On December 4, 2019 BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI), ), a pre-clinical, research-stage biopharmaceutical company developing its proprietary xB3 platform technology for the delivery of therapeutics across the blood-brain barrier (the "BBB") and the treatment of central nervous system ("CNS") disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases, reported the creation of the Medical Oncology Advisory Board and the appointments of Dr. John DeGroot M.D., Dr. Hope Rugo M.D. and Dr. Javier Cortés M.D. PhD (Press release, biOasis, DEC 4, 2019, View Source [SID1234551934]). The goals of this board will be to guide the clinical strategy and design of the xB3-001 clinical program for the treatment of HER2+ breast cancer and brain metastases. The Medical Oncology Advisory Board will be chaired by José Iglesias, MD, who has been appointed consultant Chief Medical Officer for Bioasis Technologies Inc.

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Dr. José Iglesias, Chairperson of the Advisory Board in his role of consultant Chief Medical Officer is a biopharmaceutical industry veteran with 30 years of executive experience in all phases of oncology clinical drug development covering the areas of solid tumor oncology, immuno-oncology and translational medicine. His career includes senior positions at Eli Lilly, Amgen, Abraxis Bioscience, Celgene, Bionomics, Biothera, Apobiologix and Boston Biomedical. Dr. Iglesias is author or co-author of more than 60 peer-reviewed publications with over 6,000 literature citations and an active member of ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper) and AACR (Free AACR Whitepaper). He graduated from the University of Montevideo, Uruguay, and received additional training at the Weizmann Institute of Science (Rehovot, Israel), Duke University Medical Center (Durham, NC) and the University of Toronto.

"I am delighted to welcome José to the Bioasis team, strengthening our oncology development expertise at a critical time as we progress our lead program xB3-001 for the treatment of HER2+ breast cancer and brain metastases. I am also extremely pleased to welcome John, Hope and Javier to the Medical Oncology Advisory Board. Each member is a leader in their field with proven track records of excellence in clinical practice and clinical drug development in the areas of breast cancer and CNS oncology." Deborah Rathjen added, Ph.D., Executive Chair of Bioasis. "We look forward to continuing to benefit from the strength of the collective experience of our medical board as we advance our xB3 programs toward the clinic."

Dr. José Iglesias commented, "Treatment of HER2+ breast cancer that has metastasized to the brain remains a significant challenge. To date, xB³-001 has demonstrated highly encouraging preclinical results, and I am excited to be working with Dr. Rathjen and the Bioasis team to continue to advance this class-leading technology."

Dr. John de Groot is a Professor, and Chairman ad interim, in the Department of Neuro-Oncology at The University of Texas MD Anderson Cancer Center. He is an expert in the fields of glioma angiogenesis and molecularly targeted therapy. Dr. de Groot has served as the principal investigator (PI) or co-investigator on multiple funded National Cancer Institute, foundation, and industry-sponsored grants. He is the principal investigator of numerous clinical trials involving novel agents being tested in patients with glioblastoma and is a leader of MD Anderson’s Glioblastoma Moon Shot. Dr. de Groot has over 112 peer reviewed articles. He is or has been a peer reviewer for 23 scientific journals, both national & international, and is on four editorial review boards. He completed his medical education at The University of Texas Medical Branch at Galveston, and pursued internship and residency at The Johns Hopkins School of Medicine.

Dr. Hope S. Rugo is Professor of Medicine at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, where she is also the director of Breast Oncology and Clinical Trials Education. She is a principal investigator of multiple clinical trials focusing on combining novel targeted therapeutics with standard treatment to improve the treatment of both early and late stage breast cancer and improving safety with targeted agents and has published widely in this area with over 200 peer reviewed articles. Dr. Rugo is an active member of the Translational Breast Cancer Research Consortium (TBCRC), a principal investigator of several TBCRC trials and is the co-chair of the Triple Negative Working Group. She is a member of the Breast Committee for the Alliance cooperative group, and is an associate editor for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting educational book. Dr. Rugo graduated from the University of Pennsylvania School of Medicine. She completed a residency in internal medicine followed by a fellowship in hematology and oncology at UCSF as well as a research fellowship at Stanford University.

