Categories
News

CritiTech PES partner 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
danieleramian@comcast.net
425-306-8716

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

Categories
News

CritiTech PES partner NanOlogy Presents Updated Clinical Data on Targeted Injections of NanoPac® for Pancreatic Cancer and Mucinous Cystic Neoplasms on DDW2020 Site

Updated clinical data from both trials available through Digestive Disease Week® (DDW) Online Education Site

FT. WORTH, (May 14, 2020) — NanOlogy, LLC, a clinical-stage oncology company, announced today that updated data from two of its ongoing clinical trials were presented as abstracts last week through the DDW ePosters and ePresentations site . The clinical trials are evaluating endoscopic ultrasound guided fine needle injection (EUS-FNI) of NanoPac® (submicron particle paclitaxel) suspension for treatment of locally advanced pancreatic cancer (LAPC) and mucinous cystic neoplasms (MCNs/IPMNs) of the pancreas.

The lead author of the abstract on intratumoral NanoPac for LAPC is Neil Sharma, MD (Parkview Cancer Institute – Fort Wayne, IN). The lead author of the abstract on intracystic NanoPac for MCNs/IPMNs is Mohamed O. Othman, MD (Baylor College of Medicine – Houston, TX).

Pancreatic Cancer

The Phase 2a dose-rising and expansion trial is evaluating over 6 months the safety and preliminary efficacy of NanoPac delivered intratumorally by EUS-FNI in patients with LAPC, concurrent with or following SOC therapy for the disease. After completing the dose-rising cohort (n=11), a dose expansion cohort has now fully enrolled (n=22) in which patients receive 2 monthly intratumoral (IT) injections of NanoPac. FDA has also recently allowed expansion of up to 30 additional patients who will receive up to 4 monthly IT injections.

Dr. Sharma’s abstract submitted to DDW in December 2019 reports data from the first 7 evaluable subjects from the dose expansion cohort. No drug-related local or systemic SAEs were reported including no reports of acute pancreatitis in any subject, 4 subjects had a partial response, 2 had stable disease, and 1 had progressive disease. Encouraging data has continued to accrue from the fully enrolled dose expansion (2- injection) cohort, which are expected to be presented later in 2020

Pancreatic Cyst

The Phase 2a dose rising and expansion trial is evaluating over 6 months the safety and preliminary efficacy of NanoPac delivered intracystically by EUS-FNI following aspiration in patients with MCNs/IPMNs. The study has now completed enrollment (n=19) with patients in the dose expansion phase (n=8) receiving two intracystic injections of NanoPac 12 weeks apart.

Dr. Othman’s abstract also submitted in December reports data from the first 9 subjects who had completed the trial. No confirmed drug-related local or systemic SAEs were reported including no reports of acute pancreatitis. Plasma paclitaxel levels have not exceeded 1 ng/mL indicating that NanoPac particles are retained in the cyst over time. Evaluation of cyst volume showed decreases ranging from 8% to 89% in 8 subjects, 6 of whom showed a volume decrease > 50%. Cyst volume increased in 1 subject.

Based on encouraging results from both trials, NanOlogy is designing follow-on clinical protocols for evaluation by FDA.

In 2020, about 57,600 new cases of pancreatic cancer will be diagnosed in the U.S. and 47,050 people will die from the disease. Pancreatic cancer is currently the third most frequent cause of cancer related death in western countries and is predicted to become the second leading cause of death from cancer within the next 10 years. It is one of the few cancers for which no meaningful improvement in survival has been achieved over recent time with only an 8% survival rate at 5 years.

MCNs/IPMNs are a subset of pancreatic cysts that risk progression to pancreatic cancer. While estimates vary widely, as many as 30,000 new cases of high risk MCNs/IMPNs are diagnosed annually in the U.S. These patients may ultimately be required to undergo surgical resection of the pancreas to remove the lesion, a complicated procedure associated with high morbidity. No approved drug therapy exists in the U.S to treat the condition.

In addition to pancreatic neoplasms, NanOlogy clinical programs are advancing in genitourinary, peritoneal, lung, and dermal cancers.

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 (10,507,195) both valid until 2036 in the US and pending globally.

