On April 20, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that clinical abstracts featuring TG-1101 and TGR-1202 have been selected for presentation at the upcoming 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 2 – 6, 2017, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, APR 20, 2017, View Source [SID1234518652]). Details of the data presentations are outlined below. Schedule your 30 min Free 1stOncology Demo! Oral Presentation:
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Title: Ublituximab and ibrutinib for previously treated genetically high-risk chronic lymphocytic leukemia: Results of the GENUINE Phase 3 study
Abstract Number: 7504
Presentation Date & Time: Saturday, June 3, 2017 3:00 PM – 6:00 PM CT
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Jeffrey P. Sharman, MD
Poster Discussion Presentation:
Title: Tolerability and activity of chemo-free triplet combination of TGR-1202, ublituximab, and ibrutinib in patients with advanced CLL and NHL
Abstract Number: 7511
Presentation Date & Time: Monday, June 5, 2017 8:00 AM-11:30 AM CT (Poster Viewing); 1:15 PM-2:30 PM CT (Poster Discussion)
Session Title: Poster Discussion Session, Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Loretta Nastoupil, MD
Trials in Progress Poster Presentation:
Title: KI intolerance study: A phase 2 study to assess the safety and efficacy of TGR-1202 in pts with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K-delta inhibitor therapy
Abstract Number: TPS7569
Presentation Date & Time: Monday, June 5, 2017 8:00 AM-11:30 AM CT
Session Title: Poster Session, Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Colleen Dorsey, BSN, RN
The above abstracts will be released publicly on May 17, 2017 through the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.
Year: 2017
RedHill Biopharma Announces Peer-Reviewed Publication of the Positive YELIVA® Phase I Study Results in Advanced Solid Tumors
On April 20, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported the publication of an article describing the positive results from the Phase I clinical study with YELIVA (ABC294640)1 in advanced solid tumors (Press release, RedHill Biopharma, APR 20, 2017, View Source [SID1234518651]). Schedule your 30 min Free 1stOncology Demo! The article2, entitled "A Phase I Study of ABC294640, a First-in-Class Sphingosine Kinase-2 Inhibitor, in Patients with Advanced Solid Tumors", was authored by scientists from the Medical University of South Carolina (MUSC) Hollings Cancer Center and Apogee Biotechnology and was published in Clinical Cancer Research. The article is available online on the journal’s website3.
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YELIVA is a Phase II-stage, proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. By inhibiting the SK2 enzyme, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid signaling molecule that promotes cancer growth and pathological inflammation.
The open-label, dose-escalation, pharmacokinetic (PK) and pharmacodynamic (PD) first-in-human Phase I study with YELIVA treated 21 patients with advanced solid tumors, most of whom were gastrointestinal cancer patients, including pancreatic, colorectal and cholangiocarcinoma cancers. The Phase I study was conducted at the MUSC Hollings Cancer Center and led by Principal Investigators Melanie Thomas, MD, and Carolyn Britten, MD.
The primary objectives of the study were to identify the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) and to evaluate the safety of YELIVA. The secondary objectives of the study were to determine the pharmacokinetic (PK) and pharmacodynamic (PD) properties of YELIVA and to assess its antitumor activity.
Final results from the Phase I study with YELIVA in patients with advanced solid tumors confirmed that the study successfully met its primary and secondary endpoints, demonstrating that the drug is well-tolerated and can be safely administered to cancer patients. There was one partial response in a patient with cholangiocarcinoma and six patients had stable disease as their best response.
The study included the first-ever longitudinal analyses of plasma S1P levels as a potential PD biomarker for activity of a sphingolipid-targeted drug. The administration of YELIVA resulted in a rapid and pronounced decrease in S1P levels over the first 12 hours, with return to baseline at 24 hours, which is consistent with clearance of the drug.
A Phase II study with YELIVA for the treatment of advanced hepatocellular carcinoma (HCC) is ongoing at MUSC Hollings Cancer Center. The study is supported by a grant from the NCI, awarded to MUSC, which is intended to fund a broad range of studies on the feasibility of targeting sphingolipid metabolism for the treatment of a variety of solid tumor cancers, with additional support from RedHill.
A Phase Ib/II study with YELIVA for the treatment of refractory or relapsed multiple myeloma is ongoing at Duke University Medical Center. The study is supported by a $2 million grant from the NCI Small Business Innovation Research Program (SBIR) awarded to Apogee, in conjunction with Duke University, with additional support from RedHill.
A Phase I/II clinical study evaluating YELIVA in patients with refractory/relapsed diffuse large B-cell lymphoma and Kaposi sarcoma patients is ongoing at the Louisiana State University Health Sciences Center. The study is supported by a grant from the NCI awarded to Apogee, with additional support from RedHill.
