On March 2, 2017 Geron Corporation (Nasdaq:GERN) reported an abstract submitted by Janssen Research & Development, LLC describing non-clinical data on imetelstat has been accepted for presentation as a poster at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held in Washington, D.C. from April 1-5, 2017 (Press release, Geron, MAR 2, 2017, View Source;p=RssLanding&cat=news&id=2250980 [SID1234517934]). The abstract is available on the AACR (Free AACR Whitepaper) website at www.aacr.org.

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Abstract Title: Telomerase inhibitor imetelstat in combination with the BCL-2 inhibitor venetoclax enhances apoptosis in vitro and increases survival in vivo in acute myeloid leukemia (Abstract #1101)

AACR Session Title: Combination Therapy 1
Session Date: Monday, April 3, 2017
Session Time: 8:00 a.m. ET – 12:00 p.m. ET
In accordance with AACR (Free AACR Whitepaper) policies, abstracts submitted to the AACR (Free AACR Whitepaper) Annual Meeting are embargoed from the time of submission. To be eligible for presentation at the AACR (Free AACR Whitepaper) Annual Meeting, information contained in the abstract, as well as additional data and information to be presented at the Annual Meeting, may not be made public before the abstract has been presented in connection with the AACR (Free AACR Whitepaper) Annual Meeting.

On March 2, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that new Phase 1 data for IPI-549, an orally administered immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), will be presented in a clinical trial poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017 taking place in Washington, D.C. April 1 – 5 (Press release, Infinity Pharmaceuticals, MAR 2, 2017, View Source;p=RssLanding&cat=news&id=2251054 [SID1234517936]). A Phase 1 clinical study is ongoing to explore the safety and activity of IPI-549 both as a monotherapy and in combination with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, in patients with advanced solid tumors. IPI-549 is believed to be the only PI3K-gamma inhibitor in clinical development.

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Details of the presentation are as follows:
Poster presentation time: Tuesday, April 4, 2017, 8:00 a.m. – 12:00 p.m. ET
Title: IPI-549-01 – A Phase 1/1b, First-in-Human Study of IPI-549, a PI3K-Gamma Inhibitor, as Monotherapy and in Combination with Nivolumab in Patients with Advanced Solid Tumors
Abstract number: CT089
Lead author: Jedd Wolchok, M.D., Ph.D., Chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center (MSK), as well as Associate Director of the Ludwig Center for Cancer Immunotherapy and Director of the Parker Institute for Cancer Immunotherapy, both at MSK
Location: Convention Center, Halls A-C, Poster Section 33

About the IPI-549 and the Ongoing Phase 1 Study
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 increases antitumor immunity by targeting tumor-associated myeloid cells and overcomes immune checkpoint blockade resistance in preclinical tumor models.1,2 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing to explore the activity, safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in patients with advanced solid tumors.3 The study includes monotherapy and combination dose-escalation phases, in addition to a monotherapy expansion cohort and combination expansion cohorts. Overall, the study is expected to enroll approximately 175 patients.

The expansion cohorts evaluating IPI-549 plus Opdivo will include patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN). There is a great need for additional treatment options for the growing number of patients living with these types of cancers, which account for more than 17 percent of all new cancer cases in the U.S.4,5 Additionally, patients enrolled in the combination expansion cohorts represent a difficult-to-treat population, as they must have demonstrated initial resistance or subsequently develop resistance to a PD-1 or PD-L1 therapy immediately prior to enrolling in the study.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On March 2, 2017 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) reported that it will present new data related to its clinical and preclinical immuno-oncology and anti-cancer stem cell therapeutic candidates in a total of six presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting to be held April 1-5, 2017 in Washington, DC (Press release, OncoMed, MAR 2, 2017, View Source [SID1234517949]).

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Among the presentations will be three posters detailing preclinical data for OncoMed’s novel anti-TIGIT (OMP-313M32) immuno-oncology therapeutic candidate. These will be the first data that the company has shared publicly for its anti-TIGIT antibody program. New data will also be presented on biomarker research associated with the Phase 1b portion of OncoMed’s tarextumab (anti-Notch2/3, OMP-59R5) clinical trial in small cell lung cancer and OncoMed’s preclinical GITRL-Fc trimer (OMP-336B11) program. In addition, xenograft data will be presented for anti-RSPO3 (OMP-131R10) in combination with taxane chemotherapy in colorectal cancer.

The following abstracts have been selected for presentation by OncoMed scientists:

Sunday, April 2, 2017 1:00 PM — 5:00 PM
Title: Pharmacodynamic biomarkers for anti-TIGIT treatment and prevalence of TIGIT expression in multiple solid tumor types
Presenting author: Fiore Cattaruzza, Pharm. D., Ph.D., Senior Scientist II, Translational Medicine
Abstract Number: 599
Session: T-cell Immunity to Cancer: New Progress
Location: Poster section 26; Poster board 3

Monday, April 3, 2017 8:00 AM – Noon
Title: Antibody against TIGIT (T-cell immunoreceptor with Ig and ITIM domains) induces anti-tumor immune response and generates long-term immune memory
Presenting author: Angie Inkyung Park, Ph.D., Senior Director Immunotherapy
Abstract Number: 2003
Session: Tumor Microenvironment
Location: Poster section 44; Poster board 18

Title: Circulating Tumor Cells (CTCs) in patients with extensive-stage small cell lung cancer and their association with clinical outcome
Abstract number: 1727
Presenting author: Chun Zhang, Ph.D., Director, Translational Medicine
Session: Liquid Biopsies 1: Circulating Tumor Cells
Location: Poster section 30; Poster board 17

Title: R-SPONDIN3 antagonism sensitizes colorectal cancer to taxane treatment
Abstract Number: 1911
Presenting author: Marcus Fischer, Scientist
Session: Normal and Neoplastic Stem Cells
Location: Poster section 41; Poster board 12

Monday, April 3, 2017 1:00 PM — 5:00 PM
Title: Anti-TIGIT induces T cell mediated anti-tumor immune response and combines with immune checkpoint inhibitors to enhance strong and long term anti-tumor immunity
Abstract number: 2612
Presenting author: Minu Srivastava, Ph.D., Senior Scientist II
Session: Checkpoints 2: Small Molecule Inhibitors (Note: anti-TIGIT is a monoclonal antibody)
Location: Poster section 25; Poster board 1

Wednesday, April 5, 2017 8:00 AM – Noon
Title: Prevalence of GITR expression and pharmacodynamic (PD) biomarkers in syngeneic tumor models treated by a GITR agonist (GITRL-Fc)
Abstract number: 5621
Presenting author: Min Wang, Ph.D., Director, Translational Medicine
Session: Immune Checkpoints and Immunosurveillance
Location: Poster section 25; Poster board 23

Regulus 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, Regulus, MAR 2, 2017, View Source [SID1234517975]).

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On March 1, 2017 Celgene Corporation (CELG) and Agios Pharmaceuticals (AGIO) reported that the U.S. Food and Drug Administration (FDA) has accepted Celgene’s New Drug Application (NDA) for enasidenib (AG-221/CC-90007) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation (Press release, Agios Pharmaceuticals, MAR 1, 2017, View Source;p=RssLanding&cat=news&id=2250587 [SID1234517906]). The NDA was granted Priority Review and has been given a Prescription Drug User Fee Act (PDUFA) action date of Aug. 30, 2017. Celgene completed the NDA submission in late December 2016.

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"We accelerated this application – submitting the NDA just three years after the first patient was treated in the enasidenib pivotal investigational trial – because we believe that there is a significant unmet need for people with relapsed or refractory AML," said Michael Pehl, president, Hematology/Oncology for Celgene. "The acceptance of the enasidenib NDA is a significant milestone in what we hope will be a new era of molecularly targeted therapies for patients with this devastating disease."

Enasidenib is a first-in-class, oral, targeted inhibitor of mutant IDH2. The NDA submission is based on results from AG221-C-001, a single-arm phase I/II study of enasidenib in patients with advanced hematologic malignancies with an IDH2 mutation. Early data from the relapsed or refractory AML patients in this study were presented at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

"Having received NDA acceptance and priority review for enasidenib, we look forward to working with our partner Celgene and the FDA to advance a first-in-class therapy for relapsed or refractory AML with an IDH2 mutation," said David Schenkein, M.D., chief executive officer at Agios. "We hope that the continued adoption of molecular profiling and availability of new targeted therapies such as enasidenib will have a significant impact on patients living with AML."

Additionally, Abbott has submitted a Premarket Approval (PMA) application for the FDA approval of an IDH2 assay on the Abbott m2000 RealTime System, a polymerase chain reaction (PCR) molecular diagnostics instrument. IDH2 mutations occur in about 8 to 19 percent of AML patients. Recent publications have highlighted the advances in the understanding of the genetics underlying AML and the need for routine mutational analysis at diagnosis and relapse.

Celgene is also evaluating enasidenib compared with conventional therapy in older patients with an IDH2 mutation and relapsed or refractory AML in the ongoing phase III IDHENTIFY trial (NCT02577406).

Enasidenib is an investigational drug that has not been approved for any use in any country.

About Acute Myelogenous Leukemia (AML)

AML, a cancer of blood and bone marrow characterized by rapid disease progression, is the most common acute leukemia affecting adults. Undifferentiated blast cells proliferate in the bone marrow rather than mature into normal blood cells. AML incidence significantly increases with age, and according to the American Cancer Society, the median age of onset is 66. Less than 10 percent of U.S. AML patients are eligible for bone marrow transplant and the vast majority of patients do not respond to chemotherapy and progress to relapsed/refractory AML. The five-year survival rate for AML is approximately 20 to 25 percent. IDH2 mutations are present in about 8 to 19 percent of AML cases.