City of Hope Doctors Present New Research on CAR T Cell Therapy, Bone Marrow Transplants and Other Treatments for Blood Cancers

On November 19, 2018 City of Hope reported that it will present data on new findings on immunotherapies, including CAR T cell therapy, bone marrow transplants and other treatments for blood cancers, at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting Dec. 1-4 in San Diego (Press release, City of Hope, NOV 19, 2018, View Source [SID1234531447]).

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City of Hope is addressing some of the hardest-to-treat cancers by accelerating innovative clinical research approaches. The institution was a pioneer in bone marrow and stem cell transplants — and the transplantation program is now one of the largest, most successful programs of its kind in the U.S. Its CAR T therapy program was the first to treat patients with CAR T cells targeting the IL13Rα2 antigen in glioblastomas, and the first to offer CAR T trials targeting CD123 in acute myeloid leukemia.

City of Hope doctors will make special presentations at the ASH (Free ASH Whitepaper) conference. Joseph Alvarnas, vice president for government affairs and associate clinical professor of hematology and hematopoietic cell transplantation, will chair an ASH (Free ASH Whitepaper) Practice Partnership Lunch titled "How to Incorporate Palliative Care Into Practice: Addressing Barriers and Solutions," which addresses how patients with hematologic malignancies often have difficulty accessing high-quality symptom management and palliative care because of preconceived perceptions as well as limited reimbursement, and discusses solutions. The lunch takes place Sunday, Dec. 2, 2018, 11:15 a.m.-12:30 p.m., in the Marina Ballroom G (Marriott Marquis San Diego Marina).

City of Hope researchers will also make presentations on the following data:

610: CD19-CAR Therapy Using Naive/Memory or Central Memory T Cells Integrated into the Autologous Stem Cell Transplant Regimen for Patients with B-NHL
Type: Oral
Session: 731. Clinical Autologous Transplantation
Session Date and Time: Monday, Dec. 3, 2018: 7:45 a.m.
Location: Grand Hall B (Manchester Grand Hyatt San Diego)
Presenter: Leslie Popplewell, M.D., associate clinical professor, Department of Hematology & Hematopoietic Cell Transplantation

965: The Cerebroventricular Environment Reprograms Locally Infused CAR T Cells for Superior Activity Against Both CNS and Systemic B Cell Lymphoma
Type: Oral
Session: 703. Adoptive Immunotherapy: Preclinical Studies to Improve Safety and Efficacy of CAR-T Cells
Session Date and Time: Monday, Dec. 3, 2018: 5:30 p.m.
Location: San Diego Ballroom B (Marriott Marquis San Diego Marina)
Presenter: Xiuli Wang, Ph.D., research professor, Department of Hematology & Hematopoietic Cell Transplantation

399 Mosunetuzumab, a Full-Length Bispecific CD20/CD3 Antibody, Displays Clinical Activity in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (NHL): Interim Safety and Efficacy Results from a Phase 1 Study
Type: Oral
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)
Session Date and Time: Sunday, Dec. 2, 2018: 12:30 p.m.
Location: Pacific Ballroom 20 (Marriott Marquis San Diego Marina)
Presenter: Elizabeth Lihua Budde, M.D., Ph.D., assistant professor, Department of Hematology & Hematopoietic Cell Transplantation

300 Rapid MRD-Negative Responses in Patients with Relapsed/Refractory CLL Treated with Liso-Cel, a CD19-Directed CAR T-Cell Product: Preliminary Results from Transcend CLL 004, a Phase 1/2 Study Including Patients with High-Risk Disease Previously Treated with Ibrutinib
Type: Oral
Session: 642. CLL: Therapy, excluding Transplantation
Session Date and Time: Sunday, Dec. 2, 2018: 8:45 a.m.
Location: Pacific Ballroom 20 (Marriott Marquis San Diego Marina)
Presenter: Tanya Siddiqi, assistant clinical professor, Department of Hematology & Hematopoietic Cell Transplantation

620: Muscle Depletion Is an Important and Clinically Relevant Predictor of Outcomes after Autologous Hematopoietic Cell Transplantation
Type: Oral
Session: 904. Outcomes Research—Malignant Conditions: Outcomes in Lymphoid Malignancies and Stem Cell Transplant
Session Date and Time: Monday, Dec. 3, 2018: 7:15 a.m.
Location: Room 24B (San Diego Convention Center)
Presenter: Alex Iukuridze, clinical research assistant, Department of Population Sciences

