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RefleXion Highlights New Research at ASTRO 2020 Evaluating Feasibility of Biology-guided Radiotherapy to Treat Metastatic Cancer

On October 22, 2020 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality for treating all stages of cancer, reported that eight clinical abstracts evaluating the use of its novel technology were accepted for presentation during the virtual American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, Oct. 24-28 (Press release, RefleXion Medical, OCT 22, 2020, View Source [SID1234568866]).

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"We are thrilled to have eight abstracts from leading academic clinicians highlighting our technology," said Sean Shirvani, M.D., senior vice president of Clinical and Medical Affairs at RefleXion. "The presentations will share new data on the potential of BgRT for targeting tumors in diverse anatomic locations and from varied histologies, including non-small cell lung, prostate and pancreatic cancers. The investigations also explore the exciting opportunity of leveraging PET information as a future biomarker with BgRT.

"Through our clinical partnerships, we continue to produce comprehensive, evidence-based research that builds on the strong foundation of previously published studies," continued Shirvani. "We believe the RefleXion X1 can form the backbone of any radiotherapy clinic, as it delivers IMRT/SBRT/SRS and unlocks opportunities for procedural growth with BgRT in local and metastatic disease."

The following presentations taking place during ASTRO 2020 evaluate RefleXion’s novel technology:

Sunday, Oct 25, 2:15 PM. Poster Session 02, Poster Hall:

2686 "Simultaneous Integrated Boost of Lung Tumors in the Stereotactic Ablative Setting using BgRT Tracked Delivery"
2831 "Use of a Detailed Process Map for Clinical Workflow of a New Biology-guided Radiotherapy (BgRT) Machine"
2768 "Feasibility of Biology-Guided Radiotherapy for Pancreatic Tumors: An Assessment of Normalized Target SUV"
Monday, Oct 26, 12:20 PM Physics 06 – Imaging and Response Assessment:

SS 21 – "Increased 18F-FDG Metabolic Activity During Lung SBRT Predicts Risk of Disease Progression: Results from a Prospective Study of Serial Inter-Fraction PET/CTs"
Tuesday, Oct 27:

3:15 PM QP-19 – Physics – Motion Management "Feasibility of Biology-guided Radiotherapy (BgRT) Targeting FDG Avid Liver Metastases"
2:00 PM 2268 PV 06 Poster "FDG-PET Metrics in Advanced Non-Small Cell Lung Cancer (NSCLC): A Systematic Review and Meta-Analysis"
2:00 PM 2258 PV 06 Poster "Prognostic Value of FDG-PET Metrics for Advanced NSCLC Patients Treated with First-line Immunotherapy"

The Mary Kay Foundation℠ Awards $1 Million in Research Grants to Top Universities for Cancers Affecting Women

On October 22, 2020 The Mary Kay Foundation℠ recently reported that awarded $1 million in grants to ten researchers on the frontline battling cancers that primarily affect women (Press release, The Mary Kay Foundation, OCT 22, 2020, View Source [SID1234568865]). The grants, which benefit institutions in Mary Kay’s home state of Texas all the way to Wisconsin and New York, are part of The Mary Kay Foundation’s annual cancer research grant cycle, totaling nearly $24 million since inception.

After reviewing more than 75 applications, The Mary Kay Foundation Research Review Committee awarded $100,000 grants to 10 accredited cancer research institutions. This year’s grant recipients include:

Beckman Research Institute of City of Hope
Columbia University Irving Medical Center
NYU Grossman School of Medicine
Stanford University School of Medicine
The University of Texas Health Science Center at San Antonio
University of California San Diego
UT Southwestern Medical Center
The University of Tennessee Health Science Center
University of Virginia
University of Wisconsin School of Medicine and Public Health
"The Mary Kay Foundation has a two-fold mission: to end gender-based violence and empower researchers to find cures for cancers that primarily affect women," said Michael Lunceford, President of The Mary Kay Foundation Board of Directors. "Over the past several decades, our research grants have enabled some of the country’s top medical minds to make breakthroughs in treatments that we’re so proud of. Our hope—and belief—is that this year’s grantees will continue that inspiring research trend."

That research includes innovative studies from scientists like Dr. Hua Yu, Associate Chair and Professor in the Department of Immuno-Oncology at the Beckman Research Institute of City of Hope. Dr. Yu will use the grant provided by The Mary Kay Foundation to study the opposing roles of PARP and PARG inhibitors in regulating ovarian cancer immune responses. Dr. Paul Lambert, Howard M. Temin Professor and Chair of Oncology at the University of Wisconsin Schools of Medicine and Public Health, will use the funds to research the role of human’s microbiome in cervical cancer. In New York, Dr. Alberto Ciccia, Assistant Professor of Genetics & Development at Columbia University Medical Center, will use the funds to study large-scale functional analysis of BRCA1/2 single nucleotide variants.

"By offering continued support for these scientists and institutions," added Lunceford, "we are continuing Mary Kay’s ultimate goal, which is to better the lives of women everywhere."

bioAffinity Technologies to Present Poster at World Conference on Lung Cancer 2020

On October 22, 2020 bioAffinity Technologies, a privately held biotech company, reported its poster "Automated Flow Cytometry Test Distinguishes Cancer from Non-Cancer in Sputum with High Sensitivity and Specificity" has been accepted for presentation at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, Singapore, Worldwide Virtual Event (WCLC 2020) from Jan. 28 to 31, 2021 (Press release, BioAffinity Technologies, OCT 22, 2020, View Source [SID1234568864]).

bioAffinity Technologies will present results of its test validation trial for CyPath Lung, a non-invasive test for the early detection of lung cancer, that evaluated the test’s ability to distinguish people at high risk for lung cancer from high-risk patients with the disease. The test validation trial resulted in CyPath Lung specificity of 88% and sensitivity of 82%, similar to far more invasive procedures currently used to diagnose lung cancer. CyPath Lung performed even better, with 92% sensitivity and 87% specificity, in the group of cancer and cancer-free high-risk participants who had no nodules or small nodules less than 2 cm in diameter.

