Incyte to Report First Quarter Financial Results

On April 13, 2018 Incyte Corporation (Nasdaq:INCY) reported that it has scheduled its first quarter 2018 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, May 1, 2018 (Press release, Incyte, APR 13, 2018, View Source;p=RssLanding&cat=news&id=2342471 [SID1234525296]).

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The schedule for the press release and conference call/webcast is as follows:


Q1 2018 Press Release:

May 1, 2018 at 7:00 a.m. ET

Q1 2018 Conference Call:

May 1, 2018 at 8:00 a.m. ET

Domestic Dial-In Number:

877-407-3042

International Dial-In Number:

201-389-0864

Conference ID Number:

13678858

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13678858.

The live webcast with slides can be accessed at www.incyte.com under For Investors, Events and Presentations and will be available for replay for 30 days.

Calithera Biosciences to Present New Preclinical Data for CB-839 at AACR Annual Meeting 2018

On April 13, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that preclinical research for its glutaminase inhibitor CB-839 will be shared as poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 in Chicago (Press release, Calithera Biosciences, APR 13, 2018, View Source [SID1234535242]). CB-839 is a potent, selective, orally bioavailable glutaminase inhibitor in Phase 2 trials. The company and its academic collaborators will highlight data of CB-839 in novel therapeutic combinations in preclinical models of selected cancers.

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"Tumor metabolism is a novel therapeutic approach that exploits the way in which cancer cells utilize nutrients to grow and survive," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "CB-839, a novel glutaminase inhibitor, has the potential to be developed in combination with standard of care cancer therapeutics such as CDK4/6 or PARP inhibitors to improve patient outcomes."

Preclinical data will be presented by Ethan Emberley, PhD, in a poster titled, "The glutaminase inhibitor CB-839 synergizes with CDK4/6 and PARP inhibitors in preclinical models," on April 17, 2018 (Abstract #3509/6). Data will be presented demonstrating that CB-839 synergizes with the CDK4/6 inhibitor palbociclib in colorectal carcinoma, triple negative breast cancer (TNBC), and ER+ breast cancer cell lines, and enhances anti-tumor activity in both an ER+ breast cancer and a colorectal cancer (CRC) xenograft tumor model. CB-839 treatment in combination with the PARP inhibitors niraparib and talazoparib has synergistic anti-proliferative activity in TNBC, CRC, non-small cell lung carcinoma, ovarian and prostate cancer cells. In vivo, the combination of CB-839 with PARP inhibitors enhances anti-tumor activity compared to single agent treatment in a CRC tumor xenograft model. Two additional posters will be presented by academic collaborators:

Suppression of clear cell ovarian carcinoma growth by glutaminase-1 inhibitor as single agent and in combination with PARP-1 inhibitor
Abstract # LB-253/20
Presenter: T. Li, Laboratory of Othon Iliopoulos, Massachusetts General Hospital Tuesday April 17, 2018

Combination treatment with CB-839 and romidepsin induces apoptosis and suppresses cell viability in preclinical models of chondrosarcoma
Abstract #1329/7
Presenter: T.N. Sheikh, Laboratory of Gary Schwartz, Columbia University Monday, April 16, 2018

About CB-839

Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents

Bristol-Myers Squibb and Illumina Announce Strategic Collaboration to Develop and Commercialize Companion Diagnostics for Bristol-Myers Squibb’s Oncology Immunotherapies

On April 13, 2018 Bristol-Myers Squibb Company (NYSE: BMY) and Illumina, Inc. (NASDAQ: ILMN) reported a collaboration that will utilize Illumina’s next-generation sequencing (NGS) technology to develop and globally commercialize in-vitro diagnostic (IVD) assays in support of Bristol-Myers Squibb’s oncology portfolio (Press release, Bristol-Myers Squibb, APR 13, 2018, View Source [SID1234525302]). The companies plan to develop a diagnostic version of the Illumina TruSight Oncology 500 assay to measure potentially predictive genomic biomarkers, including Tumor Mutation Burden (TMB). Illumina’s TruSight Oncology 500 assay is being developed to detect most of the known biomarkers for oncology therapeutics, including TMB and Microsatellite Instability for immunotherapies.

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"Through our deep understanding of cancer biology and emerging research, we recognize the importance for physicians to know each patient’s biomarker status to help fight their cancer in a more personalized way," said Saurabh Saha, M.D., Ph.D., Senior Vice President, Global Head of Translational Medicine, Bristol-Myers Squibb. "We are excited to partner with Illumina to pursue development of diagnostics that can help predict which patients will have the potential to benefit most from our immunotherapies."

