NanOlogy Granted a US Patent for Its Investigational Drugs in Combination with Immune Checkpoint Inhibitors in the Treatment of Cancer

FORT WORTH (March 7, 2023) — NanOlogy LLC, a clinical-stage oncology company, announced today issuance of a US patent titled: Local Delivery of Antineoplastic Particles in Combination with Systemic Delivery of Immunotherapeutic Agents for the Treatment of Cancer. The patent (11,583,499) is valid in the US until November 25, 2038, and has corresponding filings globally. It adds to an extensive global intellectual property portfolio of more than 250 issued or filed patents covering composition, formulation, use, and technology.

The new patent covers a method of treating cancer by intratumoral administration of large surface area microparticle (LSAM) taxanes in combination with systemic administration of immune checkpoint inhibitors (ICIs).

ICIs are often used in combination with other systemic cancer therapies particularly in the treatment of solid tumors to prime the immune system to increase response. A growing body of preclinical and clinical data demonstrate local and systemic immunomodulation following local delivery of NanOlogy’s LSAM investigational drugs together with outside research pointing to the value of treating the primary tumor in neoadjuvant, locally advanced, and metastatic settings to improve clinical outcomes.

“The Cancer Research Institute estimates more than 5000 clinical trials are underway worldwide with immune checkpoint inhibitors; many are combination trials with other systemic cancer agents in solid tumors.” said Gere DiZerega, MD, NanOlogy Chief Medical Officer. “The goal is to identify which combinations can increase the immune response thereby increasing the overall solid tumor response to treatment. Unfortunately, a key challenge is the stacking of severe toxicities that can occur when multiple systemic therapies are used in combination.”

“With this patent added to our portfolio, NanOlogy is in a strong position to further investigate clinically whether the combination of its local LSAM investigational drugs with systemic ICIs increases response without adding toxicity as suggested in our preclinical and early clinical research”, added Marc Iacobucci, a Managing Director for NanOlogy. “Our goal is to improve cancer treatment and potentially offer a strategy for product lifecycle extension for ICIs when used in combination with our drugs.”

In all, NanOlogy clinical programs have advanced tumor directed LSAM investigational drugs in multiple solid tumors including pancreas, lung, bladder, peritoneal, ovarian, prostate, and dermal cancers. More than 170 patients have been treated to date across its clinical trials with signals of tumor and immune response and no confirmed drug-related serious adverse events.

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a private clinical-stage interventional oncology drug company formed in 2015 to improve the treatment of solid tumors based on a proprietary particle engineering technology platform for tumor-directed drug therapy to maximize drug in tumor and minimize systemic toxicity. Taxane drug particles 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), Canada, Europe, Japan, China, Hong Kong, South Korea, Australia, Indonesia, and Russia valid through June 2036. The composition patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, formulations, methods, and technology. NanOlogy investigational drugs have advanced clinical trials in multiple solid tumors with growing evidence of clinical benefit.

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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