On November 1, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that responses to U.S. Food and Drug Administration (“FDA”) requests for additional information relating to the physician-sponsored Investigational New Drug (“IND”) application to study WP1066 as a potential treatment for brain tumors have been submitted (Press release, Moleculin, NOV 1, 2017, View Source [SID1234521391]).

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“We have been working closely with MD Anderson to help them respond to questions from the FDA,” commented Walter Klemp, Chairman and CEO of Moleculin. “A favorable response from the FDA on this request for IND would mean we will have two distinctly different potential cancer drugs in clinic, both Annamycin and WP1066.”
As the Company has disclosed previously, the physician-sponsored IND had been placed on clinical hold pending satisfactory responses to questions provided by the FDA. An MD Anderson physician is planning to conduct a Phase 1 clinical trial to study WP1066 in patients with glioblastoma or melanoma that has metastasized to the brain. Standard FDA procedure is to respond to such IND submissions within 30 days.

On November 1, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported initiated a phase 1b/2a immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM) designed to evaluate cemiplimab (also known as REGN2810), a PD-1 inhibitor developed by Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), in combination with Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12 (Press release, Inovio, NOV 1, 2017, View Source [SID1234521388]).

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The open-label trial of 50 patients will be conducted at approximately 30 U.S. sites, and the primary endpoints are safety and tolerability. The study will also evaluate immunological impact, progression-free survival and overall survival.

GBM is a devastating disease for both patients and caregivers. It is the most aggressive brain cancer and its prognosis is extremely poor, despite a limited number of new therapies approved over the last 10 years. The median overall survival for patients receiving standard of care therapy is approximately 15 months and the average five-year survival rate is less than three percent.

Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, “Inovio is successfully executing on its immuno-oncology strategy through both combination and in monotherapy trials. Our clinical partnerships and collaborations with MedImmune, Genentech and Regeneron each provide for clinical evaluation of Inovio immunotherapies combined with checkpoint inhibitors, given a strong scientific rationale to combine an immunotherapy, which generates antigen-specific killer T cells, with a checkpoint inhibitor which augments T cell activity. I believe that INO-5401, a three antigen product targeting WT-1, PSMA and hTERT, offers great potential to address multiple cancers. Our INO-5401 combination study in GBM, as well as its sister study in advanced bladder cancer, represents an important opportunity for Inovio and its collaborators to address significant unmet medical need.”

Under a May 2017 agreement between Inovio and Regeneron, the combination trial will be solely conducted and funded by Inovio, based upon a mutually agreed upon trial design, and Regeneron will supply cemiplimab. Inovio and Regeneron will jointly conduct immunological analyses in support of the study. Regeneron, as part of their immuno-oncology collaboration with Sanofi, is developing cemiplimab both as a monotherapy and in combination with other therapies for the treatment of various cancers.

On November 1, 2017 Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that two oral and four poster presentations detailing clinical and preclinical results will be featured at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition(Press release, Fate Therapeutics, NOV 1, 2017, View Source [SID1234521387]). The meeting will be held December 9-12, 2017 in Atlanta, Georgia.

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An oral presentation will describe the generation of CD8αβ+ T cells from an induced pluripotent stem cell (iPSC) line engineered to express a chimeric antigen receptor (CAR). This breakthrough was led by Dr. Michel Sadelain, MD, PhD, Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center (MSK), under the Company’s multi-year sponsored research collaboration with MSK. As part of the collaboration, Fate Therapeutics has created clonal iPSC master cell lines engineered to express CARs and other functional elements and are also modified to attenuate alloreactivity and enhance persistence for off-the-shelf CAR T-cell immunotherapy. The Company’s first iPSC-derived CAR T-cell product candidate FT819, which is derived from a clonal iPSC master cell line engineered to express a CAR targeting CD19 and edited to remove T-cell receptor (TCR) expression, is undergoing preclinical development.

A second oral presentation will describe the production under current good manufacturing practice (cGMP) conditions of FT500, the Company’s first-of-kind natural killer (NK) cell product candidate derived from a clonal iPSC master cell line. The transformative manufacturing paradigm, which will be described by Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota, enables the efficient production of a large clonal population of NK cells in a single production run and is capable of yielding thousands of doses of homogeneous drug product for off-the-shelf delivery to patients. Fate Therapeutics plans to file a landmark Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) in the first quarter of 2018 to initiate first-in-human clinical investigation of FT500 in combination with FDA-approved checkpoint inhibitors for the treatment of advanced solid tumors.

In addition, Fate Therapeutics will present clinical data from the PROTECT study of ProTmune, a next-generation hematopoietic cell graft for patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Key clinical outcomes, including incidence rates of acute graft-versus-host disease, cancer relapse and survival at 100 days following HCT, for the seven subjects administered ProTmune in the Phase 1 stage of PROTECT will be released. Three other poster presentations will highlight additional iPSC-derived immuno-oncology product candidates that the Company is developing.

