On December 8, 2017 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, reported that SL-401, a novel targeted therapeutic directed to CD123, will be featured in four presentations at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held December 9-12, 2017 in Atlanta, GA (Press release, Stemline Therapeutics, DEC 8, 2017, View Source [SID1234522473]).

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Details on the presentations are listed below. Presentations will be available on the Stemline website, Scientific Presentations tab, after their delivery, as well as at our Stemline corporate booth (#3122) at ASH (Free ASH Whitepaper) 2017.

SL-401: BPDCN (Clinical)

Title: Results of Pivotal Phase 2 Trial of SL-401 in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 1298
Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster I
Date/Time: Saturday, December 9, 2017 5:30 PM–7:30 PM
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

SL-401: AML in CR with MRD (Clinical)

Title: Results from Ongoing Phase 2 Trial of SL-401 As Consolidation Therapy in Patients with Acute Myeloid Leukemia (AML) in Remission with High Relapse Risk Including Minimal Residual Disease (MRD)
Presenter: Andrew Lane, MD, PhD; Dana-Farber Cancer Institute
Abstract: 2583
Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster II
Date/Time: Sunday, December 10, 2017 6:00 PM–8:00 PM
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

SL-401: Myeloproliferative neoplasms (Clinical)

Title: Results from Ongoing Phase 2 Trial of SL-401 in Patients with Myeloproliferative Neoplasms Including Chronic Myelomonocytic Leukemia and Primary Myelofibrosis
Presenter: Mrinal Patnaik, MBBS; Mayo Clinic
Abstract: 2908
Session: 634. Myeloproliferative Syndromes: Clinical: Poster II
Date/Time: Sunday, December 10, 2017 6:00 PM–8:00 PM
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

SL-401 + Azacitidine: High risk MDS and elderly AML (Preclinical) – Oral Presentation

Title: Resistance to SL-401 in AML and BPDCN Is Associated with Loss of the Diphthamide Synthesis Pathway Enzyme DPH1 and Is Reversible By Azacitidine
Presenter: Andrew A. Lane, Dana-Farber Cancer Institute
Abstract: 797
Session: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Novel Therapeutics and Mechanisms of Resistance in Myeloid Disease
Date/Time: Monday, December 11, 2017 5:30 PM
Location: Georgia World Congress Center, Building B, Level 2, B207-B208

About BPDCN
Please visit the BPDCN awareness booth (#3143) at ASH (Free ASH Whitepaper) 2017 and www.bpdcninfo.com.

On December 8, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported the schedule of data presentations for the Company’s lead compounds, TGR-1202, (umbralisib), the Company’s once-daily PI3K delta inhibitor, and TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, at the upcoming 59th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, being held December 9-12, 2017, at the Georgia World Congress Center in Atlanta, Georgia (Press release, TG Therapeutics, DEC 8, 2017, View Source [SID1234522474]).

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Poster presentations at the ASH (Free ASH Whitepaper) 2017 meeting include the following:

Sunday December 10, 2017:

Title: Phase I/II Study of Pembrolizumab in Combination with Ublituximab (TG-1101) and Umbralisib (TGR-1202) in Patients with Relapsed/Refractory CLL
• Abstract Number: 3010
• Session: 642. CLL: Therapy, excluding Transplantation: Poster II
• Date and Time: Sunday, December 10, 2017; 6:00 PM – 8:00 PM ET
• Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
• Presenter: Anthony R. Mato, MD, University of Pennsylvania, Philadelphia, PA

Title: Umbralisib/TGR-1202 as a Novel Dual PI3K/CK1 Inhibitor Has a Unique Therapeutic Role in Silencing Oncogenes in Aggressive Lymphomas
• Abstract Number: 2809
• Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster II
• Date and Time: Sunday, December 10, 2017; 6:00 PM – 8:00 PM ET
• Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
• Presenter: Ipsita Pal, PhD, Columbia University Medical Center, New York, NY

Title: Differential Regulation of T Cells By PI3K Delta Inhibitors in a CLL Murine Model
• Abstract Number: 3009
• Session: 642. CLL: Therapy, excluding Transplantation: Poster II
• Date and Time: Sunday, December 10, 2017; 6:00 PM – 8:00 PM ET
• Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
• Presenter: Kamira K. Maharaj, BS, Moffit Cancer Center, Tampa, FL
Monday, December 11, 2017:

Title: An Integrated Safety Analysis of the Next Generation PI3Kδ Inhibitor Umbralisib (TGR-1202) in Patients with Relapsed/Refractory Lymphoid Malignancies
• Abstract Number: 4037
• Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
• Date and Time: Monday, December 11, 2017; 6:00 PM – 8:00 PM ET
• Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
• Presenter: Matthew S. Davids, MD, Dana Farber Cancer Institute, Boston, MA

Title: KI Intolerance Study: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib (TGR-1202) in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-δ Inhibitor Therapy
• Abstract Number: 4314
• Session: 642. CLL: Therapy, excluding Transplantation: Poster III
• Date and Time: Monday, December 11, 2017; 6:00 PM – 8:00 PM ET
• Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
• Presenter: Anthony R. Mato, MD, University of Pennsylvania, Philadelphia, PA

