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DRUG:

NanoDoce (docetaxel nanoformulation)

i
Other names: LSAM-DTX
Associations
Trials
Company:
NanOlogy
Drug class:
Tubulin polymerization promoter, Microtubule stabilizer
Associations
Trials
over2years
Phase 1/2 Trial Results of a Large Surface Area Microparticle Docetaxel for the Treatment of High-Risk Non-muscle Invasive Bladder Cancer. (PubMed, J Urol)
Post-TURBT direct-injection and intravesical LSAM-DTX was well tolerated and demonstrated clinical response for patients with high-risk NMIBC. Favorable immune cell infiltration and checkpoint receptor increases following LSAM-DTX treatment warrants investigation alone as well as in combination with immune checkpoint inhibitor therapy.
P1/2 data • Journal
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PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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docetaxel • NanoDoce (docetaxel nanoformulation)
over3years
[VIRTUAL] Initial Results from a Phase 1/2 Trial of Large Surface Area Microparticle Docetaxel for High-Risk Non-Muscle Invasive Bladder Cancer (AUA 2021)
LSAM-DTX treatment was safe by both intramural injection and intravesical instillations. PK analysis demonstrated negligible systemic exposure. Preliminary efficacy data suggest post-TURBT intramural injection and intravesical instillation of high dose LSAM-DTX may prevent recurrence in patients with hrNMIBC for 6-months.
P1/2 data • Late-breaking abstract
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PD-L1 (Programmed death ligand 1)
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docetaxel • NanoDoce (docetaxel nanoformulation)
over3years
Submicron particle docetaxel intratumoral injection in combination with anti-mCTLA-4 into 4T1-Luc orthotopic implants reduces primary tumor and metastatic pulmonary lesions. (PubMed, Med Oncol)
Myeloid-derived suppressor cells (MDSC) were reduced in bloods in SPD ± anti-mCTLA-4 groups (p < 0.05). These data demonstrate that both SPD and anti-mCTLA-4 produce local anti-tumor effects as well as reductions in metastasis which are significantly enhanced when administered in combination.
Journal • Combination therapy
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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NanoDoce (docetaxel nanoformulation)
over4years
Intratumoral submicron particle docetaxel inhibits syngeneic Renca renal cancer growth and increases CD4+, CD8+, and Treg levels in peripheral blood. (PubMed, Invest New Drugs)
CD4+, CD8+ and Treg populations were increased in peripheral bloods from animals administered IT NanoDoce. Additional evaluation of the effect of IT NanoDoce on peripheral and local immune cell populations as well as the impact on sites of distant tumor growth are warranted.
Journal
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CD8 (cluster of differentiation 8)
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docetaxel • NanoDoce (docetaxel nanoformulation)