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

On March 7, 2023   /   Home Page, NanOlogy Press Release  
NanOlogy Granted a US Patent for Its Investigational Drugs in Combination with Immune Checkpoint Inhibitors in the Treatment of Cancer

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

 

  • Covers intratumoral delivery of certain LSAM investigational drugs with systemic Immune Checkpoint Inhibitors
  • Strengthens position to continue investigating whether combination therapy increases response without adding toxicity
  • Potential product lifecycle extension strategy for ICIs

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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Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
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NanOlogy Completes Enrollment in Phase 2a Trial of Intratumoral LSAM-PTX with SOC in Patients with Nonoperable Lung Cancer

On November 11, 2022   /   Home Page, NanOlogy Press Release  
NanOlogy Completes Enrollment in Phase 2a Trial of Intratumoral LSAM-PTX with SOC in Patients with Nonoperable Lung Cancer

NanOlogy Completes Enrollment in Phase 2a Trial of Intratumoral LSAM-PTX with SOC in Patients with Nonoperable Lung Cancer

FORT WORTH (November 11, 2022) — NanOlogy LLC, a clinical-stage interventional oncology drug company, announced enrollment is complete in a Phase 2a trial of intratumoral (IT) large surface area microparticle paclitaxel (LSAM-PTX) with standard of care (SOC) therapy in patients with nonoperable lung cancer.

The single arm trial (NCT04314895) enrolled 18 subjects at four clinical sites with primary or recurrent nonoperable locally advanced stages II and III with nodal disease or stage IV advanced disease. Up to three monthly doses of IT LSAM-PTX were administered and subjects enrolled into the trial had prior or concurrent chemotherapy, radiotherapy, and/or immune checkpoint inhibitor (ICI) therapy as part of SOC.

The primary outcome measure for the trial is safety, as determined by treatment emergent adverse events. Secondary measures include plasma paclitaxel concentration, tumor response, survival, and immune response by flow cytometry analysis. A safety assessment was completed for each of the initial three subjects prior to open enrollment.

Preliminary data to date indicate IT LSAM-PTX is well tolerated with encouraging signs of tumor and immune response. Final data and clinical study report are expected by 3Q2023.

Lung cancer has the highest mortality of any cancer with 2.2 million new cases and 1.8 million deaths estimated globally in 2020 by GLOBOCAN. ICIs are rapidly becoming a SOC for the treatment of lung cancer often combined with other agents to increase response.

NanOlogy is in the planning stages of further clinical research in lung cancer to evaluate its LSAM investigational drugs combined with ICIs bolstered by a recently allowed US patent that covers use of locally delivered LSAM taxanes with systemic ICIs.

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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Opus Biotech Communications
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NanOlogy Publishes Review Article of Preclinical and Clinical Research Supporting LSAM-DTX

On September 20, 2022   /   Home Page, NanOlogy Press Release  
NanOlogy Publishes Review Article of Preclinical and Clinical Research Supporting LSAM-DTX

NanOlogy Publishes Review Article of Preclinical and Clinical Research Supporting LSAM-DTX

FORT WORTH, Texas–September 20, 2022–NanOlogy LLC, a clinical-stage interventional oncology drug company, announced today that a review article of preclinical and clinical research supporting its investigational drug, large surface area microparticle docetaxel (LSAM-DTX), has been published in Drug Delivery and Translational Research (DDTR).

The review article entitled Local administration of large surface area microparticle docetaxel to solid carcinomas induces direct cytotoxicity and immune‑mediated tumoricidal effects: preclinical and clinical studies provides a review of preclinical research that supports tumor-directed LSAM-DTX as well as promising results from the high-risk nonmuscle invasive bladder cancer arm of a clinical trial of local LSAM-DTX in urothelial carcinoma, which were published earlier this year in The Journal of Urology. The articles also follows an earlier review of preclinical and clinical research supporting another NanOlogy investigational drug, large surface area microparticle paclitaxel (LSAM-PTX), published in DDTR in 2020.

Highlights from the current article:

  • LSAM-DTX is retained in the tumor as a depot for continuous drug release after intratumoral injection in a range of solid tumor preclinical models.
  • LSAM‑DTX in combination with an immune checkpoint inhibitor demonstrated synergy in a preclinical metastatic breast cancer model.
  • Evidence of efficacy is seen in preclinical xenograft models of bladder, prostate, and renal cancer as well as evidence of an abscopal effect in a preclinical syngeneic renal cell adenocarcinoma model.
  • In the high risk nonmuscle invasive bladder cancer clinical trial arm (n=19) of a dose escalation/expansion trial of intramural and intravesical LSAM-DTX in urothelial carcinoma, 100%/78%/50% of subjects in the high-dose cohort (n=9) achieved a complete response at the 3/6/12 month timepoints respectively. Moreover, evidence suggesting favorable immunomodulation was reported after analysis of suitable tissue samples collected pre/post administration of LSAM-DTX.