A Phase Ib study to evaluate YELIVA as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy is planned to be initiated in the third quarter of 2017.
YELIVA recently received FDA Orphan Drug designation for the treatment of cholangiocarcinoma. RedHill plans to initiate a Phase IIa clinical study with YELIVA in patients with advanced, unresectable, intrahepatic and extrahepatic cholangiocarcinoma in the third quarter of 2017.
A Phase II study to evaluate the efficacy of YELIVA in patients with moderate to severe ulcerative colitis is planned to be initiated in the second half of 2017.
About YELIVA (ABC294640):
YELIVA (ABC294640) is a Phase II-stage, proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities. RedHill is pursuing with YELIVA multiple clinical programs in oncology, inflammatory and gastrointestinal indications. By inhibiting SK2, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation. SK2 is an innovative molecular target for anticancer therapy because of its critical role in catalyzing the formation of S1P, which is known to regulate cell proliferation and activation of inflammatory pathways. YELIVA was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI and radioprotection models, as well as the ABC-101 Phase I clinical study in cancer patients with advanced solid tumors. The Phase I study included the first-ever longitudinal analysis of plasma S1P levels as a potential pharmacodynamic (PD) biomarker for activity of a sphingolipid-targeted drug. The administration of YELIVA resulted in a rapid and pronounced decrease in S1P levels, with several patients having prolonged stabilization of disease. YELIVA received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma. The development of YELIVA was funded to date primarily by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including the U.S. National Cancer Institute, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Defense and the FDA Office of Orphan Products Development.
Progenics Pharmaceuticals Announces Presentations at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting
On April 20, 2017 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and other products for targeting and treating cancer, reported that data from a prospective biomarker analysis of a Phase 3 study using Progenics’ automated bone scan index (aBSI) will be presented in an oral session at the upcoming 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from June 2-6, 2017 in Chicago, Illinois (Press release, Progenics Pharmaceuticals, APR 20, 2017, View Source [SID1234518650]). In addition, a second abstract from a study on translating the Prostate Cancer Working Group (PCWG) criteria into a biomarker for prostate cancer will be presented in a poster session. Schedule your 30 min Free 1stOncology Demo! The schedule for the presentations at ASCO (Free ASCO Whitepaper) is as follows:
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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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Date & Time: Saturday, June 3, 2017, 1:15 PM-4:15 PM
Session Title: Genitourinary (Prostate) Cancer
Session Type: Oral Abstract Presentation
Title: Phase 3 prognostic analysis of the automated bone scan index (aBSI) in men with bone-metastatic castration-resistant prostate cancer (CRPC)
Abstract No.: 5006
Date & Time: Monday, June 5, 2017, 1:15 PM-4:15 PM
Session Title: Genitourinary (Prostate) Cancer
Session Type: Poster Session
Title: Translating Prostate Cancer Working Group (PCWG) criteria into a quantitative progression biomarker in metastatic Castration Resistant Prostate Cancer (mCRPC)
Abstract No.: 5068
Incyte’s Immuno-oncology and Targeted Therapy Clinical Portfolio to be Featured in More than 15 Abstracts at the 2017 ASCO Annual Meeting
On April 20, 2017 Incyte Corporation (Nasdaq: INCY) reported that more than 15 abstracts highlighting its research and development portfolio in immuno-oncology and targeted therapies will be presented at the upcoming 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois from June 2-6, 2017 (Press release, Incyte, APR 20, 2017, View Source [SID1234518648]). Schedule your 30 min Free 1stOncology Demo! Data presentations will include six abstracts from the ECHO-202/KEYNOTE-037 trial (NCT02178722), evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in various tumor types (two oral presentations, three poster discussions and one poster session). KEYTRUDA is marketed by Merck (known as MSD outside the United States and Canada).
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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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Additionally, data from ECHO-204 (NCT02327078) evaluating the safety and efficacy of epacadostat in combination with Opdivo (nivolumab) have been accepted as an oral presentation. Bristol-Myers Squibb holds development and commercial rights to Opdivo globally except for in the Ono Pharmaceutical territories of Japan, South Korea and Taiwan.
"These abstracts highlight the depth and potential of our growing clinical development portfolio of both immuno-oncology and targeted therapies," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We are especially pleased to have new data from the ECHO-202 trial evaluating epacadostat plus pembrolizumab and initial data from the ECHO-204 trial evaluating epacadostat plus nivolumab accepted. These data contributed to our recent decisions to initiate additional pivotal Phase 3 studies with Merck and BMS."
