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.

On January 3, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the 37TH Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2019 at 4:00 pm PT in San Francisco (Press release, Ultragenyx Pharmaceutical, JAN 3, 2019, View Source [SID1234532435]).

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The live and archived webcast of the company presentations will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On January 3, 2019 Clinical Genomics, a leading provider of cancer diagnostic solutions including liquid biopsy tests, reported the appointment of Betsy Hanna as president and chief executive officer (Press release, Clinical Genomics, JAN 3, 2019, View Source [SID1234532434]).

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Hanna will also join the Clinical Genomics Board of Directors.

Hanna succeeds Dr. Lawrence LaPointe as CEO, who after a decade building Clinical Genomics will transition to the new role of chief innovation officer, responsible for developing solutions to improve healthcare leading clinical trials, R&D and scientific developments. He will continue to serve as an advisor to the board.

The appointments are effective immediately.

Clinical Genomics’ board chairman Mary Padbury noted, "Both Betsy and Larry bring enormous experience in their new roles. Betsy was most recently our chief commercial officer and has a 20-year career in healthcare turning products into commercial successes. Larry, as a co-founder and an accomplished scientist, will continue to lead our innovation in this rapidly evolving field."

Ms. Hanna noted, "Clinical Genomics has been successful in science and product development. Our challenge now is to accelerate commercial growth with COLVERA, a blood diagnostic for colorectal cancer (CRC) recurrence, and InSure ONE, both now in the market. Our goal is to also expand future applications in screening."

Background: Betsy Hanna

Betsy Hanna is a healthcare and biotech leader. Most recently she was Clinical Genomics’ chief commercial officer with responsibility for developing and executing go-to-market strategies.

Ms. Hanna has two decades of healthcare industry experience including strategic marketing, U.S. and international sales management, and product launch. She joined Clinical Genomics from Origin, Inc., a clinical-stage biotech company where she was the president and chief operating officer.

Prior to Origin, Ms. Hanna had increasing responsibility during eight years at Johnson & Johnson. At J&J diagnostics, she was vice president, strategic marketing and led the global launch of two instrument platforms.

At J&J diagnostics, Hanna also served as vice president Europe, Mideast and Africa and, for J&J Vision Care, was vice president of strategic marketing and a member of the global management board.

Ms. Hanna has a BS in Chemical Engineering from the University of Illinois and an MBA from Harvard Business School.

Background: Lawrence LaPointe

Larry LaPointe, PhD, has more than two decades building healthcare companies to transform cancer testing, including most recently as co-founder of Clinical Genomics. He previously served as CTO and general manager of Enterix Inc, a cancer screening company he also co-founded.

Dr. LaPointe is a well-published research scientist and holds numerous patents in biomarker discovery, cancer detection and molecular diagnostics. He has a BS in Biology from Florida State University and a PhD in Bioinformatics from Flinders University, Australia.

Background: Clinical Genomics

Clinical Genomics is dedicated to improving patient outcomes through early detection of colorectal cancer.

COLVERA is a proprietary liquid biopsy blood test that identifies circulating tumor DNA for the detection of residual disease and early detection of colorectal cancer recurrence.
Clinical Genomics products span the spectrum of colorectal cancer testing from screening to post-treatment monitoring. InSure ONE is a one-sample fecal immunochemical test used to detect lower GI bleeding for screening in healthy adults.

On January 3, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported that Eddie Gray, Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference on Thursday, January 10, at 9 am PT (Press release, Dynavax Technologies, JAN 3, 2019, View Source [SID1234532433]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source

On January 3, 2019 1ST Biotherapeutics, Inc., a preclinical-stage biotechnology company focused on neurodegenerative diseases, immuno-oncology, and orphan diseases, and twoXAR, Inc., an artificial intelligence (AI)-driven biopharmaceutical company, reported an agreement to jointly discover and develop novel, efficacious treatments to address unmet medical needs in glioblastoma multiforme ("glioblastoma") (Press release, 1ST Bio Therapeutics, JAN 3, 2019, View Source [SID1234532432]).

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Under the agreement, twoXAR will use its proprietary AI technology to identify a set of drug candidates with the potential to slow, stop, or reverse the progression of glioblastoma. twoXAR and 1ST Biotherapeutics will select candidates from this set to test in preclinical efficacy models of glioblastoma. Following identification of one or more candidates based on those evaluated, 1ST Biotherapeutics will use its team’s expertise in drug development to optimize candidates and finalize the creation of novel, efficacious treatments. Further details of the agreement were not disclosed.

Glioblastoma is the most common and lethal primary malignant brain tumor with a median survival of approximately 15 months1. It is characterized by an aggressive tumor that infiltrates various portions of the brain and is associated with rapid onset of neurological symptoms, including nausea, vomiting, severe headaches, cognitive issues, and seizures2. Current treatment options consist of surgical resection, radiation, chemotherapy, and angiogenesis inhibitors2. However, most glioblastoma patients experience disease relapse despite these aggressive therapies. It is estimated that 25,000 people will be diagnosed with glioblastoma in 20181.

"1ST Biotherapeutics is focused on efficiently building a pipeline of first-in-class therapeutic candidates with high likelihood of clinical success," said Jamie Jae Eun Kim, CEO of 1ST Biotherapeutics. "The twoXAR team has a track record of rapidly identifying testable novel treatments that can lead to first-in-class therapeutics. This collaboration is an opportunity to combine twoXAR’s AI-driven drug discovery approach and the 1ST Biotherapeutics team’s expertise in chemistry and pharmacology to discover and develop effective molecular therapeutics for glioblastoma patients."

"We are pleased to collaborate with 1ST Biotherapeutics, because we share common goals of efficiently discovering and developing novel therapeutics for diseases with high unmet medical need, such as glioblastoma," said Andrew A. Radin, Co-Founder and CEO of twoXAR. "The 1ST Biotherapeutics team’s deep medicinal chemistry and drug development experience in CNS and oncology diseases provides a strong complement to twoXAR’s data-driven discovery approach."