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Jounce Therapeutics Initiates Phase 2 EMERGE Study of Vopratelimab in Combination with Ipilimumab in Patients with Non-Small Cell Lung Cancer or Urothelial Cancer

On June 18, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it has initiated dosing in the Phase 2 EMERGE clinical trial of its lead product candidate, vopratelimab, in combination with ipilimumab in patients with non-small cell lung cancer (NSCLC) or urothelial cancer who have progressed on or after PD-1/PD-L1 inhibitor therapies (Press release, Jounce Therapeutics, JUN 18, 2019, View Source [SID1234537158]). These patient populations represent a rapidly growing area of unmet need as PD-1 inhibitors move into earlier lines of therapy, with few options and no established standard of care for patients who progress after a PD-1/PD-L1 inhibitor.

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"The Phase 2 EMERGE clinical trial of vopratelimab and ipilimumab builds upon the original science from our founders as well as the reverse translational subset analysis from patients who benefitted in our ICONIC trial versus those who did not. Vopratelimab treatment resulted in the emergence of ICOS hi CD4 T effector cells in the peripheral blood and emergence of these cells was associated with response and improvements in progression free survival and overall survival, as presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting," said Beth Trehu, M.D., chief medical officer of Jounce Therapeutics. "Ipilimumab is known to induce a population of ICOS hi CD4 T cells, making it a scientifically logical combination partner for vopratelimab in the EMERGE study, as we have shown vopratelimab stimulates, expands and sustains ICOS hi CD4 T cells. We are pleased to have begun enrollment in the EMERGE clinical trial and expect to report preliminary efficacy data in 2020."

About the Phase 2 EMERGE Clinical Trial
The Phase 2 EMERGE clinical trial is an open-label, multi-center study to evaluate the efficacy of vopratelimab in combination with ipilimumab. In the initial stage, Jounce expects to enroll approximately 40 patients with NSCLC and approximately 40 patients with urothelial cancer. The primary endpoint is overall response rate (ORR) and secondary endpoints include safety, duration of response, progression free survival (PFS) and overall survival (OS). Additional important assessments will include close monitoring of ICOS hi CD4 T cell emergence, and a range of other biomarkers, including exploratory assessment of potential predictive biomarkers. Jounce expects to report preliminary efficacy and biomarker relationships to clinical outcomes on up to 80 patients in 2020.

Patients and physicians interested in the Phase 2 EMERGE trial can contact [email protected]. For more information on this trial, please visit View Source (Identifier: NCT03989362).

About Vopratelimab
Jounce’s lead product candidate, vopratelimab (formerly JTX-2011), is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell COStimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab was assessed in a Phase 1/2 clinical trial that we refer to as ICONIC. In the initial Phase 1/2 portion of ICONIC, vopratelimab was found to be safe and well-tolerated, both alone and in combination with nivolumab, an anti-PD-1 antibody. At the June 2018 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), we reported Response Evaluation Criteria in Solid Tumors, or RECIST, responses and other tumor reductions as determined by investigator assessment that were associated with an ICOS pharmacodynamic biomarker. We subsequently reported that these responses were durable, lasting six or more months and that all responders, as determined by investigator assessments, remained on study for more than one year. ICONIC also included dose-escalation Phase 1 portions to assess vopratelimab in combination with pembrolizumab, an anti-PD-1 antibody, and in combination with ipilimumab, an antibody that binds to CTLA-4 on certain T cells. This Phase 1 portion established the safety of vopratelimab in combination with each of ipilimumab and pembrolizumab.

SELLAS Life Sciences Announces Closing of $15 Million Public Offering

On June 18, 2019 SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) ("SELLAS" or the "Company"), a late-stage biopharmaceutical company focused on the development of novel cancer immunotherapeutics for a broad range of indications, reported the closing of its previously announced underwritten public offering of (i) 26,367,200 shares of common stock together with common stock warrants (the "common warrants") to purchase 26,367,200 shares of common stock and (ii) 73,632,800 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock, together with common warrants to purchase 73,632,800 shares of common stock (Press release, Sellas Life Sciences, JUN 18, 2019, View Source [SID1234537157]). At closing, SELLAS received aggregate net proceeds from the offering of approximately $13.5 million, after deducting underwriting discounts and commissions and estimated offering expenses. The common warrants have an initial exercise price of $0.50 per share and have a 5-year term.

SELLAS intends to use the net proceeds from the offering to commence a pivotal Phase 3 trial for its lead clinical candidate, galinpepimut-S ("GPS"), as a monotherapy in acute myeloid leukemia patients following second complete remission and to continue its Phase 1/2 basket type trial of GPS in combination with pembrolizumab, as well as for general corporate purposes and funding its working capital needs.

A.G.P./Alliance Global Partners acted as sole book-running manager for the offering. Maxim Group LLC acted as co-manager.

A registration statement on Form S-1 relating to the offering was filed with the Securities and Exchange Commission (the "SEC") on May 23, 2019, amended on June 6, 2019 and June 13, 2019, and was declared effective on June 13, 2019. The offering was made only by means of a prospectus. SELLAS’ SEC filings are available to the public from the SEC’s website at www.sec.gov. Copies of the final prospectus relating to the offering may also be obtained by contacting A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor New York, NY 10022 or via telephone at 212-624-2006 or email: [email protected].