Select key abstracts and presentations include:
Immuno-oncology abstracts
Efficacy and Safety of Epacadostat Plus Pembrolizumab Treatment of NSCLC: Preliminary Phase 1/2 Results of ECHO-202/KEYNOTE-037 (Abstract #9014, poster discussion)
Saturday, June 3, 2017, 8:00 – 11:30 a.m. CT, Hall A, Poster Board 340; Discussion 3:00 – 4:15 p.m. CT, Hall D2
Epacadostat Plus Pembrolizumab in Patients with Advanced RCC: Preliminary Phase 1/2 Results from ECHO-202/KEYNOTE-037 (Abstract #4515, poster discussion)
Sunday, June 4, 2017, 8:00 – 11:30 a.m. CT, Hall A, Poster Board #193; Discussion 11:30 – 12:45 p.m. CT, Arie Crown Theater
Efficacy/Safety of Epacadostat Plus Pembrolizumab in Triple-Negative Breast Cancer and Ovarian Cancer: Phase 1/2 ECHO-202 Study (Abstract #1103, poster session)
Sunday, June 4, 2017, 8:00 – 11:30 a.m. CT, Hall A, Poster Board #95
Epacadostat Plus Pembrolizumab in Patients with Advanced Urothelial Carcinoma: Preliminary Phase 1/2 Results of ECHO-202/KEYNOTE-037 (Abstract #4503, oral presentation)
Monday, June 5, 2017, 8:36 – 8:48 a.m. CT, Arie Crown Theater
Safety of Epacadostat 100 mg BID Plus Pembrolizumab 200 mg Q3W in Advanced Solid Tumors: Phase 2 Data from ECHO-202/KEYNOTE-037 (Abstract #3012, poster discussion)
Monday, June 5, 2017, 8:00 – 11:30 a.m. Hall A, Poster Board #107; Discussion 4:45 – 6:00 p.m. CT, Hall D1
Epacadostat Plus Nivolumab in Patients with Advanced Solid Tumors: Preliminary Phase 1/2 Results of ECHO-204 (Abstract #3003, oral presentation)
Monday, June 5, 2017, 2:15 – 2:27 p.m. CT, Hall D1
CX-1158-101: A first-in-human phase 1 study of CB-1158, a small molecule inhibitor of arginase, as monotherapy and in combination with an anti-PD-1 checkpoint inhibitor in patients with solid tumors (Abstract #3005, oral presentation)
Monday, June 5, 2017, 2:39 p.m. – 2:51 p.m. CT, Hall D1
Epacadostat Plus Pembrolizumab in Patients with SCCHN: Preliminary Phase 1/2 Results from ECHO-202/KEYNOTE-037 (Abstract #6010, oral presentation)
Tuesday, June 6, 2017, 8:12 – 8:24 a.m. CT, S100a
Targeted therapy abstract
Ongoing Phase 1/2 Study of INCB050465 for Relapsed/Refractory (R/R) B-Cell Malignancies (CITADEL-101) (Abstract #7530, poster session)
Monday, June 5, 2017, 8:00 – 11:30 a.m. CT, Hall A, Poster Board #292
Full session details and data presentations at the ASCO (Free ASCO Whitepaper) 2017 annual meeting can be found here.
Immune Design Announces Presentations at the 2017 ASCO Annual Meeting
On April 20, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported that new and updated data from two ongoing clinical trials of CMB305 and G100, as well as translational data examining the association of immunological response with improved survival in CMB305 and LV305 patients, will be presented in an oral and two posters presentations at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 2 – 6, 2017 in Chicago (Press release, Immune Design, APR 20, 2017, View Source [SID1234518647]). The ASCO (Free ASCO Whitepaper) presentation details are as follows: Schedule your 30 min Free 1stOncology Demo! ORAL PRESENTATION
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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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Immune response, safety, and survival impact from CMB305 in NY-ESO-1+ recurrent soft tissue sarcomas (STS)
Abstract # 11006
Session Title: Sarcoma
Date: Friday, June 2, 2017
Time: 3 p.m. — 6 p.m. CT (oral session)
Location: S100bc
Presenter: Neeta Somaiah, M.D., Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center
POSTER PRESENTATIONS
The Association of CMB305 or LV305-induced and baseline anti-NY-ESO-1 immunity with survival in recurrent cancer patients
Abstract # 3090
Session Title: Developmental Therapeutics—Immunotherapy
Date: Monday, June 5, 2017
Time: 8 a.m. — 11:30 a.m. CT (poster session)
Location: Hall A
Presenter: Seth M. Pollack, M.D., Fred Hutchinson Cancer Research Center
Intratumoral G100 to induce systemic immune responses and abscopal tumor regression in patients with follicular lymphoma
Abstract # 7537
Session Title: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic Leukemia
Date: Monday, June 5, 2017
Time: 8 a.m. — 11:30 a.m. CT (poster session)
Location: Hall A
Presenter: Christopher Flowers, M.D., Department of Hematology and Medical Oncology, Emory University School of Medicine
Additional data than those included in the abstracts may be included in the presentations.