On May 13, 2019 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported that its multi-cancer test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) (Press release, Grail, MAY 13, 2019, View Source [SID1234536233]). The investigational blood test is in development for the early detection of multiple cancer types in individuals aged 50 or older. The FDA grants Breakthrough designation to devices that have the potential to provide for more effective diagnosis of life-threatening diseases such as cancer. The goal of the FDA’s Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices granted the designation by speeding up their development, assessment, and review.

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"We’re excited the FDA recognizes the potential of our multi-cancer early detection blood test. There are no effective early detection tests for the majority of cancer types, and many deadly cancers are often detected too late. We hope our test may offer a chance to address these challenges," said Jennifer Cook, Chief Executive Officer. "We have made significant progress developing our multi-cancer test and look forward to sharing new data at ASCO (Free ASCO Whitepaper) and other medical conferences this year."

GRAIL previously reported data from the first pre-planned sub-study of its Circulating Cell-free Genome Atlas (CCGA) study, which showed that its three prototype next-generation sequencing (NGS) blood tests were able to detect multiple deadly cancer types from a single blood draw, with a low rate of false positive results (high specificity).1 The company has since selected methylation as its preferred approach and has developed a methylation sequencing blood test that preferentially targets the most informative regions of the genome to both detect the presence of multiple types of cancer and identify the tissue of origin (the part of the body where the cancer originated). The blood test is currently being evaluated in the second pre-planned sub-study of CCGA.

New results from CCGA will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including data on the ability of the company’s methylation technology to identify the tissue of origin when cancer is present. An analysis of survival of participants whose cancer was detected by the methylation technology, compared with those whose cancer was not detected by the technology, will also be presented.

About GRAIL’s Clinical Program

GRAIL is conducting what the company believes to be one of the largest clinical research programs ever pursued in genomic medicine. The program consists of three large-scale studies designed to enroll approximately 165,000 participants to create an atlas of genomic cancer signals in the blood, and to develop and evaluate GRAIL’s blood test for the early detection of multiple cancer types. Approximately 115,000 participants have been enrolled to date.

The CCGA study is a prospective, observational, longitudinal study that has completed enrollment of approximately 15,000 people with and without cancer across 142 sites in the United States and Canada. GRAIL is conducting three pre-planned sub-studies within CCGA to discover, train, and validate its multi-cancer early detection test.

The STRIVE study is a prospective, observational, longitudinal cohort study that has completed enrollment of approximately 100,000 women at the time of their screening mammogram across 37 sites in the United States. STRIVE is designed for clinical validation of GRAIL’s multi-cancer test in an intended use population. GRAIL anticipates reporting data from STRIVE in 2020.

The SUMMIT study is a prospective, observational, longitudinal cohort study that is enrolling participants in London in the United Kingdom. The study is designed to enroll approximately 50,000 men and women who do not have a cancer diagnosis at the time of enrollment. Approximately half of the participants will be people at high risk of lung and other cancers due to a significant smoking history, and the other half will be people who are not at high risk for cancer based on smoking history. SUMMIT is designed for clinical validation of GRAIL’s multi-cancer test in a second intended use population and to evaluate clinical utility of the test in a high-risk population.

About GRAIL’s Methylation Technology

GRAIL is developing an NGS blood test for the early detection of multiple deadly cancer types. GRAIL’s methylation technology preferentially targets the most informative regions of the genome and uses machine-learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin when cancer is present.

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 May 13, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported enrollment of the first patient in its NanoKnife Irreversible Electroporation (IRE) "Data IRE Cancer Treatment" clinical study (DIRECT) (Press release, AngioDynamics, MAY 13, 2019, View Source [SID1234536232]).

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The DIRECT Study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer. The first patient enrollment closely follows the United States Food and Drug Administration’s (FDA) April 1, 2019 approval of AngioDynamics’ investigational device exemption (IDE) application.

"The enrollment of our first patient soon after receiving FDA approval is a strong signal that clinicians are eager to evaluate treatment alternatives that improve the dismal prognosis for Stage III pancreatic cancer patients," said Brent Boucher, AngioDynamics Senior Vice President and General Manager of Oncology. "We look forward to confirming that our proprietary NanoKnife technology offers a compelling alternative to the current standard of care and believe that this study will provide a pivotal dataset for claims and reimbursement purposes."

AngioDynamics’ DIRECT clinical study features a comprehensive data collection strategy that will provide meaningful clinical information to healthcare professionals, support a regulatory indication for the treatment of Stage III pancreatic cancer, and facilitate reimbursement for hospitals and treating physicians. The next-generation study is classified as a Category B IDE by the FDA, which allows participating sites to obtain coverage for procedures performed in addition to any related routine costs.

