On June 27, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release its financial results for the second quarter 2019 after the close of market on Tuesday, July 30, 2019 (Press release, Veracyte, JUN 27, 2019, View Source [SID1234537312]). Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 5:00 p.m. Eastern time on the same day.

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The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call can be accessed as follows:

U.S./Canada participant dial-in number (toll-free):

(855) 541-0980

International participant dial-in number:

(970) 315-0440

Conference I.D.:

9769085

On June 27, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the Ministry of Health Labour and Welfare (MHLW) granted an additional approval for FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for Rozlytrek (entrectinib) for the treatment of neurotrophic tyrosine receptor kinase (NTRK) fusion positive solid tumors on June 26, 2019 (Press release, Chugai, JUN 27, 2019, View Source [SID1234537292]). The approval enables FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic for Rozlytrek by detecting NTRK fusion genes (fusion genes between NTRK1, NTRK2, NTRK3 and other genes). Rozlytrek is a ROS1/TRK inhibitor and was approved for the treatment of adult and pediatric patients with NTRK fusion positive advanced and recurrent solid tumors on June 18, 2019.

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"The conventional concept of cancer treatment focuses on the site where the cancer started. However, it is drastically changing with the emergence of a completely new approach called tumor agnostic treatment; an approach which targets genomic mutations that drive cancers instead of the tumor location in the body. We are proud of the MHLW approval of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for Rozlytrek which represents this new tumor agnostic treatment approach," said Dr. Minoru Watanabe, Chugai’s Vice President, Head of Foundation Medicine Unit. "A comprehensive genomic profiling test is especially beneficial in identifying rare gene mutations expressed in multiple cancer types, including NTRK gene fusions. Chugai will further strive to provide services to help physicians’ swift and appropriate decision making in order to realize patient-centric healthcare."

Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection and analysis of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from patient’s tumor tissues. As a comprehensive companion diagnostic function, it can be also used as a companion diagnostic for certain molecular-targeted drugs approved in Japan.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare providers through comprehensive genomic profiling.

[Note]
A press release issued on June 18, 2019: Anti-Cancer Agent Rozlytrek, Approved for the Treatment of NTRK Fusion Gene Positive Advanced/Recurrent Solid Tumors
View Source

Approval information The underlined part has been newly added.

Brand name FoundationOne CDx Cancer Genomic Profile
Nonproprietary name
Gene mutation analysis program (for use in cancer genome profiling)
Somatic gene mutation analysis program (for use in assessing anticancer drug indications)
Intended uses or indications
The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
EGFR exon 19 deletions and EGFR exon 21 L858R alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
NTRK1/2/3 fusion gene Solid tumors entrectinib
Conditions for approval
The necessary measures must be taken to ensure that the product is used by a physician with adequate knowledge and experience of cancer genomic medicine at a medical institution with a cancer genome profiling-based medical system pursuant to the "Guidelines for the Development of Core Hospitals and Other Facilities for Cancer Genomic Medicine," and in compliance with the scope and timing of testing stipulated in the most recent guidelines, etc., of relevant academic societies.
Appropriate procedures and controls to protect personal information and up-to-date security and privacy protection measures to prevent unauthorized access must be implemented for tumor tissue specimens sent to the laboratory and for information obtained from these specimens.
Quality control of input data must be performed as described in the Remarks column of the attached Application Form. Any changes to the quality control of input data as described in the Remarks column of the Application Form (excluding minor changes specified by Order of the MHLW in Article 23-2-5, paragraph (11) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices ["the Act"]) must be approved by the MHLW Minister pursuant to Article 23-2-5, paragraph (11) of the Act. Note that this approval applies mutatis mutandis to the provisions of Article 23-2-5 paragraph (13), Article 23-2-6, and Article 23-2-7 of the Act.
About Rozlytrek
Rozlytrek is an oral tyrosine kinase inhibitor that blocks ROS1 (c-ros oncogene 1) and TRK (neurotrophin receptors) family strongly and selectively. It blocks ROS1 and TRK kinase activity, and inhibits proliferation of cancer cells with ROS1 or NTRK gene fusions. Rozlytrek has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration and Priority Medicines designation by the European Medicines Agency for the treatment of NTRK fusion gene positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or have no acceptable standard therapies. FDA has granted priority review for Rozlytrek for the treatment of NTRK fusion-positive solid tumors and ROS1 fusion-positive non-small cell lung cancer (NSCLC). In Japan, Chugai filed an application for approval of ROS1 fusion gene positive NSCLC in March 2019.

