On October 7, 2019 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, reported new data validating the performance of its investigational multi-cancer early detection blood test for the first time in an independent cohort of participants. The results from this validation analysis demonstrate the ability of GRAIL’s technology to detect more than 20 cancer types across all stages with a single, very low false positive rate. When cancer was detected, the test also identified where the cancer was located in the body (the tissue of origin) with high accuracy. In a pre-specified group of 12 deadly cancer types, which are responsible for approximately two-thirds of all cancer deaths, there was an even greater detection rate.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

GRAIL’s large-scale clinical study program is designed to train and develop a multi-cancer early detection test, as well as validate its performance. This new analysis, comprising data from the second pre-planned sub-study of its foundational Circulating Cell-free Genome Atlas (CCGA) study, evaluated performance of the test in an independent group of participants. Performance in the validation analysis was consistent with previously reported results from data used to train GRAIL’s cancer detection algorithm to classify cancer and non-cancer signals.

"Today, cancer remains the second leading cause of death worldwide, and we believe an effective multi-cancer early detection technology has the potential to transform the cancer care landscape," said Hans Bishop, Chief Executive Officer at GRAIL. "We are excited to present these new validation data that support the potential clinical applicability of our targeted methylation technology, and reinforce our ongoing efforts to bring our multi-cancer early detection test into the clinic to begin returning test results to patients."

The independent set used to validate GRAIL’s test included participants from the CCGA (n=927; 654 cancer, 273 non-cancer) and STRIVE (n=337 non-cancer) studies, spanning more than 20 cancer types across all stages. These new data show strong performance at high specificity (99.3%), representing a very low false positive rate. A low false positive rate is important for tests designed for use at population-scale in order to minimize unnecessary testing and associated harms.

The overall detection rate for the group of 12 pre-specified deadly cancer types at 99.3 percent specificity was 76 percent (n=273/359; 95% confidence interval: 72-81%), and a combined analysis of this group of cancers showed robust detection across all stages with detection rates of 39 percent (27-52%), 69 percent (56-80%), 83 percent (75-90%), and 92 percent (86-96%) at stages I (n=62), II (n=62), III (n=102), and IV (n=130), respectively.

In this group of 12 high mortality cancers, a tissue of origin result was provided for 97 percent (265/272), and of these, the test correctly identified the tissue of origin in 93 percent of cases (246/265). Accurately identifying where the cancer originated in the body is critical to inform the diagnostic work-up and next steps.

The 12 pre-specified deadly cancers in the independent validation set include anal, bladder, colorectal, esophageal, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreatic, plasma cell neoplasm, and stomach.

"Performance validation with an independent group of participants is critical prior to returning results of a multi-cancer early detection test to patients," said Minetta Liu, MD, Research Chair and Professor, Department of Oncology, Mayo Clinic. "The promising results from this independent validation demonstrate the robustness of the test’s performance, its ability to detect more than 20 cancer types across all stages, and its generalizability to broader populations due to a low false positive rate."

In the group of more than 20 cancer types, the overall detection rate at 99.3 percent specificity was 55 percent (n=361/659; 95% confidence interval: 51-59%), with detection rates of 18 percent (13-25%), 43 percent (35-51%), 81 percent (73-87%), and 93 percent (87-96%) at stages I (n=185), II (n=166), III (n=134), and IV (n=148), respectively. A tissue of origin result was provided for 96 percent (344/359), and of these, the test correctly identified the tissue of origin in 93 percent of cases (321/344).

These new data will be presented at the inaugural ASCO (Free ASCO Whitepaper) 2019 Breakthrough in Bangkok, Thailand, taking place October 11-13.

ASCO Breakthrough Presentation Details

Abstract 44

Minetta Liu, et al. Simultaneous multi-cancer detection and tissue of origin (TOO) localization using targeted bisulfite sequencing plasma cell-free DNA (cfDNA)

Poster Session: October 11, 2019: 1:45 – 2:15PM ICT, Centara Grand at CentralWorld

About CCGA

The Circulating Cell-free Genome Atlas (CCGA) study is a prospective, observational, longitudinal, case-control study that has completed enrollment of approximately 15,000 participants with and without cancer across 142 sites in the United States and Canada. CCGA is designed to characterize the landscape of genomic cancer signals in the blood and to discover, train, and validate GRAIL’s multi-cancer early detection blood test through three pre-planned sub-studies.