In addition to LSAM-DTX, NanOlogy clinical programs have advanced tumor-directed LSAM-PTX in pancreas, lung, peritoneal, ovarian, prostate, and dermal cancers.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts active ingredients into stable large surface area microparticles (LSAMs) of pure drug optimized for tumor-directed therapy and continuous drug release to maximize drug delivered to the tumor and minimize systemic toxicity.

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, 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.

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.

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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Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
+425-306-8716

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NanOlogy Publishes Results from a Phase 1/2 Clinical Trial of Large Surface Area Microparticle Docetaxel in High-Risk Non-Muscle Invasive Bladder Cancer

On August 1, 2022   /   Home Page, NanOlogy Press Release  
NanOlogy Publishes Results from a Phase 1/2 Clinical Trial of Large Surface Area Microparticle Docetaxel in High-Risk Non-Muscle Invasive Bladder Cancer

NanOlogy Publishes Results from a Phase 1/2 Clinical Trial of Large Surface Area Microparticle Docetaxel in High-Risk Non-Muscle Invasive Bladder Cancer

 

FORT WORTH (August 1, 2022) — NanOlogy LLC, a clinical-stage interventional oncology drug company, announced today that results from a clinical trial of Large Surface Area Microparticle Docetaxel (LSAM-DTX) in High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) have been published in The Journal of Urology®.

The research article entitled Phase 1/2 Trial Results of a Large Surface Area Microparticle Docetaxel for the Treatment of High-Risk Non-Muscle Invasive Bladder Cancer presents safety and response data from the multi-site study (NCT03636256). Clinical investigators included Max Kates, MD (Johns Hopkins Medical Institutions), Ahmed Mansour, MD (UT Health San Antonio), Donald Lamm, MD (BCG Oncology), and Neal Shore, MD (Carolina Urologic Research Institute).

The trial followed an open-label 3+3 dose-escalation design with enrollment expansion at the highest dose. After transurethral resection of the bladder tumor (TURBT), subjects received direct-injection LSAM-DTX into the resection site and intravesical LSAM-DTX, followed by six-week induction and three-week maintenance intravesical LSAM-DTX courses. The first-in-human trial was initially designed as a 7-month study with treatment limited to 4 months to establish safety but later amended to follow patients to 12 months despite the treatment limitation. Tumor recurrence was evaluated by cytology, cystoscopy, or biopsy. Pharmacokinetic analysis of blood and multiplex immunofluorescence analysis of tumor microenvironment were conducted pre/post treatment.

Nineteen subjects were enrolled, 14 with prior bacillus Calmette-Guérin (BCG) exposure, and 16 with one or more prior TURBTs. Direct-injection and intravesical LSAM-DTX were well-tolerated with minor recorded treatment-related local and systemic adverse events. Median recurrence free survival was 12.2 months in the high-dose and expansion cohorts and was significantly increased compared to the low dose cohorts at 5.4 months. Bladder biopsies show an increase in tumor microenvironment immunogenicity, including increases in adaptive (T cells) and innate (NK cells) effector cells. Notably, immune checkpoint receptor expression was increased across multiple cell types, suggesting LSAM-DTX in combination with immune checkpoint inhibitor therapy may provide additional benefit in treatment of HR-NMIBC.

Worldwide, an estimated 573,000 people were diagnosed with bladder cancer in 2020 and 81,000 people will be diagnosed with bladder cancer in the United States in 2022. About 40% of patients are at higher risk for disease progression at time of diagnosis (GLOBOCAN 2020; SEER). Recurrence rates are high in these patients with currently available treatments, potentially leading to disease progression and cystectomy. Bladder cancer has among the highest life-time treatment costs of all cancers and the negative impact to patient quality of life in patients facing cystectomy is severe. A significant need exists for better drug therapies to stave off disease progression.

“Bladder cancer at high risk for progression needs better treatment options,” said Max Kates, MD, Director, Bladder Cancer Program and Associate Professor of Urology of the Brady Urological Institute at Johns Hopkins Medicine. “In this Phase 1/2 clinical trial, LSAM-DTX showed promising signs of preventing disease progression and interesting immunogenic effects with minimal adverse events. Further clinical research is warranted to confirm these findings.”

NanOlogy is planning further clinical development of LSAM-DTX, which it believes has therapeutic potential in NMIBC and muscle invasive bladder cancer, which also showed promising results in a separate arm of the trial and will be reported once finalized.

In addition to LSAM-DTX, NanOlogy clinical programs have advanced tumor-directed investigational drugs in pancreas, lung, peritoneal, ovarian, prostate, and dermal cancers.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts active ingredients into stable large surface area microparticles (LSAMs) of pure drug optimized for tumor-directed therapy and continuous drug release to maximize drug delivered to the tumor and minimize systemic toxicity.

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, 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.

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.

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.

