On April 20, 2017 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported that the Company will release its first quarter 2017 financial results on Monday, May 8, 2017 (Press release, Epizyme, APR 20, 2017, View Source [SID1234518644]). Schedule your 30 min Free 1stOncology Demo! Epizyme also announced that two posters on interim efficacy and safety data from its ongoing Phase 2 study of tazemetostat in adult patients with molecularly defined solid tumor will be presented on June 6, 2017 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago. The Company plans to hold a conference call to discuss the interim findings on Thursday, May 18, 2017 at 8:30 a.m. ET, after the ASCO (Free ASCO Whitepaper) abstracts have been released.
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!
Considering the planned conference call, Epizyme will not host a separate conference call to discuss its first quarter 2017 financial results.
The Phase 2 data posters will be presented in the ASCO (Free ASCO Whitepaper) session listed below:
Sarcoma Cancer: General Poster Session
Sunday, June 4, 2017, 8:00 a.m. – 11:30 a.m. CDT
Abstract No.: 11058, Poster Board No.: 381
Title: Phase 2 multicenter study of the EZH2 inhibitor tazemetostat in adults with INI1 negative epithelioid sarcoma (NCT02601950)
Location: Hall A
Sarcoma Cancer: General Poster Session
Sunday, June 4, 2017, 8:00 a.m. – 11:30 a.m. CDT
Abstract No.: 11057, Poster Board No.: 380
Title: Phase 2 multicenter study of the EZH2 inhibitor tazemetostat in adults with synovial sarcoma (NCT02601950)
Location: Hall A
About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing phase 2 programs in non-Hodgkin lymphoma (NHL), certain genetically defined solid tumors, including INI1-negative and SMARCA4-negative tumors and synovial sarcoma, and mesothelioma.
Month: April 2017
CB-1158 Phase I Data Accepted for an Oral Presentation at the ASCO Annual Meeting
On April 20, 2017 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that clinical data for its drug candidate CB-1158, an orally bioavailable arginase inhibitor, will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from June 2 to June 6, 2017 in Chicago, Illinois (Press release, Calithera Biosciences, APR 20, 2017, View Source [SID1234518643]). Clinical results to be presented include monotherapy data from Calithera’s Phase I trial in solid tumors. CB-1158 is being developed in collaboration with Incyte Corporation. Schedule your 30 min Free 1stOncology Demo! 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.
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!
Abstract #3005
Presenter: Kyriakos Papadopoulos MD, South Texas Accelerated Research Therapeutics
Date: June 5, 2017
Session: 1:15 p.m. – 4:15 p.m. CT, Developmental Therapeutics-Immunology, Hall D1
AVEO Announces Presentations at the 2017 ASCO Annual Meeting
On April 20, 2017 AVEO Oncology (NASDAQ:AVEO) reported that poster presentations for three clinical studies will be presented at the upcoming 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 2-6, 2017 (Press release, AVEO, APR 20, 2017, View Source [SID1234518642]). Schedule your 30 min Free 1stOncology Demo! Among these is a Trials in Progress presentation highlighting the ongoing Phase 3, randomized, controlled, multi-center, open-label TIVO-3 study comparing tivozanib, the Company’s potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors, to sorafenib in subjects with refractory advanced renal cell carcinoma. The remaining two presentations will highlight ficlatuzumab, the Company’s potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities, in two investigator-sponsored studies, one in head and neck squamous cell carcinoma and the other in acute myeloid leukemia.
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!
Tivozanib is partnered for oncologic indications with EUSA Pharma under an exclusive license agreement covering territories outside of North America and Asia, including Europe, South America and South Africa. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab.
