Delving into the Latest Updates on Nascent Biologics, Inc. with Synapse

Overview

AbstractPritumumab, a natural human IgG1 kappa antibody isolated from a lymph node of a patient with cervical carcinoma, has been used in a Phase II setting with brain cancer patients. The original human-human hybridoma secreted approximately 1 picogram of antibody per cell per day. This level of the antibody production posed cost constrains for late stage therapeutic clinical trials. To generate a more commercially viable antibody, a pritumumab-secreting Chinese hamster ovary (CHO) cell line was created using the GPEx® technology. This technology involved construction and cloning of heavy and light chain DNA. Both DNA sequences were cloned into the expression vector and transduced into HEK 293 cells that constitutively produces the MLV gag, pro, and pol. The pritumumab cell line was made by performing multiple rounds of transduction (multiplicity of > 1000 retrovector particles/cell) of the GPEx® Chinese Hamster Ovary (GCHO) parental cell line with retrovector made from the gene construct developed to express the pritumumab antibody light chain (LC) and the pritumumab antibody heavy chain (HC). Five independent transductions were performed: two LC and three HC. Limiting dilution method was used to establish clonal cell lines. Top clones were selected based on pritumumab antibody titer. Pritumumab expression was determined by Protein A HPLC using a generic IgG standard. Clearly, single copies of genes were inserted efficiently in unique locations throughout the genome of the CHO cells to obtain genetically stable cell line that expressed high levels of the antibody, and represented more than a 40-fold increase in production of the antibody over the original hybridoma. Flow cytometry binding and immunohistological analyses demonstrated comparability between the recombinant form of pritumumab and the hybridoma form of the protein. Thus, high level of specific productivities and titers of the CHO clones developed through the GPEx® system will allow the therapeutic antibody program to move forward into large and extended clinical trials.Citation Format: Gregory T. Bleck, Rishab K. Gupta, Beatrix Kotlan, Dona York, Mark C. Glassy. GPEx® system to increase production of pritumumab in a CHO cell line. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 2658. doi:10.1158/1538-7445.AM2014-2658

27 Nov 2009·Human Antibodies

Summary analysis of the pre-clinical and clinical results of brain tumor patients treated with pritumumab

Review

Author: Hagiwara, Hideaki ; Glassy, Mark C.

Pritumumab is a human IgG1 kappa antibody that has been derived from a B-cell isolated from a regional draining lymph node of a patient with cervical carcinoma. Specificity analysis of the antibody with human tissues showed the antigen, altered tumor-associated vimentin, to be highly restricted to various cancers and not normal cells and tissues. In various clinical trials in Japan 249 patients with brain cancer were treated with pritumumab. The overall response rate was between 25-30% with several survivors beyond 5-years post-treatment. The patients were on a low dose regimen of 1mg given twice a week for a course of 24 weeks for a total dose of 48 mgs per course. Pritumumab appears to be a safe and effective therapy in patients with malignant gliomas.

Oligoclonal and polyclonal antibody preparations

Author: Glassy, Mark C. ; Gupta, Rishab K.

A review discusses oligoclonal and polyclonal antibody preparations used in the clinic, and as the technol. matures, this use will only increase.It also discusses use of oligoclonal antibody preparations will eventually replace conventional polyclonal antibodies primarily because of advantages of more control and less variability.

100 Deals associated with Nascent Biologics, Inc.

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100 Translational Medicine associated with Nascent Biologics, Inc.

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Pipeline

Pipeline Snapshot as of 27 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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