On November 1, 2017 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, reported that it will release its third quarter 2017 financial results on Wednesday, November 8, 2017 (Press release, Savara, NOV 1, 2017, View Source [SID1234521463]). Savara management will also host a conference call for investors beginning at 5:30p.m. ET on Wednesday November 8, 2017 to discuss its third quarter 2017 financial results and to provide a business update.

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

                  Schedule Your 30 min Free Demo!

Shareholders and other interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from outside the U.S. and should request the Savara Inc. Call. A live webcast of the conference call will be available online from the Investors section of Savara’s website at View Source Replays of the webcast will be available on Savara’s website for 30 days and a telephone replay will be available through November 15th, 2017 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada, and (412) 317-0088 from elsewhere outside the U.S. and entering replay access code 10114091.

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.

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

                  Schedule Your 30 min Free Demo!

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 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]).

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

                  Schedule Your 30 min Free Demo!

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."

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

                  Schedule Your 30 min Free Demo!

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

                  Schedule Your 30 min Free Demo!