NANOBIOTIX TO PRESENT POSITIVE RESULTS FROM ITS PHASE II/III CLINICAL TRIAL OF NBTXR3 IN PATIENTS WITH SOFT TISSUE SARCOMA (STS) AND OTHER ONGOING PHASE I/II TRIALS AT UPCOMING ESMO AND ASTRO ANNUAL
CONFERENCES

On september 26, 2018 NANOBIOTIX (Euronext: NANO – ISIN:FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches in the treatment of cancer, reported that detailed results of its phase II/III clinical trial of NBTXR3 in patients with soft tissue sarcoma (STS) will be presented by Dr. Sylvie Bonvalot, MD, PhD at the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich (Germany) on the 19th of October 2018 during the Proffered Paper (Oral) presentation – Sarcoma and at the ASTRO 60th Annual Meeting in San Antonio (USA) on the 21st of October 2018 during the late-breaking abstract session (Press release, Nanobiotix, SEP 26, 2018, View Source [SID1234529667]).

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European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress
October 19 – 23, 2018 – Munich, Germany
• A phase II/III trial of hafnium oxide nanoparticles activated by radiotherapy in the treatment of locally
advance soft tissue sarcoma of the extremity and trunk wall (LBA66)
Oral communication presented by Dr. Sylvie Bonvalot, MD, PhD (Paris, France) during the Proffered Paper
presentation – Sarcoma
Date: 10.19.2018
• Elderly patients with locally advanced head and neck squamous cell carcinoma treated with NBTXR3
nanoparticles activated by radiotherapy: a phase I trial (1058P)
Poster presented by Prof. Christophe Le Tourneau (Paris, France)
Date: 10.21.2018
• Hepatocellular carcinoma and liver metastasis treated by hafnium oxide nanoparticles activated by
stereotactic body radiation therapy (711P)
Poster presented by Dr. Marc Pracht (Rennes, France)
Date: 10.21.2018
American Society for Radiation Oncology (ASTRO) 60th Annual Meeting
October 21 – 24, 2018 – San Antonio, Texas, United States
• Act.in.Sarc: An International Randomized Phase III Trial Evaluating Efficacy and Safety of First-in-Class
NBTXR3 Hafnium Oxide Nanoparticles Activated by Preoperative Radiotherapy in Locally Advanced
Soft Tissue Sarcoma (LBA7)
Oral communication presented by Dr. Sylvie Bonvalot, MD, PhD (Paris, France) during the late-breaking abstract
session
Date: 10.23.2018
• Hafnium Oxide Nanoparticles Activated by Radiation Therapy for the Treatment of Solid Tumors
(SU_44_2434)
Poster presented by Prof. Juliette Thariat, MD, PhD (Caen, France)
Date: 10.21.2018
• Hafnium Oxide Nanoparticles Activated by Radiation Therapy: An Innovative Approach for the
Treatment of Liver Cancers (SU_13_2124)
Poster presented by Dr. Enrique Chajon Rodriguez, MD, PhD (Rennes, France)
Date: 10.21.2018
• Elderly patients: NBTXR3 as a novel treatment option in locally advanced HNSCC (MO_10_2547)
Poster presented by Dr. Valentin Calugaru, MD (Paris, France)
Date: 10.22.2018
• Exploratory Dosimetric Study of the Impact of the Pre-Radiation Therapy Intra Tumoral Injection of
Hafnium Oxide Nanoparticles Along the Radiation Treatment of Extremity and Trunk Wall Soft Tissue
Sarcomas (MO_15_2596)
Poster presented by Eliane Graulieres, PhD (Toulouse, France)
Date: 10.22.2018
• Hafnium Oxide Nanoparticle Activated by Radiation Therapy Generates an Anti-Tumor Immune
Response (1096)
Poster presented by Prof. Juliette Thariat, MD, PhD (Caen, France)
Date: 10.23 2018

About NBTXR3
NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy:
• tumors through physical cell death
• metastasis due to immunogenic cell death leading to activation of the immune system
NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and Nanobiotix believes has the ability to fit into current worldwide standards of radiation care.
Nanobiotix’s broad clinical program includes 10 patient population evaluated in 7 clinical trials.
In June 2018, Nanobiotix established human proof of concept for this first-in-class product in its Soft Tissue Sarcoma (STS) Phase III clinical trial.

NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients that are unable to receive chemotherapy or cetuximab and have very limited therapeutic options. Promising results have been observed from the ongoing Phase I/II trial regarding the local control of the tumors.

Nanobiotix is running an Immuno-Oncology development program. In the United States, Nanobiotix has received approval from the U.S. Food and Drug Administration (FDA) to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).

The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma.

The first market authorization process (CE Marking) is ongoing in Europe in the STS indication.

Replimune to Present at the Leerink Partners Roundtable Series: Rare Disease & Oncology

On September 26, 2018 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immunotherapies derived from its Immulytic platform, reported that Robert Coffin, Ph.D., Chief Executive Officer and Director of Replimune, will present at the Leerink Partners Roundtable Series: Rare Disease & Oncology on Wednesday, October 3, 2018 at 11:30 AM ET at the Lotte New York Palace Hotel in New York, NY (Press release, Replimune, SEP 26, 2018, View Source [SID1234529737]).

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Curis to Present at the Cantor Fitzgerald Global Healthcare Conference

On September 26, 2018 Curis, Inc. (NASDAQ :CRIS ), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported that the Company will present at the Cantor Fitzgerald 2018 Global Healthcare Conference on Tuesday, October 2 at 5:10 PM ET in Track 4 – Grand Ballroom 1, of the InterContinental New York Barclay Hotel in New York (Press release, Curis, SEP 26, 2018, View Source [SID1234529607]).

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James Dentzer, the Company’s new President & Chief Executive Officer, will provide a brief overview of the Company’s pipeline of drug candidates and business strategy.

A live webcast of the presentation will be available by visiting the investor section of Curis’ website View Source

A replay of the webcast will be archived on the website for 30 days following the presentation.

Ultragenyx to Present at Jefferies Gene Therapy Summit

On September 26, 2018 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer, will present at the Jefferies Gene Therapy Summit on Thursday, September 27, 2018 at 8:00am ET in New York (Press release, Ultragenyx Pharmaceutical, SEP 26, 2018, View Source [SID1234530054]).

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The live and archived webcast of the company presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

Zai Lab Presents Results of its Pharmacokinetics (PK) Study for ZL-2306 (niraparib) in Chinese Ovarian Cancer Patients Showing Comparable Profile to non-Chinese Patients at the 21st Annual Meeting of the Chinese Society of Clinical Oncology

On September 26, 2018 ai Lab Limited (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, presented results of its open-label study to evaluate the pharmacokinetic (PK) profile of ZL-2306 (niraparib) made in China in Chinese ovarian cancer patients (Press release, Zai Laboratory, SEP 26, 2018, View Source;p=RssLanding&cat=news&id=2368996 [SID1234530330]). Results from the study show comparable PK profile of the Chinese patients administered ZL-2306 to that of patients evaluated in Tesaro’s global PK study. These data were presented at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) on Sept. 21, 2018, at the Xiamen International Conference and Exhibition Center (XICEC) in Xiamen, China.

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The open-label PK Study enrolled 36 Chinese patients with stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer. Patients had received no more than two lines of platinum-based therapy and were responsive to the most recent platinum-based treatment. Subjects were randomly assigned to dose levels of 100mg, 200mg and 300mg. The primary objective of the study was to assess the PK profile of ZL-2306 in Chinese patients following both single and multiple doses. The secondary objective was a safety assessment.

The study demonstrated that the drug exposure increased proportionally from 100mg to 300mg, with a Tmax of approximately three hours. Systemic exposure of ZL-2306, as measured by Cmax and AUC, increased approximately proportionally with increased dose. The half-life is 31-37 hrs. There were no unexpected safety issues noted during the trial. All key PK and safety parameters were comparable to those in global studies. The study results and population PK data did not identify ethnicity differences between Chinese and non-Chinese patients.

The positive outcome of this PK study will further enhance ZL-2306 application package in China.

About ZL-2306

ZL-2306 (niraparib) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2 inhibitor. Niraparib was approved in March 2017 by the FDA in the U.S. and by the EMA in the EU under the trade name ZEJULA in November 2017 as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Based on the approval status in the U.S. and EU, Zai Lab submitted a market registration application for niraparib in Hong Kong and plans to launch and commercialize niraparib in Hong Kong in the second half of 2018. Zai Lab believes ZL-2306 has the potential to be a first-in-class Category 1 drug for treatment across multiple solid tumor types in China.