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Physicians’ Education Resource® Announces Six Satellite Symposia at 37th Annual Miami Breast Cancer Conference®

On February 20, 2020 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will conduct six CME-accredited satellite symposia during the 37th Annual Miami Breast Cancer Conference at the Fontainebleau in Miami Beach, Florida, March 5-8 (Press release, Physicians’ Education Resource, FEB 20, 2020, View Source [SID1234554576]).

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"Our all-inclusive breast cancer conference is one of our biggest and most influential programs of the year," said Phil Talamo, president of PER. "This year we excited more than ever offering additional CME educational opportunities such as invaluable expert insights from world-renowned thought leaders, engaging symposia sessions and legendary medical crossfires. Join us in March, you won’t want to miss the 37th Annual Miami Breast Cancer Conference."

The PER satellite symposia are as follows:

Coffee Talk: Initiating Early Recognition and Intervention in a Rare Lymphoma Associated With Breast Implants, which will be held Thursday, March 5, from 9:15 to 10:45 a.m., in the meeting room Fontaine. The program will be chaired by Lloyd B. Gayle, M.D., FACS, chief of plastic surgery and vice chair of surgery, Maimonides Medical Center in Brooklyn, New York; and clinical associate professor of surgery, Weill Medical College of Cornell University in New York. To register, click here.
Managing Postoperative Pain: The Clinical Impact of Opioid-Sparing Strategies on Patients with Breast Cancer, which will be held Thursday, March 5, from 7 to 8:30 p.m., in the meeting room Fontaine. The program will be chaired by Patrick I. Borgen, M.D., chair of the department of surgery and director, breast cancer program, Maimonides Medical Center in Brooklyn, New York. To register, click here.
Coffee Talk: Perspectives on PARP, HER2/3, PI3K, and Emerging Oncogenic Targets in Breast Cancer Care, which will be held Friday, March 6, from 7 to 8:30 a.m., in the meeting room Fontaine. The program will be chaired by Mark E. Robson, M.D., chief, breast medicine service, and attending physician, breast medicine and clinical genetics services, Memorial Sloan Kettering Cancer Center; and professor of medicine, Weill Cornell Medical College in New York. To register, click here.
Leveraging Immunogenicity to Optimize Patient Outcomes in Triple Negative Breast Cancer: Current and Emerging Evidence, which will be held Friday, March 6, from 6:30 to 8:00 p.m., in the meeting room Fontaine. The program will be chaired by Joyce O’Shaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research, Texas Oncology-Baylor Charles A. Sammons Cancer Center; and chair, breast cancer research program, The US Oncology Network in Dallas, Texas. To register, click here.
Medical Crossfire: Real World Scenarios and Applications for Biosimilars in HER2-Positive Breast Cancer: Key Concepts for Clinical Decision-Making, which will be held Saturday, March 7, from 7 to 8:30 a.m., in the meeting room Fontaine. The program will be chaired by Hope S. Rugo, M.D., FASCO, professor of medicine, department of medicine (hematology/oncology), and director, breast oncology clinical trials program, University of California San Francisco Helen Diller Family Comprehensive Cancer Center in California. To register, click here.
How We Do it: Personalizing Treatment for Patients With HER2-Positive Breast Cancer, which will be held Sunday, March 8, from 7 to 8:30 a.m., in the meeting room Fontaine. The program will be chaired by Debu Tripathy, M.D., professor and chair, department of breast medical oncology, The University of Texas MD Anderson Cancer Center in Houston. To register, click here.
Each satellite is accredited by the Accreditation Council for Continuing Medical Education for 1.5 AMA PRA Category 1 Credits for physicians.

Odonate Therapeutics Announces Financial Results for the Three and Twelve Months Ended December 31, 2019

On February 20, 2020 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three and twelve months ended December 31, 2019 (Press release, Odonate Therapeutics, FEB 20, 2020, View Source [SID1234554575]).

As of December 31, 2019, Odonate had $180.5 million in cash, compared to $139.1 million as of December 31, 2018. This increase in cash resulted primarily from the receipt of $135.1 million of net proceeds from Odonate’s June 2019 underwritten public offering, less net cash used in operating activities of $96.6 million. Odonate’s net loss for the three and twelve months ended December 31, 2019 was $27.9 million and $111.8 million, or $0.91 and $4.05 per share, respectively, compared to $28.8 million and $89.0 million, or $1.17 and $3.64 per share, respectively, for the same periods in 2018.