"We are pleased to be the first enrolling site. The DIRECT Study represents an important milestone in the standardization of care for patients with Stage III pancreatic cancer. Our goal is to generate important data that should standardize and optimize the use of IRE in the treatment of locally advanced pancreatic cancer, significantly improving outcomes for patients with this late-stage diagnosis," said Dr. Robert C.G. Martin, Co-Principal Investigator of the DIRECT Study and Surgical Oncologist at the University of Louisville.

The DIRECT Study comprises a Randomized Controlled Trial at up to 15 sites, as well as a Real-World Evidence, next-generation registry at up to 30 sites, each with a NanoKnife System treatment arm and a control arm. AngioDynamics expects each NanoKnife arm to consist of approximately 250 patients with an equal number of control patients. The primary endpoint of the study is overall survival.

As part of the DIRECT Study, AngioDynamics launched AngioDIRECT.com to facilitate the enrollment of participants. The online platform provides patients and their families with information about pancreatic cancer and details about the study. It also features a physician locator to help prospective participants and referring healthcare professionals identify clinical study locations.

There are approximately 57,000 new cases and 46,000 estimated deaths from pancreatic cancer in the United States annually1. Total deaths due to pancreatic cancer are projected to increase dramatically to become the second leading cause of cancer-related deaths before 20302. The mortality rate is high due to the aggressive nature of the disease and lack of early warning signs, and less than 20 percent of patients are candidates for surgical resection at time of diagnosis3. Approximately 35 to 40 percent of patients will present with Stage III and 45 to 55 percent with metastatic disease3. Regardless of the stage of pancreatic cancer, it is one of the least survivable cancers, and survival rates have not improved substantially for more than forty years3. For all stages combined, the five-year relative survival rate is 8 percent and, for those with advanced disease at the time of diagnosis, the five-year survival rate remains at 3 percent3.

On May 13, 2019 ORIC Pharmaceuticals, a privately held, clinical-stage oncology company focused on the discovery and development of novel therapies against treatment-resistant cancers, reported the initiation of patient dosing in a Phase 1b clinical study of ORIC-101 in combination with nab-paclitaxel (marketed as Abraxane by Celgene Corporation) in patients with advanced solid tumors (Press release, ORIC Pharmaceuticals, MAY 13, 2019, View Source [SID1234536231]).

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"Phase 1b initiation of ORIC-101 in patients with cancer represents a major milestone for ORIC," said Jacob Chacko, MD, Chief Executive Officer. "ORIC’s in-house discovery team, based on findings originating from Dr. Charles Sawyers’ laboratory, identified and developed a selective and potent oral inhibitor of the glucocorticoid receptor (GR), which has been linked to treatment resistance to multiple classes of anti-cancer therapeutics across a variety of solid tumors. Building on our recently completed study in healthy volunteers, we are looking forward to this first clinical study of ORIC-101 through which we hope to begin demonstrating the potential of ORIC-101 to benefit patients with cancer."

The Phase 1b trial is a dose finding, multi-center, open label study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical efficacy of ORIC-101 combined with nab-paclitaxel in patients with advanced solid tumors. Following identification of the recommended Phase 2 dose of ORIC-101 in combination with nab-paclitaxel, ORIC intends to enroll patients into expansion cohorts in selected tumor types based upon GR levels using its proprietary immunohistochemistry assay.

Subsequent to this initial Phase 1b study of ORIC-101 in combination with nab-paclitaxel, ORIC also plans to initiate additional Phase 1b studies of ORIC-101 in combination with other anti-cancer agents, including with androgen receptor modulators in patients with advanced prostate cancer and with immunotherapy agents. Ongoing and planned clinical studies of ORIC-101 are supported by research conducted at ORIC and recent clinical studies of ORIC-101 in healthy volunteers, which demonstrated that ORIC-101 appeared to be safe and well-tolerated, with a pharmacokinetic profile sufficient for oral once-daily dosing and pharmacodynamic activity suggestive of effective target engagement.

"Despite many new anti-cancer therapies, resistance remains a significant barrier to improved outcomes in most patients with advanced cancers," said Pratik Multani, MD, Chief Medical Officer. "We are excited to evaluate the potential of ORIC-101 to overcome what we believe to be a major mechanism of resistance, overexpression of GR. This first clinical trial kicks off a robust clinical development plan to evaluate ORIC-101, the first of our programs to enter the clinic, in combination with multiple classes of anti-cancer agents across various indications that span the range of solid tumor malignancies."

Further details about the clinical study are available at ClinicalTrials.gov (NCT03928314).

On May 13, 2019 Novigenix SA, a leading ImmunoTranscriptomics company that develops and commercializes products for early cancer detection and precision medicine reported the appointment of Dr. Jan Groen to the position of Chief Executive Officer and member of the Board of Directors (Press release, Novigenix, MAY 13, 2019, View Source [SID1234536230]).