Media Contact

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
+425-306-8716

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NanOlogy Publishes Results from a Phase 1/2 Clinical Trial of its Topical Investigational Drug in the Treatment of Cutaneous Metastases of Breast Cancer

On May 3, 2022   /   Home Page, NanOlogy Press Release  
NanOlogy Publishes Results from a Phase 1/2 Clinical Trial of its Topical Investigational Drug in the Treatment of Cutaneous Metastases of Breast Cancer

NanOlogy Publishes Results from a Phase 1/2 Clinical Trial of its Topical Investigational Drug in the Treatment of Cutaneous Metastases of Breast Cancer

FORT WORTH, Texas–NanOlogy LLC, a clinical-stage interventional oncology drug company, announced today that results from a clinical trial of topical submicron particle paclitaxel (SOR007) in cutaneous metastases of breast cancer (CMOBC) have been published in Breast Cancer Research and Treatment.

The research article entitled Phase 1/2 Study of Topical Submicron Particle Paclitaxel for Cutaneous Metastases of Breast Cancer presents final safety and response data from the multi-site study (NCT03101358). Clinical investigators included Mario Lacouture, MD (Memorial Sloan Kettering Cancer Center), Julie Lang, MD (formerly USC Norris Comprehensive Cancer Center; currently Cleveland Clinic), and Sant Chawla, MD (Sarcoma Oncology Research Center).

The dose escalation/expansion trial enrolled 23 subjects across the three sites, 21 of whom had CMOBC. Three concentrations of SOR007 were evaluated (0.15%, 1.0%, and 2.0%) applied twice daily for 28 or 56 days. The primary endpoint of the study was safety and tolerability. Secondary endpoints included lesion response, lesion pain reduction, and pharmacokinetic (PK) analysis.

SOR007 was well tolerated at all concentrations allowing the 2.0% concentration to continue to the dose expansion phase of the trial. No confirmed drug-related serious adverse events were recorded, local skin reactions were minor, and systemic absorption of paclitaxel was negligible.

Lesion response was evaluated by dimensional change (RECIST 1.1) with 19 subjects evaluable at 28 days and 8 evaluable at 56 days. At the 28-day and 56-day assessments, overall response rate was 16% (3/19) and 25% (2/8), respectively. Similarly, 15/19 (79%) and 6/8 (75%) were progression free. Some lesion pain reduction was observed in 7/11 (64%) of subjects who reported pain at baseline.

Approximately 168,000 people are living with metastatic breast cancer in the United States and up to a quarter (40,000) may develop cutaneous metastases (BCRF [2021]; Krathen [2003] South Med J). CMOBC are progressive malignant skin lesions that can cause severe local pain, ulceration, disfigurement, discharge, malodor, bleeding, and infection. The negative impact to quality of life for these patients can be devastating.

NanOlogy is considering partnership strategies for further development and commercialization of SOR007, which has therapeutic potential in CMOBC and other dermal cancers.

“Cutaneous metastases are extremely troublesome for the patient and oncologist alike as the lesions are a daily reminder of the underlying metastatic disease and there are few treatment options currently available,” said Mario Lacouture, MD, Director, Oncodermatology Program, Memorial Sloan Kettering Cancer Center. “In this Phase 1/2 clinical trial, SOR007 showed promising signs of preventing lesion progression and reducing lesion pain. Further clinical research is warranted to confirm these findings.”

In addition to SOR007, NanOlogy clinical programs have advanced tumor-directed investigational drugs in pancreas, lung, bladder, peritoneal, ovarian, and prostate cancers.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts oncology active ingredients into stable large surface area microparticles of pure drug optimized for tumor-directed therapy and continuous drug release. 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, and US 11,123,322) Canada, Europe, Japan, China, Russia, and Australia all valid through June 2036. The topical formulation is covered by formulation and method of treatment patents issued in the US (US 10,449,162, US 10,918,606, US 10,555,898, US 10,842,736, & US 11,191,717) and Japan. The composition and formulation 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 drug therapy.

Disclaimers

Dr. Lacouture has provided advisory services to NanOlogy. 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 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.

Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
+425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
+404-245-0591

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

On November 9, 2021   /   Home Page, NanOlogy Press Release  
Improved Resection Rates in Locally Advanced Pancreatic Cancer Following Addition of Intratumoral NanoPac® to Standard of Care

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

Presentation of Single-Site Clinical Trial Data Analysis at ACG 2021

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.

Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
+425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
+404-245-0591

 

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Additional Data Presented at DDW® 2021 from a Phase 2 Clinical Trial of Intracystic NanoPac® for Mucinous Cystic Neoplasms of the Pancreas

On June 9, 2021   /   Home Page, NanOlogy Press Release  
Additional Data Presented at DDW® 2021 from a Phase 2 Clinical Trial of Intracystic NanoPac® for Mucinous Cystic Neoplasms of the Pancreas

Additional Data Presented at DDW® 2021 from a Phase 2 Clinical Trial of Intracystic NanoPac® for Mucinous Cystic Neoplasms of the Pancreas

FORT WORTH, Texas–(BUSINESS WIRE)–NanOlogy, LLC, a clinical-stage oncology company, announced today that additional data from its Phase 2 dose-rising and expansion clinical trial of intracystic NanoPac® for mucinous cystic neoplasms of the pancreas were presented via poster by Somashekar Krishna, MD, MPH of The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center during Digestive Disease Week held virtually from May 21-23, 2021. NanoPac is composed of large surface area microparticles of pure paclitaxel designed as a drug depot for local administration and sustained drug release over several weeks. In this study, the investigational drug was delivered once or twice via endoscopic ultrasound guided fine needle injection following aspiration of cyst fluid in patients with branch duct intraductal papillary mucinous neoplasms (BD-IPMNs) or mucinous cystic neoplasms (MCNs).

The 6-month trial enrolled 19 subjects and was completed in late 2020. The clinical study report was submitted to FDA in April 2021 and clinical trial results can be found at NCT03188991 in clinicaltrials.gov. Overall, the drug was well tolerated with no dose limiting toxicities or drug-related significant adverse events observed. Reduction in cyst volume was demonstrated in 14/19 (74%) of subjects at 6 months.

Dr. Krishna presented a series of five subjects enrolled at his clinical site in whom additional testing revealed no detectable DNA mutations in 2/4 subjects following NanoPac treatment, all of whom were positive at baseline. Absence of DNA indicates the possibility of cyst epithelial lining necrosis, a key goal in treatment. In addition, high concentrations of paclitaxel (>1000 ng/mL) were found in cyst fluid prior to the second injection at the 3-month timepoint confirming retention of NanoPac in the cyst while plasma concentrations were never greater than 3.5 ng/mL at any timepoint.

Large IPMNs or MCNs grow rapidly and are at high risk for progression to pancreatic cancer, one of the deadliest of all cancers. Surgery is recommended to eliminate the risk, but a significant number of patients refuse or cannot withstand surgery due to the associated morbidities. For these patients, there are few therapeutic options and no approved drug therapies. Additional studies of NanoPac are being considered to further evaluate its potential in these patients.

In addition to this trial, NanOlogy’s clinical programs are advancing in pancreatic, lung, genitourinary, and dermal cancers. Data from preclinical and clinical studies in a variety of solid tumors indicate persistent tumor kill, antitumoral immune response, and minimal local or systemic toxicity.

The NanOlogy large surface area microparticle (LSAM) 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), Europe, Japan, and Australia all valid until 2036, plus applications pending globally. These composition of matter patents form the foundation of an extensive intellectual property portfolio protecting the investigational drugs, methods, and technology.

 

About NanOlogy
NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to improve the treatment of solid tumors based on a proprietary supercritical precipitation technology platform.

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 and NanoPac are trademarks of NanOlogy LLC registered in the U.S. Patent & Trademark Office.

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Dan Eramian
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NanOlogy Announces First Patient Enrollment in Lung Cancer Clinical Trial

On April 26, 2021   /   Home Page, NanOlogy Press Release  
NanOlogy Announces First Patient Enrollment in Lung Cancer Clinical Trial

NanOlogy Announces First Patient Enrollment in Lung Cancer Clinical Trial

 

FT. WORTH, (April 27, 2021) — NanOlogy, LLC, a clinical-stage interventional oncology drug therapy company, announced today the first patient has been enrolled in a clinical trial of intratumoral (IT) NanoPac®(large surface area microparticle [LSAM] paclitaxel) for suspension via endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) in lung cancer. A second patient is scheduled for enrollment in early May.

The trial will evaluate safety and preliminary efficacy of up to 3 monthly IT injections of NanoPac in patients with primary or recurrent nonoperable lung cancer. Tissue and blood will be collected pre/post NanoPac administration to analyze pharmacokinetics (PK) and immune effect by multiplex immunofluorescence and flow cytometry analysis. Preclinical and clinical data indicate the long tumor residence and therapeutic drug release of several weeks enabled by LSAMs result in prolonged direct tumor cell death and favorable immunogenic effect. Notably, NanOlogy has demonstrated both clinically after administration of its investigational drugs in patients with locally advanced pancreatic cancer and high risk nonmuscle invasive bladder cancer. The current trial expects to enroll patients on immune checkpoint inhibitors (ICIs) like Keytruda®,  Opdivo®,  or Tecentriq®, which will allow for assessment of immune effect of NanoPac in combination with ICIs.

Six INDs have been established for NanOlogy investigational drugs allowing clinical trials via multiple routes of solid tumor-directed administration in patients with pancreatic, prostate, ovarian, peritoneal, bladder, and lung cancer. More than 145 patients have been administered NanOlogy drugs with no confirmed drug-related severe adverse events because of gradual, subtoxic clearance of drug from site of administration as demonstrated by clinical PK analysis.