Details for the poster presentations at ASCO (Free ASCO Whitepaper) 2017:
Title: Tivo-3: A phase 3, randomized, controlled, multi-center, open-label study to compare
tivozanib hydrochloride to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC)
Presenter: Brian I. Rini, MD, FACP, Professor of Medicine, Lerner College of Medicine,
Leader, GU Program, Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute
Abstract Number: TPS4600
Session: Genitourinary (Nonprostate) Cancer
Date and Time: Sunday, June 4, 2017, 8:00-11:30 AM CT
Title: Phase I study of the anti-HGF monoclonal antibody (mAb), ficlatuzumab, and cetuximab
in cetuximab-resistant, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)
Presenter: Julie E. Bauman, MD, MPH, Chief, Division of Hematology and Oncology,
Associate Director, Translational Research, University of Arizona Cancer Center
Abstract Number: 6038
Session: Head and Neck Cancer
Date and Time: Monday, June 5, 2017, 1:15-4:45 PM CT
Title: CyFi: A phase I study exploring the role of cMET pathway inhibition with
ficlatuzumab (Fi) combined with high-dose cytarabine (Cy) in patients with
high risk relapsed or refractory acute myeloid leukemia (AML)
Presenter: Charalambos (Babis) Andreadis, MD, Hematologic Malignancies and
Blood and Marrow Transplantation Program, University of California, San Francisco
Abstract Number: 7040
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time: Monday, June 5, 2017, 8:00-11:30 AM CT
Phase 1/2 Clinical Trial of Agenus’ anti-PD-1 Antibody Begins
On April 20, 2017 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported that the first patient has been dosed in a Phase 1/2 clinical trial of its anti-PD-1 antibody, AGEN2034. Schedule your 30 min Free 1stOncology Demo! The open-label, dose-escalation portion of the trial is designed to evaluate the safety and pharmacological activity of AGEN2034 in patients with advanced solid tumors. Part 2 of the trial is planned to evaluate the recommended dose of AGEN2034 in patients with second line cervical cancer. Preliminary safety and efficacy data are expected to be available within the next 9-12 months.
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 entry of our PD-1 antagonist into the clinic is key to our strategy to pursue combination therapies," said Garo H. Armen, Ph.D. Chairman and CEO of Agenus. "PD-1 is a clinically validated target, and to combine it with our CTLA-4 directed antibody is the backbone of Agenus’ combination strategy. We also intend to pursue combinations of PD-1 and CTLA-4 antibodies with our novel portfolio of other checkpoint antibodies as well as our neoantigen cancer vaccines."
AGEN2034 is an antagonist antibody targeting programmed death 1, or PD-1. PD-1 is an inhibitory receptor expressed on activated T cells. When this receptor interacts with PD-L1 or PD-L2 molecules expressed on cancer cells, the T cells’ ability to kill cancer cells is neutralized. Therefore, blocking PD-1 with AGEN2034 may allow T cells to recognize and kill tumor cells.
"Immune checkpoint antibodies targeting PD-1/PD-L1 and CTLA-4 have become the mainstay of I-O combinations," said Jean-Marie Cuillerot, M.D., Chief Medical Officer of Agenus. "Co-targeting the PD-1/PD-L1 axis in combination with CTLA-4 has shown a near doubling of clinical efficacy in certain indications. We believe our strategy in pursuing virally-induced cancers presents a rapid path to BLA for our PD-1 and CTLA-4 antagonists. In addition, combination approaches involving our vaccines offer a unique opportunity for differentiation in patients who are unresponsive to checkpoint directed monotherapies."
Additional information about the trial can be found here.
AGEN2034 was originally developed under a Collaborative Research and Development Agreement between Ludwig Cancer Research, 4-Antibody AG and Recepta Biopharma S.A.
Nektar Therapeutics to Host Analyst & Investor Event at 2017 ASCO Annual Meeting
On April 20, 2017 Nektar Therapeutics (Nasdaq: NKTR) reported that it will host an analyst and investor event with clinical investigators on Saturday, June 3, 2017 at 6:00 pm CDT in Chicago, IL during the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting. The event will include a presentation and discussion of updated clinical data for the company’s CD122-biased agonist, NKTR-214. 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 two studies of NKTR-214 will be reviewed at the event, including the Phase 1 dose-escalation study of NKTR-214 in combination with nivolumab in patients with melanoma, renal cell carcinoma and non-small cell lung cancer (PIVOT-02); and the Phase 1 study of monotherapy NKTR-214 in patients with advanced solid tumors (EXCEL).
Presenters will include Dr. Adi Diab, Assistant Professor, Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center, Dr. Nizar Tannir, Professor, Genitourinary Medical Oncology at the University of Texas MD Anderson Cancer Center and Dr. Michael Hurwitz, Assistant Professor of Medicine (Medical Oncology) at Yale Cancer Center.
NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting CD8+ effector T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. NKTR-214 targets CD122 specific receptors found on the surface of these cancer-fighting immune cells in order to stimulate their proliferation. In preclinical studies, treatment with NKTR-214 resulted in a rapid expansion of these cells and mobilization into the tumor micro-environment.1,2 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.
Investors and analysts are invited to listen to a live audio webcast of the presentation at View Source The event will also be available for replay for two weeks on the company’s website, www.nektar.com.
For those interested in attending this event in person, please contact [email protected]. Please RSVP in advance as seating is limited.