###

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
danieleramian@comcast.net
425-306-8716

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

Categories
Publication

NanOlogy Fact Sheet (Jan 2020)

In patients with solid carcinomas, NanOlogy™ has demonstrated that local administration of patented submicron particles continuously exposes primary tumors to therapeutic levels of taxanes for several weeks, causes a sustained tumoricidal response, produces clinical benefits without local or systemic toxicity, and may facilitate treatment of metastatic disease.

Categories
Video

Video Highlights of NanoPac® Injection for Pancreatic Cancer

Highlights of the presentation by Dr. Neil Sharma, President, Parkview Cancer Institute; Director of Advanced Interventional Endoscopy and Endoscopic Oncology Programs, Medical Director GI Oncology.  View the full 7-minute video here.

Categories
Publication

ACG 2019 Poster: NanoPac-2017-01 Mid-Study Report: Safety, Tolerability and Preliminary Efficacy of Intracyctic Submicron Particle Paclitaxel (SPP) for the Treatment of Pancreatic Mucinous Cysts

Slide 1

Pancreatic mucinous cystic lesions have significant potential for malignant transformation1; delivery of SPP as a direct intratumoral injection confirmed SPP present at the delivery site for at least 100 days in a prior study; intracystic therapy with SPP may prevent progression to cancer without corresponding systemic toxicities.

Categories
Presentation

ACG 2019 Plenary Presentation: A Novel EUS-guided Intratumoral Delivery of Submicron Particle Paclitaxel for the Treatment of Locally Advanced Pancreatic Cancer

A novel EUS-guided Intratumoral Delivery of Submicron Particle Paclitaxel for the Treatment of Locally Advanced Pancreatic Cancer. A Prospective Safety, Tolerability and Preliminary Efficacy Study.

Categories
News

Positive Preclinical Findings from Inhaled NanoPac® Lung Study Published in the Journal of Aerosol Medicine and Pulmonary Drug Delivery

Preclinical Study Demonstrated Inhaled NanoPac Shows Prolonged Retention and Limited Systemic Exposure

FORT WORTH/DALLAS, (October 30, 2018) — NanOlogy, a clinical-stage oncology development company, announced today that positive findings from a pharmacokinetic (PK) preclinical study of inhaled NanoPac (submicron particle paclitaxel for nebulized inhalation) was published in an article entitled “Pharmacokinetic Profile of Inhaled Submicron Particle Paclitaxel (NanoPac) in a Rodent Model,” in the Journal of Aerosol Medicine and Pulmonary Drug Delivery.

The preclinical PK study examined the retention of NanoPac in rat lung following a single inhalation via a nose-only exposure chamber. Data showed measurable amounts of drug in the lung at the end of the 14-day study with examined tissue being microscopically indistinguishable from normal lung tissue. The 14-day retention of drug in lung tissue came as a surprise to researchers who had never seen this length of retention before.

A follow-on preclinical study examined the therapeutic effect of inhaled NanoPac using an orthotopic model of non-small cell lung cancer (NSCLC). Histologic analysis revealed NanoPac achieved a significant decrease in primitive tumor cell population as well as significant tumor regression. Data from this study was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting this past June in an abstract entitled “NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model”. Immunohistochemistry stains of NanoPac treated animals demonstrated immune cell infiltration that suggested immune-mediated tumor kill in addition to a direct tumoricidal effect.

IND-enabling studies are underway on NanoPac to allow for a clinical trial in 2019. This work is in addition to an extensive preclinical and clinical development program underway by NanOlogy in peritoneal cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, bladder cancer, renal cancer, breast 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 that 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.

Disclaimer
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

Categories
Presentation

Pharmacokinetic Profile of Inhaled Submicron Particle Paclitaxel (NanoPac) in a Rodent Model

Inhaled chemotherapeutics may enhance pulmonary drug exposure to malignant lesions in the lung without substantially contributing to systemic toxicities. The pharmacokinetic profile of inhaled submicron particle paclitaxel (NanoPac) in healthy rodent plasma and lung tissue is evaluated here to determine administration proof-of-principle.

Categories
Presentation

Evaluation of Submicron Particle Docetaxel Directly Injected into Uro-Oncologic Xenografts

Suspensions of submicron particle taxanes (Figure 1) allow for direct administration of high, sustained levels of chemotherapeutics at the site of disease. Intratumoral (IT) injections of submicron particles of pure docetaxel (NanoDoce) into clear cell renal carcinoma (786-O), transitional cell bladder carcinoma (UM-UC-3) and prostate carcinoma (PC-3) xenografts were evaluated.

