On November 1, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on developing gene and cell-based immunotherapies for cancer, reported that five abstracts highlighting data from the Company’s adoptive cell-based therapeutic programs have been accepted for presentation at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, December 9-12, in Atlanta (Press release, Ziopharm, NOV 1, 2017, View Source [SID1234521408]).

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Data from ongoing clinical and preclinical studies will be highlighted at ASH (Free ASH Whitepaper) including research, conducted with collaborators at The University of Texas MD Anderson Cancer Center and Intrexon Corporation (NYSE:XON), that further validates the Company’s Sleeping Beauty (SB) platform in chimeric antigen receptor (CAR) modified T cell therapy and demonstrates the potential for very rapid T-cell production (<2 days) with point-of-care (P-O-C) technology.

Presentations include long-term follow-up data from the initial clinical trial infusing first-generation SB-modified CD19-specific CAR+ T cells and interim data from the Company’s ongoing clinical trial of second-generation SB-modified CD19-specific CAR+ T cells that serves as a gateway to the trial infusing T cells manufactured under the P-O-C platform.

Additional abstracts include an update on the Company’s lentiviral approach to express CD33-specific CAR with a kill switch in patients with relapsed of refractory acute myeloid leukemia, as well as preclinical data supporting the use of genetically engineered regulatory T cells to treat graft versus host disease.

Details for ASH (Free ASH Whitepaper) presentations are as follows:

Title: Long Term Follow up after Adoptive Transfer of CD19-Specific CAR+T Cells Genetically Modified Via Non-Viral Sleeping Beauty System Following Hematopoietic Stem Cell Transplantation (HSCT)
Presenter: Partow Kebriaei, M.D.
Session Title: 801. Gene Therapy and Transfer: Poster I
Date and Time: Saturday, December 9, 2017, 5:30 — 7:30 p.m. ET
Publication ID: 2059
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

Title: Shortening the Time to Manufacture CAR+ T Cells with Sleeping Beauty System Supports T-Cell Engraftment and Anti-Tumor Effects in Patients with Refractory CD19+ Tumors
Presenter: Partow Kebriaei, M.D.
Session Title: 801. Gene Therapy and Transfer: Poster I
Date and Time: Saturday, December 9, 2017, 5:30 — 7:30 p.m. ET
Publication ID: 2060
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

Title: Genetically Engineered Regulatory T Cells for Treatment of Graft-Versus-Host-Disease
Presenter: Hanspeter Waldner, Ph.D.
Session Title: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster II
Date and Time: Sunday, December 10, 2017, 6:00 — 8:00 p.m. ET
Publication ID: 3176
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

Title: CD19-Specific Chimeric Antigen Receptor-Modified T Cells with Safety Switch Produced Under “Point-Of-Care” Using the Sleeping Beauty System for the Very Rapid Manufacture and Treatment of B-Cell Malignancies
Presenter: Tim Chan, Ph.D.
Session Title: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster
Date and Time: Saturday, December 9, 2017, 5:30 — 7:30 p.m. ET
Publication ID: 1324
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

Title: Autologous T Cells Modified to Co-express CD33-Specific Chimeric Antigen Receptor and a Kill Switch for Treatment of CD33+ Acute Myeloid Leukemia
Presenter: Tim Chan, Ph.D.
Session Title: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster
Date and Time: Saturday, December 9, 2017, 5:30 — 7:30 p.m. ET
Publication ID: 1376
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

Fate Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Fate Therapeutics, 2017, NOV 1, 2017, View Source [SID1234521413]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On November 1, 2017 Geron Corporation (Nasdaq:GERN) reported financial results for the three and nine months ended September 30, 2017 (Press release, Geron, NOV 1, 2017, View Source [SID1234521431]).

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For the third quarter of 2017, the company reported a net loss of $6.9 million, or $0.04 per share, compared to $3.6 million, or $0.02 per share, for the comparable 2016 period. Net loss for the first nine months of 2017 was $20.5 million, or $0.13 per share, compared to $21.1 million, or $0.13 per share, for the comparable 2016 period. The company ended the third quarter of 2017 with $112.7 million in cash and investments.

Revenues for the three and nine months ended September 30, 2017 were $163,000 and $874,000, respectively, compared to $5.1 million and $6.1 million for the comparable 2016 periods. Revenues for the three and nine month periods ending September 30, 2016 included license fee revenue of $5.0 million in connection with an upfront payment under a license agreement signed in September 2016 with Janssen Pharmaceuticals, Inc. for certain rights to specialized oligonucleotide backbone chemistry and novel amidates.

Total operating expenses for the three and nine months ended September 30, 2017 were $7.4 million and $22.3 million, respectively, compared to $9.0 million and $27.9 million for the comparable 2016 periods. Research and development expenses for the three and nine months ended September 30, 2017 were $2.6 million and $8.5 million, respectively, compared to $4.3 million and $13.9 million for the comparable 2016 periods. The decrease in research and development expenses for the three and nine month periods ending September 30, 2017, compared to the same periods in 2016, primarily reflects lower costs for the company’s proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. and reduced personnel related expenses. General and administrative expenses for the three and nine months ended September 30, 2017 were $4.8 million and $13.8 million, respectively, compared to $4.7 million and $14.0 million for the comparable 2016 periods. The increase in general and administrative expenses for the three-month period ending September 30, 2017, compared to the same period in 2016, primarily reflects higher non-cash stock-based compensation expense. The decrease in general and administrative expenses for the nine-month period ending September 30, 2017, compared to the same period in 2016, primarily reflects lower consulting and legal costs, partially offset by higher non-cash stock-based compensation expense.

Interest and other income for the three and nine months ended September 30, 2017 was $363,000 and $1.0 million, respectively, compared to $322,000 and $871,000 for the comparable 2016 periods. The increase in interest and other income for the three and nine month periods ending September 30, 2017, compared to the same periods in 2016, primarily reflects higher yields on the company’s marketable securities portfolio.

Conference Call and Webcast

At 4:30 p.m. ET on November 1, 2017, Geron’s management will host a conference call to discuss the company’s third quarter results as well as recent events.

Participants can access the conference call live via telephone dialing 877-303-9139 (U.S.); 760-536-5195 (international). The conference ID is 1056465. A live audio-only webcast is also available through the Investors section of the company’s website at www.geron.com or at View Source The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through December 1, 2017.

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.