Kronos Bio Appoints Biopharma Industry Veteran Jorge F. DiMartino, M.D., Ph.D., as Chief Medical Officer

On November 20, 2019 Kronos Bio, Inc., dedicated to the development of first-in-class therapies that modulate historically undruggable targets, reported that it has appointed Jorge F. DiMartino, M.D., Ph.D., as Chief Medical Officer and Executive Vice President, Clinical Development. In this newly created position, Dr. DiMartino will lead Kronos Bio’s clinical function and oversee the advancement of its oncology pipeline, which includes two preclinical programs discovered via the company’s Small Molecule Microarray (SMM) screening platform (Press release, Kronos Bio, NOV 20, 2019, View Source [SID1234551533]). Dr. DiMartino will be based in Kronos’ San Mateo office.

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"As a physician-scientist focused on translational development, Jorge is ideally suited to join Kronos at this stage of our growth, as we are focused on discovering bioactive molecules against oncology targets that have historically been considered undruggable," said Norbert Bischofberger, Ph.D., President and Chief Executive Officer of Kronos. "Jorge’s deep expertise in epigenetics and protein homeostasis will be uniquely valuable in our effort to develop drugs which interfere with transcription factors, pursue targeted protein degradation, and advance highly-differentiated products into human testing."

Dr. DiMartino joins Kronos from Celgene Corp., where he served as Vice President, Translational Development, Protein Homeostasis and Epigenetics Thematic Center of Excellence. At Celgene, Dr. DiMartino built a discovery team with industry leading epigenetic profiling capabilities in pursuit of chromatin modifier targets. His translational team has driven BET and LSD1 inhibitor programs through Phase 1, delivering robust data packages to support proof of concept trial designs. Prior to Celgene, he was Group Medical Director, BioOncology/ Exploratory Clinical Development at Genentech Inc., where he was the Development Team Leader for the BCL2 (venetoclax, navitoclax) collaboration with Abbvie, Inc. and managed a team advancing a broad portfolio of early-stage oncology compounds.

"I look forward to leveraging my oncology drug development expertise, which spans drug discovery to Phase 3 trial design, to help Kronos build its clinical organization and progress its two lead preclinical programs toward Investigational New Drug applications," said Dr. DiMartino. "Kronos’ mission to discover and develop novel therapies against historically undruggable cancer targets dovetails perfectly with my passion for understanding cancer biology and translating this knowledge into clinical development strategies to benefit cancer patients."

In addition to his work in industry, since 2007 Dr. DiMartino has been an Adjunct Clinical Assistant Professor of Pediatrics in the Division of Hematology/Oncology at Stanford University School of Medicine, participating in the care of pediatric oncology patients. Earlier in his academic career, he was Assistant Professor of Pediatrics, Division of Experimental Hematology, at Cincinnati Children’s Hospital Medical Center. Prior to that, he was an Instructor in the Departments of Pathology and Pediatrics at Stanford University School of Medicine, where he studied how chimeric transcription factors mediate leukemogenesis.

Dr. DiMartino received a B.A. in genetics from the University of California, Berkeley, a Ph.D. in immunology from Cornell University Graduate School of Medical Sciences, and an M.D. from the University of California, San Diego, School of Medicine. He completed a residency in pediatrics and a fellowship in pediatric hematology/oncology at the Lucile Salter Packard Children’s Hospital at Stanford, and a post-doctoral fellowship in the Department of Pathology at Stanford.

ViewRay® to Present at the 2019 Piper Jaffray 31st Annual Healthcare Conference

On November 20, 2019 ViewRay, Inc. (NASDAQ: VRAY) reported that the Company will participate in the 2019 Piper Jaffray 31st Annual Healthcare Conference in New York, New York. Scott Drake, President and CEO, will give a presentation at 1:30p.m. Eastern Time on Wednesday, December 4, 2019 (Press release, ViewRay, NOV 20, 2019, View Source [SID1234551549]).

