On December 4, 2015 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported that it will present on its innovative nanoliposomal platform for patients with metastatic breast cancer at the 2015 San Antonio Breast Cancer Symposium, December 8 – 12, 2015 at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, Merrimack, DEC 4, 2015, View Source [SID:1234508397]).

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The presentations include a trials-in-progress abstract for the MM-302 HERMIONE Phase 2 clinical trial and a trials-in-progress abstract for the Phase 1 clinical trial investigating potential predictive response markers for ONIVYDE (irinotecan liposome injection), also known as MM-398 or "nal-IRI." MM-302 is a HER2 targeted liposomal encapsulation of doxorubicin.

Poster Sessions:

HERMIONE: A phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1) (Abstract OT3-01-01)
Ongoing Trials Poster Session 3, Ongoing Trials – HER2
Presentation: Friday, December 11, 2015 (5:00 PM CT)
Exhibit Hall A-B

A phase 1 study in patients with metastatic breast cancer to evaluate the feasibility of magnetic resonance imaging with ferrumoxytol as a potential biomarker for response to treatment with nanoliposomal irinotecan (nal-IRI, MM-398) (Abstract OT3-02-14)
Ongoing Trials Poster Session 3, Ongoing Trials – Chemotherapy
Presentation: Friday, December 11, 2015 (5:00 PM CT)
Exhibit Hall A-B

On December 4, 2015 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported key presentations of clinical and scientific data related to its products at the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), being held in Orlando, Florida, from December 5-8, 2015 (Press release, Spectrum Pharmaceuticals, DEC 4, 2015, View Source [SID:1234508399]).

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For more information about the ASH (Free ASH Whitepaper) annual meeting and for a complete list of abstracts, please refer to the conference website at View Source

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 4, 2015 Akeso Biopharma Inc. (Akeso) reported that the company has entered into a collaboration with MSD, known as Merck (NYSE:MRK) in the United States and Canada, to research, develop and commercialize immuno-oncology therapeutics (Press release, Akeso Biopharma, DEC 4, 2015, View Source [SID1234525263]). According to this agreement, MSD will obtain exclusive worldwide rights to develop and commercialize Akeso’s compound AK-107, an immune checkpoint blocking antibody discovered by Akeso in China. Under the terms of the agreement, Akeso will receive an upfront payment from MSD and up to $200 million in development and commercialization milestone payments. Additional details were not disclosed.

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"We are very pleased to establish this collaboration with MSD, the global leader in immuno-oncology. Through this collaboration, we will combine Akeso’s unique Biologics discovery platform with MSD’s well-established late-stage clinical and commercialization strengths to rapidly advance Akeso’s compound AK-107 to the global markets. This collaboration demonstrates our companies’ commitment to bring innovative therapies to the market to address unmet medical needs for cancer patients worldwide," said Dr. Michelle Y. Xia, Chairman of the Board and Chief Executive Officer of Akeso.

"We look forward to working with MSD and we will continue to explore opportunities to work together in the field of innovative biologics." "The collaboration with Akeso builds on our existing strength in the field of immuno-oncology as we remain focused on advancing the care of people with cancer by stimulating tumor-directed immune responses," said Dr. Eric Rubin, vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories. "The addition of this immune checkpoint blocking antibody, AK-107, reinforces our commitment to exploring combination approaches across tumor types."