2017 ASH (Free ASH Whitepaper) Oral Presentations

FT819 iPSC-derived CAR19 T-Cell Cancer Immunotherapy
Title: Generation of Clonal Antigen Specific CD8αβ+ Cytotoxic T Lymphocytes from Renewable Pluripotent Stem Cells for Off-the-Shelf T-Cell Therapeutics
Last Author: Michel Sadelain, MD, PhD, Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center
Publication Number: 163
Session: 703. Adoptive Immunotherapy: Immune Therapeutics for Hematologic Cancers
Date and Time: Saturday, December 9, 2017, 12:00 PM
Location: Building B, Level 2, B206

FT500 iPSC-derived NK Cell Cancer Immunotherapy
Title: Clinical Translation of Pluripotent Cell-Derived Off-the-Shelf Natural Killer Cell Cancer Immunotherapy
Last Author: Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota
Publication Number: 656
Session: 711. Cell Collection and Processing
Date and Time: Monday, December 11, 2017, 10:45 AM
Location: Building B, Level 2, B216-B217
2017 ASH (Free ASH Whitepaper) Poster Presentations

iPSC-derived CAR NK Cell Cancer Immunotherapy
Title: Engineering Human Induced Pluripotent Stem Cells with Novel Chimeric Antigen Receptors to Generate Natural Killer Cell Cancer Immunotherapies with Targeted Anti-Tumor Activity
Last Author: Dan S. Kaufman, MD, PhD, Director of Cell Therapy, UCSD
Publication Number: 1905
Session: 703. Adoptive Immunotherapy: Poster I
Date and Time: Saturday, December 9, 2017, 5:30 PM – 7:30 PM
Location: Building A, Level 1, Hall A2

iPSC-derived Cancer Immunotherapy Product Platform
Title: Multi-Functional Genetic Engineering of Pluripotent Cell Lines for Universal Off-the-Shelf Natural Killer Cell Cancer Immunotherapy
Last Author: Bahram Valamehr, PhD, VP Cancer Immunotherapy, Fate Therapeutics
Publication Number: 3187
Session: 703. Adoptive Immunotherapy: Poster II
Date and Time: Sunday, December 10, 2017, 6:00 PM – 8:00 PM
Location: Building A, Level 1, Hall A2

FT516 iPSC-derived hnCD16 NK Cell Cancer Immunotherapy
Title: Genetically Engineered Pluripotent Cell-Derived Natural Killer Cell Therapy Provides Enhanced Antibody Dependent Cellular Cytotoxicity Against Hematologic Malignancies and Solid Tumors in Combination with Monoclonal Antibody Therapy
Last Author: Dan S. Kaufman, MD, PhD, Director of Cell Therapy, UCSD
Session: 703. Adoptive Immunotherapy: Poster III
Publication Number: 4452
Date and Time: Monday, December 11, 2017, 6:00 PM – 8:00 PM
Location: Building A, Level 1, Hall A2

ProTmune
Title: ProTmune, the Next Generation Graft for Allogeneic Hematopoietic Cell Transplantation: Phase 1 Safety and Efficacy Data
First Author: Richard Maziarz, MD, Principal Investigator, Oregon Health Sciences University
Session: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution
Publication Number: 4498
Date and Time: Monday, December 11, 2017, 6:00 PM – 8:00 PM
Location: Building A, Level 1, Hall A2
About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables genetic engineering, high-throughput single-cell isolation and clonal selection of human iPSCs and supports long-term maintenance of human iPSCs as master pluripotent cell lines. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. Similar to master cell lines used for the manufacture of monoclonal antibodies, clonal iPSC master cell lines can serve as a renewable cell source for the consistent and repeated manufacture of homogeneous cell products with the potential to treat many different diseases and many thousands of patients in an off-the-shelf manner. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 90 issued patents and 100 pending patent applications.

On November 1, 2017 Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) (Cyclacel or the Company), a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases, reported that data from the Company’s Phase 3 SEAMLESS study in acute myeloid leukemia, or AML, have been selected for an oral presentation at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, Georgia, on December 11, 2017 (Press release, Cyclacel, NOV 1, 2017, View Source [SID1234521386]). SEAMLESS is a global, randomized study evaluating a regimen of oral sapacitabine alternating with intravenous decitabine versus intravenous decitabine in elderly patients with AML who are unfit for intensive chemotherapy.

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Presentation details are as follows:

Date and Time: Monday, December 11, 2017 at 6:45 p.m. EST
Abstract Title: Results of a Phase 3 Study of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles
Session Number: 616
Session Name: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Therapies for Elderly Patients with AML
Publication Number: 891
Room: Georgia World Congress Center, Bldg B, Lvl 5, Murphy BR 1-2

Abstracts for the 2017 ASH (Free ASH Whitepaper) Annual Meeting can be accessed at: View Source

On November 1, 2017 Genomic Health, Inc. (NASDAQ: GHDX) reported that the company will host a conference call and webcast on Wednesday, November 8 at 4:30 p.m. Eastern Time to discuss its third quarter 2017 financial results. The call and webcast will follow the release of the third quarter financial results after market close (Press release, Genomic Health, NOV 1, 2017, View Source [SID1234521464]).

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Conference Call Details
To access the live conference call on November 8 at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada, or +1 (224) 357-2389 internationally. The conference call ID is 5697809. Please dial in approximately ten minutes prior to the start of the call.

To access the live and subsequently archived webcast of the presentation, go to the Investor Relations section of the company’s web site at View Source Please connect to the web site at least 15 minutes prior to the presentation to allow for any software download that may be necessary.