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An audio webcast of the Company’s presentation will be available on the investor relations section of ViewRay’s website at www.viewray.com. A replay of the webcast will be available for 7 days after the date of the presentation.

ONC201 and ONC206 Activity in Neuro-Oncology to be Presented at SNO Conference

On November 20, 2019 Oncoceutics, Inc. reported that new data will be presented on the efficacy and mechanism of action of imipridones ONC201 and ONC206 at the 24nd Annual Scientific Meeting of the Society of Neuro-Oncology, to be held November 20th-24th in Phoenix, Arizona (Press release, Oncoceutics, NOV 20, 2019, View Source [SID1234558320]).

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These data will highlight exciting findings that have emerged over the past year, including:

Updated clinical results for ONC201 in pediatric and adult H3 K27M-mutant gliomas
Extension of ONC201 activity to other brain tumors
Synergy antitumor activity of ONC201 in combination with other treatments
Activity of ONC206 in medulloblastoma
IND-enabling studies with ONC206
Distinctions in the activity of ONC201 and ONC206
Inhibition of mitochondrial function by ONC201
The capability of the imipridone family to bind to distinct molecular targets
Oncoceutics and academic investigators will present a range of results with imipridones that will include mechanistic and efficacy findings from preclinical models that detail their unique therapeutic potential in neuro-oncology. In addition, updated safety, pharmacokinetic, pharmacodynamic, and efficacy results from clinical trials with ONC201 in high-grade glioma patients will be reported. These results are largely derived from the ongoing clinical program that is dedicated to exploring ONC201 a molecularly-defined patient population (H3 K27M-mutant glioma). The rationale for the upcoming first-in-human clinical trial of ONC206 in adult recurrent CNS tumors will also be highlighted.

Summaries and presentation information are provided below:

Date/Time Location Abstract Title Presenter

Wednesday 11/20
9:40 – 9:50 PM JW Marriott Selective targeting of dopamine receptor dysregulation in high grade gliomas with ONC201 Varun Prabhu, PhD, Oncoceutics

Thursday 11/21
5:00 – 7:00 PM Investigator Meeting

Friday 11/22
7:30 – 9:30 PM Ballroom Lawn Imipridone Structure Activity Relationship Uncovers ONC206 as the Next Bitopic DRD2 Antagonist for Oncology with Differentiated Receptor Pharmacology Varun Prabhu, PhD, Oncoceutics
7:30 – 9:30 PM Ballroom Lawn Single agent ONC201 in previously treated, progressive adult H3 K27M-mutant glioma Isabel Arrillaga-Romany, MD, PhD, MGH
7:30 – 9:30 PM Ballroom Lawn Role of ONC206 in regulating medulloblastoma tumor progression Anshu Malhotra, PhD, Emory University
7:38 – 7:42 PM Wildflower B Receptor pharmacology of ONC201: The first bitopic DRD2 antagonist for clinical neuro-oncology Josh Allen, PhD, Oncoceutics

Saturday 11/23
7:15 – 8:30 AM Grand Canyon 8-13 H3K27M glioma and ONC201 (SNO-EANO Joint session) Isabel Arrillaga-Romany, MD, PhD, MGH
3:45 – 3:55 PM Grand Canyon 1-6 Clinical efficacy of ONC201 in thalamic H3 K27M-mutant glioma Carl Koschmann, MD, Michigan Medicine
4:40 – 4:45 PM Grand Canyon 1-6 Phase I clinical trial of ONC201 in pediatric H3 K27M-mutant glioma or newly diagnosed DIPG Sharon Gardner, MD, NYU Langone Health
5:00 – 7:00 PM Ballroom Lawn Preclinical combination of ONC201 with radiotherapy or Temozolomide in GBM, DIPG and ATRT cell lines results in dopamine receptor antagonism, ATF4 induction and cell death Lanlan Zhou, MD, PhD, Brown University
5:00 – 7:00 PM Ballroom Lawn Metabolic rewiring by ONC201/TIC10 and 2-Deoxyglucose has synergistic anti-glioblastoma activity Josh Allen, PhD, Oncoceutics
5:00 – 7:00 PM Ballroom Lawn PDTM-25 Study of ONC201 in pre-clinical models of DIPG Wafik Zaky, MD, MD Anderson
5:00 – 7:00 PM Ballroom Lawn IND-enabling Characterization of ONC206 as the Next Bitopic DRD2 antagonist for Neuro-oncology Varun Prabhu, PhD, Oncoceutics

