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.

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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.

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]).

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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.

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]).

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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.

On June 18, 2019 Kleo Pharmaceuticals, Inc. (Kleo), an immuno-oncology company developing next-generation synthetic bispecific compounds designed to emulate or enhance the activity of biologics, reported that CD38-ARM, a CD38 targeting antibody recruiting molecule (ARM) to treat multiple myeloma, will be its first product candidate to move into the clinic with anticipated human studies to commence in 2020 (Press release, Kleo Pharmaceuticals, JUN 18, 2019, View Source [SID1234537153]).

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CD38-ARM is designed to recruit endogenous antibodies to multiple myeloma cancer cells, targeting them for destruction by natural killer (NK) cells and macrophages. CD38 is a validated multiple myeloma target, which is also overexpressed in chronic lymphocytic leukemia and other cancers. The molecule was chosen after showing positive signals towards safety and efficacy in preclinical models. This is the first candidate to emerge from Kleo’s strategic alliance with PeptiDream Inc., (Tokyo:4587).

"We’re excited to announce CD38-ARM as the first clinical candidate for Kleo, which is also the first clinical candidate resulting from our collaboration agreement with PeptiDream," said Douglas Manion, MD, CEO of Kleo. "PeptiDream’s PDPS technology and Kleo’s ARM platform together have created a product candidate we intend to advance into the clinic next year. CD38-ARM is being developed to enhance, complement or replace currently marketed anti-CD38 multiple myeloma drugs through better safety and efficacy. We are hopeful CD38-ARM will be the first of a series of novel clinical candidates to emerge from our innovative development platforms."

"PeptiDream takes great pride in being a strong leader in transforming peptides into new effective treatment options using our Peptide Discovery Platform System (PDPS)," stated Patrick Reid, PhD, CEO of PeptiDream. "We are pleased to partner with Kleo in CD38-ARM’s advancement into the clinic recognizing its potential in becoming the next generation of first-in-class and best-in-class immunotherapies."

On June 18, 2019 Torque, a clinical-stage immuno-oncology company developing Deep-Primed T Cell Therapeutics to direct immune power deep within the tumor microenvironment, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Torque’s first Deep-Primed T cell immunotherapy program, TRQ-1501 (Deep IL-15 Primed T cells) (Press release, Torque Therapeutics, JUN 18, 2019, View Source [SID1234537152]). The Fast Track designation is for the treatment of relapsed or refractory solid tumors and lymphomas that express any of five tumor-associated antigens (PRAME, WT-1, SSX2, Survivin, and NY-ESO-1). Torque is currently conducting a Phase 1/2 clinical trial of TRQ-1501 for this indication.

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"Patients with relapsed or refractory solid tumors and lymphomas have a poor prognosis and limited treatment options. We are delighted to receive this Fast Track designation of TRQ-1501 for a broad, tumor-agnostic indication, which provides significant flexibility for our clinical trial program," said Becker Hewes, MD, Chief Medical Officer of Torque. "Working in close collaboration with the FDA supports our goal of improving patient outcomes in multiple difficult-to-treat solid and hematologic cancers."

The FDA’s Fast Track designation is designed to facilitate the development and expedite the regulatory review of drugs and biologics that have shown the potential to address an unmet medical need associated with a serious or life-threatening disease. Fast Track status provides for more frequent interactions with the FDA during drug development and the possibility of Priority Review of New Drug or Biologic Licensing Applications.

About TRQ-1501
TRQ-1501 is an investigational immune cell therapy produced from a patient’s own T cells, which are primed to target multiple tumor-associated antigens (PRAME, WT-1, SSX2, Survivin, NY-ESO-1) and loaded with Deep IL-15 (a multimer of IL-15 cytokine) anchored to the T cells’ surface. A Phase 1/2 clinical trial of TRQ-1501 in solid cancers and lymphoma is currently enrolling (NCT03815682) and will evaluate TRQ-1501 both as a single agent and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

About Torque’s Deep-Primed Immune Cell Therapy Platform
Torque is developing a new class of Deep-Primed cellular immunotherapy designed to overcome the key challenges limiting broad use of cellular therapy in oncology, including the capability to target tumors that express multiple heterogeneous antigens, the ability to overcome the immunosuppressive microenvironment that shuts down T cell function, and the need for outpatient treatment with a high margin of safety. Torque uses its Deep-Priming technology to develop multi-targeted, antigen-primed T cells that carry surface-anchored immune-stimulatory drugs to drive a full immune response within the tumor microenvironment against tumors with heterogenous antigens.

Torque’s Deep-Priming platform uses advanced cell process engineering to:

prime and activate T cells to target multiple tumor antigens and
tether immune-stimulatory drugs to the surface of these multi-target T cells to direct immune activation in the tumor microenvironment
using a proprietary technology platform, without genetic engineering, for a high margin of safety.
Deep-Primed T cells both target multiple tumor antigens and pharmacologically activate an immune response with anchored cytokines. This process does not require genetic engineering of the T cells and so preserves the natural T cell receptor for delivering a regulated immune response, with the potential for a high margin of safety. In addition to antigen priming, immunomodulators are tethered to the surface of Deep-Primed T cells—initially IL-15 and IL-12 cytokines, and TLR agonists—that activate both innate and adaptive immunity. Administering these immunomodulators systemically to a patient can cause lethal toxicity by activating immune cells throughout the body. By loading precise doses of cytokines onto the surface of T cells, Deep Priming focuses the immune response to target the tumor, without systemic exposure.

In hematologic cancers, this new class of immune cell therapeutics has the potential to improve on the initial success of single-target CAR T therapeutics with expanded efficacy and also move cell therapy treatment out of the hospital with a high margin of safety. For solid tumors, Deep-Primed T cells have the potential to enable efficacy against tumors with heterogeneous antigens protected by hostile microenvironments, which are not readily addressable with the first generation of immune cell therapies.