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

Pieris Pharmaceuticals 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, Pieris Pharmaceuticals, 2018, MAR 15, 2018, View Source [SID1234524844]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Adaptimmune Sees Positive Early Results in Cancer Treatment

On March 16, 2018 Shares of Adaptimmune Ltd. surged late Thursday after the company reported it saw three partial responses in three of the four myxoid/ round cell liposarcoma (MRCLS) patients the company dosed with its NY-ESO SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cells (Press release, BioSpace, MAR 15, 2018, View Source [SID1234524855]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The news sent company stock up more than 20 percent to $12.41 per share. Since that spike, shares have fallen back some to $10.74 as of 10:51 a.m.

Those positive results are also good news for GlaxoSmithKline, which licensed the NY-ESO SPEAR T-cell therapy program last fall. The two companies initiated their collaboration in 2014 and last year the pharma giant exercised its option to exclusively license Adaptimmune’s NY-ESO SPEAR T-cell therapy program. The transition has not yet been completed.

MRCLS is a type of liposarcoma that is characterized by the proliferation of adipocyte (fat cell) precursors called lipoblasts that have undergone differentiation arrest. MRCLS represents about 30 to 35 percent of liposarcomas and 5 to 10 percent of all adult soft tissue sarcomas. It is estimated that there are approximately 2000 patients in the United States and Europe with MRCLS each year.

Rafael Amado, Adaptimmune’s chief medical officer, said the company is encouraged by the initial responses in the first patients dosed. He said the news validates the potential for its platform to treat a broad range of tumors, including those known to be unresponsive to current immunotherapy treatments.

"Although MRCLS is a soft tissue sarcoma which commonly expresses NY-ESO, there are fundamental differences in its clinical course, natural history, molecular signature, and responsiveness to standard treatments that make it distinct from synovial sarcoma. As we expect data from our other trials with our wholly owned assets throughout 2018, these results in a second solid tumor strengthen our conviction that our pipeline of unique TCRs will be capable of addressing multiple solid tumors," Amado said in a statement.

So far Adaptimmune has dosed four patients with its treatment. Of the three partial responses the company said two have been confirmed and one has yet to be confirmed. The other patient was classified as having stable disease. Adaptimmune said the doses were well-tolerated. However, the company said it did see cases of cytokine release syndrome (CRS), a systemic inflammatory response that has been a persistent concern in other CAR-T and cell therapy trials. The CRS cases Adaptimmune patients encountered were managed following standard treatment guidelines, the company said.

Two years ago the U.S. Food and Drug Administration placed a partial clinical hold on the NY-ESO SPEAR T-cell study for MRCLS. The hold was lifted after Adaptimmune revised the trial protocol.

In addition to its NY-ESO SPEAR T-cell study, Adaptimmune is using SPEAR T-cells in two clinical trials targeting MAGE-A10, one in non-small cell lung cancer (NSCLC), and a triple tumor study in bladder, melanoma, and head & neck cancers. Both studies are dose escalation trials that evaluate three doses of transduced SPEAR T-cells, administered after a lymphodepleting chemotherapy regimen. In addition to the MAGE-A10 trial, Adaptimmune is also targeting MAGE-A4. The newly manufactured SPEAR T-cell at the Philadelphia site will be used in a multiple tumor study in bladder, melanoma, head & neck, ovarian, non-small cell lung, esophageal, and gastric cancers.

Kiadis Pharma to Present at the Cowen and Company 38th Annual Health Care Conference

On March 14, 2018 Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing a T-cell immunotherapy product designed to reduce Graft versus Host Disease (GVHD) in hematopoietic stem cell transplantations (HSCT), reported that Arthur Lahr, Chief Executive Officer, will present at the Cowen 38th Annual Health Care Conference on Wednesday, March 14, 2018 at 10:00am EDT in Boston, MA (Press release, Kiadis, MAR 15, 2018, View Source [SID1234525132]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For more information, please contact:

Kiadis Pharma:
Karl Hård, Head of IR & Communications
Tel. +31 611 096 298
[email protected]

Optimum Strategic Communications:
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 (0) 203 714 1787
[email protected]