Categories
News

New Cancer Answer

FORT WORTH, Texas—Researchers have been trying to develop therapeutic agents powerful enough to destroy tumors without harmful effects to healthy cells for a long time. NanOlogy is working toward this goal by trying to transform systemic chemotherapy into local delivery of naked nanoparticles to treat various forms of cancer with greater efficacy and safety.

DFB Pharmaceuticals is collaborating with CritiTech and US Biotest to form NanOlogy, a clinical-stage pharmaceutical development company. The objective is to finance and develop a breakthrough technology platform to produce patented, naked nanoparticle forms of paclitaxel and docetaxel for local delivery.

DFB, a private Texas investment group that develops new healthcare products and businesses—and has realized more than $1.5 billion in value through startups; strategic acquisition and sale of companies and technologies; internal product development; and brand optimization and healthcare operations—is strong in business management, according to Marc Iacobucci, managing director of NanOlogy and DFB.

CritiTech, a private Kansas particle engineering company, uses proprietary Supercritical Precipitation Technology (SCP Technology) to optimize the delivery of challenging drug substances, potent molecules and poorly soluble compounds, and to improve the efficacy, drug delivery options, dosing regimen and pharmacokinetics of wide variety of drugs, including oral, injectable and inhaled drugs. US Biotest, a private California company dedicated to developing therapeutics to address serious unmet medical needs, builds on strong relationships with industry experts, academic institutions and leading physicians to provide product development strategy and support and manage efficient delivery of programs from nonclinical through late-stage clinical trials.

As Dr. Maurie Markman, president of medicine and science at Cancer Treatment Centers of America, explained, “Systemic administration of paclitaxel and docetaxel is associated with significant adverse effects. Physicians and scientists have known for decades that paclitaxel and docetaxel are effective cancer-killing agents, and have long searched for ways to preferentially retain high concentration of drug at the treatment site to increase efficacy. The NanOlogy technology may offer a solution by enabling local delivery of large, sustained amounts of the drug at the site of disease and reducing systemic exposure and systemic side effects.”

The sterile suspension has been designed to be injected directly into tumors, cysts, peritoneum or other body cavities. Studies show that the nanoparticles remain and slowly release for four weeks, resulting in prolonged local exposure, while systemic forms of taxanes remain at the treatment site for a short time before being cleared from the body quickly.

“The nanoparticle technology platform uses sonic energy and supercritical carbon dioxide to reduce paclitaxel and docetaxel API crystals by up to 400 times into stable, naked nanoparticles with greatly increased surface area and special geometry,” explains Iacobucci. “These nanoparticles are suspended prior to use in simple vehicles without coating agents and administered in a concentrated form directly to the site of disease where they release the drug for weeks at a time.”

The company has developed sterile suspension forms of NanoPac (nanoparticle paclitaxel) and NanoDoce (nanoparticle docetaxel) as well as an inhaled form of NanoPac. A topical form called SOR007 (nanoparticle paclitaxel) ointment was developed by an affiliate, DFB Soria, and licensed to NanOlogy for clinical development in oncology.

NanOlogy’s clinical development program for NanoPac in 2017 includes clinical trial evaluation of its sterile suspension in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer and pancreatic mucinous cysts. The company recently announced enrollment of the first patient in a Phase 2 clinical trial of intraperitoneally administered NanoPac sterile suspension in patients with ovarian cancer, the fifth leading cause of cancer-related death in women. The trial will assess both the safety and effectiveness of NanoPac administration following surgery.

“If successful, we may add to the newer treatment options that are just becoming available and ideally improve the prognosis and quality of life for patients diagnosed with ovarian cancer,” Iacobucci said.

In addition, clinical trial evaluation of SOR007 ointment is underway for actinic keratosis (under affiliate Soria), and is expected to begin in the fourth quarter for cutaneous metastases. Clinical trials in various cancers are planned in 2018 for NanoDoce, pending approval of its IND, and the inhaled version of NanoPac is in a preclinical efficacy study for lung cancer.

November 8th, 2017
ILENE SCHNEIDER