"We are pleased to have recently announced the completion of enrollment in CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer," said Kevin Tang, Chief Executive Officer of Odonate. "We expect to report top-line results from CONTESSA in the third quarter of 2020."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays. In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system (CNS) metastases are eligible for both cohorts.

Eureka Therapeutics to Present at 6th Annual Immuno-Oncology 360° Conference

On February 20, 2020 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T cell therapies to treat solid tumors, reported that President and CEO Dr. Cheng Liu will be presenting at the 6th Annual Immuno-Oncology 360° Conference (IO360°) in New York on February 27, 2020 (Press release, Eureka Therapeutics, FEB 20, 2020, View Source [SID1234554574]).

Dr. Liu will be presenting the use of Eureka’s novel antibody-TCR receptor (ARTEMIS T cell) that has been engineered with a proprietary human TCR-mimic antibody to target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex on HCC cancer cells.

Presentation Details

Title: Innovation Hour: New Scientific Frontiers in Cell Therapies for Solid Tumors

Speaker: Dr. Cheng Liu, President and CEO

Date: Thursday, February 27, 2020

Program: Cell & Gene Therapy Day, Track B

Time: 10:40 – 11:40 a.m. EST

IMV to Host Conference Call & Webcast to Report Updated Results from DeCidE1, its Ongoing Phase 2 Study of DPX-Survivac in Patients with Advanced Recurrent Ovarian Cancer

On February 20, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage biopharmaceutical company pioneering a novel class of immunotherapies, reported that company management will host a conference call & webcast to report topline results from DeCidE1, an ongoing Phase 2 study evaluating its lead compound, DPX-Survivac, in patients with advanced recurrent ovarian cancer, on Tuesday, February 25, 2020 at 8:00 am EST (Press release, IMV, FEB 20, 2020, View Source [SID1234554573]).

IMV aims to make immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer. Patients with advanced, recurrent ovarian cancer have limited treatment options. The five-year survival rate for women with advanced disease is less than 30%1.

In 2020, the standard of care for recurrent cancer is single-agent chemotherapy, which elicits a response rate of ~12% with limited duration of benefit and severe adverse effects. There is a significant need for more effective and better-tolerated therapies in recurrent ovarian cancer.

Conference Call & Webcast Information

Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (International).

All interested parties are able to register and access the live audio webcast by clicking the link available under the Investors section of the company’s website: "Events, Webcasts & Presentations".

The webcast will be recorded and available on the IMV website for 30 days following the call.

About the DeCidE1 Study

"DeCidE1" is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac with intermittent low dose cyclophosphamide. This phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and –resistant ovarian cancer. Patients received two subcutaneous injections of DPX-Survivac three weeks apart and every eight weeks thereafter, and intermittent low dose CPA, one week on, and one week off for up to one year. Paired tumor biopsies were performed prior to treatment and on treatment.

Primary endpoints of this study are overall response rate, disease control rate and safety. Secondary endpoints include cell mediated immunity, immune cell infiltration in paired biopsy samples, duration of response, time to progression, overall survival and biomarker analyses.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of targeted immunotherapies designed to elicit antigen-specific functional, robust and sustained de novo T cell response. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of five unique HLA-restricted survivin peptides formulated in IMV’s proprietary DPX drug delivery platform and known to induce a cytotoxic CD8+ T cell response against survivin expressing cancer cells.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

Company has recently published data with DPX-Survivac (as single regimen or in combination with Merck’s Keytruda) at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2019 (see poster) and at the ASCO (Free ASCO Whitepaper)-SITC symposium in February 2020 (see poster).

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

NanoString Highlights Groundbreaking Spatial Genomics Research Using Expanding Portfolio of GeoMx High-Plex RNA Atlas Products at 2020 Advances in Genome Biology and Technology (AGBT) Conference

On February 20, 2020 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported ten scientific studies utilizing the GeoMx Digital Spatial Profiler (DSP) that will be showcased at the 2020 Advances in the Genome Biology and Technology (AGBT) conference being held at the JW Marriott in Marco Island, Florida (Press release, NanoString Technologies, FEB 20, 2020, View Source [SID1234554572]). These studies span cancer translational research to neuroscience discovery applications, illustrating the platform’s flexibility and opportunity to spatially map distinct cell types and quantitate biological activity. NanoString will also be hosting the 2nd Annual Spatial Genomics Summit on Sunday, February 23rd from 12 – 4pm ET. Attendees do not need to be registered for AGBT to attend the Summit.

