On April 26, 2021 NanOlogy, LLC, a clinical-stage interventional oncology drug therapy company, reported the first patient has been enrolled in a clinical trial of intratumoral (IT) NanoPac(large surface area microparticle [LSAM] paclitaxel) for suspension via endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) in lung cancer (Press release, NanOlogy, APR 26, 2021, View Source [SID1234578482]). A second patient is scheduled for enrollment in early May.
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The trial will evaluate safety and preliminary efficacy of up to 3 monthly IT injections of NanoPac in patients with primary or recurrent nonoperable lung cancer. Tissue and blood will be collected pre/post NanoPac administration to analyze pharmacokinetics (PK) and immune effect by multiplex immunofluorescence and flow cytometry analysis. Preclinical and clinical data indicate the long tumor residence and therapeutic drug release of several weeks enabled by LSAMs result in prolonged direct tumor cell death and favorable immunogenic effect. Notably, NanOlogy has demonstrated both clinically after administration of its investigational drugs in patients with locally advanced pancreatic cancer and high risk nonmuscle invasive bladder cancer. The current trial expects to enroll patients on immune checkpoint inhibitors (ICIs) like Keytruda, Opdivo, or Tecentriq, which will allow for assessment of immune effect of NanoPac in combination with ICIs.
Six INDs have been established for NanOlogy investigational drugs allowing clinical trials via multiple routes of solid tumor-directed administration in patients with pancreatic, prostate, ovarian, peritoneal, bladder, and lung cancer. More than 145 patients have been administered NanOlogy drugs with no confirmed drug-related severe adverse events because of gradual, subtoxic clearance of drug from site of administration as demonstrated by clinical PK analysis.
Please visit the NanOlogy website (www.nanology.us) for more information on the company and its programs.