Elranatamab API Manufacturers

General Description:

Elranatamab, identified by CAS number 2408850-14-4, is a notable compound with significant therapeutic applications. Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is a humanized immunoglobulin 2-alanine kappa antibody derived from two monoclonal antibodies (mAbs), an anti-BCMA mAb and an anti-CD3 mAb, each of which contributes one heavy chain and one light chain to drug structure. The resulting 4-chain bispecific antibody is covalently linked via five inter-chain disulfide bonds. On August 14, 2023, the FDA granted accelerated approval to elranatamab for the treatment of multiple myeloma.

Indications:

This drug is primarily indicated for: Elranatamab is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Elranatamab undergoes metabolic processing primarily in: Elranatamab is expected to be metabolized into small peptides by catabolic pathways. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Absorption:

The absorption characteristics of Elranatamab are crucial for its therapeutic efficacy: Elranatamab exhibits dose-proportional pharmacokinetics over the dose range of 6 to 76 mg, which is 0.079 to 1 times the approved recommended dosage. In subjects who received a weekly dosing of 76 mg over 24 weeks, the maximum concentration of 33.6 mcg/mL was achieved at the end of the weekly dosing regimen. The mean (coefficient of variation %) C_max was 3.8 (94%) mcg/mL at the first full 76 mg dose. At 24 weeks and steady-state, the C_max was 33.6 (48%) mcg/mL and 20.1 (55%) mcg/mL. Following subcutaneous administration, the mean bioavailability of elranatamab was 56.2%. The T_max ranged from three to seven days. The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Elranatamab is an important consideration for its dosing schedule: The mean (CV%) half-life of elranatamab is 22 (64%) days at a dose of 76 mg. This determines the duration of action and helps in formulating effective dosing regimens.

Volume of Distribution:

Elranatamab is distributed throughout the body with a volume of distribution of: The mean (CV%) steady-state volume of distribution of elranatamab was 7.76 L (33%). This metric indicates how extensively the drug permeates into body tissues.

Clearance:

The clearance rate of Elranatamab is a critical factor in determining its safe and effective dosage: The mean (CV%) clearance is 0.324 L/day (100%) following 24 weeks dosing. It reflects the efficiency with which the drug is removed from the systemic circulation.

Pharmacodynamics:

Elranatamab exerts its therapeutic effects through: Elranatamab works to prevent multiple myeloma tumour growth. It causes a transient elevation of circulating cytokines IL-2, IL-6, IL-8, IL-10, TNF-α, and IFN-γ. The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Elranatamab functions by: BCMA is a B cell maturation antigen that binds several ligands to activate various survival signalling pathways, including NF-kappa B, STAT3, ERK1/2, and AKT/PI3K signalling pathways. It is often overexpressed in malignant plasma B cells, including multiple myeloma cells, making it a promising therapeutic target for T-cell engaging antibodies. Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed T-cell engaging antibody. It binds BCMA on plasma cells, plasmablasts, and multiple myeloma cells and CD3 on T-cells leading to cytolysis of the BCMA-expressing cells. Elranatamab activated T-cells, caused pro-inflammatory cytokine release, and resulted in multiple myeloma cell lysis. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Classification:

Elranatamab belongs to the None, classified under the direct parent group Peptides. This compound is a part of the Organic Compounds, falling under the Organic Acids superclass, and categorized within the Carboxylic Acids and Derivatives class, specifically within the Amino Acids, Peptides, and Analogues subclass.

Categories:

Elranatamab is categorized under the following therapeutic classes: Amino Acids, Peptides, and Proteins, Antibodies, Monoclonal, Bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, Bispecific Monoclonal Antibodies, Blood Proteins, Immunoglobulins, Proteins, Serum Globulins. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.

Experimental Properties:

Further physical and chemical characteristics of Elranatamab include:

• Molecular Weight: 148500.0
• Molecular Formula: C6440H9958N1738O2010S49