Please visit the NanOlogy website (www.nanology.us) for more information on the company and its programs.

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About NanOlogy

NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to finance and clinically advance tumor-directed drug therapy for solid tumors based on a proprietary supercritical precipitation technology platform.

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 regulatory authority for commercial distribution. NanOlogy, NanoDoce, and NanoPac are trademarks of NanOlogy LLC.

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Opus Biotech Communications
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NanOlogy Completes Enrollment of Bladder Cancer Clinical Trial

On March 9, 2021   /   Home Page, NanOlogy Press Release  
NanOlogy Completes Enrollment of Bladder Cancer Clinical Trial

NanOlogy Completes Enrollment of Bladder Cancer Clinical Trial

FT. WORTH, (March 9, 2021) — NanOlogy, LLC, a clinical-stage oncology company, today announced that enrollment has been completed in its clinical trial of NanoDoce® for bladder cancer.

Local bladder cancer at high risk for progression often requires removal of the bladder resulting in a severe lifelong quality of life issues. NanOlogy enrolled 36 bladder cancer patients in a Phase 1/2 two-arm trial evaluating direct injection/instillation of NanoDoce® Suspension.

The first arm (n=19) included patients with high risk nonmuscle invasive bladder cancer. A high majority to date had a complete response at 3 months with 12 month data available in 2Q2021.

The second arm (n=17) included patients with muscle invasive bladder cancer. More than half have retained their bladder with no intervention at the initial study endpoint, now extended up to 12 months to test durability. These preliminary results will be updated and published once final.

###

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to finance and clinically advance tumor-directed drug therapy for solid tumors based on a proprietary supercritical precipitation technology platform.

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 regulatory authority for commercial distribution. NanOlogy, NanoDoce, and NanoPac are trademarks of NanOlogy LLC.

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Dan Eramian
Opus Biotech Communications
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NanOlogy Enrolls First Patient in Phase 2 Clinical Trial of NanoPac® for Intratumoral Treatment of Prostate Cancer

On November 4, 2020   /   Home Page, NanOlogy Press Release  
NanOlogy Enrolls First Patient in Phase 2 Clinical Trial of NanoPac® for Intratumoral Treatment of Prostate Cancer

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NanOlogy Enrolls First Patient in Phase 2 Clinical Trial of NanoPac® for Intratumoral Treatment of Prostate Cancer

 

  • Follows completion of a first-in-human dose-rising study of a single focal injection of NanoPac in patients with local prostate cancer
  • Evaluates multiple intratumoral injections of NanoPac for safety, tumor response, and immune effect

DALLAS (November 4, 2020) — NanOlogy LLC, a clinical-stage oncology company advancing intratumoral therapy for solid tumors, has enrolled the first patient in a Phase 2 clinical trial of NanoPac® (sterile nanoparticulate paclitaxel) for suspension via intratumoral injection for local prostate cancer. The single arm trial is evaluating up to 3 monthly injections of the investigational drug in patients scheduled for prostatectomy approximately 90 days after the first injection. Patients will be followed for safety and tumor response. Immune effects will be evaluated via multiplex immunohistochemistry and flow cytometry.

Craig G. Rogers, MD (Henry Ford Cancer Institute), a clinical investigator for the Phase 2 trial, commented: “NanoPac completed a first-in-human clinical safety trial in 2019. In this innovative second trial, we will be evaluating both safety and efficacy of multiple intratumoral injections of NanoPac in patients with prostate cancer. We will also be analyzing tissue and blood for immune response and what therapeutic potential NanoPac may offer patients suffering from local disease. This trial aligns with our vision of offering precision medicine approaches along with cutting edge clinical trials at Henry Ford Cancer Institute.”

The multicenter Phase 2 trial expects to enroll up to 18 patients with localized prostate cancer (tumors classified as <T3 and Gleason ≥ 6) scheduled for prostatectomy three months after enrollment. In the trial, subjects will receive up to 3 monthly intratumoral injections (days 1, 29, 57) of NanoPac at a dose determined by lesion size. The primary outcome measures will be safety, tolerability, and tumor response. Tumor response will be measured by change in tumor dimension and volume, PSA, PSA-density, and PI-RADS compared to baseline. Prostate and related tissues will be evaluated after biopsy or post-surgery for tumor cell regression via histology and presence of drug in lymph nodes. Immune effects will be analyzed by multiplex immunohistochemistry (IHC) on tissue samples and flow cytometry on blood samples obtained in the study. Drug plasma levels of paclitaxel will also be measured during the trial. The trial is identified as NCT04221828 in clinicaltrials.gov.

