Data on Exicure’s TLR9 Agonist Spherical Nucleic Acid (SNA™) Construct Presented at the 4th CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference

On October 1, 2018 Exicure, Inc. (OTCQB:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional, spherical nucleic acid (SNA) constructs, repoted its presented data in a poster session on Sunday, September 30 at the 4th CRI-CIMT-EATI-AACR International Immunotherapy Conference: Translating Science into Survival in New York, New York (Press release, Exicure, OCT 1, 2018, View Source;p=RssLanding&cat=news&id=2369523 [SID1234529700]).

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!

The poster titled "AST-008, a novel TLR9 agonist SNA, induces abscopal antitumor effects in mouse tumor models" supports the ongoing clinical development of the Company’s proprietary SNA technology and highlights new data showing the effects of Exicure’s technology on mouse tumor models through a systemic immune response.

These data presented in the poster session show that both subcutaneous and intra-tumoral administration of AST-008 into one tumor lesion in the mouse model leads to systemic antitumor activity at a distant, un-injected tumor.

"These new data, along with data from other pre-clinical tumor model studies in combination with an anti-PD-1 antibody, and our recently completed Phase 1 trial support the continued advancement of Exicure’s drug candidate AST-008," said Dr. David Giljohann, Chief Executive Officer of Exicure. "We intend to launch our Phase 1b/2 clinical trial in combination with a checkpoint inhibitor in Q4 of 2018."

TESARO Announces Data Presentations at the SITC 2018 Annual Meeting

On October 1, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported that data from a total of five abstracts will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting from November 7-11, 2018 in Washington, D.C (Press release, TESARO, OCT 1, 2018, View Source [SID1234529719]).

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!

"At this year’s SITC (Free SITC Whitepaper) Annual Meeting, we are excited that several abstracts will be presented highlighting data from our rapidly advancing immuno-oncology portfolio, including an oral presentation of the first clinical data of TSR-022, our anti-TIM-3 antibody, in combination with TSR-042, our anti-PD-1 antibody," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "In addition, data from the GARNET trial of TSR-042 in recurrent non-small cell lung cancer (NSCLC) patients will be featured in a poster presentation. TSR-042 is the foundation of our lung cancer strategy and provides a strategic advantage for TESARO in further developing niraparib, TSR-022, and TSR-033, our anti-LAG-3 antibody."

Please plan to visit TESARO at Booth #333 for information about our pipeline.

Details of TESARO’s oral and poster presentations are as follows (all times local):

TSR-022 (anti-TIM-3)
A phase 1 study of TSR-022, an anti-TIM-3 monoclonal antibody, in combination with TSR-042 (anti-PD-1) in patients with colorectal cancer and post-PD-1 NSCLC and melanoma (AMBER)
Oral presentation; Abstract: 10877; Session: Friday, November 9, 2018, 2:15 PM – 4:50 PM
Poster Number: O21; Location: Hall E, Walter E. Washington Convention Center

Triple checkpoint blockade targeting PD-1, TIM-3, and LAG-3 improves T cell reinvigoration and antitumor efficacy over single and double combinations
Poster Number: P365; Abstract: 10823; Location: Hall E, Walter E. Washington Convention Center

The antitumor efficacy of TIM-3 blockade in a murine model of sarcoma
Poster Number: P677; Abstract: 10720; Location: Hall E, Walter E. Washington Convention Center

TSR-042 (anti-PD-1)
GARNET: Preliminary safety, efficacy, pharmacokinetic, and biomarker characterization from a Phase 1 clinical trial of TSR-042 (anti-PD-1 monoclonal antibody) in patients with recurrent/advanced NSCLC
Poster Number: P326; Abstract: 10853; Location: Hall E, Walter E. Washington Convention Center

TSR-033 (anti-LAG-3)
A phase 1 dose escalation study of TSR-033, an anti-LAG-3 monoclonal antibody, in patients with advanced solid tumors (CITRINO)
Poster Number: P325; Abstract: 10332; Location: Hall E, Walter E. Washington Convention Center

About TSR-042, TSR-022, and TSR-033

TSR-042 is an investigational humanized anti-programmed death (PD)-1 monoclonal antibody that binds with high affinity to the PD-1 receptor and effectively blocks its interaction with the ligands PD-L1 and PD-L2. TSR-042 is the only anti-PD-1 therapy being studied as monotherapy every 3 weeks for 4 doses then every 6 weeks thereafter. TSR-042 was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3 (TSR-075).

