On December 4, 2015 Stemline Therapeutics, Inc. (Nasdaq:STML) reported that SL-401 and SL-801 will be the subject of five poster presentations at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, being held December 5-8, 2015 at the Orange County Convention Center in Orlando, FL (Press release, Stemline Therapeutics, DEC 4, 2015, View Source [SID:1234508402]).

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Investigators will present updated clinical data from the lead-in and ongoing expansion stages of the SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), as well as three additional presentations highlighting preclinical data supporting SL-401’s clinical development in mastocytosis as a single agent and in multiple myeloma in combination with approved agents. SL-801 will be the subject of a presentation detailing its broad preclinical anti-cancer activity in both solid and hematologic cancers in anticipation of the start of clinical trials.

Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "On Monday evening, investigators will present initial efficacy and safety data from the lead-in and ongoing expansion stages of the SL-401 pivotal trial in BPDCN. We are very pleased with the initial outcomes of the ongoing study. Our experience from the lead-in stage enabled us to develop a regimen with specific dosing parameters that, since implementation, has generated a therapeutic window with manageable safety and high levels of clinical activity."

Details on the presentations are listed below and abstracts are available on the ASH (Free ASH Whitepaper) conference website. Additionally, all abstracts and posters will be available on the Stemline website soon after the presentations.

SL-401 Presentations

Lead-in Stage Results of a Pivotal Trial of SL-401, an Interleukin-3 Receptor (IL-3R) Targeting Biologic, in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) or Acute Myeloid Leukemia (AML)
Lead Author: Marina Konopleva, MD, PhD
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX
Date: Monday, December 7, 2015
Presentation Time: 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall A

A Novel Agent SL-401 Triggers Anti-Myeloma Activity By Targeting Plasmacytoid Dendritic Cells: Implications for a Novel Immune-Associated Mechanism
Lead Author: Arghya Ray, Ph.D.
The LeBow Institute for Myeloma Therapeutics and Jerome Lipper Myeloma Center, Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA
Date: Sunday, December 6, 2015
Presentation Time: 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall A

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Patient-Derived Xenografts Are Faithful Genomic and Phenotypic Models of Primary Leukemia and Respond to the IL3 Receptor Targeting Agent SL-401 In Vivo
Lead Author: Amanda Christie, B.A.
Department of Hematologic Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA
Date: Monday, December 7, 2015
Presentation Time: 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall A

CD123 Immunostaining in Systemic Mastocytosis: Differential Expression in Disease Subgroups and Potential Prognostic Value
Lead Author: Animesh Pardanani, MBBS, Ph.D.
Department of Hematology, Mayo Clinic College of Medicine, Rochester, MN
Date: Sunday, December 6, 2015
Presentation Time: 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall A

SL-801 Presentations

SL-801, a Novel, Reversible Inhibitor of Exportin-1 (XPO1) / Chromosome Region Maintenance-1 (CRM1) with Broad and Potent Anti-Cancer Activity
Lead Author: Janice Chen, Ph.D.
Stemline Therapeutics, Inc., New York, NY
Date: Monday, December 7, 2015 ?
Presentation Time: 6:00 PM – 8:00 PM ?
Location: Orange County Convention Center, Hall A

On December 04, 2015 TG Therapeutics, Inc. (Nasdaq:TGTX) reported the schedule of data presentations for their lead compounds at the upcoming 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper), to be held December 5-8, 2015, at the Orange County Convention Center in Orlando, Florida (Press release, TG Therapeutics, DEC 4, 2015, View Source [SID:1234508403]).

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Presentations on TG-1101 and TGR-1202 at the ASH (Free ASH Whitepaper) meeting include the following:

Clinical Posters:

Title: Ublituximab + TGR-1202 Demonstrates Activity and Favorable Safety Profile in Relapsed/Refractory B-Cell NHL and High-Risk CLL: Phase I Results
Abstract Number: 1538
Session: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster I
Date and Time: Saturday, December 5, 2015; 5:30 PM- 7:30 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Matthew Lunning, DO

Title: A Phase I Trial of TGR-1202, a Next Generation Once Daily PI3K-Delta Inhibitor in Combination with Obinutuzumab Plus Chlorambucil, in Patients with Chronic Lymphocytic Leukemia
Abstract Number: 2942
Session: 642. CLL: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 6, 2015; 6:00 PM-8:00 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Daruka Mahadevan, MD, PhD

Title: Ublituximab (TG-1101), A Novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Combination With Ibrutinib is Highly Active in Patients With Relapsed And/Or Refractory Mantle Cell Lymphoma; Results of a Phase II Trial
Abstract Number: 3980
Session: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster III
Date and Time: Monday, December 7, 2015; 6:00 PM- 8:00 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Kathryn Kolibaba, MD

Title: TGR-1202, a Novel Once Daily PI3K-Delta Inhibitor, Demonstrates Clinical Activity with a Favorable Safety Profile in Patients with CLL and B-Cell Lymphoma
Abstract Number: 4154
Session: 642. CLL: Therapy, excluding Transplantation: Poster III
Date and Time: Monday, December 7, 2015; 6:00 PM- 8:00 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Owen O’Connor, MD, PhD

Non-Clinical Oral Presentation:

Title: Disruption of the mTOR-eIF4F Axis By Selectively Targeting PI3Kdelta and Proteasome Potently Inhibits Cap Dependent Translation of c-Myc in Aggressive Lymphomas
Abstract Number: 593
Oral Session: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Novel Therapies and Targets in Lymphoma
Date and Time: Monday, December 7, 2015; 10:30 AM – 12:00 PM ET
Presentation Time: 11:30 AM ET
Location: Orange County Convention Center, Tangerine 1 (WF1)
Presenter: Changchun Deng, MD, PhD

A copy of the above referenced abstracts can be viewed online through the ASH (Free ASH Whitepaper) meeting website at www.hematology.org.