The GeoMx Digital Spatial Profiler provides researchers high throughput, high multi-plex, spatial profiling of RNA and protein targets in a variety of sample types, including both fresh frozen and formalin-fixed, paraffin-embedded (FFPE) tissue sections. GeoMx DSP is currently available for read-out using NanoString’s nCounter Analysis System, allowing analysis of up to 96 proteins and 96 RNA targets. Beginning mid-2020, GeoMx DSP will be enabled to read-out on Illumina’s Next Generation Sequencers (NGS), which will increase the number of RNA targets that can be analyze by approximately twenty-fold. First NGS-enabled assay will be Cancer Transcriptome Atlas for human samples, which profiles more than 1,800 genes within oncology and immune pathways. This will be followed in 2021 with launch of the Whole Transcriptome Atlases for human and mouse.

"As one of the first labs in the world to have acquired the GeoMx DSP platform, we are enthusiastic about the potential to discover novel biology with the system," said Alex Swarbrick Ph.D., Garvan Institute of Medical Research, Sydney, Australia. "We used the GeoMx Whole Transcriptome Atlas to spatially characterize distinct cell types in triple negative breast cancer. These data allowed us to track the spatial heterogeneity of cancer signaling pathways and of T cell subsets, leading to insights inaccessible to bulk or single-cell RNA sequencing."

"2020 is shaping up to be the breakthrough year for spatial biology," said Brad Gray, president and CEO of NanoString. "At the AGBT conference, researchers will highlight the powerful new capabilities that will be unlocked using NGS read-out, including our Cancer Transcriptome and Whole Transcriptome Atlases. I’d like to thank all of our customers and collaborators that have worked so diligently to make such groundbreaking research a reality."

At AGBT 2020, studies performed by leading academic researcher centers demonstrate three major applications for GeoMx DSP:

Discovering novel spatial biomarkers that are not readily detectable by traditional bulk profiling

Spatial landscape of the immune microenvironment in metastatic prostate cancer using GeoMx Digital Spatial Profiler
Pete Nelson, MD, et al., Fred Hutchinson Cancer Research Center, Seattle, WA USA
Used GeoMx DSP Cancer Transcriptome Atlas to interrogate tissue microarrays of metastatic prostate cancer samples and characterize immune responses. Spatial analysis revealed intra-patient heterogeneity that would not have been readily apparent from bulk RNA profiling experiments.

Spatial proteomic characterization of the tumor and immune microenvironment reveals features associated with response to neoadjuvant HER2-targeted therapy
Katherine McNamara et al., Stanford University, Palo Alto, CA, USA
Used spatial proteomic analysis of biopsies from on-treatment HER2+ breast cancer patients to stratify responders v. non-responders early during a course of neoadjuvant HER2-targeted therapy. GeoMx analysis allowed unique segmentation of cell populations to provide insight into the effect of innate immune markers, ER status, and PAM50 subtype on treatment response.

Identification of cell type-specific RNA biomarker candidates in melanocytic tumors using GeoMx Digital Spatial Profiling
Maija Kiuru, MD, Ph.D., University of California, Davis, CA, USA
GeoMx Cancer Transcriptome Atlas analysis revealed microenvironment-specific expression of a novel cell-type specific biomarker, DAMP, in response to early melanoma development. This marker may allow for more sensitive detection of melanoma via patch biopsy.

Single-nucleus RNA-seq reveals distinct intratumoral transcriptomic heterogeneity in treatment-naïve and chemoradiotherapy-treated primary pancreatic ductal adenocarcinoma
William Hwang, MD, Ph.D., et al. et al., Broad Institute, Cambridge, MA, USA
GeoMx Cancer Transcriptome Atlas and Whole Transcriptome Atlas applications were used to profile tumor, fibroblast, and immune compartments in Pancreatic ductal adenocarcinoma (PDAC) samples from twelve patients. Differential gene expression was measured in tumor and fibroblast compartments between treatment groups and by levels of immune infiltration.

