On March 12, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported two niraparib presentations at the 2017 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, March 12 to 15, 2017, in National Harbor, Maryland (Press release, TESARO, MAR 12, 2017, View Source [SID1234518110]).

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!

Please visit TESARO during SGO at Booth #325 for information about VARUBI, niraparib and our pipeline.

Presentation Details:

Monday, March 13, 2017 10:45 AM to 11:45 AM
ENGOT-OV16/NOVA: Results of secondary efficacy endpoints of niraparib maintenance therapy in ovarian cancer
Abstract: 8084, Oral Presentation, Location: Hall A, Time: 11:10 AM

Monday, March 13, 2017 3:30 PM — 5:00 PM and Tuesday, March 14, 2017 3:30 PM — 4:30 PM
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of niraparib maintenance treatment in patients with advanced ovarian cancer following response on frontline platinum-based chemotherapy — Trial-in-progress (PRIMA)
Abstract:8121, Poster Presentation 203, Location: Hall BC

About Niraparib

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three pivotal trials. In pre-clinical studies, niraparib was found to concentrate in the tumor relative to plasma, delivering selective, greater than 90% durable PARP inhibition and a persistent anti-tumor effect.

TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients who have received first-line treatment for ovarian cancer (the PRIMA trial), a registrational Phase 2 trial in patients who have received multiple lines of treatment for ovarian cancer (the QUADRA trial), and a Phase 3 trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab and niraparib plus bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

The niraparib New Drug Application (NDA) has been accepted for priority review by the FDA and is supported by data from the ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study that enrolled 553 patients, either with or without a germline BRCA mutation, with recurrent ovarian cancer following complete or partial response to their most recent platinum-based chemotherapy. The full results of the ENGOT-OV16/NOVA trial were presented in detail at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress in Copenhagen on October 8, 2016 by Dr. Mansoor Raza Mirza, M.D., Medical Director of the Nordic Society of Gynecologic Oncology (NSGO) and principal investigator. These data were simultaneously published in the New England Journal of Medicine.

Regulatory applications are under review for niraparib in the U.S. and Europe and TESARO expects to launch niraparib in the U.S. in the first half of 2017 and in Europe by year-end 2017, pending regulatory approvals. Niraparib is an investigational agent and, as such, has not been approved by the U.S. FDA, European Medicines Agency (EMA), or any other regulatory agencies.

About Ovarian Cancer
Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years. Without an active treatment following chemotherapy, the majority of women who have responded to platinum-based chemotherapy undergo "watchful waiting" — a period without any anti-cancer treatment during which a patient and their healthcare provider will monitor signs of the disease returning. If approved, niraparib may address the difficult "watchful waiting" periods experienced by patients with recurrent ovarian cancer in between cycles of platinum-based chemotherapy.

Jounce Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Jounce Therapeutics, 2018, MAR 10, 2017, View Source [SID1234524940]).

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!

(Filing, Annual, Trillium Therapeutics, 2016, MAR 10, 2017, View Source [SID1234518069])

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!

(Filing, 10-K, Athersys, MAR 10, 2017, View Source [SID1234518071])

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!

On March 9, 2017 OncoResponse, an immuno-oncology antibody discovery company, reported that it has closed its ongoing $22.5 million Series A financing round and has appointed Mike Gallatin, Ph.D., Albert Yu, M.D., and Elizabeth Jaffee, M.D. to its Scientific Advisory Board (SAB) (Press release, OncoResponse, MAR 9, 2017, View Source [SID1234522897]). The newly-appointed SAB members join original members James Welsh, M.D. and David Hong, M.D., both investigators at MD Anderson Cancer Center. Kristine Swiderek, Ph.D., CSO of OncoResponse, is chair of the SAB.

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!