"The identification of biomarkers for targeted therapies is emerging as a key part of a cancer patient’s journey, from treatment selection through response monitoring and allows physicians to follow the evolution of a patient’s tumor over time," said Garret Hampton, Ph.D., Executive Vice President of Clinical Genomics at Illumina. "Next-generation sequencing assays, such as a companion diagnostic (CDx) version of TruSight Oncology 500, are ideally suited to the comprehensive interrogation of a patient’s cancer. With BMS’ leading position in immunotherapy development, we see tremendous promise in this partnership to co-develop next-generation sequencing-based diagnostics that can identify effective therapeutic combinations and provide global access to these targeted drugs."

Cancer immunotherapy works by helping the immune system mount an anti-cancer response, a process that depends in part on the recognition of cancer-specific proteins called neoantigens. Bristol-Myers Squibb’s clinical development program includes 24 clinical-stage molecules designed to target different immune system pathways across more than 50 types of cancers, and through its translational capabilities, has identified a number of potentially predictive biomarkers, including PD-L1, TMB, MSI-H/dMMR and LAG-3.

Syndax to Present at the 2018 American Association for Cancer Research Annual Meeting

On April 13, 2018 Syndax Pharmaceuticals, Inc. ("Syndax,"the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported twelve oral and poster presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14-18, 2018 in Chicago, Illinois (Press release, Syndax, APR 13, 2018, View Source [SID1234525305]).

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Details on Presentations
Oral Presentations:
Title: Safety, efficacy, and immune correlates of alternative doses and schedules of entinostat combined with pembrolizumab in patients with advanced solid tumors – results from SNDX-275- 0141 phase I trial
Presenter: Anthony W. Tolcher, M.D.
Category: Clinical Trials
Session: Biomarkers in Immuno-oncology
Abstract Number: CT179
Location: N Hall C – McCormick Place North (Level 1)
Date and Time: Tuesday April 17, 2018; 3:50 PM – 4:05 PM C.T.
Title: VTP-50469 is a novel, orally-available Menin-MLL1 targeted inhibitor effective against MLL-Rearranged and NPM1-mutant leukemia
Presenter: Andrei V. Krivtsov, PhD
Category: Experimental and Molecular Therapeutics
Session: Early Novel Drug Development
Abstract Number: 4958
Location: McCormick Place South, Room S102 (Level 1)
Date and Time: Tuesday April 17, 2018; 3:50 PM – 4:05 PM C.T.
Title: Entinostat transforms the suppressive tumor microenvironment of breast

Title: Epigenetic reprogramming of the tumor microenvironment by Entinostat increases tumor sensitivity to multivalent immunotherapy combinations with an IL-15 superagonist plus vaccine or immune checkpoint blockade
Category: Immunology
Session: Modifiers of the Tumor Microenvironment 2
Abstract Number: 1740
Location: McCormick Place South, Exhibit Hall A, Poster Section 33
Date and Time: Monday April 16, 2018; 8:00 AM – 12:00 PM C.T.
Title: Epigenetic modulation of the tumor microenvironment enhances immune checkpoint
efficacy in a murine model of pancreatic cancer
Category: Immunology
Session: Modifiers of the Tumor Microenvironment 2
Abstract Number: 1746
Location: McCormick Place South, Exhibit Hall A, Poster Section 33
Date and Time: Monday April 16, 2018; 8:00 AM – 12:00 PM C.T.
Title: Activity of entinostat alone and in combination with cisplatin in a panel of low passage adenoid cystic carcinoma patient-derived xenograft (PDX) models
Category: Tumor Biology
Session: Translational Therapeutics in Cancer Models 2
Abstract Number: 2146
Location: McCormick Place South, Exhibit Hall A, Poster Section 7
Date and Time: Monday April 16, 2018; 1:00 PM – 5:00 PM C.T.
Title: Antitumor activity of HDAC inhibition in bladder cancer mouse models correlates with enhanced immune response
Category: Immunology
Session: Immune Mechanisms Invoked by Therapies 1
Abstract Number: 2748
Location: McCormick Place South, Exhibit Hall A, Poster Section 33
Date and Time: Monday April 16, 2018; 1:00 PM – 5:00 PM C.T.
Title: Overcoming resistance to DNA targeted agents by epigenetic activation of Schlafen 11
(SLFN11) expression with class I histone deacetylase inhibitors
Category: Molecular and Cellular Biology/Genetics
Session: Late-Breaking Research: Molecular and Cellular Biology / Genetics 2
Abstract Number: LB-244
Location: McCormick Place South, Exhibit Hall A, Poster Section 45
Date and Time: Tuesday April 17, 2018; 8:00 AM – 12:00 PM C.T.
Title: Pediatric Preclinical Testing Consortium evaluation of the menin inhibitor, VTP-50469, against xenograft models of MLL-rearranged infant acute lymphoblastic leukemia
Category: Tumor Biology
Session: Pediatrics 2: Preclinical Therapies, Resistance, and Stem Cells
Abstract Number: 3187
Location: McCormick Place South, Exhibit Hall A, Poster Section 7
Date and Time: Tuesday April 17, 2018; 8:00 AM – 12:00 PM C.T.

Title: Histone deacetylase inhibitor, Entinostat enhances the tumor specific immune response by generating T-cell central memory in the TME
Category: Immunology
Session: Immunomodulatory Agents and Interventions 1
Abstract Number: 3761
Location: McCormick Place South, Exhibit Hall A, Poster Section 32
Date and Time: Tuesday April 17, 2018; 8:00 AM – 12:00 PM C.T.
Title: Manipulating the breast tumor microenvironment with histone deacetylase inhibitors for
more robust and durable T cell responses
Category: Immunology
Session: Immunomodulatory Agents and Interventions 2
Abstract Number: 4700
Location: McCormick Place South, Exhibit Hall A, Poster Section 33
Date and Time: Tuesday April 17, 2018; 1:00 PM – 5:00 PM C.T.
All accepted abstracts will be published in the 2018 Proceedings of the AACR (Free AACR Whitepaper). Session
information is available online via the Annual Meeting Itinerary Planner through the AACR (Free AACR Whitepaper) website
at www.aacr.org.

AACR 2018: GamaMabs Pharma to present new data on expression of Anti-Müllerian Hormone type II Receptor in non-gynecological cancers and on first ADC candidate targeting AMHRII

On April 12, 2018 GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting AMHRII for the treatment of cancer, reported the presentation of two posters on its AMHRII program at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, taking place from April 14 to 18 in Chicago, USA (Press release, GamaMabs Pharma, APR 12, 2018, View Source [SID1234525281]).

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The results of extensive investigations show AMHRII expression in a majority of tumor samples in a wide range of non-gynecological tumors such as colorectal and lung cancers, hepatocarcinoma or renal cell carcinoma. Moreover internalization capabilities and selective distribution of the target have been utilized to design a first AMHR2 based ADC approach.

The presentation details are as follows:
• Title: Anti-Müllerian Hormone type II Receptor (AMHRII) found expressed in
human non-gynecological solid tumors, suggesting potential broader applications
for anti-AMHRII-based therapy
o Abstract number: 774
o Date and time: April 15, 2018, 1pm – 5pm (CT)
o Session category/title: Experimental and Molecular Therapeutics
o Location: Section 36

• Title: Anti-Müllerian hormone type II receptor (AMHRII), a cancer target for
GM103, a novel antibody-drug conjugate (ADC)
o Abstract number: 1779
o Date and time: April 16, 2018, 8am – 12pm (CT)
o Session category/title: Therapeutic Antibodies, including Engineered
Antibodies 1
o Location: Section 34

The studies were performed with GamaMabs’ partners, including the Curie Institute (Paris, France), the Gustave Roussy Institute (Villejuif, France), Massachusetts General Hospitals (Boston, USA), the Léon Bérard Cancer Center (Lyon, France), Nantes University Hospital (France), the Montpellier Cancer Research Institute (France), Abzena (UK) and the Helsinki University Hospital (Finland).

"We are happy to be able to share such groundbreaking data on AMHRII expression, unveiling its potential as a novel target in a wide range of solid tumors," said Jean-François Prost, VP R&D at GamaMabs. "The results with GM103 clearly show, as a proof of concept, that AMHRII is also a suitable target for treating AMHRII-positive solid tumors with an ADC."

"We are committed to expanding our development plans beyond gynecological cancers, in particular for our lead program GM102," said Stéphane Degove, CEO at GamaMabs. A copy of the above referenced abstracts can be viewed online through the AACR (Free AACR Whitepaper) meeting website. Following the presentation, the data presented will be available on the Publications page of GamaMabs’ website.