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.

On September 26, 2018 Kitov Pharma (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company, reported that Hadas Reuveni, Ph.D., Chief Technology Officer at Kitov’s subsidiary, TyrNovo Ltd., will present pre-clinical data on NT219, an anti-tumor resistance drug candidate, in a poster session at the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (Press release, Kitov Pharmaceuticals , SEP 26, 2018, View Source [SID1234529665]): Translating Science into Survival, to be held September 30 – October 3, 2018, in New York.

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"We are pleased to have been chosen to present an abstract at the upcoming AACR (Free AACR Whitepaper) meeting. These very exciting data, which we had also presented at a cancer conference earlier this year, hold great promise for mobilizing the patient’s immune system against tumors," Dr. Reuveni commented. "In the future, tumors in patients who have functional immune systems may respond to NT219 both by blocking feedback pathways, overcoming drug resistance, and by removing the ‘protective shield’ from the tumor, allowing anti-tumor immune attack."

The poster demonstrates NT219’s efficacy in synergy with immuno-oncology therapies, which are widely used today, but to which unfortunately most patients still do not respond. In double autologous PDX models, dosing with NT219 converted tumors that were resistant to pembrolizumab (Keytruda) into responsive tumors. The models also demonstrated the efficacy of NT219 in enhancing the immunotherapeutic potential of cetuximab (Erbitux).

Abstract: B127
Abstract Title: NT219, A Novel Dual Inhibitor of STAT3 and IRS1/2, Converts Immuno-Oncology Resistant Tumors to Responders
Session Date: Tuesday, October 2, 2018
Session Time: 12.45 p.m. – 3.15 p.m. EDT
Session Location: Poster Session B, New York Marriott Marquis, Westside Ballroom

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation and inhibiting the phosphorylation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1/2 and signal transducer and activator of transcription 3 (STAT3), respectively. While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers, including sarcoma, melanoma, pancreatic, lung, head & neck, prostate and colon cancers, by preventing the tumors from developing drug resistance and reversing resistance after it had been acquired. NT219 is developed by TyrNovo Ltd., a Kitov Pharma company. For more information on TyrNovo please visit View Source

On September 26, 2018 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that Hugh Cole, chief business officer and head of corporate development at Jounce, will present at the 2018 Cantor Global Healthcare Conference on Wednesday, October 3, 2018 at 1:40 p.m. ET in New York, NY (Press release, Jounce Therapeutics, SEP 26, 2018, View Source;p=RssLanding&cat=news&id=2369015 [SID1234529664]).

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A live webcast of the presentation will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of the webcast will be archived for 30 days following the presentation.

On September 26, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that results from a prospective study conducted by Leiden University Medical Center (LUMC) in The Netherlands of the use of the Delcath Hepatic CHEMOSAT Delivery System to treat patients with metastatic ocular melanoma with liver metastases, were presented as a poster at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting this week (Press release, Delcath Systems, SEP 26, 2018, View Source;p=RssLanding&cat=news&id=2369022 [SID1234529645]).

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The study—Percutaneous Hepatic Perfusion in Patients with Unresectable Liver Metastases from Ocular Melanoma using Delcath Systems’ Second Generation (GEN 2) Hemofiltration System: A Prospective Phase 2 Study—was conducted by researchers at LUMC reported by T.S. Meijer, MD. The study prospectively evaluated tumor response rate, safety, overall survival (OS), overall progression-free survival (PFS) and hepatic progression-free survival (hPFS) in 35 patients with ocular melanoma liver metastases treated at LUMC from February 2014 to June 2017. In accordance with the study’s protocol, patients were treated with a maximum of two cycles of PHP Therapy and a total 67 PHP treatments were administered to the 35 patients in the study.

Post-treatment assessments were possible in 32 patients. Results of the study, according to RECIST 1.1, showed that a complete response was observed in one patient (3.1%) and a partial response was observed in 21 patients (65.6%), resulting in an objective response rate of 68.7%. Stable disease was observed in four patients (12.5%), for a total disease control rate of 81.2%. Median OS was 15.6 months, median PFS was 8.6 months, and median hPFS was 10.8 months.

In their safety analysis, the researchers reported a total of 14 serious adverse events, including one case of cardiac ischemia, five cases of prolonged hospital admission to treat peri-procedure complications, and eight patients re-hospitalized for a variety of post-procedure symptoms. No deaths occurred on the study. No severe bleeding complications, myocardial or cerebral infarctions were observed. Hematologic toxicities of Grade 3/4 were observed in most patients, with 18 (54.5%) patients experiencing thrombocytopenia and 22 patients (66.7%) experiencing neutropenia. The researchers stated that hematologic events were manageable or self-limiting. Additionally, no grade 3 or 4 hepatic serious adverse events were observed by the researchers. The LUMC investigators concluded that, in their institution’s study, PHP Therapy was shown to have a manageable adverse event profile and to be a potentially valuable treatment for certain patients with ocular melanoma liver metastases.

Commenting on the study, Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Delcath Systems, said, "The results from the LUMC study are very encouraging since they are from a prospective trial with endpoints very similar to those in our amended Registration Trial in this same patient population. The LUMC team intends to submit a more extensive analysis of their data for publication, and we look forward to the publication of those more detailed results."

The CIRSE 2018 annual meeting was held in Lisbon, Portugal September 22-25, 2018.

On September 26, 2018 Sutro Biopharma, Inc., a clinical stage drug discovery, development and manufacturing company focused on leveraging its proprietary integrated cell-free protein synthesis platform, XpressCF, to create a broad variety of optimally designed, next-generation protein therapeutics for cancer and autoimmune disorders, reported the pricing of its initial public offering of 5,667,000 shares of its common stock at a price to the public of $15.00 per share (Press release, Sutro Biopharma, SEP 26, 2018, View Source [SID1234529637]). All of the shares are being offered by Sutro. The shares are expected to begin trading on The Nasdaq Global Market on September 27, 2018 under the symbol "STRO." The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Sutro, are expected to be approximately $85.0 million. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 850,050 shares of common stock.

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Cowen and Piper Jaffray are acting as joint book-running managers for the offering. JMP Securities and Wedbush PacGrow are acting as co-managers.

In addition to the shares sold in the public offering, Sutro announced the concurrent sale of additional shares of common stock at the initial offering price, for gross proceeds of approximately $10.0 million, in a private placement to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. The sale of these shares will not be registered under the Securities Act of 1933, as amended.

The closing of the initial public offering is not conditioned upon the closing of the concurrent private placement.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on September 26, 2018. The offering is being made only by means of a prospectus. A copy of the final prospectus relating to the offering, when available, may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (631) 274-2806; or from Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, Suite 800, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.