Title: PI3K-Delta Inhibitors Induce Primary Monocyte Cytotoxicity but Do Not Alter Monocyte Differentiation
• Abstract Number: 4284
• Session: 641. CLL: Biology and Pathophysiology, excluding Therapy: Poster III
• Date and Time: Monday, December 11, 2017; 6:00 PM – 8:00 PM ET
• Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
• Presenter: Daphne Friedman, MD, Durham VA/Duke University Medical Center, Durham, NC
The above referenced abstracts can be viewed online through the ASH (Free ASH Whitepaper) meeting website at www.hematology.org. Following each presentation, the data presented will be available on the Publications page of the Company’s website at www.tgtherapeutics.com.

TG THERAPEUTICS INVESTOR & ANALYST EVENT

TG Therapeutics will also host a reception on Sunday, December 10, 2017 beginning at 8:00pm ET with featured presentations beginning promptly at 8:15pm ET. The event will take place at the Ritz Carlton Atlanta (Downtown) in the Salon I/II Room on the lower level. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics December 2017 Investor & Analyst Event.

On December 8, 217 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the first subject has been treated in the APOLLO study of FATE-NK100 in women with ovarian cancer resistant to, or recurrent on, platinum-based treatment (Press release, Fate Therapeutics, DEC 8, 2017, View Source [SID1234522461]). The clinical trial is intended to evaluate the safety and determine the maximum dose of FATE-NK100, the Company’s first-in-class, donor-derived adaptive memory natural killer (NK) cell cancer therapy, as a monotherapy when administered intraperitoneally in the outpatient setting. A clinical assessment of patients with ovarian cancer has previously shown that endogenous NK cells within the peritoneal fluid exhibit an altered phenotype with reduced cytolytic function.

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"Women today often are treated with intraperitoneal chemotherapy, and the administration of FATE-NK100 directly within the peritoneal cavity is an exciting therapeutic strategy to restore NK cell function, promote persistence and inhibit tumor growth," said Melissa A. Geller, M.D., Associate Professor in the Department of Obstetrics, Gynecology and Women’s Health, Division of Gynecologic Oncology at the University of Minnesota and the lead investigator of the clinical trial at the Masonic Cancer Center. "Ovarian cancer is a disease of middle age women, and over 60% of women with ovarian cancer initially present with advanced disease. For these women, the rate of recurrence is around 70%, and there is an urgent need for novel therapeutic strategies since standard treatments in the recurrent setting provide dismal response rates especially in platinum resistant disease."

The APOLLO study is an open-label, accelerated dose-escalation, Phase 1 clinical trial of FATE-NK100 in subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer. Up to three dose levels of FATE-NK100 are intended to be assessed to evaluate safety and determine the maximum dose. Other endpoints to be evaluated include objective response rate at 28 days, and progression-free and overall survival at six months. Subjects with stable disease or better at Day 28 following infusion may be considered for retreatment with FATE-NK100.

Ovarian cancer is the fifth leading cause of cancer-related death among women, and is the deadliest of gynecologic cancers. The American Cancer Society estimates that in 2017, about 22,440 new cases of ovarian cancer will be diagnosed and 14,080 women will die of ovarian cancer in the United States. While a high proportion of women respond to initial platinum-based chemotherapy, around 70% of patients diagnosed with ovarian cancer will have a recurrence. While recurrent ovarian cancer is treatable, it is rarely curable and there is a significant need for more effective, better-tolerated therapies.

About FATE-NK100
FATE-NK100 is a first-in-class, donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In preclinical studies, FATE-NK100 has demonstrated enhanced anti-tumor activity across a broad range of hematologic and solid tumors, with augmented cytokine production, improved persistence and increased resistance to immune checkpoint pathways compared to other NK cell therapies that are being clinically administered today. FATE-NK100 is produced through a feeder-free, seven-day manufacturing process during which NK cells sourced from a healthy donor are activated ex vivo with pharmacologic modulators.

About APOLLO
APOLLO is an open-label, accelerated dose-escalation, Phase 1 clinical trial in subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer designed to evaluate the safety and determine the maximum dose of a single infusion of FATE-NK100 as a monotherapy when administered via intraperitoneal catheter after out-patient chemotherapy followed by sub-cutaneous IL-2 administration. Up to three dose levels of FATE-NK100 are intended to be assessed (1×107 cells/kg, >1×107 cells/kg to ≤3×107 cells/kg, and up to 1×108 cells/kg). In the event a dose limiting toxicity is observed, the clinical trial will convert to a 3+3 design. A ten-subject expansion cohort is expected to be enrolled at the maximum dose level. Other endpoints include objective response rate at 28 days, and progression-free and overall survival at six months, post-infusion of FATE-NK100. The clinical trial is being conducted at the Masonic Cancer Center, University of Minnesota as an investigator-initiated study.