611: Phase I Study of Yttrium-90 Labeled ANTI-CD25 (aTac) Monoclonal Antibody PLUS BEAM for Autologous Hematopoietic CELL Transplantation (AHCT) in Patients with Mature T-CELL NON-Hodgkin Lymphoma, the "a-TAC-BEAM Regimen"
Type: Oral
Session: 731. Clinical Autologous Transplantation
Session Date and Time: Monday, Dec. 3, 2018: 8 a.m.
Location: Grand Hall B (Manchester Grand Hyatt San Diego)
Presenter: Jasmine M. Zain, M.D., associate clinical professor, Department of Hematology & Hematopoietic Cell Transplantation, and director, T cell Lymphoma Program

4016 Adult Patients with ALL Treated with CD62L+ T Naïve/Memory-Enriched T Cells Expressing a CD19-CAR Mediate Potent Antitumor Activity with a Low Toxicity Profile
Type: Poster
Session: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation
Session Date and Time: Monday, Dec. 3, 2018, 6-8 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Samer K. Khaled, M.D. assistant clinical professor, Department of Hematology & Hematopoietic Cell Transplantation

2181: Clinical Outcomes of MDS Patients Who Were Allogeneic Hematopoietic Stem Cell Transplant Candidates but Did Not Proceed with Transplantation
Type: Poster
Session: 732. Clinical Allogeneic Transplantation
Session Date and Time: Saturday, Dec. 1, 2018, 6:15-8:15 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Rohan Gupta, clinical resident/fellow, Department of Medical Oncology & Therapeutics Research

1411: Novel BAFF-R CAR T-Cell Therapy for CD19 Antigen-Loss Relapsed B Cell Tumors
Type: Poster
Session: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation
Session Date and Time: Saturday, Dec. 1, 2018, 6:15-8:15 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Hong Qin, Ph.D., associate research professor, Department of Hematology & Hematopoietic Cell Transplantation

3967: Disease Burden Subgroup Analysis of Health-Related Quality of Life of Blinatumomab Versus Standard-of-Care Chemotherapy in Patients with Relapsed or Refractory Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia in a Randomized, Open-Label Phase 3 Study (TOWER)
Type: Poster
Session: 612. Acute Lymphoblastic Leukemia
Session Date and Time: Monday, Dec. 3, 2018, 6-8 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Anthony Stein, M.D., co-director, Gehr Family Center for Leukemia Research, clinical professor, Department of Hematology & Hematopoietic Cell Transplantation

Pulse Biosciences, Inc. Announces Commencement of Rights Offering

On November 19, 2018 Pulse Biosciences, Inc. (Nasdaq: PLSE) ("Pulse Biosciences" or the "Company"), a novel medical therapy company bringing to market its proprietary CellFX Nano-Pulse Stimulation (NPS) platform, reported that it has commenced its previously announced rights offering of $45,000,000 of its common stock (Press release, Pulse Biosciences, NOV 19, 2018, View Source [SID1234531448]). The subscription rights will expire and have no value if they are not exercised prior to 5:00 p.m. Eastern Time on Thursday December 6, 2018 (the "Expiration Date").

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Pursuant to the rights offering, Pulse Biosciences is distributing, at no charge to the holders of its common stock, non-transferable subscription rights to purchase up to $45,000,000 of shares of its common stock at a subscription price per share equal to the lesser of (i) $13.33 per share (the "Initial Price") or (ii) the volume weighted average price (the "Alternate Price") of the Company’s common stock as calculated for the five-trading day period through and including the Expiration Date.

Stockholders wishing to exercise subscription rights must timely pay $13.33 per share, the Initial Price, for the number of shares of common stock they wish to acquire. If the Alternate Price is lower than the Initial Price on the Expiration Date, any excess subscription amounts paid by a subscribing holder will be applied towards the purchase of additional shares in the rights offering. Stockholders who fully exercise their basic subscription rights will be entitled to subscribe for additional shares that are not purchased by other stockholders, on a pro rata basis and subject to availability and ownership limitations.

A registration statement relating to the shares of common stock was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on November 6, 2018. A prospectus relating to the offering was filed with the SEC on November 19, 2018 and is available on the SEC’s website.

Stockholders may exercise their subscription rights by delivering documentation of their subscription and payment in the manner specified in the prospectus relating to the rights offering. Beneficial stockholders (i.e. stockholders whose shares are in a brokerage account), should exercise their subscription rights as indicated in the instructions provided by their broker-dealer. Procedures and dates set-forth by broker-dealers may differ from those in offering documents. Investors wishing to participate in the Company’s offering are encouraged to contact their broker-dealer for further information.

Questions about the rights offering and requests for copies of the prospectus relating to the rights offering may be directed to Broadridge Corporate Issuer Solutions, Inc., the Company’s information and subscription agent for the rights offering, after the Record Date by calling (888) 789-8409 (toll-free) or by emailing [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer will be made only by means of the prospectus forming a part of the effective registration statement.

Bausch Health Announces Participation In Upcoming Investor Conferences

On November 19, 2018 Bausch Health Companies Inc. (NYSE/TSX: BHC) reported that the company will participate in three upcoming investor conferences (Press release, Valeant, NOV 19, 2018, View Source [SID1234531479]).