This second clinical trial follows completion of a first-in-human phase 2a dose-rising trial (NCT03077659) at a single institution to establish the safety of a single focal injection of NanoPac into the tumor-bearing lobe of patients scheduled for prostatectomy. Selected findings from the first trial:

  • No drug related SAEs including no prostatitis reported
  • Highest dose up to 75mg of NanoPac well tolerated
  • Mean reductions in tumor volume, PSA-density, and percent adenocarcinoma in biopsy
  • Peak paclitaxel plasma concentration was well below toxicity threshold at all timepoints, while drug was detected in all prostatectomy tissue specimens following prostatectomy.

A summary of study findings submitted to FDA can be found under NCT03077659 in the clinicaltrials.gov database.

Prostate cancer affects about 3 million men in the USA with 191,930 new cases and 33,330 deaths estimated for 2020 by the American Cancer Society®. Patients at higher risk for disease progression may face surgical removal of the prostate or radiation therapy. Unfortunately, these patients may suffer incontinence or impotence, which significantly decreases quality of life. If the cancer becomes metastatic, patients have an estimated 5-year survival rate of only 31%.

In addition to prostate cancer, NanOlogy clinical programs are advancing in other genitourinary cancers, as well as gastrointestinal, peritoneal, lung, and dermal cancers. Data from preclinical and clinical studies in a variety of solid tumors have shown persistent tumor kill, antitumoral immune response, and minimal local or systemic toxicity.

The NanOlogy large surface area particle therapeutic platform is based on a proprietary supercritical precipitation technology that converts taxane API crystals into stable particles of pure drug with disproportionate size to surface area ratio. The particles are covered by two composition of matter patents (US 9,814,685) and (10,507,195) both valid until 2036 in the US and pending globally, forming the foundation of an extensive intellectual property portfolio protecting the investigational drugs and technology.

###

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to finance and clinically advance intratumoral therapy for solid tumors based on a proprietary supercritical precipitation particle technology platform.

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 and NanoPac are trademarks of NanOlogy LLC.

Media Contact

Dan Eramian
Opus Biotech Communications
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NanOlogy Announces Initiation of a Lung Cancer Clinical Trial Following FDA Allowances of Two IND Applications for NanoPac® in Lung Cancer

On June 9, 2020   /   Home Page, NanOlogy Press Release  
NanOlogy Announces Initiation of a Lung Cancer Clinical Trial Following FDA Allowances of Two IND Applications for NanoPac® in Lung Cancer

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NanOlogy Announces Initiation of a Lung Cancer Clinical Trial Following FDA Allowances of Two IND Applications for NanoPac® in Lung Cancer

  • First-in-human clinical trial of intratumoral (IT) injections of NanoPac in non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) is expected to begin enrollment in August
  • The clinical trial follows FDA allowance of IT NanoPac in neoplasms of the lung
  • FDA also allowed a second IND for nebulized inhalation of NanoPac in NSCLC

FT. WORTH, (June 9, 2020) — NanOlogy, LLC, a clinical-stage oncology company, announced today initiation of a clinical trial of IT NanoPac® (submicron particle paclitaxel) for suspension via endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) in NSCLC and SCLC. The trial follows FDA allowance of an investigational new drug (IND) application for IT NanoPac in neoplasms of the lung. A second IND was also allowed by FDA for a nebulized inhaled form of NanoPac in NSCLC. Five INDs have been established for NanoPac allowing progress of clinical trials via multiple routes of targeted administration for a variety of solid tumors including pancreatic, prostate, ovarian, peritoneal, and now lung.

Clinical Trial of NanoPac in Lung Cancer
The first study to proceed will be a Phase 2a dose-rising and expansion trial (NCT04314895) evaluating the safety and tolerability of up to 3 monthly IT injections of NanoPac delivered via EBUS-TBNI, concurrent with standard of care therapy, in patients with primary or recurrent NSCLC or SCLC. In addition to safety and pharmacokinetics (PK), the study will measure progression free survival, overall survival, and tumor response determined from CT scan imaging. Blood and biopsy samples will be evaluated for immune effect through flow cytometry and multiplex immunohistochemistry analysis. The trial will begin at two clinical sites: Parkview Healthcare Institute in Fort Wayne, Indiana and University of Florida Health Cancer Center in Gainesville, Florida. More clinical sites will follow. The first subject is expected to be enrolled in August 2020.

Preclinically, a nebulized inhaled form of NanoPac was retained in lung tissue for more than 14 days in a PK model and caused tumor regression and immune cell infiltration in an orthotopic model of NSCLC. Clinical plans for inhaled NanoPac are under development.

Other Clinical Experience with Targeted Delivery of NanoPac
To date, approximately 70 patients have received targeted injections of NanoPac across clinical trials in the prostate and pancreas. Another 30 patients have received intraperitoneal NanoPac for peritoneal and ovarian cancers. NanoPac has been well tolerated in these study subjects with no confirmed drug-related serious adverse events reported. Along with safety and tolerability, signs of activity have also been observed across the clinical programs.

