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..

德克萨斯州沃思堡-（BUSINESS WIRE）-临床肿瘤公司NanOlogy LLC，今天宣布，肿瘤内（IT）大表面积微粒紫杉醇（LSAM-PTX）在局部晚期胰腺癌（LAPC）中的2期临床试验的初步安全性和临床结果在胰腺印刷前在线发表，两张海报在波士顿举行的第九届AACR胰腺癌特别会议上发表，报告了降级和免疫数据从审判。。

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..

题为“局部晚期胰腺癌对肿瘤内注射大表面积微粒紫杉醇的反应：安全性和临床结果的初步报告”的研究文章提供了剂量递增和2次注射组群的安全性和响应数据。临床研究人员包括医学博士Neil Sharma，医学博士Simon Lo，医学博士Mohamed Othman和医学博士Antonio Mendoza Ladd。。

“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.”.

首席研究员兼作者尼尔·沙玛（Neil Sharma）说：“胰腺癌是最致命的癌症之一，5年生存率仅为12%，医学博士。“这项研究的中期结果，特别是潜在的降级和免疫调节，令人鼓舞，需要扩大研究范围，以进一步评估新辅助IT LSAM-PTX联合标准治疗的临床益处。”。

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.

剂量递增/扩展试验（NCT03077685）在三个队列中的四个临床部位招募了54名受试者，包括一次注射递增（n=10），两次注射扩展（n=25）和四次注射扩展（n=19）。该研究文章报告了前两个队列中可评估受试者的数据，而第三个队列正在等待最终读数。

Highlights include:.

重点包括：。

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..

大多数治疗紧急不良事件（84%）为轻度至中度，被认为与潜在疾病和合并症有关。未报告确诊的治疗相关严重不良事件或胰腺炎。最常见的不良事件是腹痛和恶心。在整个研究中，归因于LSAM-PTX的血浆紫杉醇水平并不显着。。

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.

在2次注射队列中，22名（36%）可评估受试者中的8名从不可切除疾病降至可切除疾病。六名受试者接受了五次R0切除和一次R1切除的手术。切除受试者的平均存活率增加至35个月，而未切除受试者的平均存活率增加至19个月。

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..

LSAM-PTX治疗前/治疗后组织可用于通过多重免疫荧光从6名接受切除的受试者进行免疫表型分析。尽管胰腺癌被认为是“冷”肿瘤，但随着免疫效应细胞和NK细胞浓度的增加以及免疫抑制细胞浓度的降低，观察到了良好的抗肿瘤免疫调节作用。。

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.

在来自2次注射组的可评估受试者中，疾病控制率在3个月时为82%（18/22），在6个月时为94%（16/17）。

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.

此外，在最近的AACR胰腺癌特别会议上，两张海报展示了LSAM-PTX之后的2期临床试验的降期和免疫数据。

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).

第一张海报（B004）题为：“EUS引导局部管理大表面积微粒紫杉醇与局部晚期胰腺癌新辅助化疗：单中心经验”，由Harishankar Gopakumar医学博士（伊利诺伊大学医学院）提出。

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..

在第二组试验中，13名（46%）LAPC受试者中有6名前瞻性收集了数据，除了Parkview Health的新辅助化疗外，还接受了每月2次内镜超声引导下LSAM-PTX细针注射（EUS-FNI）随后于2018年至2019年接受手术。。

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.

添加到新辅助化疗中的LSAM-PTX的EUS-FNI是安全的并且导致肿瘤体积显着减少，病理学检查中显着的肿瘤坏死以及TME免疫表型构型的有利变化。

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.

初步结果表明，在新辅助化疗中加入LSAM-PTX可以提高LAPC对可切除疾病的降期率并改善临床结果。

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).

第二张海报（A048）题为：“增强局部晚期胰腺癌（LAPC）与大表面积微粒紫杉醇（LSAM-PTX）肿瘤内的免疫反应”，由Andrew Hendifar博士（Cedars-Sinai医疗中心）提交。

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.

在治疗之前和之后收集血液样品用于流式细胞术分析，所述流式细胞术分析来自试验的第三队列中的14名受试者，除了先前或当前的SOC治疗之外还接受4个月的LSAM-PTX的EUS-FNI。

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..

来自用IT LSAM-PTX处理的LAPC受试者的血液的免疫分型显示外周免疫调节至与抗肿瘤免疫作用相关的表型，包括有利的免疫监视，并且与切除组织中TME中发现的变化一致。通常与不良临床结果相关的免疫抑制细胞类型在六个月时减少。。

Anti-tumor immunomodulation without immunosuppression suggests that IT LSAM-PTX may be amenable to combination with immunotherapy.

没有免疫抑制的抗肿瘤免疫调节表明它LSAM-PTX可能适合与免疫疗法组合。

About NanOlogy

关于纳米

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.

NanOlogy，LLC（www.NanOlogy.us）是一家私营的临床阶段肿瘤学公司，成立于2015年，旨在通过专有的颗粒工程技术平台优化用于肿瘤内递送的研究药物来改善实体瘤的治疗。纳米临床项目在多种实体瘤（包括胰腺癌，肺癌，膀胱癌，腹膜癌，卵巢癌，前列腺癌和皮肤癌）中拥有先进的研究药物。

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..

研究药物涵盖美国（9814685105719510993927和11123322）发布的物质专利组成，以及全球其他主要司法管辖区，包括加拿大，欧洲，日本，中国，韩国，澳大利亚和印度，均有效至6月2036年。组成专利构成了广泛的知识产权组合的基础，该组合包含130多项已发布的专利，这些专利保护纳米研究药物，配方，方法和技术。。

Disclaimers

免责声明

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.

本公告包含经修订的1995年“私人证券诉讼改革法”中定义的前瞻性声明，包括有关我们产品开发，业务和其他活动的声明。此类声明受任何药物开发计划固有的风险和不确定性的影响，这些风险和不确定性可能由于开发，临床，监管，市场，竞争，技术或其他因素而导致实际结果出现重大差异。

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.

截至本公告发布之日，所有前瞻性声明均已发布，本公司不承担更新这些声明的任何意图或义务。纳米研究药物尚未按照美国FDA的要求证明是安全有效的，并且未经FDA或任何其他管辖区批准用于商业分销。

NanOlogy is a trademark of NanOlogy LLC..

NanOlogy是NanOlogy LLC。的商标。。