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.

On September 26, 2018 Novavax, Inc. (NASDAQ: NVAX) reported that it will present at the Ladenburg Thalmann 2018 Healthcare Conference and the Cantor Global Healthcare Conference 2018, both in the first week of October (Press release, Novavax, SEP 26, 2018, View Source [SID1234529628]).

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Conference details are as follows:

Ladenburg Thalmann 2018 Healthcare Conference

Date and Time: Tuesday, October 2, 12:00 p.m. – 12:25 p.m.
Location: Track 5, Montmartre, Sofitel New York
Live webcast: www.novavax.com, "Investors"/"Events"

Cantor Global Healthcare Conference 2018

Date and Time: Wednesday, October 3, 10:55 a.m. – 11:25 p.m.
Location: Track 2, Empire Ballroom 1, InterContinental New York Barclay Hotel
Live webcast: www.novavax.com, "Investors"/"Events"