Jounce Therapeutics Completed Enrollment in First Cohort of Phase 1 Clinical Trial with its PD-1 Inhibitor, JTX-4014

On January 3, 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 the company completed enrollment in the first cohort for its Phase 1 dose escalation clinical trial of JTX-4014 as monotherapy in patients with solid tumors (Press release, Jounce Therapeutics, JAN 3, 2019, View Source;p=RssLanding&cat=news&id=2382004 [SID1234532441]). JTX-4014 is a fully human IgG4 monoclonal antibody designed to specifically bind to PD-1 and block its interaction with its ligands, PD-L1 and PD-L2, to augment anti-tumor T cell activity. Jounce is developing JTX-4014 for potential use in combination with its pipeline of future product candidates.

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"We believe combination therapy will be the mainstay of cancer immunotherapy treatment and that PD-1 checkpoint inhibitors like JTX-4014 will be an important component of future regimens," said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. "As we continue to build and progress our immunotherapy pipeline, including macrophage and other cold tumor target treatments, we believe it is important for us to have our own PD-1 inhibitor to potentially combine with these novel agents."

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics and to identify the recommended Phase 2 dose of JTX-4014 monotherapy in patients with advanced solid tumors. For more information on this trial, please visit View Source (Identifier: NCT03790488).

About JTX-4014
JTX-4014 is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. Jounce is developing JTX-4014 for potential use in combination with its pipeline of future product candidates. JTX-4014 is currently in Phase 1 clinical development.

AbbVie and Tizona Therapeutics Announce Strategic Collaboration to Develop First-in-Class Immunotherapy for Cancer Targeting CD39

On January 3, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Tizona Therapeutics, Inc. ("Tizona"), a privately held immunotherapy company, reported that they have entered into a global, strategic collaboration to develop and commercialize CD39-targeted therapeutics, including TTX-030, a first-in-class antibody for the treatment of cancer (Press release, AbbVie, JAN 3, 2019, View Source [SID1234532450]).

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The ATP-adenosine axis has recently emerged as a key immune regulatory switch in the tumor microenvironment (TME) by controlling the inflammatory and suppressive activities of immune cells. CD39 is the enzyme responsible for the initial steps in the conversion of immune stimulatory extracellular ATP to immune suppressive adenosine in the TME. Inhibition of CD39 with TTX-030 represents a novel and differentiated approach to targeting this pathway.

"Immuno-oncology is one of AbbVie’s key focus areas in our mission to discover and develop medicines that drive transformational improvements in cancer treatment," said Mo Trikha, Ph.D., Vice President, Head of Oncology Early Development, AbbVie. "Exploring the tumor microenvironment as a source of targets that can be modulated to inhibit cancer growth holds tremendous promise. The Tizona team has generated compelling preclinical data for their TTX-030 program, and we look forward to a productive collaboration focused on rapidly advancing this novel first-in-class antibody."

"Tumors employ various strategies to create a tolerogenic microenvironment, which reduces the immune system’s ability to detect and fight cancer," said Courtney Beers, Ph.D., Vice President, Immunology, Tizona. "Preclinical research shows that inhibiting CD39 may hold the key to restoring and bolstering immune responses against tumors. In AbbVie, we have a partner who shares our passion for science and commitment to delivering breakthrough innovation to patients with cancer. We look forward to advancing this exciting program."

Under the terms of the agreement, Tizona has received an upfront payment of $105 million for the exclusive option to license the CD39 program including TTX-030. In addition, AbbVie has made an equity investment in Tizona. Tizona will lead clinical development through completion of Phase 1b studies, after which AbbVie has an exclusive option to lead global development and commercial activities. Tizona retains an option to co-develop and co-promote in the United States and is eligible for success-based development and commercial milestones and tiered royalties on net sales.

An investigational new drug application for TTX-030 has been accepted by the US Food and Drug Administration.

TTX-030, the Adenosine Axis, and the Tumor Microenvironment

TTX-030 is a monoclonal antibody that inhibits the activity of CD39, a cell surface enzyme upregulated on tumors, exhausted T cells, as well as many suppressive cell types as an immune evasion strategy. It catalyzes the conversion of ATP to AMP, the first step in the generation of adenosine. By blocking the action of CD39, TTX-030 prevents the formation of immune suppressive extracellular adenosine, which would otherwise inhibit effector cells in the tumor microenvironment (TME). In addition to preventing the formation of suppressive adenosine, TTX-030 prevents the degradation of ATP, preserving its ability to stimulate dendritic and myeloid-derived cells responsible for innate immunity and immune cell priming necessary for adaptive immunity.

Lilly to Participate in J.P. Morgan Healthcare Conference

On January 3, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2019 (Press release, Eli Lilly, JAN 3, 2019, View Source [SID1234532392]). David A. Ricks, Lilly’s chairman and chief executive officer, will participate in a fireside chat from 6:00 p.m. to 6:25 p.m. Eastern time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

AbbVie to Host Fourth-Quarter and Full-Year 2018 Earnings Conference Call

On January 3, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will announce its fourth-quarter and full-year 2018 financial results on Friday, January 25, 2019 before the market open (Press release, AbbVie, JAN 3, 2019, View Source [SID1234532409]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern). It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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Rigel to Present at the 37th Annual J.P. Morgan Healthcare Conference

On January 3, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that Raul Rodriguez, the company’s president and CEO, is scheduled to present a company overview at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 11:00am PT in San Francisco, CA (Press release, Rigel, JAN 3, 2019, View Source [SID1234532425]).

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To access the live webcast of the presentation or the subsequent archived recording, log on to www.rigel.com. Please connect to Rigel’s website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.