On May 18, 2017 ArQule, Inc. (Nasdaq: ARQL) reported that preclinical data for ARQ 531 in diffuse large B-cell lymphoma (DLBCL) in vitro and in vivo tumor models will be presented on June 23, 2017 at EHA (Free EHA Whitepaper) Congress in Madrid, Spain (Press release, ArQule, MAY 18, 2017, View Source [SID1234519210]). The data supports clinical trials with ARQ 531 in the ibrutinib resistant patient population. A phase 1 trial with ARQ 531 in patients with B-cell malignancies refractory to other therapeutic options, including ibrutinib, is planned to commence by the third quarter of 2017. ARQ 531 is an investigational, orally bioavailable, potent and reversible inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK). Schedule your 30 min Free 1stOncology Demo! Presentation Details
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Friday, June 23, 2017: Non-Hodgkin and Hodgkin Lymphoma – Biology
ARQ 531
Abstract E1400
ARQ 531, a reversible BTK inhibitor, demonstrates potent anti-tumor activity in ABC-DLBCL and GCB-DLBCL
E-poster Screens
Time: 9:30 AM CET
About BTK and ARQ 531
ARQ 531 is an investigational, orally bioavailable, potent and reversible Bruton’s tyrosine kinase (BTK) inhibitor. Biochemical and cellular studies have shown that ARQ 531 inhibits both the wild type and C481S-mutant forms of BTK. The C481S mutation is a known emerging resistance mechanism for first generation irreversible BTK inhibitors. In preclinical studies ARQ 531 has demonstrated high oral bioavailability as well as good ADME, pharmacokinetic and metabolic properties. The company plans to initiate a phase 1 trial by the third quarter of 2017. BTK is a therapeutic target that has been clinically proven to inhibit B-cell receptor signaling in blood cancers.
Month: May 2017
Agios to Present Updated Clinical Data from PKR Activator AG-348 at EHA
On May 18, 2017 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic diseases, reported that updated clinical data from the fully enrolled, ongoing Phase 2 study (DRIVE PK) of AG-348 in adults with pyruvate kinase (PK) deficiency, a rare, potentially debilitating, congenital anemia, will be presented at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place June 22-25, 2017 in Madrid, Spain. AG-348 is a wholly owned, novel, first-in-class, oral activator of both wild-type (normal) and mutated pyruvate kinase-R (PKR) enzymes (Press release, Agios Pharmaceuticals, MAY 18, 2017, View Source [SID1234519209]).
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The accepted abstracts are listed below and available online on the EHA (Free EHA Whitepaper) conference website: View Source!*listing=3*browseby=2*sortby=1*media=3*ce_id=1181*label=15531
Oral presentation by Agios:
Title: Effects of AG-348, a pyruvate kinase activator, in patients with Pyruvate Kinase Deficiency: updated results from the DRIVE-PK study
Date & Time: Saturday, June 24, 2017 from 11:30-11:45 a.m. CET
Session Title: Sickle cell disease, enzymes
Abstract Code: S451
Location: Room N109
Presenter: Rachael Grace, M.D., Dana-Farber Boston Children’s Cancer and Blood Disorder Center
Updated data from the DRIVE PK study will be presented at the time of the meeting.
