Interim Results from a NanOlogy Phase 2 Clinical Trial of its Intratumoral Investigational Drug in the Treatment of Locally Advanced Pancreatic Cancer

• Research article published in Pancreas Journal reports initial safety and clinical outcome data from a Phase 2a clinical trial of IT LSAM-PTX in LAPC.
• Two posters presented at AACR Special Conference on Pancreatic Cancer report downstaging and immune data from the trial.

FORT WORTH, Texas–(BUSINESS WIRE)–NanOlogy LLC, a clinical-stage oncology company, announced today that initial safety and clinical outcomes from a Phase 2 clinical trial of intratumoral (IT) large surface area microparticle paclitaxel (LSAM-PTX) in locally advanced pancreatic cancer (LAPC) were published online ahead of print in Pancreas and two posters were presented at the ninth AACR Special Conference on Pancreatic Cancer in Boston reporting downstaging and immune data from the trial.

The research article entitled Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome provides safety and response data from dose escalation and 2-injection cohorts. Clinical investigators included Neil Sharma, MD, Simon Lo, MD, Mohamed Othman, MD, and Antonio Mendoza-Ladd, MD.

“Pancreatic cancer is among the most lethal cancers with 5-year survival of only 12%,” said lead investigator and author, Neil Sharma, MD. “The interim results from this study, particularly the potential for downstaging and immunomodulation, are encouraging and warrant expanded studies to further evaluate the clinical benefit of neoadjuvant IT LSAM-PTX in combination with standard of care therapy.”

The dose escalation/expansion trial (NCT03077685) enrolled 54 subjects across four clinical sites in three cohorts including one-injection escalation (n=10), two-injection expansion (n=25), and four-injection expansion (n=19). The research article reports data from evaluable subjects in the first two cohorts while the third is pending final readout. Highlights include:

• Most treatment-emergent adverse events (84%) were mild to moderate and considered related to underlying disease and comorbidities. No confirmed treatment-related severe adverse events or pancreatitis were reported. The most common adverse events were abdominal pain and nausea. Plasma paclitaxel levels attributed to LSAM-PTX were unremarkable throughout the study.
• In the 2-injection cohort, 8 of 22 (36%) evaluable subjects were downstaged from nonresectable to resectable disease. Six subjects underwent surgery with five R0 resections and one R1 resection. Mean survival increased in resected subjects to 35 months versus 19 months for nonresected subjects.
• Tissue was available pre/post LSAM-PTX treatment for immunophenotypic profiling via multiplex immunofluorescence from the 6 subjects undergoing resection. Despite pancreatic cancer being considered a “cold” tumor, favorable antitumor immunomodulation was observed with increases in concentrations of immune effector cells and NK cells along with decreases in concentrations of immune suppressor cells.
• In evaluable subjects from the 2-injection cohort, disease control rate was 82% (18/22) at 3 months and 94% (16/17) at 6 months.

Additionally, two posters presented downstaging and immune data from the Phase 2 trial following IT LSAM-PTX at the recent AACR Special Conference on Pancreatic Cancer.

The first poster (B004) entitled: “EUS guided local administration of large surface area microparticle paclitaxel with neoadjuvant chemotherapy in locally advanced pancreatic cancer: A single center experience” was presented by Harishankar Gopakumar, MD (University of Illinois College of Medicine).

• Data were collected prospectively on 6 of 13 (46%) LAPC subjects in the second cohort of the trial who received 2 monthly endoscopic ultrasound-guided fine needle injections (EUS-FNI) of LSAM-PTX in addition to neoadjuvant chemotherapy at Parkview Health and subsequently underwent surgery from 2018 to 2019.
• EUS-FNI of LSAM-PTX, added to neoadjuvant chemotherapy, was safe and resulted in a significant reduction in tumor volume, significant tumor necrosis on pathology exam, and favorable changes in TME immunophenotypic configuration.
• The preliminary results suggest that adding LSAM-PTX to neoadjuvant chemotherapy could increase the rate of downstaging of LAPC to resectable disease and improve clinical outcomes.

The second poster (A048) entitled: “Enhancing the immune response in locally advanced pancreatic cancer (LAPC) with intratumoral of large surface area microparticle paclitaxel (LSAM-PTX)” was presented by Andrew Hendifar, MD (Cedars-Sinai Medical Center).

• Blood samples were collected before and after treatment for flow cytometry analysis from 14 subjects in the third cohort of the trial who received 4 monthly EUS-FNI of LSAM-PTX in addition to prior or current SOC therapy.
• Immunophenotyping of blood from LAPC subjects treated with IT LSAM-PTX demonstrates peripheral immunomodulation to a phenotype associated with anti-tumor immune effects, including favorable immunosurveillance, and is consistent with changes found in the TME in resected tissues. Immunosuppressive cell types typically associated with poor clinical outcomes were reduced at six months.
• Anti-tumor immunomodulation without immunosuppression suggests that IT LSAM-PTX may be amenable to combination with immunotherapy.

About NanOlogy

NanOlogy, LLC (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 (9,814,685, 10,507,195, 10,993,927, and 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 130 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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