Spatial Profiling of the Immune Landscape of Solid Tumors Treated with Low Dose Radiation and Immunotherapy Using High Plex RNA Profiling with the GeoMx Platform
Krisztian Homicsko, MD, Ph.D., et al., Ludwig Institute for Cancer Research, Lausanne, Switzerland
This project interrogated gene expression changes associated with low-dose radiation immunogenic induction therapy in ovarian cancer. GeoMx Cancer Transcriptome Atlas analysis revealed a pretreatment microenvironment associated with favorable response to therapy, and allowed in depth analysis of needle core biopsies, providing important spatial information in samples that would not have been ideal for bulk transcriptomic assays.

Localizing and quantifying the immune contexture of human glioma with GeoMx high -plex RNA profiling
Troy McEachron, MD, et al., University of Southern California, Los Angeles, CA, USA
Combined single cell RNA sequencing with GeoMx Cancer Transcriptome Atlas analysis to characterize immune cell distribution in glioma samples. GeoMx DSP demonstrates that synchronizing digital pathology and bioinformatics provides layers of insight that conventional methods couldn’t.

Spatial mapping of the whole transcriptome in FFPE tissue

Neural stem cell differentiation trajectories in the developing human brain revealed by whole-transcriptome in situ spatial profiling
Kenny Roberts, MD, Ph.D., et al. et al., Sanger Institute, Cambridge, UK
GeoMx DSP Whole Transcriptome Atlas was used to distinguish the transcriptomic profiles of neural stem cells, intermediate progenitors and neurons in the fetal human cerebral cortex at 14 and 19 post-conception weeks. This study examined cell type specific gene expression programs throughout the cortical germinal zones, subplate and the maturing cortical plate and identified spatiotemporal gene expression correlated with neural stem cell self-renewal and differentiation.

Single Cell Programs of Immune Activation in Human MSI vs MSS Colorectal Carcinoma
Jonathan Chen, MD, Ph.D., et al. et al., Broad Institute, Cambridge, MA, USA
GeoMx DSP Cancer Transcriptome Atlas and Whole Transcriptome Atlas were used to interrogate how tumor and microenvironment interactions vary spatially within colorectal cancers, allowing spatial mapping of signatures linked to single cell RNA sequencing. This study highlights the capacity of GeoMx to identify locations of specific cell populations distributed across tissues.

Measuring the Spatial Whole Transcriptome and High-Plex Proteins on FFPE samples from Glioblastoma Multiforme Immunotherapy Clinical Trials Using Digital Spatial Profiling

Yue Lu Ph.D., et al., Institute Systems Biology, Seattle, WA, USA
GeoMx Cancer Transcriptome Atlas analysis of glioblastoma multiforme (GBM) samples generated a high-resolution spatial map of the tumor microenvironment and provided the framework for creating a GBM tumor atlas. Use of whole transcriptome sequencing combined with spatial analysis provides the potential to discover the biology underpinning response to new immunotherapy treatment for glioblastoma.

Phenotyping of single cells through spatial profiling algorithms

Mapping intratumoural heterogeneity of triple negative breast cancer through integrated single cell RNA-Sequencing and whole transcriptome Digital Spatial Profiling
Alex Swarbrick Ph.D. et al., Garvan Institute of Medical Research, Sydney, Australia
Primary, untreated, triple negative breast cancer (TNBC) was profiled using GeoMx DSP whole transcriptome. Segmentation was performed based on visual markers characterize immune and stromal cells in the invasive edge, tumor core, and distant stromal regions with the goal of discovering novel therapeutic targets in TNBC.

Updating immune cell deconvolution for the spatial genomics era
Danaher Ph.D. et al., NanoString Technologies, Seattle, WA USA
GeoMx DSP Cancer Transcriptome Atlas was used to estimate abundance of different immune cell types using novel computational methods. This allows researchers to study how immune cells interact spatially in different regions of a tissue.

Enabling pathway analysis of RNA expression in formalin-fixed paraffin embedded tissues with the GeoMx DSP Platform.
Boykin et al., NanoString Technologies, Seattle, WA USA
GeoMx Cancer Transcriptome Atlas, bulk RNA sequencing, and NanoString nCounter analysis was used to profile the same samples. This project demonstrates how GeoMx analysis can be expanded beyond single gene analysis to understand how biological pathways vary spatially in different regions of a tissue.

NanoString is currently accepting applications to a Technology Access Program for its Cancer Transcriptome Atlas using the DSP technology at [email protected].

To learn more about GeoMx DSP, please visit View Source