Sunday, June 5, 2016

First commercial SHIKARI® kits for nivolumab (Opdivo®) in the whole world marketfrom Matriks Biotek®




By the mid of June with these new additions there will be total of 24 kits for biological drug testing for 12 different drugs widely used for treatment of diseases, such as inflammation, cancer and allergic disorders and osteoporosis.
As with all therapeutic proteins, there is a potential for immunogenicity. In order to benefit from your most valuable biological drug we recommend to measure trough levels along with anti-drug antibodies together from samples taken just before the administration of following dose by SHIKARI® ELISA kits.
We are hoping that patients, clinicians and biosimilar drug producers benefit from our products at most. Others to come soon...
Nivolumab is a humanized IgG4 monoclonal anti-PD-1 antibody. Its molecular weight is 146 kDa. Mechanism of Action: Programmed death 1 (PD-1) receptor is a type I membrane protein of 268 amino acids. PD-1 is expressed on the surface of activated T cells, B cells, and macrophages. The binding of PD-1 and its ligands (PD-L1 and PD-L2) on a tumor cell contributes to inhibition of active T-cell immune surveillance of tumors. By inhibiting the PD-1 receptor from binding to its ligands, nivolumab reactivates tumor-specific cytotoxic T lymphocytes in the tumor microenvironment and reactivates anti-tumor immunity. Clinical Dose Selection: The selection of nivolumab dose and schedule of 3 mg/kg Q2W was based on the observed clinical safety and efficacy from 306 patients in trial MDX1106-03 across different dose levels and tumor types.
Immunogenicity:
As with all therapeutic proteins, there is a potential for immunogenicity. Of 532 patients who were treated with OPDIVO 3 mg/kg every 2 weeks and evaluable for the presence of anti-nivolumab antibodies, 67 patients (12.6%) tested positive for treatmentemergent anti-nivolumab antibodies by an electrochemiluminescent (ECL) assay. Neutralizing antibodies against nivolumab were detected in five patients (0.9%). There was no evidence of altered pharmacokinetic profile or toxicity profile with anti-nivolumab binding antibody development. Of 105 patients who were treated with OPDIVO in combination with ipilimumab and evaluable for the presence of anti-nivolumab antibodies, 23 patients (21.9%) tested positive for treatment-emergent anti-nivolumab antibodies by an ECL assay. Neutralizing antibodies against nivolumab were detected in one patient (1%). There was no evidence of altered toxicity profile with anti-nivolumab antibody development. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
Further reading; Drug information, trough levels and immunogenicity.

1 comment:

  1. Opdivo® is a trade mark of Bristol-Myers Squibb

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