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"Following the successful commercialization of its first product for early colon cancer detection, Novigenix is ready to expand its product offering based on its unique ImmunoTranscriptomics technology platform. I very much look forward to working with its dynamic team to build on this initial success"

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Dr. Jan Groen has many years of experience in the life science industry with a focus on emerging technologies, product development and commercialization. Dr. Groen was previously the President and CEO of MDxHealth SA (Euronext), an epigenetic diagnostic company focusing on urological cancers. During his 9 years at MDxHealth, Dr. Groen oversaw growth of total cumulative revenue to over US$100 million, the raising of more than US$80 million in equity financing, the establishment of a CLIA service laboratory in the United States and an ISO service laboratory in Europe, and the team expansion to over 220 staff to sell their prostate and other cancer diagnostic tests. Dr. Groen is co-founder of ViroClinics, founder CEO of DxOrange and has held numerous international executive management and board mandates in international diagnostic companies. He currently serves on the board of Angle Plc and Destina Genomics. He holds a Ph.D. degree in Medical Microbiology from the Erasmus University Rotterdam, a BSc in Clinical Laboratory Studies, and has published more than 125 papers in international scientific journals in the field of clinical diagnostics

"We are delighted to welcome Jan as the CEO of Novigenix. Jan’s decision to join Novigenix is testament to the potential and leadership position of our ImmunoTranscriptomics-based cancer diagnostic and precision medicine pipeline," said Dr. Brian Hashemi, Executive Chairman of the Board of Directors at Novigenix. "Jan’s leadership and considerable experience will contribute to making Colox the new colorectal cancer screening standard, while further developing our technology into other indications."

Novigenix is committed to unravel a new understanding of the human host response against cancer. The company was founded on the vision that ImmunoTranscriptomics will bring unprecedented advances in diagnosing and treating cancer patients leading to significant improvement in healthcare. Novigenix’s unique ImmunoTranscriptomics technology enables an accelerated identification of disease specific mRNA signatures of circulating immune cells, which combined with machine learning and predictive algorithms, can predict onset and progression of disease. The Company has established a valuable multicultural biobank and database of over 1,400 patients at risk of colorectal cancer (CRC) and has launched its first blood-based molecular diagnostic product, Colox, for the early detection of colon cancer. Colox is currently being distributed in Switzerland by Unilabs and Dr. Risch laboratory.

"Following the successful commercialization of its first product for early colon cancer detection, Novigenix is ready to expand its product offering based on its unique ImmunoTranscriptomics technology platform. I very much look forward to working with its dynamic team to build on this initial success," said Dr. Jan Groen.

About ImmunoTranscriptomics

ImmunoTranscriptomics consists of analyzing gene expression modifications (mRNA signatures) induced by the immune response to various triggers, such as the onset of cancer. The company has developed state-of-the-art bioinformatics capabilities, in particular deep neural network and machine learning, to generate mathematical models based on these mRNA signature analyses to predict the onset and progression of disease. Machine learning enables the continuous improvement of test performances with collection of new data through the development of predictive and adaptive analytics algorithms.

About Colox for colorectal cancer

Colox is the first liquid biopsy molecular diagnostic CRC test based on ImmunoTranscriptomics signature. It has the highest performance for non-invasive detection of pre-cancerous lesions. Worldwide each year, more than one million new cases of CRC are diagnosed and 500,000 people die from the disease. Current standard of care for CRC screening is cumbersome and invasive. As a result, the majority of individuals at average risk resist testing. Colox is a blood test designed to screen adults aged 50 or older, who have an average-risk for CRC. Since the launch Colox on the Swiss self-pay market, over 4,000 patients have benefited from the test.

On May 13, 2019 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial results for the three months ended March 31, 2019 (Press release, Trillium Therapeutics, MAY 13, 2019, View Source [SID1234536228]).

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"We are continuing to make progress toward achieving our 2019 milestones," said Robert L. Kirkman, M.D., Executive Chairman of Trillium Therapeutics. "We have treated the first patient under our amended TTI-621 intravenous protocol that will allow us to dose cutaneous T-cell lymphoma patients beyond 0.5 mg/kg, one quarter ahead of schedule. We remain focused on our plan to seek FDA guidance in mid-2019 on a proposed pivotal trial of intratumoral TTI-621 in patients with cutaneous T-cell lymphoma. We also took steps to reduce our expenses and extend our cash runway without impacting the expected timing of our clinical milestones."

First Quarter 2019 Financial Results:

As of March 31, 2019, Trillium had cash and cash equivalents and marketable securities, and working capital of $52.4 million and $42.3 million, respectively, compared to $45.4 million and $34.2 million, respectively at December 31, 2018. The increase in cash and cash equivalents and marketable securities, and the increase in working capital was due mainly to an equity financing in February 2019.

Net loss for the three months ended March 31, 2019 of $10.7 million was higher than the loss of $8.6 million for the three months ended March 31, 2018. The net loss was higher due mainly to a net foreign currency loss of $557 for the three months ended March 31, 2019 compared to a net foreign currency gain of $1,553 in the prior year comparable quarter, and higher manufacturing costs, partially offset by lower clinical trial expenses.