Relapsing Refractory Multiple Myeloma - Pipeline Insight, 2024

This “Relapsing Refractory Multiple Myeloma- Pipeline Insight, 2024” report provides comprehensive insights about 55+ companies and 60+ pipeline drugs in Relapsing Refractory 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

Relapsing Refractory Multiple Myeloma: Understanding

Relapsing Refractory Multiple Myeloma: Overview

Multiple myeloma (MM) is a hematologic disorder which is characterized by a proliferation of malignant, monoclonal plasma cells in the bone marrow (BM) and/or extramedullary sites. Relapsed refractory multiple myeloma (RRMM) occurs when an individual has treatment for multiple myeloma, but the cancer returns or does not respond to treatment. Refractory myeloma develops as a result of cancer cells making certain changes. The longer cancer cells live, grow, and divide, the more gene changes (mutations) they collect. Some of these mutations can help protect the cancer cells from being killed by medications. Additionally, myeloma cells cause bone marrow changes that make it easier for the cells to survive. By modifying their environment, the cells may be able to “hide” from cancer drugs and the immune system. As a result, myeloma becomes more difficult to treat. MM is essentially a stage in the spectrum of monoclonal gammopathy. It is thought to arise from a pre-malignant, asymptomatic phase of clonal plasma cell growth called monoclonal gammopathy of undetermined significance (MGUS). MGUS is defined as detecting monoclonal immunoglobulins in the blood or urine without evidence of end-organ damage. This is quite common and is known to be detectable in over 3% of persons above age 50. It appears that the cell of origin is a post-germinal center plasma cell. This is typically a benign condition, although as noted above, it has a risk of progression to MM of about 1% per year. Presenting Features Patients generally present with bone pain (60%), fatigue (30%), weight loss (25%), paresthesia (5%), and recurrent infections (particularly pneumonia and urinary tract infections) with streptococcus pneumonia, Hemophilus influenza and Escherichia coli being the most common causative agents. Examination may reveal fever (0.7%), hepatomegaly (4%), splenomegaly (1%) and lymphadenopathy (1%). Pulmonary and pleural involvement are rare except in advanced disease. Cardiac involvement is seen with accompanying amyloidosis. Extra-medullary plasmacytomas are seen in 7% upfront and up to 20% at relapse. Cord compression (caused by an extra-medullary plasmacytoma or bony fragments from vertebral fractures) is rare (5%). Peripheral neuropathy is also rare at initial presentation and suggests amyloidosis or POEMS syndrome. The NCCN guidelines recommend the following diagnostic studies: Complete blood count (CBC) with differential, platelet count BUN, creatinine, electrolytes, albumin, calcium levels, Serum LDH and beta-2 macroglobulin, Serum immunoglobulins, serum protein electrophoresis (SPEP), serum immunofixation electrophoresis (SIFE), 24-hour proteinuria, urine protein electrophoresis (UPEP), urine immunofixation electrophoresis (UIFE), Serum-free light chain (FLC) assay. New regimens which include the novel agents thalidomide, bortezomib and lenalidomide as single-agents or in combination with dexamethasone have shown significant activity in patients with relapsed MM and are generally well tolerated. These agents have set the stage for the development of next-generation immunomodulatory drugs (IMiDs) and proteasome inhibitors, i.e. pomalidomide and carfilzomib in relapsed and/or refractory disease.

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

Relapsing Refractory Multiple Myeloma Emerging Drugs Chapters

This segment of the Relapsing Refractory 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.

