Improved Resection Rates in Locally Advanced Pancreatic Cancer Following Addition of Intratumoral NanoPac^® to Standard of Care

FORT WORTH, Texas–(November 9, 2021)–NanOlogy LLC, a clinical-stage interventional oncology drug company, announced today a single-site analysis of data from an ongoing Phase 2a clinical trial (NCT03077685) of intratumoral (IT) NanoPac^® (large surface area microparticle [LSAM] paclitaxel) suspension showed improved resection rates in locally advanced pancreatic cancer (LAPC). The results were presented by Neil Sharma, MD (President, Parkview Cancer Institute, Chair, Upper GI Oncology Program, Assistant Professor, Indiana University School of Medicine) at the American College of Gastroenterology annual meeting (ACG 2021) at a plenary session on October 27, 2021.

The presentation entitled Improved Resection Rates in Locally Advanced Pancreatic Cancer Following EUS-FNI of Large Surface Area Microparticle Paclitaxel described results from a single clinical site analysis of a subset of nonsurgical patients (n=13) treated with two monthly administrations of IT NanoPac via endoscopic ultrasound guided fine needle injection (EUS-FNI) together with neoadjuvant standard of care.

Highlights from the analysis:

• 7/13 (54%) of subjects considered nonsurgical at enrollment were restaged to surgical after addition of IT NanoPac to neoadjuvant standard of care (SOC) therapy.
• Of 6 subjects who ultimately underwent surgery, 5 resulted in R0 resections (margin negative for tumor upon pathology examination) and 1 resulted in R1 resection (microscopic tumor remnants only).
• A decrease in tumor size was seen in 5/6 subjects who underwent surgery. Mean decrease was 25% (range 4%-50%).
• Mean time to surgery in the 6 subjects was 7 months (range 4 to 12) after initiation of IT NanoPac via EUS-FNI.

NanoPac (LSAM paclitaxel) suspension is composed of large surface area microparticles of pure paclitaxel designed for tumor entrapment and sustained drug release after local administration. The Phase 2a clinical trial was designed as a dose escalating and expansion study in 3 phases:

• The first phase (n=10) was a single IT administration of escalating doses of NanoPac suspension to establish safety.
• The second phase (n=22) expanded the highest dose to 2 monthly IT administrations. The presentation made at ACG was based on a 13-subject subset from this phase.
• The third phase, which is currently underway, expands to up to 4 monthly IT administrations, and has enrolled 12 subjects as of this release.

NanoPac has been well tolerated in this trial to date with no confirmed drug-related systemic adverse events and transient mild/moderate abdominal pain as the primary local adverse event. No pancreatitis has been reported.

In addition to Dr. Sharma, clinical investigators in the trial include Simon Lo, MD (Cedars Sinai), Mohamed Othman, MD (Baylor College of Medicine), and Antonio Mendoza Ladd, MD (formerly Texas Tech University Health Sciences Center).

The American Cancer Society estimates nearly 58,000 new cases of pancreatic cancer in the United States for 2021 with more than 47,000 deaths. Pancreatic cancer is among the deadliest of cancers with no significant reduction in mortality despite decades of research. NanOlogy is planning to expand to a randomized clinical trial of neoadjuvant IT NanoPac in addition to SOC versus neoadjuvant SOC alone in LAPC to further evaluate safety and efficacy pending results from the current study.

In addition to this trial, NanOlogy clinical programs have advanced in lung, bladder, 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 LSAM-taxane 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, China, 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.

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 therapy.

Disclaimers

This announcement contains forward-looking statements as 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 the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, 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 to be safe and effective as required by U.S. FDA and have not been approved by FDA or any other jurisdiction for commercial distribution. NanOlogy, NanoDoce, and NanoPac are trademarks of NanOlogy LLC.