Poster presentation by Agios collaborator:
Title: Ex-vivo treatment of red blood cells from 15 Pyruvate Kinase (PK)-deficient patients with AG-348, an allosteric activator of PK-R, increases enzymatic activity, protein stability and ATP levels
Date & Time: Saturday, June 24, 2017 from 5:30-7:00 p.m. CET
Session Title: Enzymes and sickle cell disease
Abstract Code: P614
Location: Poster area (Hall 7)
Author: Richard van Wijk, Ph.D., University Medical Center Utrecht
Encore presentations by Agios and Celgene:
Title: Enasidenib in mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML): Results of a phase 1 dose-escalation and expansion study
Date & Time: Saturday, June 24, 2017 from 4:00-4:15 p.m. CET
Oral Abstract Session: Targeted treatment of AML
Abstract Code: S471
Location: Hall D
Presenter: Eytan Stein, M.D., Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College
Title: Differentiation syndrome associated with enasidenib, a selective inhibitor of mutant isocitrate dehydrogenase 2 (mIDH2)
Poster Session Date & Time: Friday, June 23, 2017 from 5:15-6:45 p.m. CET
Session Title: Acute myeloid leukemia – Clinical 3
Abstract Code: P215
Location: Poster area (Hall 7)
Author: Amir Tahmasb Fathi, M.D., Massachusetts General Hospital and Harvard Medical School
About Agios
Agios is focused on discovering and developing novel investigational medicines to treat cancer and rare genetic diseases through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across both therapeutic areas, Agios has multiple first-in-class investigational medicines in clinical and/or preclinical development. All Agios programs focus on genetically identified patient populations, leveraging our knowledge of metabolism, biology and genomics. For more information, please visit the company’s website at www.agios.com.
About Agios/Celgene Collaboration
IDHIFA (enasidenib) and AG-881 are part of Agios’ global strategic collaboration with Celgene Corporation focused on cancer metabolism. Under the terms of the 2010 collaboration agreement, Celgene has worldwide development and commercialization rights for IDHIFA (enasidenib). Agios continues to conduct clinical development activities within the IDHIFA (enasidenib) development program and is eligible to receive reimbursement for those development activities and up to $95 million in remaining payments assuming achievement of certain milestones and royalties on net sales. Celgene and Agios intend to co-commercialize IDHIFA (enasidenib) in the U.S. Celgene will reimburse Agios for costs incurred for its co-commercialization efforts.
Acceleron Announces Clinical Presentations on Luspatercept at the 22nd Congress of the European Hematology Association
On May 18, 2017 Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to treat serious and rare diseases, reported that two abstracts on luspatercept will be presented at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Madrid, Spain on June 22-25, 2017 (Press release, Acceleron Pharma, MAY 18, 2017, View Source [SID1234519208]). Luspatercept is being developed as part of the global collaboration between Acceleron and Celgene. Schedule your 30 min Free 1stOncology Demo! The oral and poster presentations will include efficacy, duration of response, and long-term safety results from the ongoing Phase 2 studies with luspatercept in myelodysplastic syndromes (MDS) and beta-thalassemia. The presentations at the conference will include updated information beyond that included in the abstracts available online on the EHA (Free EHA Whitepaper) conference website. The beta-thalassemia presentation will review results updated from the ASH (Free ASH Whitepaper) 2016 presentation in December and the MDS presentation will highlight results updated from the recent International Symposium on MDS earlier this month.
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Oral presentation
Title: Luspatercept Increases Hemoglobin and Decreases Transfusion Burden in Adults with Beta-Thalassemia (Abstract: S129)
Session: Thalassemia
Date: Friday, June 23rd
Time: 11:45 a.m. CEST (IFEMA, Room N105)
Poster presentation
Title: Luspatercept Increases Hemoglobin and Reduces Transfusion Burden in Patients with
Lower-Risk Myelodysplastic Syndromes (MDS): Long-Term Results from Phase 2 PACE-MDS Study (Abstract: P666)
Session: Myelodysplastic Syndromes – Clinical 2
Date: Saturday, June 24th
Time: 5:30 – 7:00 p.m. CEST (IFEMA, Poster Area, Hall 7)
The luspatercept clinical poster and slides from the oral presentation will be available immediately following the presentations at the conference in the "Science" section on Acceleron’s website, www.acceleronpharma.com.
About Luspatercept
Luspatercept is a modified activin receptor type IIB fusion protein that acts as a ligand trap for members in the transforming growth factor-beta superfamily involved in the late stages of erythropoiesis (red blood cell production). Luspatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoiesis stimulating agents (ESAs), which stimulate the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. Phase 3 clinical trials are underway to evaluate the safety and efficacy of luspatercept in patients with myelodysplastic syndromes (the "MEDALIST" study) and in patients with beta-thalassemia (the "BELIEVE" study). For more information, please visit www.clinicaltrials.gov.