NanOlogy Submicron Particle Therapeutic Platform
The NanOlogy submicron particle therapeutic platform is based on a proprietary production technology that converts taxane API crystals into stable submicron particles of pure drug with disproportionate size to surface area ratio. The particles are covered by two composition of matter patents (US 9,814,685) and (US 10,507,195) both valid until 2036 in the US and pending globally. In addition to lung cancer, NanOlogy clinical programs are advancing in pancreatic, genitourinary, peritoneal, ovarian, and dermal cancers. 

About Lung Cancer
In 2020, an estimated 228,820 new cases of lung cancer will be diagnosed in the U.S. and 135,720 people will die from the disease. Lung cancer is by far the leading cause of cancer deaths in the U.S. responsible last year for 22% of all cancer-related deaths (SEER). Globally, lung cancer is also the most common form of cancer and the deadliest accounting for an estimated 2.1 million annual new cases and 1.8 million deaths (GLOBOCAN 2018).

###

About NanOlogy
NanOlogy, LLC (www.nanology.us) is a private clinical-stage oncology company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for targeted, sustained delivery of proven drugs aimed at increasing their value in the treatment of cancer and other serious diseases.

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 for commercial distribution. NanOlogy and NanoPac are trademarks of NanOlogy LLC.

Media Contact

Dan Eramian
Opus Biotech Communications
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NanOlogy Clinical Updates on Local Injection of NanoPac® for Pancreatic Cancer and Mucinous Cystic Neoplasms of the Pancreas

On November 7, 2019   /   Home Page, NanOlogy Press Release  
NanOlogy Clinical Updates on Local Injection of NanoPac® for Pancreatic Cancer and Mucinous Cystic Neoplasms of the Pancreas

 

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NanOlogy Clinical Updates on Local Injection of NanoPac® for Pancreatic Cancer and Mucinous Cystic Neoplasm of the Pancreas

Interim data from both clinical trials presented at the 2019 American College of Gastroenterology (ACG) Conference in San Antonio

FT. WORTH (November 7, 2019) — NanOlogy LLC, a clinical-stage oncology company, announced today that interim data were presented last week at the 2019 ACG annual meeting from two of its clinical trials each evaluating endoscopic ultrasound guided fine needle injection (EUS-FNI) of NanoPac (submicron particle paclitaxel): one for treatment of locally advanced pancreatic cancer (LAPC) and the other for treatment of mucinous cystic neoplasms of the pancreas (MCNs).

The pancreatic cancer clinical update of intratumoral NanoPac for treatment of LAPC was presented by Simon K. Lo, MD (Cedars-Sinai) as part of the Pancreatic Cancer/Esophagus plenary session.

The Phase 2a dose-rising and expansion pancreatic cancer trial is evaluating the safety and preliminary efficacy of NanoPac delivered intratumorally by EUS-FNI over 6 months in patients with nonresectable LAPC. After completion of the dose-rising phase, the trial has now enrolled 16 of 22 subjects into the dose expansion phase of the trial in which patients are receiving two intratumoral injections of NanoPac 4 weeks apart.

Highlights from Dr. Lo’s presentation on the dose expansion phase of the trial:

  • No drug-related local or systemic serious adverse events have been reported to date (n=25) including no reports of acute pancreatitis.
  • Of 7 subjects who have completed the 6-month study to date, one subject had a partial response with restaging from nonresectable to resectable (see video), 3 had stable disease, 1 had progressive disease, and 2 were withdrawn from the study.
  • Tumor volume decreases ranging from 7% to 76% have been seen in 7 of 11 subjects upon latest mpMRI to date at either the 3- or 6-month time point.
  • CA19-9 reductions of greater than 20% have been seen in 5 of 11 subjects upon latest measure to date at either the 3- or 6-month time point.

The pancreatic cyst clinical update on intracystic NanoPac for treatment of MCNs of the pancreas was presented during the poster sessions by Mohamed O. Othman, MD (Baylor College of Medicine). Dr Othman’s poster was recognized as a Presidential Poster, a distinction given to fewer than 5% of accepted abstracts each year, and was ultimately named co-winner for high quality, novel, unique and interesting research.

The Phase 2a dose rising and expansion pancreatic cyst trial is evaluating the safety and preliminary efficacy of NanoPac delivered intracystically by EUS-FNI following aspiration in patients with MCNs. The study is also enrolling in the dose expansion phase of the study and patients are receiving two intracystic injections of NanoPac 12 weeks apart.

Highlights from Dr. Othman’s poster presentation on the trial:

  • No drug-related local or systemic serious adverse events (SAE) have been reported to date (n=15) including no reports of acute pancreatitis. One case of gastric outlet obstruction that was possibly drug-related occurred in a subject who had a recent unrelated endoscopic procedure for hepatobiliary dysfunction. This condition was subsequently added as an exclusion criterion for the trial.
  • Plasma paclitaxel levels for all subjects analyzed have not exceed 1ng/mL suggesting that NanoPac particles are retained in the cyst over time.
  • Cyst volume decreases ranging from 8% to 89% have been seen in 9 of 11 subjects at last available imaging at either the 3- or 6-month time point.

