
• IBI3003
• CM313
• Lenalidomide
• Modakafusp alfa
• FT576
• Magrolimab
• FHND6091
• Talquetamab
• CT103A
• GPC-100
• ONC201

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