GlycoMimetics’ GMI-1271 Receives FDA Breakthrough Therapy Designation for Adult Relapsed/Refractory Acute Myeloid Leukemia
On May 17, 2017 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for treatment of adult relapsed/refractory acute myeloid leukemia (AML) to the company’s drug candidate GMI-1271, an E-selectin antagonist currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial in patients with AML (Press release, GlycoMimetics, MAY 17, 2017, View Source [SID1234617412]). The U.S. Food and Drug Administration (FDA) had previously granted Orphan Drug designation and Fast Track Status for GMI-1271 in AML.
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In the ongoing clinical trial, GMI-1271 is being administered, along with chemotherapy, to patients with relapsed or refractory AML as well as those 60 years of age and older with newly diagnosed disease. Data from this trial were presented in 2016 at meetings of the European Hematology Association (EHA) (Free EHA Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper). In the trial, patients treated with GMI-1271 achieved higher than expected remission rates and lower than expected 30- and 60-day mortality rates in early evaluations of patients with relapsed/refractory AML as well as in newly diagnosed patients. In March 2017, the Company announced that the first of two patient cohorts in the Phase 2 portion of the trial of GMI-1271 had completed enrollment. In April 2017, the Company announced plans to present further data updates on both patient populations in the ongoing AML trial at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
The FDA grants Breakthrough Therapy designation to companies to help accelerate development and review of drug candidates when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The designation is designed to expedite the development and review of designated therapies, without changing FDA standards for new drug approval.
"The FDA’s granting to GMI-1271 of Breakthrough Therapy designation will further help GlycoMimetics to accelerate the development of GMI-1271 as a treatment for this very difficult-to-treat patient population," said Helen Thackray, MD, Chief Medical Officer of GlycoMimetics. "We believe GMI-1271 when combined with chemotherapy has the potential to address an unmet therapeutic need for individuals living with AML. We are encouraged by our clinical results to date, and look forward to working closely with the FDA to bring this novel therapy to patients as quickly as possible."
About AML
Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia in adults. Each year in the United States, about 19,900 people (usually older than 45 years of age) are diagnosed, and about 10,400 people die from all forms of the disease, according to the American Cancer Society. Unlike other cancers that start in an organ and spread to the bone marrow, AML is known for rapid growth of abnormal white blood cells that gather in the bone marrow, getting in the way of normal blood cell production. The lack of normal blood cells can cause some of the symptoms of AML, including anemia (shortage of red blood cells resulting in tiredness and weakness), neutropenia (shortage of white blood cells that may lead to increased infections), and thrombocytopenia (shortage of platelets in the blood that may lead to excessive bleeding). Current treatment options for AML consist of reducing and eliminating cancer cells mainly through chemotherapy, radiation therapy, and stem cell transplantation.
Sumitomo Dainippon Pharma announces the Clinical Data will be presented at ASCO 2017
On May 18, 2017 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada) reported that a total of 12 presentations including clinical data for investigational anti-cancer agents napabucasin (BBI608), amcasertib (BBI503) and WT2725 will be presented at the poster session of the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 2 to June 6, 2017 (Press release, Dainippon Sumitomo Pharma, MAY 17, 2017, View Source [SID1234519264]).