In October 2015, OncoResponse secured an initial closing of its Series A financing co-led by ARCH Venture Partners, Canaan Partners, and MD Anderson, with William Marsh Rice University and Alexandria Real Estate Equities also participating. In May 2016, OncoResponse secured an additional investment by Baxalta (now Shire), which was followed by supplemental investments from GreatPoint Ventures and the Helsinn Investment Fund in October 2016. The recent investment by current insiders and HT Family Office brings the total Series A financing to $22.5 million, which will be used to support OncoResponse’s ongoing efforts to interrogate the humoral response of elite responders to cancer immunotherapy to identify antibodies and potential targets for novel therapeutic development.

OncoResponse utilizes a clinically validated platform technology to rapidly screen antibodies made by the human immune system and identify those with exceptional reactivity to cancer. The Company has a strategic alliance with MD Anderson Cancer Center, which provides continuous access to patient samples across multiple cancer indications and to oncology and translational medicine expertise including clinical and regulatory input.

"HT Family Office is an excellent addition to our solid investor base and we warmly welcome them along with our new Scientific Advisory Board members, who bring extensive industry and oncology expertise to our team," said Clifford J. Stocks, CEO of OncoResponse. "With the final closing of our Series A, we look ahead to the continued development of our research programs that aim to expand the promise of immuno-oncology by identifying therapeutically relevant antibodies from patients with elite response to cancer immunotherapy in a number of oncology indications."

"OncoResponse’s approach to addressing the unmet need in patients who are partial or non-responders to immunotherapy is harmonized with our investment strategy," said Alvin Syh, General Manager of HT Family Office. "We are honored to be able to support the advancement of this potentially transformative technology at such a crucial time in the Company’s development."

New members of the OncoResponse Scientific Advisory Board include:

Mike Gallatin, Ph.D.

Dr. Gallatin is a Senior Advisor on the Frazier Healthcare Partners Life Sciences team and brings over 35 years of experience as a scientist and executive to the OncoResponse Scientific Advisory Board. He co-founded Calistoga Pharmaceuticals (acquired by Gilead) and Stromedix Pharmaceuticals (acquired by Biogen Idec) and served as President of Calistoga, which was the first company to demonstrate the clinical benefit of an isoform selective PI3K (idelalisib) inhibitor in hematologic malignancies. Dr. Gallatin was one of the founding scientists at ICOS Corporation (acquired by Eli Lilly and Company), where he served as VP and Scientific Director. Earlier in his career, Mike developed expertise in the fields of immunology/inflammation and oncology while on the faculty at the Fred Hutchinson Cancer Center. Dr. Gallatin received his Ph.D. from the University of Alberta Department of Immunology and was a Damon Runyon-Walter Winchell and American Cancer Society fellow at Stanford University in the laboratory of Dr. Irving Weissman.

Albert Yu, M.D.

Dr. Yu has over 20 years of clinical drug development experience and expertise. He previously served as Vice President of Clinical Development at Omeros Corporation and as Chief Medical Officer and Vice President of Clinical Affairs at Calistoga Pharmaceuticals. At Calistoga, he played a key role in the development of Zydelig for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia. Prior to that, he was Senior Director of Clinical Operations, Research & Affairs at ICOS Corporation, where he was instrumental in the development of Cialis for the treatment of erectile dysfunction. Dr. Yu received his B.S. in biology from Massachusetts Institute of Technology and his M.D. from the University of Washington. He is trained in internal medicine, critical care medicine and pulmonary disease.

Elizabeth M. Jaffee, M.D.

Dr. Jaffee is an international leader in the development of immune based therapies for pancreatic and breast cancers. She is currently Deputy Director of the Sidney Kimmel Comprehensive Cancer Center and Professor of Oncology at Johns Hopkins University, where her research focuses on evaluating mechanisms of immune tolerance to cancer, the identification of human tumor antigens recognized by T cells, and the analysis of antitumor immune responses in breast and pancreatic cancers. Prior to joining Johns Hopkins, she served as a research fellow and principal investigator at the University of Pittsburgh. Dr. Jaffee received her B.A. in biology and immunology magna cum laude from Brandeis University and her M.D. from New York Medical College. She completed her medical residency at Presbyterian-University Hospital in Pittsburgh, Pennsylvania.