Quest Diagnostics Declares Quarterly Cash Dividend

On November 20, 2019 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.53 per share, payable on January 29, 2020 to shareholders of record of Quest Diagnostics common stock on January 14, 2020 (Press release, Quest Diagnostics, NOV 20, 2019, View Source [SID1234551534]).

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Heat Biologics Announces Additional Positive Top Line Phase 2 Data of HS-110 plus Nivolumab in Advanced NSCLC Patients

On November 20, 2019 Heat Biologics, Inc. (NASDAQ:HTBX), reported additional positive Phase 2 interim top line data from Cohort A of the Company’s Phase 2 trial of its T-cell activating cell-based therapy, HS-110, in combination with Opdivo (nivolumab) in advanced non-small cell lung cancer (NSCLC) at a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy on November 19, 2019 available at View Source (Press release, Heat Biologics, NOV 20, 2019, View Source [SID1234551518]). Cohort A enrolled only previously treated patients who have never received a checkpoint inhibitor (CPI).

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The Company reported median overall survival (mOS) of 16.9 months with 50% of patients censored with median follow up of 17 months. This compares favorably to the 12.2 months mOS reported in the Checkmate 057[i] study with Bristol-Myers Squibb’s nivolumab (Opdivo) alone in a similar patient population. The Company also reported an objective response rate (ORR) per iRECIST of 22%, and a disease control rate (DCR) of 48%, with tumor shrinkage observed in 46% of patients.

Moreover, mOS of patients experiencing dermal injection site reactions (ISR) was 42.1 months. Statistically significant improvement in progression-free survival (PFS) and mOS was observed compared to those without ISR (Hazard Ratio = 0.51, p=0.042 and Hazard Ratio = 0.14, p <0.0001, respectively).

Jeff Hutchins, Ph.D., Heat’s Chief Scientific and Operating Officer commented, "The data from Cohort A is extremely encouraging and builds upon our recently announced data in Cohort B, a population consisting of patients who previously progressed on a checkpoint inhibitor and were re-challenged with HS-110 plus nivolumab. Of special interest in Cohort A is a prospectively defined subset of PD-L1 positive patients who achieved a median overall survival of 42.1 months (95% CI; 15.8 – 42.1). This is particularly compelling when compared to overall survival rates in published literature of 1st or 2nd line checkpoint inhibitor monotherapy."

Highlights for Cohort A patients are presented below:

Median Overall Survival of 16.9 months (50% of patients still alive with median follow up of 17 months)
Median overall survival of ISR positive patients was 42.1 months (95% CI; 15.8 – 42.1) vs. an ISR negative mOS of 5.9 months (95% CI; 1.4 – 11.6) (Hazard Ratio = 0.14, p <0.0001)
A prospectively defined analysis of PD-L1 negative vs. PD-L1 positive showed a difference in mOS of 16.9 months (95% CI; 5.5 – unk) to 42.1 months (95% CI; 1.6 – 42.1), respectively
Objective Response Rate by iRECIST of 22% and DCR of 48%
Tumor shrinkage in 46% of patients
Patients who achieved stable disease or better showed statistically significant decreases in peripheral blood T cell subsets from baseline while on combination treatment
Jeff Wolf, Heat’s CEO, commented, "We are strongly encouraged by this latest data release and believe the data from both Cohorts A and B will be helpful as we advance partnership and collaboration discussions."