On June 03, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported that its SL-401 Phase 2 clinical data in blastic plasmacytoid dendritic cell neoplasm (BPDCN) will be the subject of an oral presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting being held in Chicago, IL (Press release, Stemline Therapeutics, JUN 3, 2016, View Source [SID:1234512974]). The presentation will take place tomorrow, Saturday, June 4th, at 5 PM CT.

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Details on the ASCO (Free ASCO Whitepaper) presentation are as follows:

Title: Results from Phase 2 registration trial of SL-401 in patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Lead-in completed, Expansion stage ongoing
Presenter: Naveen Pemmaraju, M.D., MD Anderson Cancer Center
Abstract No.: 7006
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date/Time: Saturday, June 4, 2016; 5:00 – 5:12PM CT
Location: Arie Crown Theater

Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, noted, "We are honored that our Phase 2 results have been selected for oral presentation at ASCO (Free ASCO Whitepaper). We believe this selection underscores the exciting clinical data we have witnessed with SL-401, and highlights the increased awareness of BPDCN, a devastating malignancy with high unmet medical need."

Dr. Bergstein concluded, "Our investigators plan to provide updated enrollment figures, response rates and duration, as well as preliminary progression-free and overall survival data from the trial. Needless to say, we continue to remain extremely excited about this program and its impressive progress. Over the remainder of the year, we look forward to providing further clinical and regulatory updates relating to SL-401 and across our entire clinical pipeline."

On June 3rd, 2016 Genoscience Pharma, a company focused on discovering and developing small molecules to treat cancer by targeting cancer stem cells, reported that it will present data on its most promising candidate at The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2016: June 3 – 7, Chicago, Illinois (Press release, GenoScience, JUN 3, 2016, View Source [SID:1234512975]).

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The details for the data presentations at ASCO (Free ASCO Whitepaper) are as follows.

Poster Presentation

Title : Preclinical characterization of GNS561, a novel first in class autophagy inhibitor able to kill hepatocellular carcinoma cancer stem cells

Publication Number: e15600
Session Date: from June 3rd, 2016 to June 7th, 2016
Session: Clinical: Hepatocellular Carcinoma and Cholangiocarcinoma
Room: The McCormick Place Convention Center, Chicago

Abstract:

In spite of successful approval and wide application of sorafenib, the prognosis for patients with advanced hepatocellular carcinoma (HCC) remains poor. In recent years, highly tumorigenic sub-populations of cancer cells named Cancer Stem Cells (CSCs) have been implicated in post-treatment tumor recurrence. Indeed, CSCs are resistant to chemotherapy, and they have the ability to regenerate all the cell types within the tumor. For this reason, innovative drugs with original mechanism of action which tackle CSCs would likely improve cancer treatment of patients.

Antitumor activity of GNS561 was tested on a panel of cancer cell lines. Its effect on HCC CSCs subpopulation was assessed by flow cytometry (ALDH activity, CD133 expression) and by sphere formation assay. Tolerance and plasma and liver pharmacokinetic were evaluated after single and repeated dosing in mice and rats. In vivo GNS561 activity was tested in orthotopic mouse models.

GNS561 demonstrated autophagy inhibition and apoptosis induction activities related to lysosome disruption. It showed potent antitumor activity against a panel of human cancer cell lines. In HCC cell lines, GNS 561 was active on both whole populations (mean EC50 2µM) and subpopulations displaying CSC features (high ALDH and CD133 positivity). Further, GNS561 was effective against a panel of HCC tumors even from patients harboring sorafenib resistance. In mouse, GNS561 was found well tolerated and highly selectively trapped in the liver (exposure ratio liver/plasma about 170 animals), and showed a significant tumor growth inhibition in orthotopic HCC mouse models.

Our results provide a rationale for testing autophagy flux disruption as a novel therapeutic strategy for HCC. GNS561 is a liver selective drug active against both the whole tumor bulk and CSCs, which offers great promise for HCC treatment.

On June 03, 2016 NewLink Genetics Corporation (NASDAQ:NLNK) reported that it will present two posters highlighting the indoleamine 2,3-dioxygenase pathway (IDO) inhibitor indoximod, at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5 in Chicago (Press release, NewLink Genetics, JUN 3, 2016, View Source [SID:1234512977]).

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The company’s two abstracts at ASCO (Free ASCO Whitepaper) will highlight:

Abstract 3075: Updates on Phase 1b/2 trial of the indoleamine 2,3-dioxygenase pathway (IDO) inhibitor indoximod plus checkpoint inhibitors for the treatment of unresectable stage 3 or 4 melanoma;
Time: 8:00 AM to 11:30 AM
Date: Sunday, June 5, 2016
Poster Discussion Session: Developmental Therapeutics—Immunotherapy
Abstract 3020: Interim analysis on Phase 2 trial of the indoleamine 2,3-dioxygenase pathway (IDO) inhibitor indoximod plus gemcitabine/nab-paclitaxel for the treatment of metastatic pancreas cancer.
Time: 8:00 AM to 11:30 AM
Date: Sunday, June 5, 2016
Poster Discussion Session: Developmental Therapeutics—Immunotherapy
About NewLink Genetics’ Indoleamine 2,3-Dioxygenase (IDO) Pathway Inhibitors

The indoleamine 2,3-dioxygenase (IDO) pathway regulates immune response by suppressing T cell function and enabling local tumor immune escape. NewLink Genetics is researching two IDO pathway inhibitors, GDC-0919 (in partnership with Genentech) and indoximod, both small-molecule product candidates that have the potential to disrupt mechanisms by which tumors evade the immune system. NewLink Genetics’ indoximod and GDC-0919 each have a distinct mechanism of action within the IDO pathway and are in Phase 1 or 2 clinical trials for a range of cancers, including breast cancer, melanoma, and other solid tumors.

About NewLink Genetics Corporation

On June 2, 2016 Argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies to treat cancer and severe autoimmune diseases, reported data published in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting (Chicago, USA) presenting efficacy and safety data from its ARGX-111 Phase 1 expansion study in patients with MET amplified tumors (Press release, arGEN-X, JUN 2, 2016, View Source [SID:1234512983]). The data confirm ARGX-111 to have a favorable safety profile and to continue to show signs of anti-tumor activity. The abstract can be accessed here.

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In addition, data from preclinical studies demonstrate depletion of MET-positive myeloid-derived suppressor cells (MDSCs) by ARGX-111. These data provide an exciting new perspective for therapeutic intervention in MET cancer biology in targeting both the tumor cells and the tumor microenvironment.

About ARGX-111

ARGX-111 is a Met-targeting human monoclonal SIMPLE Antibody that modulates all known mechanisms of action of the receptor. ARGX-111 benefits from POTELLIGENT-enhanced Antibody Dependent Cellular Cytotoxicity (ADCC), which drives the immune system to destroy
c-MET positive cells of the primary tumor and the circulating tumor cells that are responsible for metastasis; and from NHance, which is thought to drive tissue penetration. This unique combination results in a potentially best-in-class drug candidate for c-Met therapies. ARGX-111 is tested in a Phase 1 safety expansion cohort in MET-amplified patients.

Phase 2, Parellel-Arm Study of Receptor Tyrosine Kinase (RTK) Inhibitor MGCD265 in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Activating Genetic Alterations in Mesenchymal-Epithelial Transition Factor (MET)"

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