About NTRK fusion gene positive cancer
NTRK fusion gene is an abnormal gene that can be formed by fusing the NTRK genes (NTRK1, NTRK2, NTRK3 encode TRKA, TRKB, TRKC protein, respectively) and other genes (ETV6, LMNA, TPM3, etc.) as a result of chromosomal translocation1-3). The TRK fusion kinase made from NTRK fusion gene is thought to promote cancer cell proliferation. There is very rare expression of NTRK fusion but in various adult and pediatric solid tumors, including infantile fibrosarcoma, glioma, glioblastoma, diffuse intrinsic pontine glioma (DIPG), congenital mesoblastic nephroma, melanoma, inflammatory myofibroblastic tumor (IMT), uterus sarcoma, soft tissue tumor, gastrointestinal stromal tumor (GIST), secretory carcinoma of breast, secretory carcinoma of salivary gland, cancer of unknown primary, lung cancer, colorectal cancer, appendiceal cancer, breast cancer, gastric cancer, ovarian cancer, thyroid cancer, cholangiocarcinoma, pancreatic cancer, head and neck cancer, and various sarcomas.

Trademarks used or mentioned in this release are protected by laws.

[References]

Martin-Zanca D, Hughes SH, Barbacid M. A human oncogene formed by the fusion of truncated tropomyosin and protein tyrosine kinase sequences. Nature 1986; 319(6056): 743-8.
Martin-Zanca D, Oskam R, Mitra G, Copeland T, Barbacid M. Molecular and iochemical Characterization of the Human trk Proto-Oncogene. Molecular and Cellular Biology 1989; 9(1): 24-33.
Lange AM, Lo HW. Inhibiting TRK Proteins in Clinical Cancer Therapy. Cancers 2018; 10: 105.

On June 27, 2019 Vycellix, Inc. reported that the Company, founded by leading medical researchers at Sweden’s world renowned Karolinska Institutet, has been included as a collaborative partner in the new Competence Center for Next-Generation NK Cell-based Cancer Immunotherapy ("NextGen-NK") being established at Karolinska Institutet ("KI"), Stockholm, Sweden (Press release, Vycellix, JUN 27, 2019, View Source [SID1234537313]).

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Vinnova, Sweden’s innovation agency, is making a significant investment in NextGen-NK, where universities and companies together will conduct world-class research and innovation in areas that are important for Sweden while contributing to its global sustainability goals. NextGen-NK has received commitments from a consortium of key opinion leaders and experts from academia and the biotech industry to collectively collaborate with the goal of creating a recognized world-class research environment in the field of natural killer cell-based immunotherapy targeting cancers.

NextGen-NK is scheduled to receive up to approximately $12 million in funding over the next five-years from multiple stakeholders including Vinnova, Karolinska Institutet and its industry partners with the opportunity to apply for extended funding for an additional 5-years at a similar level. NextGen-NK will be led by its Director, Hans-Gustaf Ljunggren, M.D., Ph.D., Professor at the Department of Medicine at KI, former Dean of Research at KI, former Director of the Center for Infectious Medicine at KI, Chief Medical Officer for Vycellix, and member of the Nobel Assembly at KI.

"We are extremely honored, humbled and grateful to Vinnova for recognizing the potential global impact on human health by establishing NextGen-NK," stated Dr. Ljunggren. "We propose to develop a precision-medicine strategy to direct NK cells to their cancer targets and to optimally stimulate NK cell activity in the body. And by assembling leading scientists and clinicians, including those whom have played key roles over the past four decades of NK cell innovation, this collaboration and discovery-network is expected to generate outcomes that go far beyond the capability of any individual partner."

NextGen-NK’s Co-Directors will be: Evren Alici, M.D., Ph.D., Associate Professor at the Department of Medicine at KI, Head of the Gene & Cell Therapy Group at KI, and CEO of Vycellix; and Karl-Johan Malmberg, M.D., Ph.D., Professor at the Department of Cancer Immunology, Institute for Cancer Research, Oslo University Hospital and member of Vycellix’s Scientific Advisory Board.

