On September 21, 2021 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported that initial results from a Phase 1/2 clinical trial of intramural/intravesical (IMI/IVT) NanoDoce (large surface area microparticle [LSAM] docetaxel) suspension in high-risk nonmuscle invasive bladder cancer (hrNMIBC) were presented by Max Kates, MD (Johns Hopkins Medicine) at the American Urological Association annual meeting (AUA2021) via virtual platform on September 12, 2021 (Press release, NanOlogy, SEP 21, 2021, View Source;utm_medium=rss&utm_campaign=aus2021_presentation_highlights_pr [SID1234590065]).

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The oral presentation entitled Initial Results from a Phase 1/2 Trial of Large Surface Area Microparticle Docetaxel for High-Risk Non-Muscle Invasive Bladder highlighted safety and preliminary efficacy data from the multicenter dose-rising/confirmation clinical trial that enrolled 19 subjects. In addition to Dr. Kates, contributing clinical investigators were Ahmed Mansour, MD (UT Health San Antonio), Donald Lamm, MD (BCG Oncology), and Neal Shore, MD (Carolina Urologic Research Center).

Highlights from the presentation:

Overall, NanoDoce was well tolerated. Most treatment emergent adverse events were mild to moderate, and no severe adverse events were attributable to the study drug.
Systemic absorption of docetaxel was negligible and below the threshold for systemic toxicity in all subjects.
Across all doses and subjects (n=19), complete response (CR) at 3 months as 68% (13/19) and durability for responding subjects at 12 months was CR of 31% (4/13).
In the high-dose cohort (n=6), 6/6 maintained CR > 6 months with 4 subjects showing durability at 12 months, 1 subject showing recurrence, and 1 subject lost to follow up.
Tissue biopsies suitable for multiplexed immunofluorescence were obtained pre/post NanoDoce in 5 subjects. Analysis revealed directional increases in density of T Cells, macrophages (including PD-L1), and NK cells, and decreases in myeloid and MDSC cells.
NanoDoce (LSAM docetaxel) suspension is composed of large surface area microparticles of pure docetaxel designed for local administration and sustained drug release over time. In the dose-rising phase of the study (n=13), 3mg to 15mg of investigational drug were delivered IMI into and around the tumor resection bed post transurethral resection of bladder tumor (TURBT) followed by multiple periodic IVT of 50mg to 75mg. No dose limiting toxicities were encountered allowing target of 15mg IMI and 75mg IVT NanoDoce to continue into dose confirmation (n=6). Subjects were followed for up to one year. A separate study arm evaluated a post-TURBT single IMI/IVT administration of NanoDoce for safety over a 45-day period in 17 patients with muscle invasive bladder cancer. These data will be reported separately once final.

The American Cancer Society estimates 83,730 new cases of bladder cancer in the United States for 2021 with more than 20,000 presenting with hrNMIBC. For these patients, bladder removal often follows, which results in among the highest lifetime treatment costs and negative impact to quality of life of any cancer. NanOlogy is in planning of a later phase clinical trial in hrNMIBC.

In addition to this trial, NanOlogy clinical programs have advanced in lung, pancreatic, and other cancers. Data from preclinical and clinical studies in a variety of solid tumors have shown evidence of tumor kill, minimal local or systemic toxicity, and favorable antitumoral immune effects, which includes published preclinical research of NanoDoce synergy in combination with an immune checkpoint inhibitor.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts taxane API crystals into stable LSAMs of pure drug for tumor-directed therapy and sustained drug release. The taxane particles are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, & US 10,993,927), Canada, Europe, Japan, Russia, and Australia all valid through June 2036, plus applications pending globally. These composition of matter patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, methods, and technology.