20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

UroGen Pharma has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, UroGen Pharma, 2018, MAR 15, 2018, View Source [SID1234527437]).

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Incyte Targeted Therapy and Immuno-Oncology Portfolio to be Featured in 15 Abstracts at the AACR Annual Meeting 2018

On March 15, 2018 Incyte Corporation (Nasdaq:INCY) reported that 15 abstracts from its research and development portfolio will be presented at the upcoming 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Chicago, Illinois from April 14-18, 2018 (Press release, Incyte, MAR 15, 2018, View Source;p=RssLanding&cat=news&id=2338255 [SID1234524809]). These abstracts include the first pre-clinical data from the Company’s recently announced AXL/MER, TIM-3 and LAG-3 antibody programs in patients with advanced solid tumors.

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"We are excited to present a broad collection of abstracts from our robust development portfolio at this year’s AACR (Free AACR Whitepaper) Annual Meeting," said Reid Huber, Ph.D., Incyte’s Chief Scientific Officer. "The acceptance of these abstracts and their results represent the progress Incyte continues to make in the pursuit of R&D excellence and ultimately innovation in the treatment of cancer and other serious diseases."

Key abstracts include:

Immuno-Therapy

Combination of a T Cell Activating Immunotherapy with Immune Modulators Alters the Tumor Microenvironment and Promotes More Effective Tumor Control in Preclinical Models (Abstract #1761, Immunology – Modifiers of the Tumor Microenvironment 2)

Monday, April 16, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 33
Identification of p-AKT as a PD marker for MER Kinase in Human G361 Cells (Abstract #2367, Molecular and Cellular Biology/Genetics – Kinases and Phosphatases)

Monday, April 16, 2018, 1:00 p.m. – 5:00 p.m. CDT, Chicago, Poster Section 17
Characterization of INCB081776, a Potent and Selective Dual AXL/MER Kinase Inhibitor (Abstract #3759, Immunology – Immunomodulatory Agents and Interventions 1)

Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 32
INCAGN02390, a Novel Antagonist Antibody that Targets the Co-Inhibitory Receptor TIM-3 (Abstract #3825, Immunology – Therapeutic Antibodies, Including Engineered Antibodies 3)

Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 34
INCAGN02385 is an Antagonist Antibody Targeting the Co-Inhibitory Receptor LAG-3 for the Treatment of Human Malignancies (Abstract #3819, Immunology – Therapeutic Antibodies, Including Engineered Antibodies 3)

Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 34
Epacadostat plus Durvalumab in Patients with Advanced Solid Tumors: Preliminary Results of the Ongoing, Open-Label, Phase 1/2 ECHO-203 Study (Abstract #CT177, Session CTMS03 – Biomarkers in Immuno-Oncology [minisymposium])

Tuesday, April 17, 2018, 2:45 p.m. – 5:00 p.m. CDT, Chicago, N Hall C – McCormick Place North (Level 1)
Targeted Therapy

INCB052793, a JAK1 Selective Inhibitor, is Highly Efficacious in PDX and Xenograft Models of Acute Myeloid Leukemia (AML) Expressing Elevated Endogenous pSTAT3/pSTAT5 (Abstract #1867, Experimental and Molecular Therapeutics – Experimental Agents and Combinations for Hematologic Malignancies 2)

Monday, April 16, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 38
The Evaluation of INCB059872, an FAD-directed Inhibitor of LSD1, in Preclinical Models of T-ALL (Abstract #1893, Experimental and Molecular Therapeutics – Experimental Agents and Combinations for Hematologic Malignancies 2)

Monday, April 16, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 38
The FAD-directed LSD1 Specific Inhibitor, INCB059872, is a Promising Epigenetic Agent for AML Therapy by Inducing Differentiation of Leukemic Stem/Progenitor Cells (Abstract #1888, Experimental and Molecular Therapeutics – Experimental Agents and Combinations for Hematologic Malignancies 2)

Monday, April 16, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 38
INCB059872, a Novel FAD-directed LSD1 Inhibitor, is Active in Prostate Cancer Models and Impacts Prostate Cancer Stem-like Cells (Abstract #1379, Molecular and Cellular Biology/Genetics – Epigenetic Therapy)

Monday, April 16, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 16
In Vivo Assessment of the Combination of the JAK1-Selective Inhibitor Itacitinib with First- and Second-Generation EGFR Inhibitors in Models of Non-Small Cell Lung Cancer (Abstract #2938, Experimental and Molecular Therapeutics – Novel Experimental Combinations)

Monday, April 16, 2018, 1:00 p.m. – 5:00 p.m. CDT, Chicago, Poster Section 41
The FAD-Directed LSD1 Specific Inhibitor, INCB059872, Inhibits Cell Migration and Metastasis by Suppressing Premetastatic Niche Formation in a Spontaneous Metastasis Mouse Model (Abstract #3929, Experimental and Molecular Therapeutics – Resistance and Biology)

Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 39
The BET Inhibitor INCB057643 Suppresses ALDH Activity by Targeting the ALDH1A1 Super-Enhancer in High-Grade Serous Ovarian Cancer (Abstract #3685, Clinical Research – Molecular Classification of Tumors 1: Epigenetic Therapy, Functional and Molecular Imaging, and Tumor Heterogeneity)

Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 28
Effect of JAK/STAT or PI3Kδ Plus PD-1 Inhibition on the Tumor Microenvironment: Biomarker Results From a Phase 1b Study in Patients with Advanced Solid Tumors (Abstract #CT176, Session CTMS03 – Biomarkers in Immuno-oncology [minisymposium])

Tuesday, April 17, 2018, 2:45 p.m. – 5:00 p.m. CDT, Chicago, N Hall C – McCormick Place North (Level 1)
Anti-Tumor Efficacy of INCB057643, a Novel BET Bromodomain Inhibitor, in Castration-Resistant Prostate Cancer as Single Agent and in Combination Therapy (Abstract #5793, Experimental and Molecular Therapeutics – Canonical Targets 2)

Wednesday, April 18, 2018, 8:00 a.m. – 12:00 p.m. CDT, Chicago, Poster Section 36
Full session details and data presentation listings for AACR (Free AACR Whitepaper) 2018 can be found at: View Source!/4562

Deciphera Pharmaceuticals, Inc. to Report Clinical and Preclinical Data with DCC-2618 at the Upcoming 2018 American Association for Cancer Research (AACR) Annual Meeting

On March 15, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that two abstracts highlighting DCC-2618, the Company’s KIT and PDGFRα inhibitor have been selected for presentation at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 14-18, 2018 in Chicago, IL (Press release, Deciphera Pharmaceuticals, MAR 15, 2018, View Source [SID1234524792]).

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Details of the presentations on DCC-2618 are as follows:

Poster Title: Pharmacokinetic (PK), Safety and Tolerability Profile of DCC-2618 in a Phase 1 Trial Supports 150mg QD Selected for a Pivotal Phase 3 Trial
Author: Filip Janku, M.D., Ph.D.
Session: Phase I Clinical Trials 1
Abstract #: CT029
Date & Time: Sunday Apr 15, 20181:00 PM – 5:00 PM CT
Location:McCormick Place South, Hall A, Poster Section 42, poster board # 22

Poster Title: Inhibition of Oncogenic and Drug-resistant PDGFRα and KIT Alterations by DCC-2618
Author:Bryan D. Smith
Session: Resistance and Biology
Abstract #: 3925
Date & Time: Tuesday, April 17, 20188:00 AM – 12:00 PM CT

"We are pleased to present these data demonstrating potent inhibition of KIT and PDGFRα alterations and mutations with DCC-2618 at the upcoming AACR (Free AACR Whitepaper) annual meeting," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "Importantly, these results support the growing body of clinical data reported with DCC-2618 in solid tumors and the selection of 150mg once daily as the dose for the recently initiated pivotal Phase 3 trial of DCC-2618 in gastrointestinal stromal tumors (GIST)."

About DCC-2618

DCC-2618 is a KIT and PDGFRα kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, glioblastoma multiforme and systemic mastocytosis. DCC-2618 was specifically designed to improve the treatment of GIST patients by inhibiting a broad spectrum of mutations in KIT and PDGFRα. DCC-2618 is a KIT and PDGFRα inhibitor that blocks initiating KIT mutations in exons 9, 11, 13, 14, 17, and 18, known to be present in GIST patients and the D816V exon 17 mutation known to be present in ASM patients. DCC-2618 inhibits PDGFRα mutations in exon 18, including the D842V mutation that drives a subset of GIST.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Navidea Biopharmaceuticals 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, Navidea Biopharmaceuticals, 2018, MAR 15, 2018, View Source [SID1234524834]).

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SYNERGY-AI Based Precision Oncology Clinical Trial Matching

On March 15, 2018 Massive Bio, Inc., a leader in providing simplified and affordable access to precision oncology to cancer patients treated at community-based oncology practices, reported that the first patient has been enrolled in a global registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool powered by a virtual tumor board (VTB) program (Press release, Massive Bio, MAR 15, 2018, View Source [SID1234555208]). This registry will assess its clinical impact on world-wide patients with advanced cancer to facilitate clinical trial enrollment (CTE), as well as financial impact.

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The SYNERGY-AI registry is the first of its kind to combine artificial intelligence, genomic biomarkers and multi-variate analysis to accelerate clinical trial matching and promote access to promising cancer therapies. SYNERGY-AI is a part of Massive Bio’s global strategic collaboration with community-based oncology practices. Established in 2014, the goal of the collaboration is to promote precision oncology approaches at the point-of-care, and to ease access to clinical trials, while reducing patient and provider burden and overall cancer care costs.

"Today’s announcement marks a one-of-a-kind clinical program which utilizes a precision medicine approach to clinical trial matching that could potentially catalyze accelerated enrollment from a patient-driven perspective, while promoting access and innovation," said Dr. Arturo Loaiza-Bonilla, MD, MSEd, Chief Medical Advisor and Co-Founder of Massive Bio. "Initiation of this study also represents a significant milestone for Massive Bio, as we have the opportunity to help over 1,500 patients to enroll in therapeutic cancer trials. Most importantly, we believe this program has the potential to change the paradigm of how we approach clinical trial screening and enrollment and help many more patients in the future."