Relapsing Refractory Multiple Myeloma Emerging Drugs

Mezigdomide: Bristol-Myers Squibb Cereblon E3 ligase modulators (CELMoD) are a class of oral immunomodulatory therapeutics that are designed to stimulate the immune system and directly kill cancer cells by inducing the degradation of tumor-promoting proteins. Bristol Myers Squibb is investigating two novel CELMoD agents, mezigdomide and iberdomide, for multiple myeloma that were intentionally designed to improve upon the demonstrated efficacy of the IMiD® agents, along with manageable tolerability, ease of administration, and the potential to improve patient outcomes. These agents co-opt cereblon to induce degradation of target proteins Ikaros and Aiolos, which inhibits tumor cell proliferation, promote tumor cell death, and induce immune-stimulatory effects. Mezigdomide induces maximal degradation of Ikaros and Aiolos, leading to increased apoptosis in myeloma cells. Based on Phase I/II interim results, mezigdomide, in combination with weekly DEX (40 mg; 20 mg if >75 years of age), showed promising efficacy in a highly refractory patient population. Mezigdomide is currently being investigated in Phase III stage of development for the treatment of Relapsed or Refractory MultipleMyeloma.

Iopofosine: Cellectar Biosciences, Inc.Iopofosine is a small-molecule Phospholipid Drug Conjugate™ designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments. Iopofosine is currently being evaluated in the CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM), a Phase 2b study in r/r multiple myeloma (MM) patients and the CLOVER-2 Phase 1 study for a variety of pediatric cancers. The U.S. Food and Drug Administration granted iopofosine Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for WM, MM, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. The European Commission granted an ODDs for r/r MM and WM.

ORIC-533: ORIC Pharmaceuticals ORIC-533, an orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy- and immunotherapy-based treatment regimens, being developed for multiple myeloma. Currently the drug is in Phase I stage of Clinical trial evaluation for the treatment of Relapsed or Refractory Multiple Myeloma.

Relapsing Refractory Multiple Myeloma: Therapeutic Assessment

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

Major Players in Relapsing Refractory Multiple Myeloma

There are approx. 55+ key companies which are developing the therapies for Relapsing Refractory Multiple Myeloma. The companies which have their Relapsing Refractory Multiple Myeloma drug candidates in the most advanced stage, i.e. phase III include, Bristol-Myers Squibb.

Phases

This 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

Relapsing Refractory 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

• 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.

Relapsing Refractory Multiple Myeloma: Pipeline Development Activities

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

Relapsing Refractory Multiple Myeloma Report Insights

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

Relapsing Refractory 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 Relapsing Refractory Multiple Myeloma drugs?
• How many Relapsing Refractory 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 Relapsing Refractory Multiple Myeloma?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Relapsing Refractory 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 Relapsing Refractory Multiple Myeloma and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Bristol-Myers Squibb
• I-MAB Biopharma
• Pfizer
• Arcellx
• Gilead sciences
• Novartis
• Array Biopharma
• Hrain Biotechnology Co., Ltd.
• Cartesian Therapeutics
• Xencor
• Takeda
• Sorrento Therapeutics
• Heidelberg Pharma AG
• Ichnos Sciences
• Allogene Therapeutics
• Harpoon Therapeutics
• Cellectis
• Poseida Therapeutics
• Regeneron Pharmaceuticals
• ONK Theraputics
• TeneoOne
• i TeosTherapeutics
• Oricell Therapeutics
• Anaveon AG
• Luminary Therapeutics
• Seagen Inc.
• Trillium Therapeutics Inc.
• Virtuoso BINco, Inc.
• Seagen Inc.
• Trillium Therapeutics Inc.

Key Products

• Mezigdomide
• felzartamab
• Elranatamab
• CART-ddBCMA
• Magrolimab
• PHE885
• Encorafenib
• Human BCMA Targeted T Cells Injection
• Marizomib
• Iopofosine
• Modakafusp Alfa
• STI-6129
• HDP 101
• ISB 1442
• ALLO-605
• TAK-981
• HPN217
• LAVA-051
• EMB-06
• REGN5459
• BGB-11417
• Descartes-25
• CID-103
• FT576
• KTX-1001
• OriCAR-017
• ANV419
• LMY-920
• SEA-BCMA
• TTI-622

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