Radioimmunoconjugates in the age of modern immuno-oncology

Nasr, Dayana; Kumar, Prashanth Ashok; Zerdan, Maroun Bou; Ghelani, Ghanshyam; Dutta, Dibyendu; Graziano, Stephen L.; Lim, Seah H.

doi:10.1016/j.lfs.2022.121126

Cited by 8 publications

(5 citation statements)

References 114 publications

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“…Challenges for the development of imaging agents and RITs are like other mAb based products, especially for solid tumors ( 114 – 116 ). Optimizing the format and affinity depends on the intended use.…”

Section: Different Mab-based Formatsmentioning

confidence: 99%

Regulatory considerations in the design, development and quality of monoclonal antibodies and related products for the diagnosis and treatment of cancer

Shapiro

2024

Front. Oncol.

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Over 160 therapeutic and in vivo diagnostic monoclonal antibodies have been approved by the US FDA since the first monoclonal antibody, muromonab, was approved in 1986. Approximately 42% of these approvals were for the treatment or in vivo diagnosis of oncology indications, although some products are no longer marketed. This review will look at the history of monoclonal antibody development and approvals, discuss current antibody-based modalities, regulatory considerations for engineering approaches, critical quality attributes for different modalities, immunogenicity of mAbs across oncology products, and the future directions for development of therapeutic and diagnostic monoclonal antibody-based products.

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Section: Different Mab-based Formatsmentioning

confidence: 99%

Regulatory considerations in the design, development and quality of monoclonal antibodies and related products for the diagnosis and treatment of cancer

Shapiro

2024

Front. Oncol.

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“…Radioimmunotherapy (RIT) has been explored as cancer therapeutics for many decades [124]. RIT utilizes antibodies directed at an antigen expressed on the tumor cell surface to deliver cytotoxic radionuclides that emit α or β particles to the tumor sites.…”

Section: Radioimmunoconjugates (Ric)mentioning

confidence: 99%

Reinventing Therapeutic Proteins: Mining a Treasure of New Therapies

Niazi

Mariam

2023

Biologics

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Reinventing approved therapeutic proteins for a new dose, a new formulation, a new route of administration, an improved safety profile, a new indication, or a new conjugate with a drug or a radioactive source is a creative approach to benefit from the billions spent on developing new therapeutic proteins. These new opportunities were created only recently with the arrival of AI/ML tools and high throughput screening technologies. Furthermore, the complex nature of proteins offers mining opportunities that are not possible with chemical drugs; bringing in newer therapies without spending billions makes this path highly lucrative financially while serving the dire needs of humanity. This paper analyzes several practical reinventing approaches and suggests regulatory strategies to reduce development costs significantly. This should enable the entry of hundreds of new therapies at affordable costs.

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“…120 Radioimmunotherapy (RIT) has been explored as cancer therapeutics for many decades. 121 RIT utilizes antibodies directed at an antigen expressed on the tumor cell surface to deliver cytotoxic radionuclides that emit α or β particles to the tumor sites. After the radioimmunoconjugates (RICs) bind to the surface antigen on the tumor cells, the α or β particles emitted by the radionuclides induce DNA damage and trigger tumor cell apoptosis.…”

Section: Radioimmunoconjugates (Ric)mentioning

confidence: 99%

Reinventing Therapeutic Proteins: Optimizing Investments and Meeting Humanitarian Needs

Niazi¹,

Mariam²

2023

Preprint

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Reinventing approved therapeutic proteins for a new dose, a new formulation, a new route of administration, an improved safety profile, a new indication, or a new conjugate with a drug or a radioactive source is a creative approach to benefit from the billions spent on developing new therapeutic proteins. These new opportunities were created only recently with the arrival of AI/ML tools and high throughput screening technologies. Furthermore, the complex nature of proteins offers mining opportunities that are not possible with chemical drugs; bringing in newer therapies without spending billions makes this path highly lucrative financially while serving the dire needs of humanity. This paper analyses several practical reinventing approaches and suggests regulatory strategies to reduce development costs significantly. This should enable the entry of hundreds of new therapies at affordable costs.

show abstract

Radioimmunoconjugates in the age of modern immuno-oncology

Cited by 8 publications

References 114 publications

Regulatory considerations in the design, development and quality of monoclonal antibodies and related products for the diagnosis and treatment of cancer

Regulatory considerations in the design, development and quality of monoclonal antibodies and related products for the diagnosis and treatment of cancer

Reinventing Therapeutic Proteins: Mining a Treasure of New Therapies

Reinventing Therapeutic Proteins: Optimizing Investments and Meeting Humanitarian Needs

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