On December 8, 2017 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported that the company is scheduled to present at the 2017 BMO Capital Markets Prescriptions for Success Healthcare Conference at 11:30 AM ET on Thursday, December 14, 2017 in New York City (Press release, Pacira Pharmaceuticals, DEC 8, 2017, View Source;p=RssLanding&cat=news&id=2321829 [SID1234522467]).

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A live audio webcast of the Pacira presentation can be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the presentation date.

On December 8, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported new results from two studies with EndoPredict are being featured at the 2017 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas (Press release, Myriad Genetics, DEC 8, 2017, View Source [SID1234522466]). EndoPredict is a second-generation prognostic gene expression test for patients with breast cancer.

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"We are excited to present new data on our EndoPredict test which demonstrates our ongoing commitment to collaborate with leading academic research centers and advance personalized medicine for patients with breast cancer," said Ralf Kronenwett, M.D., Ph.D., director of International Medical Affairs, Myriad Genetics. "Importantly, these new studies add to the expanding body of evidence demonstrating how EndoPredict can be used to predict both disease recurrence as well as response to therapy."
The data are highlighted below and abstracts are available at: View Source Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS17.

EndoPredict Podium Presentation
Title: The EndoPredict score predicts residual cancer burden to neoadjuvant chemotherapy and to neuroendocrine therapy in HR+/HER2- breast cancer patients from ABCSG34.
Presenter: Peter Dubsky, M.D., Medical University of Vienna, Austria and the Breast Center St. Anna Klinik, Lucerne.
Date: Friday, Dec. 8, 2017, 3:15—5:00 p.m.
Location: Podium, GS6-04

This study was designed to show the predictive value of the EndoPredict (EP) 12-gene molecular score for tumor response to neoadjuvant chemotherapy and neoendocrine therapy. The study included biopsies from 217 women with HR+ breast cancer. Of these, 134 patients were assigned to receive neoadjuvant chemotherapy according to aggressive clinico-pathologic tumor features. The remaining 83 patients were clinically identified as having luminal A types of breast cancer and were assigned to receive neoendocrine treatment. The primary endpoint was residual cancer burden RCB0/I (i.e., good tumor response) vs. RCB II/III (i.e., poor tumor response) at time of surgery.
In the neoadjuvant chemotherapy group, 125 patients had high EP scores and nine had a low EP score. The results show that 26.4 percent of those with a high score showed a good tumor response (RCB0/I) to neoadjuvant chemotherapy, while all patients with a low score showed only a poor tumor response (Table 1). In the "luminal A" group receiving neoendocrine therapy, 39 patients had a high EP score and 44 had a low EP score. The results show that 27.3 percent of those with a low EndoPredict score and 7.7 percent with a high score achieved excellent tumor response (RCB0/I) to neoendocrine therapy (Table 1).

Table. 1 EndoPredict
Low Score EndoPredict
High Score
p-Value
Response to
Neoadjuvant
Chemotherapy 0.0 % 26.4 % p=0.0001
Response to
Endocrine Therapy 27.3 % 7.7 % P=0.015

"This exciting study is evidence that women with a high EP score responded better to neoadjuvant chemotherapy than those with a low score, while those with a low EndoPredict score responded better to neoadjuvant endocrine therapy," said Peter Dubsky, M.D., principal investigator, speaking on behalf of the Austrian Breast and Colorectal Cancer Study Group (ABCSG). "These findings are relevant to better patient selection for biomarker driven studies in the neoadjuvant setting."

EndoPredict Poster Presentation
Title: The role of EndoPredict in invasive lobular carcinoma.
Presenter: Ivana Sestak, Ph.D., Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London.
Date: Thursday, Dec. 7, 2017, 5:00—7:00 p.m.
Location: Poster, P3-08-01

This study evaluated the role of EndoPredict molecular-clinical score (EPclin) for the prediction of distant recurrence in women diagnosed with invasive lobular carcinoma (ILC) compared to those with invasive ductal carcinoma (IDC). The study included 928 women with E R+/HER2- breast cancer: 141 had ILC, 710 had IDC and 77 were mixed type.
This result shows that EndoPredict provided significant power for predicting distant recurrence in patients with both ILC (EPclin: LR-X2=5.8) and IDC (EPclin: LR-X2=13.8). Women with ILC who had a high EPclin score were at seven times increased risk of 10-year distant recurrence with endocrine therapy only than patients with low EPclin score. In comparison, women with IDC who had a high EPclin score were at five times increased risk of 10-year recurrence than patients with low EPclin score. Importantly, there was a similar 10-year distant recurrence risk in patients with a low EPclin score (~6 percent), which suggests that chemotherapy is not indicated in these patients with a low risk score regardless of tumor type.
"Our results show that EndoPredict provided highly significant prognostic information and risk stratification in women with invasive lobular carcinoma," said Ivana Sestak, Ph.D., principal investigator, Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London. "Importantly, the 10-year risk of distant recurrence in the EndoPredict low-risk groups was similar between ILC and IDC, suggesting that chemotherapy is not indicated for these patients, irrespective of tumor type."

About EndoPredict
EndoPredict is a second-generation, multigene prognostic test for patients diagnosed with breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 20,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: www.endopredict.com.