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OPKO Health’s 4Kscore® Test Highlighted in Podium Presentation at 112th American Urological Association Annual Meeting

On May 18, 2017 (GLOBE NEWSWIRE) — OPKO Health, Inc. (NASDAQ:OPK), reported that data from a prospective study conducted at Veteran Affairs (VA) hospitals confirming the 4Kscore test’s ability to accurately predict aggressive prostate cancer were presented in a podium presentation on May 16, 2017 at the 112th American Urological Association (AUA) Annual Meeting in Boston.

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The study entitled, "An Independent, Multi-Institutional, Prospective study in the Veterans Affairs Health System confirms the 4Kscore accurately predicts aggressive prostate cancer," was presented by Sanoj Punnen, M.D., Assistant Professor of Urologic Oncology at the Miller School of Medicine, Department of Urology at the University of Miami in Miami, Florida. The study is the second U.S. prospective clinical study to establish the clinical validity of the 4Kscore test to predict the presence of aggressive prostate cancer prior to performing a prostate biopsy.

The VA study was conducted at eight VA hospitals across the United States. A total of 366 men were enrolled in the study, and 208 (56%) of the participants were African American. Of all cancers diagnosed among African American men, prostate cancer is the most common (31% of all cancers), and African American men have a twofold greater risk of prostate cancer mortality compared to non-Hispanic whites.1

Overall, the 4Kscore demonstrated a high degree of accuracy for predicting the presence of aggressive (Gleason score 7 and higher) prostate cancer with an area under the receiver operator curve (AUC) of 0.81, significantly better than PSA alone or a clinical model based on PSA. Importantly, there was an equally high ability of the 4Kscore to discern aggressive disease in the African American men compared with the non-African American men (AUC = 0.80 v. 0.84, p = 0.32). The calibration and decision curve analysis were also consistent with the performance shown in the first U.S. validation study.

"The VA study confirms the 4Kscore’s accuracy in predicting a man’s risk of having aggressive prostate cancer and showed that it is an equally effective and vital clinical test for African American men, who have the highest rates of prostate cancer mortality," said Phillip Frost, M.D., Chairman and CEO of OPKO Health. "These positive results add to our growing body of clinical evidence that demonstrate 4Kscore’s utility to accurately identify the risk of aggressive prostate cancer. Moreover, these data validate the clinical value of the 4Kscore test in a VA setting and show it to be identical to the performance previously shown in community and academic sites across the U.S. and Europe."

About Prostate Cancer

According to the Prostate Cancer Foundation,2 "every 3.3 minutes a man is diagnosed with prostate cancer, and millions of men and their families are fighting the disease globally. In the United States, prostate cancer affects 1 in 8 men, making it the most common non-skin cancer in America. This means that a non-smoking man is more likely to develop prostate cancer than he is to develop colon, bladder, melanoma, lymphoma, and kidney cancers combined. In 2017 alone, it is estimated that more than 161,000 men will be diagnosed with prostate cancer, and more than 27,000 will die from the disease. A man of African descent is 73% more likely to develop prostate cancer than a Caucasian man, and more than twice as likely to die from the disease."

About the 4Kscore Test

The 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and human kallikrein-related peptidase 2 (hK2). These biomarkers are combined with a patient’s age, digital rectal exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) using a proprietary algorithm that calculates the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions. The 4Kscore test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the patient-physician shared decision making discussion. The 4Kscore test is included in the 2016 National Comprehensive Cancer Network and 2016 European Association of Urology Prostate Cancer Guidelines.

Stemline Therapeutics to Present SL-401 Updated Data from Stage 1 and 2 of Ongoing Pivotal Phase 2 BPDCN Trial at Upcoming European Hematology Association (EHA) Meeting

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]).

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.

Karyopharm’s Phase 2b SADAL Data Evaluating Selinexor in Diffuse Large B-Cell Lymphoma Selected for Oral Presentation at the 2017 European Hematology Association Annual Meeting

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]).

"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.

Onconova Therapeutics to Present a Poster Session Relating to Intravenous Rigosertib at the 2017 American Society of Clinical Oncology Annual Meeting

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]).

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

Data from Clinical Study of NewLink Genetics’ IDO Pathway Inhibitor, Indoximod, to Be Presented at the 22nd European Hematology Association Congress

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]).

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.