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

On November 1, 2017 Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, reported that it has received the U.S. Food and Drug Administration’s (FDA) response to the NT219’s pre-IND meeting package (Press release, Kitov Pharmaceuticals , NOV 1, 2017, View Source [SID1234521437]). FDA has agreed to the proposed Chemistry Manufacturing and Controls (CMC), preclinical, and clinical development plans for NT219. For the clinical development plan, the FDA agreed with TyrNovo’s proposed development plan to test NT219 in combination with gemcitabine for the treatment of advanced pancreatic cancer. The FDA further agreed that the initial clinical trial with NT219 will be a Phase I/II clinical trial, and that "the overall design of proposed first-in-human trial appears reasonable". The FDA further agreed that one-month animal toxicology studies for NT219 would be sufficient to support the IND and that no toxicology studies of NT219 together with gemcitabine would be necessary.

"We are very pleased that FDA’s Division of Oncology Products has accepted our chemistry, non-clinical, and clinical development plans for TyrNovo’s cancer drug, NT219, and we are moving forward with these development plans. We appreciate FDA’s helpful guidance and look forward to continuing to work with the FDA toward an IND submission, which based on our current development plans, we now expect to submit during the first half of 2019," said Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer.

Dr. Hadas Reuveni, TyrNovo’s Founder and CTO added: "According to the National Cancer Institute, pancreatic cancer is the fourth leading cause of cancer death in the US and is known to be one of the most aggressive and difficult-to-treat cancer types. NT219 works by overcoming drug resistance and can be combined with various oncology drugs. Our drug’s efficacy was demonstrated in preclinical patient-derived xenograft (PDX) models with various oncology therapies such as chemotherapy agents, EGFR Antibodies, MEK and mTOR inhibitors, and also in combination with immuno-oncology agents such as Keytruda. We will initially be clinically testing NT219 in combination with gemcitabine on advanced pancreatic cancer patients, based on our consistent encouraging results in preclinical PDX models. Our long-term strategy is to develop NT219 in combination with other oncology drugs and for additional oncology indications in collaboration with potential strategic partners, who have expressed solid preliminary interest in NT219."

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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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Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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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Discover why more than 1,500 members use 1stOncology™ to excel in:

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.