The WCLC is the world’s largest international gathering of clinicians, researchers and scientists in the field of lung cancer and thoracic oncology, according to the conference website. The poster, #3394, will be available to participants of the WCLC 2020 on the Virtual Event Forum beginning Jan. 28 as part of Session P07 – Early Stage/Localized Disease.

Asana BioSciences to Present Clinical Data on Oral ASN007, A Novel ERK1/2 Inhibitor, at the 32nd EORTC-NCI-AACR Symposium

On October 22, 2020 Asana BioSciences, a clinical stage biopharmaceutical company, reported that ASN007 clinical data on safety, efficacy and pharmacokinetics in solid tumor patients will be presented at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Virtual Symposium on Molecular Targets and Cancer Therapeutics (ENA 2020) to be held on October 24-25, 2020 (Press release, Asana BioSciences, OCT 22, 2020, View Source [SID1234568862]). Details of this invited presentation are as follows:

Title: Targeting ERK with novel inhibitor ASN007

Presenter: Filip Janku, MD, PhD. Associate Professor, Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center

Session Title: New Drugs on the Horizon

Date and Time: Sunday, October 25, 2020 at 21:00 CET/4:00 PM US ET

About ASN007

ASN007 is an orally bioavailable, potent and selective inhibitor of ERK1/2 designed to potently inhibit the RAS/RAF/MEK/ERK (MAPK) signaling pathway. ASN007 shows potent preclinical activity in KRAS-driven models, irrespective of subtype mutation, and in BRAF mutant models, including RAF/MEK inhibitor-resistant melanoma. ASN007 has a long target residence time and shows activity in preclinical models using an intermittent dosing schedule. ASN007 has been evaluated in patients with advanced solid tumors, including BRAF- and KRAS-mutant cancers (NCT03415126). The maximum tolerated dose levels (MTD) and recommended Phase 2 dose (RP2D) has been determined. Clinical development of ASN007 is ongoing and aims to address the medical need across a range of cancer types defined by RAS/RAF/MEK driven mutations as monotherapy and in combinations.

Daiichi Sankyo Initiates Phase 1 Trial with Immuno-Oncology Therapy DS-1055 Targeting GARP on Activated Regulatory T Cells

On October 22, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the first patient has been dosed in a first-in-human global phase 1 study evaluating DS-1055, a GARP directed immuno-oncology therapy, in patients with advanced or metastatic solid tumors who have progressed on standard treatments including checkpoint inhibitors (Press release, Daiichi Sankyo, OCT 22, 2020, https://www.businesswire.com/news/home/20201021006132/en/Daiichi-Sankyo-Initiates-Phase-1-Trial-with-Immuno-Oncology-Therapy-DS-1055-Targeting-GARP-on-Activated-Regulatory-T-Cells [SID1234568861]).

Immune checkpoint inhibitors have significantly impacted the treatment paradigm for several cancers over the past decade with improved survival for subsets of patients, but the majority of patients do not respond to current therapies or eventually develop resistance.1 GARP is highly expressed on activated regulatory T cells (Tregs) and contributes to their immunosuppressive activity.2 Research suggests that targeting GARP on Tregs may be a promising new immune intervention strategy.2 There are no GARP directed therapies currently approved for cancer treatment.

"We are pleased to initiate clinical development to further evaluate the novel mechanism behind DS-1055, which was specifically designed to decrease the number of GARP expressing regulatory T cells and restore antitumor immune response," said Arnaud Lesegretain, Vice President, Global Oncology Development, Alpha Portfolio, Daiichi Sankyo. "Evidence suggests that DS-1055 could serve as a new type of immune-based therapy for patients with various cancers, including those resistant or refractory to checkpoint inhibitors."

About the Study

The first-in-human, global, multi-center, open-label phase 1 dose escalation study will evaluate the safety, tolerability and preliminary efficacy of DS-1055 in adult patients with relapsed/refractory advanced or metastatic head and neck, gastric and esophageal cancers and other tumor types. The purpose of this study is to determine the maximum tolerated dose and recommended dose of DS-1055 for further study.

The study will evaluate safety endpoints including dose-limiting toxicities and adverse events. Efficacy endpoints include objective response rate, disease control rate, duration of response, time to response, progression-free survival and overall survival. Pharmacokinetic, immunogenicity and biomarker endpoints will also be assessed.

Approximately 40 patients will be enrolled in the U.S. and Japan. For more information visit ClinicalTrials.gov (NCT04419532).

About DS-1055

DS-1055 is a monoclonal antibody designed to target GARP (Glycoprotein-A Repetitions Predominant), a transmembrane protein expressed on the surface of activated Tregs in the tumor microenvironment. DS-1055 was designed to promote antitumor immunity through the depletion of GARP positive Tregs.

Tregs are involved in immune tolerance and have strong immunosuppressive activity.3 Tregs are accumulated in the tumor microenvironment, where they are activated and inhibit antitumor immunity through various mechanisms leading to suppression of effector T cells with antitumor activity.3 Tregs also cause resistance to immune checkpoint inhibitors.1 High Treg presence in the tumor microenvironment is associated with poor prognosis in various types of cancer.4

Targeting GARP, which is selectively expressed on activated Tregs and contributes to the function of Tregs, may be a way to decrease the number of functional Tregs in the tumor microenvironment and restore antitumor immunity.2 Preclinical evidence has shown that depletion of Tregs results in antitumor activity.5

DS-1055 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.