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

Arbutus Appoints William Collier as Next President & CEO and Announces Retirement of Current President & CEO, Mark J. Murray Ph.D.

On June 18, 2019 Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, reported the appointment of William H. Collier as President and Chief Executive Officer, effective June 24th (Press release, Arbutus Biopharma, JUN 18, 2019, View Source [SID1234537156]). Mr. Collier has also been appointed as a member of the Board of Directors of Arbutus, effective June 24th, to fill the vacancy created by the resignation of Mark J. Murray, Ph.D., from the Board of Directors. Dr. Murray will continue to serve as President and Chief Executive Officer and as a member of the Board of Directors until his retirement on June 23rd. Dr. Murray and Arbutus Biopharma entered into a consulting agreement on June 13, 2019 whereby Dr. Murray will provide transition services from June 24, 2019 to August 23, 2019.

Mr. Collier has over 30 years of experience as a senior executive in the pharmaceutical industry and previously served as President and General Manager, North America at ViiV Healthcare. At ViiV he led the industry-leading launches of several new treatments for HIV. Prior to joining ViiV in 2009, Mr. Collier held multiple senior leadership roles at GlaxoSmithKline. Earlier in his career he led the launches of new treatments for herpes and bacterial infections. Mr. Collier received his BSc in Mathematics and Management Sciences from the University of Manchester Institute of Science & Technology, UK, and served on The President’s Advisory Council on HIV/AIDS from 2014 to 2017.

"I am delighted to join Arbutus at this important inflection point in the company’s growth," said Mr. Collier. "HBV represents a global public health threat. It is the world’s most common serious liver infection and is up to 100 times more infectious than the HIV virus. It is also the primary cause of liver cancer, which is the second leading cause of cancer death in the world. Regrettably, as yet, there are no effective curative treatments for these patients. I believe that Arbutus’ diverse pipeline focused on HBV has the promise to offer people suffering from Hepatitis B a potentially curative treatment."

Dr. Mark Murray noted, "With the effective consolidation of Arbutus’s operations and scientific team in Warminster, Pennsylvania, a pipeline focused on a combination therapeutic regimen to cure HBV, and a clear strategic business plan in place, I believe this is an opportune time for me to retire and for Arbutus to move forward under Bill Collier’s leadership. I believe Bill’s extensive experience in the development and commercialization of multiple virology products and his passion for building competitive, high performing teams will be of great value to Arbutus."

"I would like to thank Mark for his service and extend a warm welcome to Bill," said Frank Torti, M.D., Chairman of Arbutus’ Board of Directors. "We are excited to have Bill join our exceptionally experienced team – one that has already demonstrated a remarkable ability to discover and develop important new anti-viral medicines – and look forward to him leading the next phase of the company’s growth."

In connection with the appointment of Mr. Collier, Arbutus entered into an employment agreement with Mr. Collier that, among other things, provides for the grant of a stock option outside of Arbutus’ 2016 Omnibus Share and Incentive Plan, or any other equity incentive plans of Arbutus, as an inducement material to Mr. Collier’s entering into employment with Arbutus in accordance with Nasdaq Stock Market LLC Listing Rule 5635(c)(4). The stock option to purchase 1,112,000 common shares of Arbutus is being granted effective as of Mr. Collier’s start date on June 24, 2019. The stock option grant was approved by the independent Executive Compensation and Human Resources Committee of the Board of Directors in accordance with Nasdaq Stock Market LLC Listing Rule 5635(c)(4). The stock option will have an exercise price per share equal to the closing price per share of Arbutus’ common shares on the Nasdaq Global Select Market on June 24, 2019. The stock option will have a ten-year term and will vest as to 25% of the common shares on the one-year anniversary of Mr. Collier’s start date and as to an additional 1/48th of the total original number of common shares subject to Mr. Collier’s stock option on the corresponding day of each month over the three year period thereafter, subject to Mr. Collier’s continued employment with Arbutus through the applicable vesting dates.

Sutro Biopharma to Present at the JMP Securities Life Sciences Conference

On June 18, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported that Steve Worsley, Chief Business Officer, will present a company overview at the JMP Securities Life Sciences Conference on Thursday, June 20 at 12:30 p.m. ET at the St. Regis Hotel in New York (Press release, Sutro Biopharma, JUN 18, 2019, View Source [SID1234537155]).

A live webcast of the presentation will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.sutrobio.com. A replay of the webcast will be available for approximately 30 days following the event.

Ionis Pharmaceuticals to present at the BMO Prescription for Success Healthcare Conference

On June 18, 2019 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), the leader in antisense therapeutics, reported that management will present a company overview at the BMO Prescription for Success Healthcare Conference at 9:20 a.m. ET on Tuesday, June 25, 2019 in New York, NY (Press release, Ionis Pharmaceuticals, JUN 18, 2019, View Source [SID1234537154]).

A live webcast of the presentation will be available on the Investors & Media section of the Ionis website. The replay will be available within 48 hours and will be archived for a limited time.