On May 18, 2017 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology indications of unmet medical need, reported that SL-401 Stage 1 and 2 data from its ongoing pivotal Phase 2 trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN) has been accepted for poster presentation at the 2017 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, to be held June 22-25, 2017 in Madrid, Spain (Press release, Stemline Therapeutics, MAY 18, 2017, View Source [SID1234519227]).

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Details on the presentation is as follows:


SL-401 – BPDCN Presentation
Title: Ongoing Phase 2 Clinical Trial Of SL-401 In Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Stage 1 And Stage 2 Results
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: P191
Session: Acute myeloid leukemia – Clinical 1
Date/Time: Friday, June 23 – 5:15-6:45 PM CET
Location: Hall 7 – Poster Area

Stemline remains on track to provide an update on BPDCN patients enrolled in Stage 3 of the Phase 2 pivotal trial in the second half of this year.

On May 18, 2017 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that interim clinical data from the ongoing Phase 2b SADAL study evaluating lead product candidate, selinexor (KPT-330), an oral Selective Inhibitor of Nuclear Export / SINE compound, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) will be featured in an oral presentation at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place June 22-25, 2017 in Madrid, Spain (Press release, Karyopharm, MAY 18, 2017, View Source [SID1234519226]).

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"DLBCL is the most common type of non-Hodgkin lymphoma among adults and there remains a high unmet medical need, particularly in the relapsed and refractory setting for patients who are not eligible for stem cell transplant or who relapse afterward," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "Previously reported data from the ongoing Phase 2b SADAL study showed that treatment with single-agent oral selinexor resulted in robust response rates with prolonged durability in patients with heavily pretreated DLBCL, including against both GCB and non-GCB (ABC) subtypes. We look forward to sharing some further detail from the SADAL study with the medical community at EHA (Free EHA Whitepaper) and ICML this year."

In addition, Karyopharm’s Phase 2b SADAL data were also selected for a poster presentation at the 14th International Conference on Malignant Lymphoma (ICML) being held June 14-17, 2017 in Lugano, Switzerland.

Details for the Oral Presentation at EHA (Free EHA Whitepaper) 2017:

Title: Single Agent Oral Selinexor Exhibits Durable Responses in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) of Both GCB and Non-GCB Subtypes: The Phase 2b SADAL Study
Presenter: Marie Maerevoet, Institute Jules Bordet, Brussels, Belgium
Abstract code: S469
Topic: Aggressive Non-Hodgkin lymphoma — Clinical
Session: Aggressive Non-Hodgkin lymphoma — Relapsed/refractory
Location: Hall C
Date and Time: Saturday, June 24, 2017 from 14:45 – 17:00 CET

Details for the Poster Presentation at ICML 2017:

Title: A Phase 2b Randomized Study of Single Agent Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Presenter: Rene-Olivier Casanovas, Hematologie Clinique, CHU Dijon, France
Poster #: 193
Location: Marquee Parco Ciani
Date and Time: From Wednesday, June 14, 2017 at 12:00 CET through Friday, June 16, 2017 at 18:30 CET

About Selinexor

Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,000 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in May 2017. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform the Company’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On May 18, 2017 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported details relating to a poster presentation addressing Intravenous Rigosertib in Second-line Higher Risk MDS at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2nd-6th in Chicago (Press release, Onconova, MAY 18, 2017, View Source [SID1234519224]).

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Further Rationale for Rigosertib in a Second-line HR-MDS Setting
Abstract Number: 7056

Title: Relationship of Bone Marrow Blast (BMBL) response to Overall Survival (OS) in a Multicenter study of Rigosertib (Rigo) in Patients with Myelodysplastic Syndromes (MDS) with Excess Blasts Progressing on or After Treatment with a Hypomethylating Agent (HMA).
Date: Monday, June 5, 2017
Time and Location: 8:00 AM — 11:30 AM, McCormick Place, Hall A
Presenter: Aref Al-Kali, MD, Mayo Clinic – Rochester, Minnesota

On May 18, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported that an abstract describing data from a clinical study of its IDO pathway inhibitor, indoximod, in combination with chemotherapeutic agents for patients with newly diagnosed acute myelogenous leukemia (AML), is now available on the website of the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress (Press release, NewLink Genetics, MAY 18, 2017, View Source [SID1234519222]).

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An infographic accompanying this announcement is available at View Source

"These data to be presented at the EHA (Free EHA Whitepaper) Congress further highlight clinical results presented at AACR (Free AACR Whitepaper) in April and to be presented at ASCO (Free ASCO Whitepaper) in June, supporting the hypothesis that the IDO pathway is central to immune suppression in cancer," said Charles J. Link, Jr., M.D., Chief Executive Officer and Chief Scientific Officer. "NewLink Genetics has two separate and distinct types of IDO pathway inhibitors in clinical development. Indoximod, which is wholly owned by NewLink Genetics, has a proposed differentiated mechanism within the IDO pathway and acts as a tryptophan mimetic having a direct effect on immune cells to reverse immune suppression used by cancer to protect itself."

