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Abstract:
1. Prescription sharing of CD22-ADC drug Ogayitozumab ozogamicin (Besponsa)
2. Introduction of CD22 targets and marketed and under development drugs
Text:
Tris is a common buffer system in biochemical experiments and formulation production, which has been widely used in the field of biomedicine. For example, one of the currently marketed COVID-19 mRNA vaccines (mRNA-1273®, Moderna, 2020) uses Tris as a buffer system. Recently, Moderna announced at the 5th Science and Technology Day event that the use of Tris buffer solution can reduce the formation of aggregates, allowing mRNA products to be stored for a long time at 2-8℃.
In this issue, the AVT product team shares another marketed product that uses Tris in its formulation, the ADC drug Ogayitozumab ozogamicin (Besponsa) developed by Pfizer.
Its formulation prescription is as follows:
Ingredient | inotuzumab ozogamicin | Polysorbate 80 | NaCl | Sucrose | Tris (Tromethamine) | Water for Injection | pH |
Content | 0.9 mg | 0.36 mg | 2.16 mg | 180 mg | 8.64 mg | 4 mL | Approx. 8.0 |
Ogayitozumab ozogamicin (Besponsa; inotuzumab ozogamicin) is an innovative ADC developed by Pfizer, consisting of a monoclonal antibody targeting CD22 and the cytotoxic agent calicheamicin. Its formulation is in lyophilized powder form. In its formulation prescription, sucrose mainly acts as a cryoprotectant, and tromethamine tris buffer acts as a pH buffer agent.
The CD22 antigen is commonly expressed on the surface of B cells, and Ogayitozumab ozogamicin can target cancer cells and bind to the CD22 antigen on their surface. Subsequently, these ADCs are internalized into cancer cells, and calicheamicin further exerts its efficacy, causing the death of cancer cells.
On June 28, 2017, BESPONSA was approved for marketing in the EU.
On August 17, 2017, the US Food and Drug Administration (FDA) approved BESPONSA for the treatment of relapsed or refractory B cell precursor acute lymphoblastic leukemia in adults. It is worth mentioning that this is the first antibody-drug conjugate targeting CD22 to be approved by the FDA.
On December 22, 2021, Pfizer's CD22 ADC drug injection Ogayitozumab ozogamicin (Besponsa) was officially approved for marketing in China and is used for relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL) in adult patients. This is the 4th ADC drug approved for marketing in China.
The global sales of BESPONSA in 2019-2021 were 1.08 billion yuan, 1.19 billion yuan, and 1.24 billion yuan, respectively (unit: RMB, data source: Yaozh.com).
About CD22:
CD22 is one of the inhibitory co-receptors on the surface of B cells and is closely related to their development, differentiation, and function. Studies have shown that CD22 is expressed on the surface of most B cell malignancies, including acute lymphoblastic leukemia, non-Hodgkin's lymphoma, and chronic lymphocytic leukemia, making it one of the hot targets for the treatment of autoimmune diseases and B cell malignancies.
Currently, drugs targeting CD22 mainly include monoclonal antibody drugs, antibody-drug conjugates (ADCs), and CAR-T therapy.
Marketed drugs targeting CD22:
In addition to Ogayitozumab ozogamicin (Besponsa), another marketed drug targeting CD22 is LUMOXITI, developed by AstraZeneca.
LUMOXITI（moxetumomab pasudotox-tdfk）is a recombinant targeted anti-toxin for CD22. It has entered phase III clinical trials for the treatment of hairy cell leukemia and phase II clinical trials for the treatment of pediatric acute lymphoblastic leukemia. Moxetumomab pasudotox was initially developed by the National Cancer Institute (NCI) and later licensed to MedImmune (a subsidiary of AstraZeneca). In 2013, Moxetumomab pasudotox was certified by the European Medicines Agency (EMA) as an orphan drug for the treatment of B-cell leukemia/lymphoma, and it was approved by the FDA for marketing in 2018. Currently, it has not been approved for marketing in China, and no company has applied for approval.
Innovative drugs targeting CD22 under development:
In addition to two marketed drugs, there are 76 drugs under development that target CD22, many of which are CAR-T therapies that combine CD19 and CD22.
AVT has launched a new product, TRIS (CDE registration number: F20220000153, DMF registration in progress). In addition, AVT has long-term stable supply of injectable sucrose and trehalose for sale, which are produced under GMP conditions, with advantages such as low endotoxin, stable domestic supply, high cost-effectiveness, DNase/RNase-Free, etc. Welcome to inquire. At the same time, AVT has trial-grade samples of TRIS-HCl available. If you need them, please feel free to contact us!