About GRAIL’s Investigational Multi-Cancer Early Detection Test

GRAIL is developing a next-generation sequencing (NGS) blood test for the early detection of multiple deadly cancer types. GRAIL’s high efficiency methylation-based technology preferentially targets the most informative regions of the genome and is designed to use its proprietary database and machine-learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin. GRAIL’s sequencing database of cancer and non-cancer methylation signatures, which GRAIL believes to be the largest of its kind, covers approximately 30 million methylation sites across the genome. More than 20 cancer types across stages are represented within the database.

DNA methylation is a natural process used by cells to regulate gene expression. It is a chemical modification to DNA and a well-studied epigenomic feature of the genome. In cancer, abnormal methylation patterns and the resulting changes in gene expression can contribute to tumor growth. For example, hypermethylation can cause tumor-suppressor genes to be inactivated.

On October 7, 2019 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported that the Company will release third quarter 2019 financial results after the close of trading on Monday, November 4, 2019 (Press release, NanoString Technologies, OCT 7, 2019, View Source [SID1234540093]). Company management will host a conference call beginning at 4:30pm ET to discuss those results and provide a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Individuals interested in listening to the conference call may do so by dialing (866) 211-0364 for domestic callers, or (647) 689-6861 for international callers. Please reference Conference ID: 9358402. To listen to a live webcast, please visit the investor relations section of the company’s website at nanostring.com.

A replay of the call will be available beginning November 4, 2019 at 7:30pm ET through midnight on November 11, 2019. To access the replay, dial (800) 585-8367 or (416) 621-4642 and reference Conference ID: 9358402. The webcast will also be available on the Company’s website for one year following the completion of the call.

On October 7, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of an expert panel consensus statement that includes appropriate use criteria for DecisionDx-Melanoma in patients with cutaneous melanoma (Press release, Castle Biosciences, OCT 7, 2019, View Source [SID1234540092]). The study was published in the peer-reviewed journal SKIN: The Journal of Cutaneous Medicine.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A panel of nine expert dermatologists, dermatologic surgeons, and dermatopathologists performed a systematic review of published evidence and developed appropriate use criteria supporting the integration of DecisionDx-Melanoma and two other validated, widely used molecular tests in melanoma patient care. The systematic review of peer-reviewed medical literature identified studies relating to clinical validity, outcomes or utility of DecisionDx-Melanoma. Employing a modified Delphi consensus technique, the panel determined the level of evidence for publications as well as an overall strength of recommendation for selected indications using standard Strength of Recommendation Taxonomy (SORT) methodology.

Key Findings

Eleven publications were identified as achieving quality levels 1 or 2, with two publications achieving the highest level of evidence (Level 1).
Eight consensus-based appropriate use criteria recommendations achieved a rating of "A" or "B", with "A" rating indicating the highest strength of recommendation.
The expert consensus-based appropriate use criteria provide an evidence-based framework to integrate the DecisionDx-Melanoma test into the management of patients with cutaneous melanoma.
"This important publication is the first to provide expert consensus-based appropriate use criteria to help clinicians integrate technologies like the DecisionDx-Melanoma test into their melanoma practice," said study co-author Darrell S. Rigel, M.D., M.S., Clinical Professor at New York University (NYU) School of Medicine. "The DecisionDx-Melanoma test has been well validated as a predictor of risk of metastasis or recurrence. The appropriate use criteria recommendations align with the current clinical use of DecisionDx-Melanoma to guide the post-diagnostic decisions to perform a sentinel lymph node biopsy surgical procedure in certain patients, and determine appropriate management plans regarding follow-up regimens, inclusion of imaging and referral to oncology."

The full published study can be accessed at the journal’s website.

On October 7, 2019 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, reported that ITM´s subsidiary, ITG Isotope Technologies Garching GmbH (ITG) and Nordic Nanovector ASA (OSE: NANO) have signed long-term global supply agreements for the medical radioisotope no-carrier-added Lutetium-177 (n.c.a. 177Lu) EndolucinBeta to support R&D, clinical and commercial supply of Betalutin (177Lu-Lilotomab-Satetraxetan) (Press release, ITM Isotopen Technologien Munchen, OCT 7, 2019, View Source [SID1234540091]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement for the study phase, ITM has partnered with Nordic Nanovector to support its clinical development. At the same time, both parties signed a commercial agreement for the supply of EndolucinBeta post Marketing Approval of Betalutin. Additional terms of the agreement are not disclosed.

