On January 3, 2019 Compass Therapeutics, a biotechnology company committed to the ambitious goal of comprehensively drugging the human immune system, reported that it will discuss its novel approach to antibody discovery and development and present data on its leading programs in a presentation at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco next week (Press release, Compass Therapeutics, JAN 3, 2019, View Source [SID1234532418]).

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Thomas Schuetz, MD, PhD, co-founder and chief executive officer of Compass, will describe the company’s focus on drugging the broadest possible array of epitopes for each candidate target; its StitchMabs technology that identifies novel combination biology and enables the discovery of next-generation bispecific antibody drug candidates; and the company’s unbiased approach to drug discovery which empowers the identification of the most promising therapeutic for each tumor type and application.

CTX-471, a fully human monoclonal antibody which targets a unique epitope on the costimulatory receptor CD137, is Compass’ lead candidate, and it has the potential to become a best-in-class CD137 agonist. It is expected to enter the clinic in the first quarter of 2019 where it will be tested in patients with various solid tumors. In preclinical models, CTX-471 induces remodeling of the tumor microenvironment and can completely eradicate extremely large tumors in animals. In IND-enabling monkey toxicology studies, CTX-471 has an excellent safety profile.

The proprietary StitchMabs platform was used to discover Compass’ second clinical candidate which is a first-in-class bispecific NK cell engager that lowers the activation threshold of NK cells and directs NK cells to kill selected cells, including tumor cells with low target antigen expression.

The presentation details are:

Date: Tuesday, January 8
Time: 3 PM Pacific Time
Location: Westin St. Francis Hotel, San Francisco, Elizabethan C Room

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 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that it has initiated an open-label, multicenter, Phase 1b/2 study of rebastinib, the Company’s investigational small molecule switch control inhibitor of TIE2 kinase, in combination with carboplatin in patients with advanced or metastatic solid tumors (Press release, Deciphera Pharmaceuticals, JAN 3, 2019, View Source [SID1234532385]).

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"We are extremely pleased with the recent progress made on our rebastinib program, including today’s announcement that we have initiated a second Phase 1b/2 clinical study of rebastinib in combination with chemotherapy," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "This second clinical study will evaluate rebastinib in combination with carboplatin, a treatment regimen that, based on preclinical observations, we believe has the potential to be an important new approach to treating patients with advanced solid tumors."

Part 1 (3+3 dose escalation) of this two part study is designed to evaluate the safety, tolerability and pharmacokinetics of 50 mg and 100 mg rebastinib twice daily (BID) when administered in combination with carboplatin, and to determine the recommended phase 2 dose (RP2D) of rebastinib in combination with carboplatin, in patients with advanced or metastatic solid tumors that are refractory to standard therapies. In part 2, the safety, tolerability and efficacy of the RP2D of rebastinib in combination with carboplatin administered once every 3 weeks will be assessed across multiple disease cohorts, including: breast cancer, ovarian cancer, and mesothelioma. This trial is expected to enroll up to 117 patients in total, with approximately 18 patients in part 1 and up to 99 patients in part 2. For more information about the clinical trial design please visit www.clinicaltrials.gov (NCT03717415).

"The biological mechanisms by which tumors co-opt the surrounding microenvironment to grow, survive and become more invasive, are becoming better understood. Recent research indicates that TIE2 kinase is involved in multiple mechanisms favoring a pro-tumoral microenvironment, including the regulation of a population of immunosuppressive macrophages, promotion of tumor angiogenesis, and function of perivascular pumps that lead to tumor cell recruitment and metastasis," said Daniel L. Flynn, Ph.D., Chief Scientific Officer of Deciphera. "In addition, use of chemotherapeutic agents are believed to enhance the recruitment of these macrophages, leading to increased tumor vascularization and dissemination. In preclinical studies rebastinib has been shown to block these unintended effects of chemotherapy, providing rationale for the potential combination of rebastinib with chemotherapy."

Preclinical information on the role of TIE2 kinase was published in Molecular Cancer Therapeutics, 2017; 16: 2486-2501 and Science Translational Medicine, July 5, 2017; 9: eaan0026.
(www.deciphera.com/science/presentation-publications/)

About Rebastinib
Rebastinib is an investigational, orally administered, potent and selective inhibitor of the TIE2 kinase, the receptor for angiopoietins, an important family of vascular growth factors in the tumor microenvironment that also activate pro-tumoral TIE2 expressing macrophages. In a Phase 1 clinical study, biomarker data have demonstrated rebastinib-induced increases in the TIE2 ligand angiopoietin 2, secondary to TIE2 inhibition. Rebastinib is currently being evaluated in a Phase 1b/2 clinical study in combination with paclitaxel (NCT03601897), in a Phase 1b/2 clinical study in combination with carboplatin (NCT03717415), and in an investigator sponsored Phase 1b trial in patients with metastatic breast cancer in combination with paclitaxel or eribulin (NCT02824575).

On January 3, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported that the Company will present at the 37th Annual J.P. Morgan Healthcare Conference on Thursday, January 10, 2019 at 11:00 a.m. PST in San Francisco, CA (Press release, Verastem, JAN 3, 2019, View Source;p=irol-newsArticle&ID=2381972 [SID1234532403]).

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A live webcast of the presentation will be available on the investors section of the Company’s website at www.verastem.com. An archived presentation will be available for 90 days.

On January 3, 2019 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported that its 500+ gene pan-cancer tumor profiling tissue assay is being used in Merck’s Phase 2 precision oncology KeyImPaCT study of biomarker-directed, pembrolizumab-based combination therapy for advanced non-small-cell lung cancer (NSCLC) (KEYNOTE-495) (Press release, Personal Genome Diagnostics, JAN 3, 2019, View Source [SID1234532419]). This study will investigate the utility of biomarker-based triage for study participants with previously untreated advanced NSCLC. The PGDx elioTM tissue complete assay is being used during the enrollment process for the analysis of tumor mutational burden (TMB) status.

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Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and TMB) will be randomized to receive pembrolizumab in combination with MK-4280 or lenvatinib. The study will involve more than 70 clinical sites worldwide.

"We are proud to collaborate with Merck on this trial. Merck is a leader in immune oncology and we view their selection of PGDx as a testament to our capabilities around TMB," said Doug Ward, Chief Executive Officer at PGDx. "With the kitted approach for the PGDx elio portfolio, we aim to expand patient access to comprehensive, local genomic testing and reduce turn-around time for results that inform critical treatment decisions for patients worldwide."

PGDx provides genomic solutions from biomarker discovery to companion diagnostic development through its CAP/CLIA certified laboratory and is developing a portfolio of regulated tissue-based and liquid biopsy genomic products to enable local next-generation sequencing (NGS) testing in laboratories worldwide.