From June 2003 to July 2015, Dr.Cortés worked in the Department of Medical Oncology at the Hospital Vall d’Hebron, Barcelona, where he has been Coordinator of the Teaching and Training Programme for Residents in Oncology and Senior Specialist in the Area of Breast Cancer with a special interest in new drug development. Dr. Cortés was the Head of the Breast Cancer Program and the Melanoma Unit from July 2006 to August 2015. From September 2015 to October 2018, he has been Head of the Breast Cancer and Gynecological tumors at Ramon y Cajal University Hospital in Madrid. He is Clinical Investigator of the Breast Cancer Research Program at Vall d’Hebron Institute of Oncology, and Head of Breast Cancer Program, IOB Institute of Oncology, Madrid and Barcelona, Spain. Dr Cortés is the author of more than 240 publications, with a focus on breast tumors and new drugs, and more than 500 communications at multiple conferences. He actively participates in the development of numerous national and international clinical investigations. Dr Cortés received a degree in Medicine and Surgery from the Universidad Autónoma de Madrid with continued studies at the University of Navarra, specializing in Medical Oncology at the Clínica Universitaria de Navarra. In addition to his medical specialties, he has two masters’ degree in Medical Direction and Clinical Management from the Universidad Nacional de Educación a Distancia (UNED) and Research Methodology in Health Sciences from the Universidad Autónoma de Barcelona as well as a degree in Statistics in Health Sciences from the same university.

On December 4, 2019 Charles River Laboratories International, Inc. (NYSE: CRL) reported updates to its online Tumor Model Compendium. Charles River’s cancer model database provides access to a comprehensive collection of well-established tumor models for early-stage oncology research (Press release, Charles River Laboratories, DEC 4, 2019, View Source [SID1234551935]).

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This update adds 79 new patient-derived xenografts (PDX), 10 new cell line-derived xenografts (CDX), and 36 new cell line (CL) models for several cancer types including: anal, colon, lung and renal cancer as well as leukemia and melanoma. Additionally, the update provides an increased depth of data for both whole exome sequencing (WES) and gene expression, with greater bioinformatics coverage:

71 new WES data sets, increasing whole exome data to 90 percent of models
92 new RNA-Seq data sets, increasing gene expression data to 87 percent of models
Charles River’s Compendium includes tumor models from a wide range of tumor subtypes for both in vivo and in vitro oncology research, including patient-derived xenografts (PDXs), cell line-derived xenografts (CDX), and syngeneic models.

This resource allows researchers to easily identify the most appropriate tumor models, leading to a more targeted study design from the start, saving time and money on the path to the clinic. The Compendium, when combined with Charles River’s robust portfolio of oncology services and scientific background, provides a highly translational platform for developing safe, effective oncology therapeutics.

Expansion of Oncology Portfolio
Charles River recently launched in vivo tumor microdialysis to support cancer research. Microdialysis is a uniquely sensitive and powerful method of sampling the tumor microenvironment of research models. With microdialysis, researchers are able to gather actionable data on the mechanism of action and perform more efficient decision making. Traditionally applied to neuroscience research, utilizing microdialysis in tumor models provides an excellent approach to model the pharmacokinetics of a given therapeutic compound.

Charles River has also developed two new research models specifically for the study of Graft vs Host Disease (GvHD). GvHD and other pharmacodynamic models can act as screening tools to evaluate the ability of immunoregulatory drugs to modulate disease progression, providing valuable information to progress the best version of a drug past preclinical testing.

Additionally, Charles River recently launched an expansion of its PDX portfolio in North America. Benefiting from over 30 years of experience, Charles River’s global PDX capabilities provide clients with the scientific guidance necessary to progress novel cancer therapeutics. To learn more about Charles River’s oncology research capabilities, visit www.criver.com.

Approved Quotes

"In oncology, we recognize the importance of identifying a model that will most closely mimic human disease, increasing translation from preclinical research to the clinic. An increased depth of data and additional model types provide an improved resource for making those critical decisions." – Birgit Girshick, Corporate Executive Vice President, Discovery & Safety Assessment, Biologics Testing Solutions, and Avian Vaccine Services at Charles River
"The application of microdialysis in oncology research provides a unique opportunity for researchers to detect and quantify multiple immunomodulators and oncometabolites from freely moving, tumor-bearing models. This insight into target engagement and mechanism of action aids faster progression into the clinic." – Arash Rassoulpour, PhD, Executive Director at Charles River
"Stem cell transplantation, while offering many anti-cancer benefits, has a high risk of complications due to the introduction of donor cells into a patient’s immune system. GvHD models provide a valuable tool to study the biology of this disease and improve success rates of stem cell transplantation as a cancer treatment." – Chassidy Hall, Site Director, Oncology Center of Excellence at Charles River

On December 4, 2019 Innovative Cellular Therapeutics (ICT), a biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for blood cancers and solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ICTCAR014, a next generation CD19-targeting CAR-T cell therapy that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells (Press release, Innovative Cellular Therapeutics, DEC 4, 2019, View Source [SID1234551918]). ICT expects to initiate a U.S. clinical trial evaluating ICTCAR014 in patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including patients whose tumors are PD-L1 positive, in the first part of 2020. Dr. David L. Porter of the Abramson Cancer Center of the University of Pennsylvania will be the Lead Principal Investigator for the clinical trial.