Indoximod in combination with chemotherapeutic agents

Initial results from the Phase 1b portion of a Phase 1b/randomized Phase 2a trial of indoximod in combination with chemotherapeutic agents, idarubicin and cytarabine, for patients with newly diagnosed AML will be presented as an e-poster (Abstract number E-912) by Ashkan Emadi, M.D., Ph.D., Associate Professor of the University of Maryland Greenebaum Comprehensive Cancer Center, at EHA (Free EHA Whitepaper) in Madrid on Friday, June 23, 2017, 9:30 AM to Saturday, June 24, 7:00 PM CET and is titled: Indoximod in Combination with Idarubicin and Cytarabine for Upfront Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia (AML): Phase 1 Report.

This study uses a conventional remission induction and consolidation protocol for patients with newly diagnosed AML. Indoximod is given orally starting on day 8 of induction onward. The Phase 1 portion evaluated three dose levels of indoximod (600 mg, 1000 mg, 1200 mg) in combination with the standard of care 7+3 chemotherapy. Twelve patients were enrolled, as of March 1, 2017. The results indicate indoximod does not appear to add significant toxicity to standard remission induction and consolidation therapy for patients with newly diagnosed AML. Initial data suggest a low rate of minimal residual disease (MRD-neg) after one cycle of induction chemotherapy.

Nicholas N. Vahanian, M.D., President and Chief Medical Officer added, "Importantly, these data support further clinical investigation of our IDO pathway inhibitors in combination with currently available therapies, such as chemotherapy for patients with newly diagnosed Acute Myeloid Leukemia (AML)."

Key findings presented from the study include:

Combination treatment with indoximod and conventional remission induction and consolidation therapy was well tolerated without adding significant toxicity
Five of 6 (83%) evaluable patients treated with indoximod (600 mg or 1000 mg) achieved complete remission, with no evidence of minimal residual disease
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape.

NewLink Genetics is currently evaluating indoximod in multiple combination studies for patients with various types of cancer including melanoma, acute myeloid leukemia, pancreatic cancer and prostate cancer.

On May 18, 2017 Nektar Therapeutics (Nasdaq: NKTR) reported its presence at the upcoming 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, where it will share updated data from clinical studies of NKTR-214. ASCO (Free ASCO Whitepaper) will take place June 2-6, 2017 in Chicago (Press release, Nektar Therapeutics, MAY 18, 2017, View Source [SID1234519221]).

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NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting CD8+ effector T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells.

"We look forward to providing updates on NKTR-214, including the first data from the PIVOT trial evaluating NKTR-214 in combination with nivolumab, as well as updated data from the monotherapy trial of NKTR-214, including I-O naïve RCC patients who received sequential checkpoint therapy following treatment with NKTR-214," said Mary Tagliaferri, M.D., Senior Vice President of Clinical Development at Nektar Therapeutics. "NKTR-214’s unique mechanism which selectively increases tumor-killing TILs, combined with its favorable safety profile and clinical activity, support our combination trials of NKTR-214 with existing checkpoint inhibitors such as nivolumab and atezolizumab, as well as other immuno-oncology mechanisms in development."

NKTR-214 targets CD122 specific receptors found on the surface of cancer-fighting immune cells in order to stimulate their proliferation. In clinical and preclinical studies, treatment with NKTR-214 resulted in expansion of these cells and mobilization into the tumor micro-environment.1,2,3 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

The abstracts published in advance of the ASCO (Free ASCO Whitepaper) meeting which were made available yesterday on the ASCO (Free ASCO Whitepaper) website at www.asco.org include preliminary data only as of February 7, 2017. Updated and additional patient data from these trials will be presented at ASCO (Free ASCO Whitepaper).

Abstract 2545/Poster 37: "Effect of a novel IL-2 cytokine immune agonist (NKTR-214) on proliferating CD8+T cells and PD-1 expression on immune cells in the tumor microenvironment in patients with prior checkpoint therapy."
Presenter: Chantale Bernatchez, Ph.D., The University of Texas MD Anderson Cancer Center
Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Date and Time: Monday, June 5, 2017 – 8:00 a.m. – 11:30 a.m. CDT
Location: Hall A

Abstract e14040: "A phase 1/2 study of a novel IL-2 cytokine, NKTR-214, and nivolumab in patients with select locally advanced or metastatic solid tumors." Diab, A., et al.
Publication abstract to be included online in the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings, a Journal of Clinical Oncology supplement.

Nektar will host an analyst and investor event with clinical investigators on Saturday, June 3, 2017 at 6:00 pm CDT in Chicago, IL during the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting.

Presenters will include lead investigators from the NKTR-214 trial: Dr. Adi Diab, Assistant Professor, Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center, Dr. Nizar Tannir, Professor, Genitourinary Medical Oncology at the University of Texas MD Anderson Cancer Center and Dr. Michael Hurwitz, Assistant Professor of Medicine (Medical Oncology) at Yale Cancer Center.

To register for the webcast of the event please visit: View Source

Seating is limited to attend the event in person, please contact [email protected] for more information.