EndolucinBeta, radiolabeled to anti-CD37 murine antibody lilotomab, is an active component of Betalutin, a next generation radioimmuno conjugate (RIC) currently under clinical development in patients who suffer from Non-Hodgkin Lymphoma (NHL). Betalutin is a drug candidate with an excellent profile. As well as leveraging an alternative therapeutic target (anti-CD37 antigen) in recurrent lymphoma patients who have relapsed following anti-CD20-based therapy, it has shown durable responses in heavily pre-treated NHL patients after a one-time administration, combined with a predictable and manageable toxicity, an important feature for elderly NHL patients who may not be suited to chemotherapy.

EndolucinBeta, a radiopharmaceutical precursor, is used in Targeted Radionuclide Therapy in the field of Precision Oncology and has marketing authorization in the EU. Radiolabeled to disease-specific targeting molecules like antibodies or peptides, the tumor tissue is precisely destroyed by cytotoxic doses of ionizing radiation. ITM has developed a unique methodology to produce a particularly highly pure form of Lutetium-177. No-carrier-added Lutetium-177 contains no metastable Lutetium-177m, therefore there is no need for cost intensive clinical waste management. This is especially important in countries with a release limit of Lutetium-177m into public sewage systems.

Marco Renoldi, Chief Operating Officer at Nordic Nanovector, said: "We are pleased to extend our collaboration with a long-standing and reliable partner such as ITM. This global supply agreement is a key milestone in the implementation of our CMC (Chemistry, Manufacturing and Controls) strategy for gaining regulatory approval for Betalutin and its subsequent commercial rollout, as it provides certainty of continued supply of n.c.a. Lutetium-177 throughout clinical development as well as after launch. The agreement with ITM, alongside other manufacturing supply and development agreements in place with specialist manufacturers at all stages of the manufacturing and supply chain for Betalutin strengthens our confidence in the ability to deliver a reliable and sustainable supply chain in support of the launch of our lead asset."

Steffen Schuster, CEO of ITM, added: "Nordic Nanovector is one of our longstanding partners, as ITM has been supplying n.c.a. Lutetium-177 to Nordic Nanovector since 2010. We are delighted that Nordic Nanovector has reaffirmed their confidence through this long term supply agreement for EndolucinBeta. In addition to the development of our own pipeline, we have once again been able to gain a strategic partner for the development of targeted radiopharmaceuticals in Precision Oncology, thereby making a significant contribution to advancing a promising treatment option for difficult-to-treat cancers. With our manufacturing facilities around the world and our unrivaled logistics network, we feel well equipped to reliably meet our partners’ needs and to enter into further strategic relationships."

On October 7, 2019 Gilead Sciences, Inc. (NASDAQ: GILD) reported that Merdad Parsey, MD, PhD, will join the company as Chief Medical Officer, effective November 1 (Press release, Gilead Sciences, OCT 7, 2019, View Source [SID1234540090]). Dr. Parsey will be responsible for the company’s global clinical development and medical affairs organizations. He will join the company’s senior leadership team and will report directly to Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. Under a new structure, William Lee, PhD, Gilead’s Executive Vice President, Research will separately report to Mr. O’Day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Parsey joins Gilead from Genentech, Inc., a member of the Roche Group, where he currently holds the position of Senior Vice President, Early Clinical Development in the Genentech Research and Early Development (gRED) group. In this role, he leads clinical development, quality, compliance, informatics and clinical operations functions. He brings to Gilead significant clinical expertise across a broad array of therapeutic areas, including inflammation, oncology and infectious diseases.

"I am delighted to welcome Merdad, a seasoned and highly respected scientist, clinician and leader, to Gilead," said Mr. O’Day. "Throughout his career, he has built a reputation as an outstanding leader among academic, industry and medical communities alike. I know Merdad’s exceptional skills and expertise will be of great benefit to Gilead as we focus on rapidly expanding our pipeline and clinical development portfolio through internal efforts and external partnerships."

Prior to his most recent tenure with Genentech, Dr. Parsey served as President and CEO of 3-V Biosciences. He has also held development roles at Sepracor, Regeneron and Merck, Inc. and has served as Assistant Professor of Medicine and Director of Critical Care Medicine at New York University School of Medicine. Dr. Parsey completed his MD and PhD at the University of Maryland, Baltimore, his residency in Internal Medicine at Stanford University and his fellowship in Pulmonary and Critical Care Medicine at the University of Colorado.

"I have had many opportunities over the course of my career to help shape clinical development strategies and programs, and I am profoundly excited to bring those experiences to Gilead, an organization I have long admired," said Dr. Parsey. "I am looking forward to working with the company’s talented teams to advance clinical development programs and build a robust pipeline that has the opportunity to change the trajectory of disease and transform the care of many more people in need around the world."