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]).

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"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).

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]).

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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."

Hitachi Chemical Advanced Therapeutics Solutions Signs Three-Year Agreement with GSK to Provide Clinical Manufacturing for T Cell Therapy

On October 1, 2018 Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS) reported that they have signed a three-year clinical manufacturing agreement with GSK, a science-led global healthcare company (Press release, HCATS, OCT 1, 2018, https://www.businesswire.com/news/home/20181001005013/en/Hitachi-Chemical-Advanced-Therapeutics-Solutions-Signs-Three-Year [SID1234529696]). Under the agreement, HCATS will manufacture GSK’s SPEAR T-cell receptor therapy targeting NY-ESO-1 for the US, Canadian and European trials. NY-ESO is expressed across a variety of tumors including sarcomas, melanoma, multiple myeloma, bladder cancer, non-small cell lung cancer, ovarian cancer and gastro-intestinal cancers.

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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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HCATS is a US subsidiary of Hitachi Chemical Co. Ltd. that engages in contract manufacturing and development of cell-based cell and gene therapy products through its PCT Global Service Platform.

"Since becoming part of Hitachi Chemical over a year ago, we have seen increasing interest in leveraging our PCT Global Service Platform both in the United States and Japan," said Robert A. Preti, PhD, CEO and President of HCATS and General Manager of the Hitachi Chemical Regenerative Medicine Business Sector. "This agreement is an exciting step for our growing global enterprise, advancing our vision to support efforts to make these transformative therapies accessible to all."

"We are extremely proud and grateful to enter into a relationship with GSK, as it provides the opportunity to partner with an industry leader," said Sanjin Zvonić, PhD, Senior Director, Business Leader, Clinical and Commercial Manufacturing of HCATS. "As with all our clients, we are committed to delivering high-quality, compliant, flexible, scalable, and cost-effective manufacturing services."

Pulse Biosciences to Present at the Cantor Global Healthcare Conference

On October 1, 2018 Pulse Biosciences, Inc. (NASDAQ: PLSE), a novel medical therapy company bringing to market its proprietary Nano-Pulse Stimulation platform, reported that Darrin Uecker, President and Chief Executive Officer, is scheduled to present at the Cantor Global Healthcare Conference in New York at 4:00 p.m. Eastern Time on Wednesday, October 3rd, 2018 (Press release, Pulse Biosciences, OCT 1, 2018, View Source [SID1234529694]).

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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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A live webcast of the presentation will be available through the Investor Relations pages of the Pulse Biosciences website at View Source and at View Source Following the live presentation, the webcast will be archived and available for replay at the same address for a period of 90 days.

Novocure to Report Third Quarter 2018 Financial Results

On October 1, 2018 Novocure (NASDAQ: NVCR) reported that it will report financial results for the third quarter 2018 on Thursday, October 25, 2018, before the U.S. financial markets open (Press release, NovoCure, OCT 1, 2018, View Source [SID1234529693]). Novocure management will host a conference call and webcast to discuss its financial results for the three and nine months ended September 30, 2018, at 8 a.m. EDT on Thursday, October 25, 2018.

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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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Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 2186119. The webcast and earnings slides presented during the webcast can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the call.