TG Therapeutics will also host a reception on Monday, December 7th, 2015 beginning at 7:45pm ET, with featured presentations beginning promptly at 8:00pm ET. The event will take place at the Hyatt Regency Orlando in the Bayhill 17/18 Room. 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. In order 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 2015 Investor & Analyst Event.

On December 3, 2015 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that Daniel Levitt, MD, PhD, Executive Vice President and Chief Medical Officer, will present a corporate update at the 26th Annual Oppenheimer Healthcare Conference on Tuesday, December 8th at 3:55p.m. Eastern Time (Press release, CytRx, DEC 3, 2015, View Source;p=RssLanding&cat=news&id=2119926 [SID:1234508391]). The conference will take place at the Westin Grand Central Hotel in New York, NY.

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A live and archived webcast of the presentation will be available on the Company’s website at www.cytrx.com/investors/presentations.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About SCLC

An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year. In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use. The five year survival rate is less than 7%, in part because an estimated 70% of patients have extensive disease at diagnosis. According to the National Cancer Institute, more than 30,000 new cases will be diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.

About Glioblastoma Multiforme

Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. The median survival after diagnosis is approximately 14 months, despite patients subsequently receiving surgical resection, radiotherapy and chemotherapy. Limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood / brain barrier.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

On December 3, 2015 Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) reported that it has initiated a Compassionate Use Program for vosaroxin. The Compassionate Use Program will be made available to eligible patients in the U.S. and selected European countries diagnosed with relapsed or refractory acute myeloid leukemia (AML) and will be managed by Clinigen Group plc’s (AIM:CLIN) Idis Managed Access (MA) division (Press release, Sunesis, DEC 3, 2015, View Source;p=RssLanding&cat=news&id=2119850 [SID:1234508393]). Clinigen Group plc’s (AIM:CLIN) Idis Managed Access (MA) division.

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Vosaroxin is an investigational treatment and is currently not approved for use by any regulatory agency. Compassionate use programs are put in place to provide access to medicines for patients who have serious, or immediately life-threatening illnesses, and for whom no alternative treatment options are available. Access is provided in response to an unsolicited request from a physician for his/her patient with an unmet medical need.

"Sunesis is committed to providing patients and healthcare providers around the globe with more options for treating relapsed and refractory AML, a disease for which the standard of care has changed little in the last four decades," said Par S Hyare, VP Global Oncology Operations, Sunesis. "We are pleased to be working with Idis MA, a recognized leader in providing ethical access to medicines that address unmet needs and will be working towards gaining approval for vosaroxin in the U.S. and Europe for the treatment of relapsed and refractory AML."

Simon Estcourt, Managing Director of Idis Managed Access, Clinigen Group said: "AML is the most common acute leukemia affecting adults, with a very low survival rate, so there is a real need for new treatment options in these patients. By using our global logistical and regulatory expertise we will work with Sunesis and the AML community to provide ethical access to vosaroxin to help eligible patients who have no alternative treatment options."

For more information about Idis’ services and its Managed Access Programs, healthcare professionals may contact Idis via telephone on +44 (0)1932 824 135, fax on +44 (0)1932 824 335. To contact Idis by e-mail, U.S. physicians only use [email protected]. Physicians from all other countries please use [email protected].

About vosaroxin
Vosaroxin is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

On December 3, 2015 Cellectis (Alternext: ALCLS – Nasdaq: CLLS) reported that it will host a conference call with Pfizer Inc. (PFE) and Servier on Monday, December 7, 2015 at 8:00 a.m. Eastern Time to discuss their previously announced UCART19 development collaboration (Press release, Cellectis, DEC 3, 2015, View Source [SID:1234508394]).

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UCART19 is a TALEN gene-edited allogeneic Chimeric Antigen Receptor T-Cell (CAR-T) immunotherapy developed by Cellectis. On November 19, 2015, Servier exercised its worldwide licensing option with Cellectis to UCART19 and entered into a global UCART19 license and collaboration agreement with Pfizer.

Conference Call Information
Cellectis, Pfizer and Servier management will host a conference call on Monday, December 7, 2015 at 8:00 a.m. ET to discuss UCART19 three-party collaboration.

Dial-In Numbers:
Live Participant Dial-In (Toll-Free US & Canada): 877-407-3104
Live Participant Dial-In (International): +1 201-493-6792
Replay Information:
Conference ID #: 13625168
Replay Dial-In (Toll Free US & Canada): 877-660-6853
Replay Dial-In (International): +1 201-612-7415
Expiration Date: 12/21/15
Webcast URL (Archived for 12 months):
http://cellectis.equisolvewebcast.com/12-7-UCART19