NK012 / Nippon Kayaku 
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 21 Diseases   1 Trial   1 Trial   18 News 
  • ||||||||||  SNB-101 / SN BioSci
    Journal:  Generation of anti-SN38 antibody for loading efficacy and therapeutic monitoring of SN38-containing therapeutics. (Pubmed Central) -  Jul 18, 2024   
    However, it has garnered significant scientific interest as a payload in conjugated nanomedicine platforms (e.g., SN-38lip, NK012, SNB-101, and ADCs) to enhance their effectiveness and safety...The immunization efficiency, reactivity, binding affinity, specificity, and cross-reactivity of purified pAb and mAb against Irinotecan, a model for the emergence of an SN38 derivative in clinical settings, were evaluated using ELISA and western blotting (WB) techniques...The affinity of both pAb and mAb also meets the acceptance criteria for quantifying SN38 in fluidic material, as well as in Therapeutic drug monitoring (TDM) studies, a crucial aspect of personalized medicine. The potential applications of the anti-SN38 antibodies extend to reducing SN38-induced systemic toxicity through an inverse targeting strategy, a novel approach that piques further interest in our findings.
  • ||||||||||  NK012 / Nippon Kayaku
    Clinical, P2 data, Journal:  A phase II study of NK012, a polymeric micelle formulation of SN-38, in unresectable, metastatic or recurrent colorectal cancer patients. (Pubmed Central) -  Aug 30, 2019   
    NK012 monotherapy yielded an RR similar to the RR of irinotecan monotherapy that was reported in the phase III EPIC trial (4.2%), and the incidence of grade ≥ 3 diarrhea was low. Based on the incidence and severity of febrile neutropenia and grade ≥ 3 neutropenia, the initial dose of NK012 28 mg/m may be too high for colorectal cancer patients who have previously been treated with an oxaliplatin-based chemotherapy regimen.
  • ||||||||||  NK012 / Nippon Kayaku
    Trial completion, Metastases:  A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) -  Feb 19, 2015   
    P2,  N=61, Completed, 
    Additional clinical development as a single agent in specific patient populations or in combination with other chemotherapy agents is warranted. Active, not recruiting --> Completed
  • ||||||||||  NK012 / Nippon Kayaku
    Trial completion:  Study of NK012 in Patients With Refractory Solid Tumors (clinicaltrials.gov) -  Mar 17, 2013   
    P1,  N=39, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed