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.

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.

ImmunoCellular Therapeutics Announces Achievement of Next Key Milestone in Stem-to-T-Cell Research Immuno-Oncology Program

On April 12, 2018 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular" or the Company) (NYSE American: IMUC) reported that it has been able to verify successful transfer of the selected T cell receptor genetic material into human hematopoietic stem cells (Press release, ImmunoCellular Therapeutics, APR 12, 2018, View Source [SID1234525479]). This milestone represents the next important step in validating the Stem-to-T-Cell approach, and is a key component of the proof-of-concept work for this technology. This achievement is a key next step to begin preclinical testing. ImmunoCellular’s Stem-to-T-Cell technology is designed to stimulate the patient’s immune system to produce an unlimited supply of killer T cells that specifically target and destroy tumor cells with minimal side effects.

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ImmunoCellular Therapeutics Logo. (PRNewsFoto/ImmunoCellular Therapeutics) (PRNewsFoto/IMMUNOCELLULAR THERAPEUTICS)

At the end of 2017, the research team at ImmunoCellular successfully transfected genetic material into human hematopoietic stem cells. That work was the basis for this most recent achievement. Successful completion of this phase of work enables the Company to begin preclinical testing in animals, which, if successful, could allow ImmunoCellular’s Stem-to-T-Cell technology to advance into human clinical testing.

"We are excited to have achieved this critical next milestone in our Stem-to-T-Cell program, and are excited to begin the preclinical animal testing that can lay the foundation for potentially proceeding toward conducting human clinical trials," said Steven J. Swanson, PhD, Senior Vice President, Research. "We and our collaborators are now working to design and implement the necessary animal studies to complete our proof-of-concept work. Our vision is to develop solutions for intractable cancers, extend the lives of cancer patients, and provide hope for a potential cure. We believe that our Stem-to-T-Cell program is potentially a game-changing treatment for cancer, and could be effective in treating many types of cancers."

Anthony J. Gringeri, PhD, President and Chief Executive Officer commented: "We are pleased with the productivity and achievements to date of our research team and the continued generation of scientific validation of our Stem-to-T-Cell program. Continued testing of our novel immuno-oncology technology may elucidate how it can be applied in a real-world therapeutic setting, and lead the way toward conducting clinical trials, including potential exploration of combination with other approaches. From a corporate perspective, we are pleased with our ability to achieve our research goals while continuing to operate in a cost-efficient manner. We are also continuing to explore potential collaborations for our clinical programs and other strategic alternatives for our Company."

About ImmunoCellular’s Stem-to-T-Cell Program

Based on the technology in-licensed from The California Institute of Technology in 2014 ImmunoCellular’s Stem-to-T-Cell program is designed to harness the power of the immune system in highly directed and specific ways to engineer highly antigen-specific tumor killing. At the core of the Stem-to-T-Cell technology is the harvesting of stem cells from cancer patients and then cloning into them T cell receptors that are specific for cancer cells. These engineered stem cells can then be reintroduced into the patient and are pre-programed to produce daughter cells that are antigen specific killer T cells that are capable of identifying, binding to, and killing cancer cells. Because stem cells are immortal, these reengineered stem cells could provide a natural and perpetual source of T cells that can target and destroy cancer cells in the patient.

The Stem-to-T-Cell platform has the potential to address many types of cancer, including both solid and hematological tumors and has the potential to result in a potentially curative therapy for many different types of cancers. The stem cell platform represents a novel and more direct approach to generating killer T cells by using the patient’s stem cells as starting material. Thus, ImmunoCellular’s Stem-to-T-Cell technology shares some similarities with other immuno-oncology technologies, such as CAR-T, and could potentially be used in combination approaches. Unlike CAR-T therapies which deliver a large bolus of active T cells into the patient’s circulation and have been associated with toxicity in some patients, ImmunoCellular’s approach enables a more gradual and measured release of killer T cells and has the potential for lower toxicity while also yielding a more sustained response.