On June 27, 2019 LSK BioPharma (LSKB) reported that it has completed the unblinding and preliminary review of topline data from its ANGEL Study, a Phase III clinical trial for rivoceranib (apatinib) which enrolled 460 advanced or metastatic gastric cancer patients (Press release, LSK BioPharma, JUN 27, 2019, View Source [SID1234537293]). While the rivoceranib arm did achieve better median overall survival (OS) compared with placebo, and a result comparable to other approved drugs in gastric cancer, the result was not statistically significant. Overall survival was the primary endpoint in the ANGEL study. Rivoceranib demonstrated a highly significant improvement in median progression-free survival (PFS), which was a secondary endpoint. Rivoceranib was also generally well tolerated and safety results were consistent with prior studies. LSKB will conduct analyses as additional data become available such as overall response rate (ORR) and time-to-progression, follow surviving patients, and keep an open dialogue with regulatory agencies to determine the appropriate path to approval for rivoceranib in this gastric cancer monotherapy indication. The Company plans to continue ongoing clinical development programs in other indications including, earlier lines of therapy for gastric cancer with combination therapy, colorectal cancer, and hepatocellular carcinoma.

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About Rivoceranib (Apatinib)

Rivoceranib, also known as apatinib or Aitan (brand name) in China, is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib is investigational outside of China including in the United States; and safety and efficacy have not been established. It acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis.

LSKB, which holds the global rights (ex-China), has completed enrollment of a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib (apatinib) is currently listed in 260 clinical studies on www.clinicaltrials.gov with over 20,000 patients enrolled or planned to be enrolled in trials targeting numerous cancers including GC, colorectal cancer (CRC), HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

Rivoceranib was developed by Advenchen Laboratories in Southern California under the designation YN968D1. The compound was exclusively licensed to Hengrui in China (2005) and LSKB (2007) for rest of the world.

On June 27, 2019 TriSalus Life Sciences, an oncology company focused on overcoming infusion barriers to improve patient outcomes, reported the creation of a world-class scientific advisory board (SAB) to support advancement of the company’s strategy to deliver therapeutics more effectively into solid tumors (Press release, TriSalus Life Sciences, JUN 27, 2019, View Source [SID1234537314]). The aim of integrating targeted therapeutics and delivery using the company’s proprietary Pressure-Enabled Drug Delivery (PEDD) is to provide therapeutic benefit by overcoming dense tumor stroma, improving the functionality of the poor vasculature, and activating the immune system to target tumor cells in pancreatic and liver cancers.

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The new SAB is composed of preeminent experts across medical, surgical and radiation oncology, and immunology. The SAB will collaborate with TriSalus in all aspects of research, including preclinical, clinical, and commercial evaluation of new therapeutics, and in assessing the combining of PEDD with currently approved cytotoxic and immuno-oncology (I-O) regimens.

"We are deeply gratified to have attracted some of the most renowned thought leaders, healthcare providers, and visionaries in oncology who, like TriSalus, are fully committed to finding and validating more effective treatments for solid tumors," said Mary T. Szela, CEO and president of TriSalus Life Sciences. "The collective clinical and scientific expertise of the SAB members provides a powerful resource to identify more effective methods for treating solid tumors and will help accelerate our efforts to change the outcomes of certain cancers."

In recently presented preclinical and clinical data at the American Association of Immunologists’ annual meeting, targeted regional delivery of chimeric antigen receptor T cell (CAR-T) and checkpoint inhibitors into solid tumors using PEDD significantly increased therapeutic effect compared with low-pressure delivery. Importantly, there was no increase in liver inflammation or toxicity, which are known adverse side effects associated with some systemic treatments.

Scientific Advisory Board Members

Vincent Picozzi, MD

Dr. Picozzi is the director of the Pancreatic Center of Excellence at the Digestive Disease Institute at Seattle’s Virginia Mason Medical Center, and also serves as a practicing physician in Virginia Mason’s division of Hematology-Oncology. Dr. Picozzi has received numerous clinician accolades and directs an active clinical research program. He has published more than 100 papers and abstracts and is a featured speaker at virtually every national clinical oncology meeting. Dr. Picozzi is also chair of the Precision Promise℠ Clinical Trial Consortium while managing one of the largest U.S. pancreaticobiliary oncology practices.