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"The clearance of our first U.S. IND is a significant step as we expand our U.S. activities," said Larry (Lei) Xiao, Ph.D., Chairman and Chief Executive Officer of ICT. "Building upon the encouraging data presented in November at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which showed objective response rate of over 92%, the ICTCAR014 program highlights our accelerated and de-risked approach for developing novel immunotherapies. Our development strategy translates rapid clinical proof-of-concept trials in China into U.S. and global development programs with the goal of regulatory approval through expedited review pathways. We look forward to advancing ICTCAR014 into our first U.S. clinical trial."

About ICTCAR014
The U.S. Food and Drug Administration (FDA) has cleared ICT’s Investigational New Drug (IND) application for ICTCAR014, a next generation CD19-targeting CAR-T cell therapy that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells. ICT is moving ICTCAR014 into a U.S. clinical trial. ICTCAR014, referred to as an "armored" CAR-T cell therapy, has already demonstrated encouraging results in proof-of-concept human trials in China. As highlighted in ICT’s presentation at the November 2019 Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting, ICTCAR014 demonstrated a 92.3% objective response rate (53.8% complete remission; 38.5% partial remission) in 13 initial patients with relapsed or refractory non-Hodgkin lymphoma. Significant tumor shrinkage and limited toxicity were observed.

On December 4, 2019 Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, reported the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $6.25 per share, before underwriting discounts and commissions, for gross proceeds of $125,000,000 (Press release, Ardelyx, DEC 4, 2019, View Source [SID1234551936]). In addition, Ardelyx has granted the underwriters of the offering the right for a period of 30 days to purchase up to an additional 3,000,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about December 9, 2019, subject to customary closing conditions.

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Ardelyx currently expects to use its existing cash, cash equivalents and short-term investments and the net proceeds from the offering to support its activities for the clinical development and potential commercialization of tenapanor for the treatment of hyperphosphatemia in patients with chronic kidney disease, or CKD, on dialysis, for regulatory activities to support the submission of a New Drug Application, in such indication, as well as for clinical trials and nonclinical studies for other product candidates, and for general corporate purposes and working capital.

Citigroup, Cowen, SVB Leerink and Piper Jaffray are acting as joint book-running managers for the offering.

A registration statement on Form S-3 (File No. 333-217441) relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on May 4, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained when available by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at [email protected]; or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 4, 2019 Moffitt Cancer Center, a leader in the clinical care and research of blood malignancies, reported that it will present its top clinical research at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Dec. 7-10 at the Orange County Convention Center in Orlando, Fla (Press release, Moffitt Cancer Ctr, DEC 4, 2019, View Source [SID1234551919]).

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Moffitt faculty are authors on more than 80 abstracts accepted for this year’s meeting, and will be presenting 37 including the four following oral presentations:

Date/Time: Saturday, Dec. 7, 3:00 p.m.

Abstract: 245

Title: Characteristics and Outcomes of Patients Receiving Bridging Therapy While Awaiting Manufacture of Standard of Care Axicabtagene Ciloleucel CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory Large B-Cell Lymphoma: Results from the US Lymphoma CAR-T Consortium

Presenter: Michael Jain, M.D., Ph.D., Assistant Member, Department of Blood and Marrow Transplant and Cellular Immunotherapy

Location: Hall E2, Level 2

Date/Time: Monday, Dec. 9, 8:00 a.m.

Abstract: 569

Title: The First-in-Class Anti-CD47 Antibody Magrolimab (5F9) in Combination with Azacitidine Is Effective in MDS and AML Patients: Ongoing Phase 1b Results

Presenter: David Sallman, M.D., Assistant Member, Department of Malignant Hematology

Location: W311EFGH, Level 3

Date/Time: Monday, Dec. 9, 11:15 a.m.

Abstract: 676

Title: Phase 2 Results of APR-246 and Azacitidine (AZA) in Patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)

Presenter: David Sallman, M.D., Assistant Member, Department of Malignant Hematology

Location: W311ABCD, Level 3 (Orange County Convention Center)

Date/Time: Monday, Dec. 9, 4:45 p.m.

Abstract: 842

Title: Combined Treatment with Lenalidomide and Epoetin Alfa Leads to Durable Responses in Patients with Epo-Refractory, Lower Risk Non-Deletion 5q [Del(5q)] MDS: Final Results of the E2905 Intergroup Phase III Study – an ECOG-ACRIN Cancer Research Group Study, Grant CA180820, and the National Cancer Institute of the National Institutes of Health

Presenter: Alan F. List, M.D., Senior Member, Department of Malignant Hematology

Location: W311ABCD, Level 3

If you’d like to schedule an interview with any Moffitt experts during the annual meeting, please contact Kim Polacek at [email protected].

You can also learn more about the cancer center by visiting booth no. 1464 on the exhibit floor during the meeting.