NanOlogy Clinical and Preclinical Immune Data Presented at NACLC and SITC

• Interim response and peripheral immunomodulation data from its Phase 2 clinical trial of IT LSAM-PTX in stage 3/4 lung cancer was selected for presentation during the poster discussion session during IASLC’s North American Conference on Lung Cancer.
• A poster reporting clinical and preclinical antitumor immunomodulation data of LSAM-DTX across multiple tumor types was presented at the Society for Immunotherapy of Cancer annual meeting.

FORT WORTH, Texas--(BUSINESS WIRE)-- NanOlogy LLC, a clinical-stage oncology company, reports data presented as posters during recent oncology conferences.

A poster entitled Phase 2a Intratumoral Large Surface Area Microparticle Paclitaxel in Stage 3/4 Lung Cancer was presented during IASLC’s North American Conference on Lung Cancer in Chicago on December 2, 2023. The poster was authored by clinical investigators Hiren Mehta, Abhishek Biswas, Sarah Wang, Jason Akulian, Christine Argento, et.al. It was one of only about 10% of posters selected for discussion during the poster discussion session. Summarizing presented data:

• The early phase lung cancer trial demonstrated safety and tolerability of intratumoral (IT) LSAM-PTX in combination with various concurrent therapies, including systemic immunotherapy.
• Disease Control Rate for evaluable subjects at 3- and 6-months was 80% (8/10) and 86% (6/7), respectively.
• Flow cytometry and safety data suggest IT LSAM-PTX may cause immunomodulation, including increases in immune effectors cells and decreases in Tregs and immune suppressor cells, and complement systemic therapy without significantly increasing adverse events.

A poster entitled Local administration of large surface area microparticle docetaxel is associated with antitumor immunomodulation across multiple tumor types was presented during the Society for Immunotherapy of Cancer (SITC) annual meeting on November 4, 2023. The poster was authored by Holly Maulhardt, Alyson Marin, et.al. Summarizing presented data:

• Immunophenotyping in 3 diverse tumor settings found commonalities in antitumor immunomodulation following local LSAM-DTX, including changes in T cells and MDSCs.
• NMIBC clinical subjects demonstrated infiltrations of CD4+T, CD8+ T, and NK cells.
• Mice administered IT LSAM-DTX into renal tumor xenografts had increased circulating T cells and reduced M2-macrophage levels in the blood and spleen when compared to IV docetaxel.
• IT LSAM-DTX in a metastatic breast cancer model increased T cells in the TME and reduced thoracic metastasis when combined with systemic immunotherapy.
• Preclinical/clinical antitumor immunomodulation suggests that IT LSAM-DTX may be amenable to combination with immunotherapy.

About NanOlogy

NanOlogy, LLC (http://www.nanology.us) is a private clinical-stage oncology company formed in 2015 to improve the treatment of solid tumors with investigational drugs optimized for intratumoral delivery by a proprietary particle engineering technology platform. NanOlogy clinical programs have advanced investigational drugs in multiple solid tumors including pancreas, lung, bladder, peritoneal, ovarian, prostate, and dermal cancers. The investigational drugs are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, US 10,993,927, and US 11,123,322), and other major jurisdictions worldwide, including Canada, Europe, Japan, China, South Korea, Australia, and India valid through June 2036. The composition patents form the foundation of an extensive intellectual property portfolio of over 100 issued patents protecting NanOlogy investigational drugs, formulations, methods, and technology.

Disclaimers

This announcement contains forward-looking statements defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven safe and effective as required by U.S. FDA and have not been approved by FDA or any other jurisdiction for commercial distribution. NanOlogy is a trademark of NanOlogy LLC.

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