Christopher Crane, MD

Dr. Crane serves as vice chair for the Department of Radiation Oncology at New York’s Memorial Sloan Kettering Cancer Center, where he specializes in gastrointestinal (GI) cancers. Previously, he was program director and chief of the GI section of the Radiation Oncology division at MD Anderson Cancer Center. Dr. Crane leads and conducts clinical trials in GI cancers focused on combining molecular targeted therapies with radiotherapy. In addition, he focuses on the role of radiation dose escalation using novel technologies in the curative treatment of liver and pancreatic cancers, and has helped develop novel technologies to treat GI malignancies, particularly pancreatic cancer.

Philip A. Philip, MD

Dr. Philip is a professor of Oncology, Pharmacology, and Medicine and the Kathryn E. Cramer, MD, Endowed Chair for Cancer Research in the Department of Oncology at the Karmanos Cancer Institute at Wayne State University School of Medicine. He leads the gastrointestinal and neuroendocrine cancers team and is the vice president of Medical Affairs. He also chairs the gastrointestinal cancers committee at the Southwest Oncology Group (SWOG) and sits on the GI Steering Committee that oversees gastrointestinal cancer research nationally. Dr. Philip has been the principal investigator of many Phase I-III trials. He is a frequent national and international lecturer, and has authored more than 200 manuscripts, review articles, and editorials, in addition to co-editing a book on pancreatic cancer and another on GI cancers. Dr. Philip’s major research interest lies in the development of new therapies for GI and neuroendocrine cancers, with a special focus on pancreatic cancer.

Gabriela Plesa, MD, Ph.D.

Dr. Plesa is director of Translational Research Operations and deputy director of the Clinical Cell and Vaccine Production Facility (CVPF) at the University of Pennsylvania. Dr. Plesa has been part of the group led by preeminent immunologist/oncologist Dr. Carl June for 15 years, where she acquired extensive translational research experience largely focused on adoptive immunotherapy with genetically engineered human cells. She has led the effort of opening multiple new investigational cell therapy studies at UPenn, focusing on development of IND-enabling data, clinical approaches, GMP manufacturing processes, and regulatory strategy for launching Phase I and II clinical trials with novel cellular therapeutic approaches. Dr. Plesa is experienced in alliance management as well as federal, university, and regulatory approval requirements for initiating and implementing clinical trials for cellular biologics.

Aravind Arepally, MD

Dr. Arepally is section chief for vascular and interventional radiology at Piedmont Radiology, an affiliate of Piedmont Healthcare. Formerly, he served as clinical director for the Center for Bioengineering Innovation and Design at Johns Hopkins. Dr. Arepally is a co-founder of TriSalus Life Sciences’ predecessor Surefire Medical, Inc. and has coordinated with research labs at Duke University and Johns Hopkins to develop new embolic platforms, including advanced catheter systems for targeted delivery of embolics. He holds multiple patents and has authored more than 150 papers, books, and abstracts. Dr. Arepally was principal investigator of multiple National Institutes of Health (NIH) grants and other grants and is the recipient of numerous national awards for his research in the field of MRI, device development, and embolization applications. He also lectures internationally on minimally invasive procedures.

Steven Katz, MD

Chairman, Scientific Advisory Board

Dr. Katz is director of the Complex Surgical Oncology Fellowship Program and Office of Therapeutic Development at Roger Williams Medical Center. He also serves as associate professor of Surgery at Boston University School of Medicine. A surgeon with expertise in liver and pancreatic surgery, Dr. Katz’s research focuses on immunotherapy for liver metastases and sarcoma. He has served as principal investigator of four Hepatic Immunotherapy for Metastases (HITM) trials testing regional infusion of CAR-T cells for liver metastases, and he also leads the Immunotherapy for Peritoneal Carcinomatosis (IPC) program, investigating CAR-T infusions for stage IV abdominal cancers. In addition, Dr. Katz serves as a reviewer for several scientific and clinical journals and is a member of the Cancer Gene Therapy editorial board, among others.