Nanology plans to design follow-on clinical trials for both pancreatic cancer and pancreatic cysts in 2020 to further advance the programs toward regulatory submission.

In 2019, an estimated 57,000 new cases of pancreatic cancer will be diagnosed in the U.S. and 46,000 people will die from the disease. Pancreatic cancer is among the deadliest cancers with 9% survival rate at 5 years. It is also one of the few cancers for which no meaningful improvement in survival has been achieved in the last two decades. MCNs are a subset of pancreatic cysts that risk progression to pancreatic cancer. Patients with high risk MCNs may undergo surgical resection of the pancreas to remove the lesion, a complicated procedure associated with mortality and morbidity rates of 2% and 30% respectively. For both the disease itself and one of its common precursors, Nanology investigational drugs may offer a new way to help prevent or treat pancreatic cancer.

In addition to these trials, NanOlogy is advancing its therapeutic platform in preclinical and clinical programs across genitourinary, peritoneal, lung, and dermal cancers. The NanOlogy therapeutic platform is based on a proprietary submicron particle production technology that reduces the size of taxane API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The characteristics of the particles have recently been granted a composition of matter patent valid in the US (9,814,685) and Australia until 2036, and pending globally.

###

About NanOlogy
NanOlogy, LLC (www.nanology.us) is a private clinical-stage oncology company developing a submicron particle therapeutic platform designed for local delivery to increase the effectiveness of cancer treatment while reducing the serious adverse effects normally associated with systemic chemotherapy.

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 safe and effective as required by U.S. FDA and have not been approved for commercial distribution.

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Dan Eramian
Opus Biotech Communications
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NanOlogy announces First Patient Enrolled in a Phase 1/2 Clinical Trial of NanoDoce® for Treatment of Bladder Cancer

On April 12, 2019   /   Home Page, NanOlogy Press Release  
NanOlogy announces First Patient Enrolled in a Phase 1/2 Clinical Trial of NanoDoce® for Treatment of Bladder Cancer

 

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NanOlogy announces First Patient Enrolled in a Phase 1/2 Clinical Trial of NanoDoce® for Treatment of Bladder Cancer

  • NanOlogy may offer an alternative treatment option for patients with bladder cancer

  • Investigational drug, NanoDoce, is injected locally into tumor resection bed via cystoscope guidance followed by intravesical instillation

FT. WORTH, Texas (April 9, 2019) —NanOlogy, a clinical-stage oncology company, today announced the first patient has been enrolled in a clinical trial of NanoDoce (sterile submicron particle docetaxel suspension) for treatment of bladder cancer. The Phase 1/2 dose-rising trial will evaluate the safety and preliminary efficacy of NanoDoce for patients with high-risk non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC).

In 2019, an estimated 80,000 new cases of bladder cancer will be diagnosed in the United States and an estimated 18,000 will die from the disease. Despite being one of the top five cancer diagnoses in the U.S., the last drug FDA approved for NMIBC was more than a decade ago. Of all cancers, bladder cancer tends to have the highest lifetime treatment costs due to the frequency of recurrence, progression to MIBC often requiring removal of the bladder (cystectomy), and lifetime cost of care thereafter.

In the NanOlogy clinical trial, following transurethral resection of the bladder tumor, subjects will receive direct injections of NanoDoce into the base of the index tumor resection site in combination with an intravesical instillation of NanoDoce. Additional intravesical instillations of NanoDoce will be administered to NMIBC subjects while MIBC subjects will follow institutional standard of care.

The local delivery of submicron particle docetaxel suspension [NanoDoce] represents an important step in evaluating new therapies for the treatment bladder cancer”, said Dr. Donald Lamm, MD, President of BCG Oncology and principal investigator on the trial. “Preclinical studies suggest the submicron particle technology improves both the penetration of drug into the bladder wall and its duration of activity. If this investigational drug can be proven to delay or prevent disease progression and need for cystectomy, it would contribute significantly to the quality of life of patients with this disease.”

An abstract from preclinical studies of NanoDoce was presented in February at the 2019 Genitourinary Cancer Symposium. In one of the studies, NanoDoce administered via intratumoral injection resulted in prolonged, high concentration of drug in tumor tissue, significant tumor regression, and immune cell infiltration in a xenograft animal model of transitional cell bladder carcinoma. The immune cell infiltration is of particular interest to NanOlogy for future research into the role NanoDoce may play in combination with immunoncology therapy for the treatment of advanced disease.

This work is in addition to extensive preclinical and clinical development programs underway by NanOlogy in peritoneal/ovarian cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, renal cell carcinoma, non-small cell lung cancer, and cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

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 in accordance with the requirements of the U.S. FDCA and have not been approved by FDA for commercial distribution.

Media Contact

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

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