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Joseph C. Papa, chairman and chief executive officer, is scheduled to participate at the 30th Annual Piper Jaffray Healthcare Conference in New York on Nov. 27, 2018 at 10:30 a.m. ET.

Paul S. Herendeen, executive vice president and chief financial officer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Evercore ISI HealthconX Conference on Nov. 28, 2018 in Boston at 3:30 p.m. ET.

Paul S. Herendeen, executive vice president and chief financial officer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the 2018 Citi Global Healthcare Conference on Dec. 5, 2018 in New York at 8:45 a.m. ET.

Live webcasts and audio archives of the events will be available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source

Bexion Pharmaceuticals, Inc. Presents Clinical Data at 2018 SNO Annual Meeting

On November 19, 2018 Bexion Pharmaceuticals, Inc., a clinical – stage biopharmaceutical company focused on rare brain and solid tumors, reported that a clinical oral report followed by poster review and a second case study poster were presented at the Society of Neuro – Oncology (SNO) Annual Meeting held November 16 – 18 in New Orleans, LA (Press release, Bexion, NOV 19, 2018, View Source [SID1234531577]). The SNO Annual Meeting brings together more than 2600 research ers and clinicians in the field of neuro – oncology.

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Bexion’s representation:
High – Grade Glioma O utcomes in the Phase 1 BXQ – 350 Trial of Cancer – Selective SapC – DOPS Nanovesicles

Vinay Puduvalli, MD, Professor and Director, Division of Neuro – Oncology, The Ohio State University Comprehensive Cancer Center gave an oral presentation on November 16 th discussing the safety outcomes of High Grade Glioma (HHG) patients from a Phase 1a BXQ – 350 trial (NCT02859857). This was followed by a traditional poster viewing.

Initial Experience in Ependymoma with Investigational Cancer – Targeting BXQ – 350 SapC – DOPS Nanovesicles: A Rare Tumor Case Study

During a poster presentation on Saturday November 17 th , John Villano MD, Director, Clinical Neuro – Oncology Research Program, Markey Cancer Center and Professor of Medicine, University of Kentucky HealthCare discussed the safety profile in a rare tumor type resulting from a Phase 1a BXQ – 350 trial (NCT02859857).

"Bexion was honored to participate in the SNO Annual meeting. We are exc ited to have presented new BXQ – 350 data from our Phase 1 program by our Principal Investigators ," stated Dr. Ray Takigiku, Founder and CEO of Bexion.

About BXQ – 350
BXQ – 350 is a unique formulation of a synthetically produced, human lysosomal protein, Saposin C (sphingolipid activator protein, or SapC), and the phospholipid dioleoylphosphatidylserine (DOPS).

AIVITA Biomedical Announces Treatment of First Two Patients in Phase 2 Glioblastoma Trial

On November 16, 2018 AIVITA Biomedical reported that it has dosed the first two patients in its Phase 2 clinical trial in patients with newly diagnosed glioblastoma (Press release, AIVITA Biomedical, NOV 16, 2018, View Source [SID1234531407]). The trial is designed to investigate AIVITA Biomedical’s next-generation patient-specific cancer treatment, uniquely targeting the patient’s tumor-initiating cells.

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The first two patients were treated at the University of California Irvine (UCI) Comprehensive Brain Tumor Program under the direction of UCI Health neuro-oncologist and Principal Investigator Daniela Bota, MD, PhD.

AIVITA will enroll approximately 55 patients in its ROOT OF CANCER Glioblastoma trial to receive the Company’s patient-specific cancer treatment, which is administered in a series of subcutaneous injections alongside standard care. AIVITA is also expanding access to the trial, having recently adding the University of California San Diego and John Wayne Cancer Institute as clinical sites.

"I am very proud of the AIVITA team for so effectively running three clinical programs in two countries," said Dr. Bob Dillman, Chief Medical Officer at AIVITA. "This is enabled by a quick, reliable and inexpensive manufacturing process and a treatment protocol that truly complements the regime of cancer care."

AIVITA’s ROOT OF CANCER technology is also the subject of an ongoing multi-center Phase 2 clinical trial treating ovarian cancer in the USA, and an application to commercialize the treatment of melanoma patients in Japan. Previously, this treatment was tested in two Phase 2 trials in patients with advanced melanoma and approved for Phase 3 testing. These clinical studies demonstrated a 72% 2-year survival rate and a 54% 5-year survival rate, supporting AIVITA’s conditional commercial approval application in Japan. The Company is considering Japanese strategic partners for this program.

About the ROOT OF CANCER Glioblastoma trial

AIVITA’s treatment is a platform technology applicable to any solid tumor type and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established by AIVITA, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917