On December 5, 2019 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported it will present interim efficacy, immunological and safety data from its ongoing KEYNOTE-890 study of TAVO in combination with KEYTRUDA in patients with late-stage, heavily pretreated, chemo-refractory metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio Breast Cancer Symposium (SABCS) Annual Meeting being held December 10-14, 2019 (Press release, OncoSec Medical, DEC 5, 2019, View Source [SID1234551971]).

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The poster, titled "Phase 2, open-label study of intratumoral tavokinogene telseplasmid (tavo) plus electroporation in combination with intravenous pembrolizumab therapy in patients with inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) (KEYNOTE- 890/OMS-I141)," will be presented by lead author Melinda L. Telli, MD on Thursday, December 12th from 5:00 p.m. – 7:00 p.m. CST.

The SABCS abstracts are listed on the conference website under Abstracts at View Source!/7946 .

On December 5, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the European Medicines Agency ("EMA") has agreed to the Company’s proposed Pediatric Investigation Plan ("PIP") for omburtamab (Press release, Y-mAbs Therapeutics, DEC 5, 2019, View Source [SID1234551989]). The decision was made on the basis of a positive opinion from EMA’s Pediatric Committee ("PDCO"). Omburtamab is being developed by Y-mAbs for the treatment of CNS/leptomeningeal metastases from neuroblastoma which is the indication targeted by the PIP, as well as a number of additional cancer indications.

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As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application ("MAA") for any new medicinal product in Europe.

"We are pleased to announce this important regulatory milestone. The approval of the PIP provides Y-mAbs with a clear path for registration of omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. We look forward to continuing to work with EMA and PDCO to bring this important therapy to the European market as soon as possible," said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer further notes, "We are preparing the European submission of the marketing authorization application for omburtamab, and plan for submission in the second half of 2020. This is a vital step forward in our efforts of bringing omburtamab to the market in Europe, and it demonstrates the close and constructive interactions established with the regulatory authorities in Europe.

Researchers at Memorial Sloan Kettering ("MSK") developed the therapeutic product referenced in this statement, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product and in Y-mAbs.

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.