Keryx Biopharmaceuticals Announces Participation in an Upcoming Investor Conference

On October 1, 2018 Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with kidney disease, reported that it will participate in the Ladenburg Thalmann 2018 Healthcare Conference on Tuesday, October 2, 2018 in New York (Press release, Keryx Biopharmaceuticals, OCT 1, 2018, View Source/news-releases/news-release-details/keryx-biopharmaceuticals-announces-participation-upcoming-2" target="_blank" title="View Source/news-releases/news-release-details/keryx-biopharmaceuticals-announces-participation-upcoming-2" rel="nofollow">View Source [SID1234529682]).

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!

At the conference, Keryx will be participating in a 25 minute panel discussion titled Renal Anemia on Tuesday, October 2, 2018 at 3:30 p.m. Eastern time at the Sofitel New York in New York City.

A live audio webcast of both the panel discussion will be accessible from Keryx’s website at View Source within the Investor Relations section under "events and presentations." An archived version of the webcast will be available for at least 15 days following the conclusion of the panel discussion.

Thermo Fisher Scientific to Hold Earnings Conference Call on Wednesday, October 24, 2018

On October 1, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that it will release its financial results for the third quarter before the market opens on Wednesday, October 24, 2018, and will hold a conference call on the same day at 8:30 a.m. EDT (Press release, Thermo Fisher Scientific, OCT 1, 2018, View Source [SID1234529720]).

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!

During the call, the company will discuss its third quarter financial performance, as well as future expectations. To listen, call (844) 579-6824 within the U.S. or (763) 488-9145 outside the U.S. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can be found in that section of our website under "Financial Results." The webcast will be available under "Webcasts and Presentations" through Friday, November 9, 2018.

PharmaCyte Biotech Reports Completion of Crucial FDA-Required Study for Pancreatic Cancer Trial

On October 1, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully determined the modified site and chromosome location of the cytochrome P450-2B1 gene in the DNA of the genetically altered human cells known as 22P1G that will be encapsulated and used together with the cancer prodrug ifosfamide in PharmaCyte’s upcoming clinical trial (Press release, PharmaCyte Biotech, OCT 1, 2018, View Source [SID1234529683]). The cytochrome P450-2B1 gene is responsible for producing the enzyme that activates the ifosfamide into its cancer-killing form. The "integration site" information from this study was another requirement requested by the FDA. The site of integration was to be defined and included in PharmaCyte’s Investigational New Drug Application (IND) before the start of the clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).

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!

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "This study answers one of the key questions that was raised in our pre-IND meeting with the FDA. It represents the culmination of a long, complicated and expensive series of experiments as well as interpretation of a plethora of data that was generated over the last 12 months and is congruent with earlier data that we generated. Without these findings, we would be unable to submit our IND to the FDA, so this completed study moves us a significant step closer to submitting our IND to the FDA."

The study was an exceedingly complicated one that involved the latest cutting-edge techniques such as Next Generation Sequencing (NGS) as well as more classical techniques of polymerase chain reaction (PCR) analysis and DNA sequencing. The comprehensive and voluminous set of data that was generated from these tests was subjected to a robust and multi-faceted analysis. In addition to providing a better characterization of the cells at the DNA level, this analysis has revealed that the cytochrome P450-2B1 expression construct is located on human chromosome 9 in PharmaCyte’s 22P1G cell line. Additional analyses have revealed that the location of the construct is in a benign region of the human genome that should be "safe." This supports the previous conclusion that the 22P1G cells have a good safety profile.

The data obtained from the in-depth analyses also confirm data that has been previously announced by PharmaCyte that concerned enzymatic assays and Southern blotting analyses (a method used in molecular biology for detection of specific DNA sequence in DNA samples) of the 22P1G cells.