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Napabucasin: Study results, 7 presentations Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type 9052 A phase 1b/2 study of napabucasin with weekly paclitaxel in advanced, previously treated non-squamous non-small cell lung cancer. June 3, 2017 8：00 AM-11：30 AM (local time), Hall A 201 Study： NCT01325441 Non-small cell lung cancer 3529 Phase 1b/II study of cancer stemness inhibitor napabucasin (BBI-608) in combination with FOLFIRI +/- bevacizumab (bev) in metastatic colorectal cancer (mCRC) patients (pts). June 3, 2017 8：00 AM-11：30 AM (local time), Hall A 246 Study： NCT02024607 Colorectal cancer 4106 A phase Ib/II study of cancer stemness inhibitor napabucasin (BBI-608) in combination with gemcitabine (gem) and nab-paclitaxel (nabPTX) in metastatic pancreatic adenocarcinoma (mPDAC) patients (pts). June 3, 2017 8：00 AM-11：30 AM (local time), Hall A 118 Study： NCT02231723 Pancreatic cancer 5548 A phase 1b/2 study of napabucasin with weekly paclitaxel in advanced, previously treated platinum resistant ovarian cancer. June 3, 2017 1：15 PM-4：45 PM (local time) , Hall A 201 Study： NCT01325441 Ovarian Cancer 9553 A phase Ib study of napabucasin plus weekly paclitaxel in patients with advanced melanoma. June 3, 2017 1：15 PM-4：45 PM (local time) , Hall A 201 Study： NCT01325441 Melanoma 2 1084 A phase 2 study of napabucasin with weekly paclitaxel in previously treated metastatic breast cancer. June 4, 2017 8：00 AM-11：30 AM (local time) , Hall A 201 Study： NCT01325441 Breast cancer 4077 BBI608-503-103HCC: A phase Ib/II clinical study of napabucasin (BBI608) in combination with sorafenib or amcasertib (BBI503) in combination with sorafenib (Sor) in adult patients with hepatocellular carcinoma (HCC). June 3, 2017 8：00 AM-11：30 AM (local time) , Hall A BBI HCC 103 Study： NCT02279719 Hepatocellular carcinoma
Napabucasin: Study design, 2 presentations Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type TPS3619 CanStem303C trial: A phase III study of napabucasin (BBI-608) in combination with 5-fluorouracil (5-FU), leucovorin, irinotecan (FOLFIRI) in adult patients with previously treated metastatic colorectal cancer (mCRC). June 3, 2017 8：00 AM-11：30 AM (local time) , Hall A CanStem303C Study： NCT02753127 Colorectal cancer TPS4148 CanStem111P trial: A phase III study of napabucasin (BBI-608) plus nab-paclitaxel (nab-PTX) with gemcitabine (gem) in adult patients with metastatic pancreatic adenocarcinoma (mPDAC). June 3, 2017 8：00 AM-11：30 AM (local time) , Hall A CanStem111P Study： NCT02993731 Pancreatic cancer
Amcasertib: Study results, 2 presentations Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type 6032 A phase 1b/2 study of amcasertib, a first-in-class cancer stemness kinase inhibitor in advanced head and neck cancer. June 5, 2017 1：15 PM-4：45 PM (local time) , Hall A 101 Study： NCT01781455 Head and Neck cancer 6036 A phase 1b/2 study of amcasertib, a first-in-class cancer stemness kinase inhibitor, in advanced adenoid cystic carcinoma. June 5, 2017 1：15 PM-4：45 PM (local time), Hall A 101 Study： NCT01781455 Adenoid Cystic Carcinoma 3
WT2725: Study results, 1 presentation Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type 2066 Initial phase 1 study of WT2725 dosing emulsion in patients with advanced malignancies. June 5, 2017 1：15 PM-4：45 PM (local time), Hall A D8350004Study ：NCT01621542 Solid tumors, Hematologic malignancies *The abstract is now available on the official website of ASCO (Free ASCO Whitepaper). There is the link to applicable abstract on abstract number of each study. (Reference)
【About napabucasin:BBI608】 Napabucasin is an investigational first-in-class anti-cancer agent created by Boston Biomedical, Inc., wholly-owned subsidiary of Sumitomo Dainippon Pharma. Napabucasin is an orally -administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways by targeting STAT3.
【About amcasertib:BBI503】 Amcasertib is an investigational anti-cancer agent created by Boston Biomedical, Inc. Amcasertib is an orally-administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways, including Nanog, by targeting stemness kinases.
【About WT2725】 WT2725 is an investigational therapeutic cancer peptide vaccine derived from Wilms’ tumor gene 1 (WT1) protein. WT2725 is expected to treat various types of hematologic malignancies and solid tumors that express WT1, by inducing WT1-specific cytotoxic T-lymphocytes that attack WT1-expressing cancer cells.