On December 2, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported that SL-401, a novel targeted therapeutic directed to CD123, will be featured in seven presentations, including three oral presentations, at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, being held December 3-6, 2016 at the San Diego Convention Center in San Diego, CA (Press release, Stemline Therapeutics, DEC 2, 2016, View Source [SID1234516890]).

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Investigators will deliver an oral presentation on updated clinical data from the SL-401 Phase 2 trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN). Additional presentations include early clinical data from ongoing SL-401 clinical trials in patients with acute myeloid leukemia (AML) in remission with high relapse risk (selected for oral presentation), high-risk myeloproliferative neoplasms (MPN), and relapsed/refractory multiple myeloma. Preclinical data to be presented include an oral presentation of SL-401 activity against cancer stem cells (CSCs) of AML and myelodysplastic syndrome (MDS), as well as SL-401 activity against CSCs of myeloma and SL-401 efficacy in combination with SL-801, a novel XPO1 inhibitor, against myeloma and other malignancies.

Details on the presentations are listed below. Additionally, presentations will be available on the Stemline website, Scientific Presentations tab, after their delivery.

Details on the presentations are as follows:

SL-401 – BPDCN (Clinical) – Oral Presentation
Title: Results from Phase 2 Trial Ongoing Expansion Stage of SL-401 in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 342
Session: 613. Acute Myeloid Leukemia: Clinical Studies: Optimizing Current AML Therapy
Date/Time: Sunday, December 4, 2016 10:45 AM PT
Location: Marriott Marquis San Diego Marina, Pacific Ballroom

SL-401 – AML in CR with MRD (Clinical) – Oral Presentation
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: 215
Session: 613. Acute Myeloid Leukemia: Clinical Studies: Innovations in Induction Therapy
Date/Time: Saturday, December 3, 2016 5:00 PM PT
Location: Marriott Marquis San Diego Marina, San Diego Ballroom AB

SL-401 – Myeloproliferative neoplasms (Clinical)
Title: Results from Ongoing Phase 2 Trial of SL-401 in Patients with Advanced, High-Risk Myeloproliferative Neoplasms Including Chronic Myelomonocytic Leukemia
Presenter: Mrinal Patnaik, MBBS; Mayo Clinic
Abstract: 4245
Session: 634. Myeloproliferative Syndromes: Clinical: Poster III
Date/Time: Monday, December 5, 2016 6:00 PM – 8:00 PM PT
Location: San Diego Convention Center, Hall GH

SL-401 — Multiple myeloma (Clinical)
Title: Results from Ongoing Phase 1/2 Trial of SL-401 in Combination with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Presenter: Myo Htut, MD; City of Hope
Abstract: 5696
Date/Time: Thursday, December 1, 2016 publication release
Location: Published online on ASH (Free ASH Whitepaper) abstract website

SL-401 – AML and MDS cancer stem cells – Oral Presentation
Title: SL-401 Mediates Potent Cytotoxicity Against CD123+ AML and MDS with Excess Blasts and Demonstrates Therapeutic Benefit in PDX Model
Presenter: Rajeswaran Mani, PhD; Ohio State University
Abstract: 580
Session: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Targeting Leukemia-Initiating Cells
Date/Time: Monday, December 5, 2016 ?7:45 AM PT
Location: San Diego Convention Center, Room 24

SL-401 in combination with SL-801 — Multiple myeloma and other malignancies
Title: SL-401, a Targeted Therapy Directed to the Interleukin-3 Receptor (CD123), and SL-801, a Reversible Inhibitor of Exportin-1 (XPO1), Display Synergistic Anti-Tumor Activity Against Hematologic Malignancies in Vitro
Presenter: Janice Chen, PhD; Stemline
Abstract: 4724
Session: 802. Chemical Biology and Experimental Therapeutics: Poster III
Date/Time: Monday, December 5, 2016 6:00 PM – 8:00 PM PT
Location: San Diego Convention Center, Hall GH

SL-401 – Multiple myeloma
Title: SL-401, a Novel IL-3Rα/CD123—Directed Agent Targets Stem-like Cells in Multiple Myeloma
Presenter: Arghya Ray, PhD; Dana-Farber Cancer Institute
Abstract: 4463
Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster III
Date/Time: Monday, December 5, 2016 6:00 PM – 8:00 PM PT
Location: San Diego Convention Center, Hall GH

On December 2, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX), reported the schedule of data presentations for their lead compounds, TGR-1202, the Company’s once-daily PI3K delta inhibitor, and TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, at the upcoming 58th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, being held December 3-6, 2016, at the San Diego Convention Center in San Diego, California (Press release, TG Therapeutics, DEC 2, 2016, View Source [SID1234516891]).

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Presentations at the ASH (Free ASH Whitepaper) 2016 meeting include the following:

Oral Presentations:

Title: Silencing c-Myc Translation as a Therapeutic Strategy through Targeting PI3K Delta and CK1 Epsilon in Hematological Malignancies
Abstract Number: 291
Oral Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Cell Signaling
Date and Time: Sunday, December 4, 2016; 7:30 AM – 9:00 AM PT
Presentation Time: 8:00 AM PT
Location: San Diego Convention Center, Room 5AB
Presenter: Changchun (George) Deng, MD, PhD, Columbia University, New York, NY
Title: TGR-1202 in Combination with Ibrutinib in Patients with Relapsed or Refractory CLL or MCL: Preliminary Results of a Multicenter Phase I/Ib Study
Abstract Number: 641
Oral Session: 642. CLL: Therapy, excluding Transplantation: Targeted Therapy: Novel Agents and Combinations
Date and Time: Monday, December 5, 2016; 7:00 AM – 8:30 AM PT
Presentation Time: 8:00 AM PT
Location: San Diego Convention Center, Room 5AB
Presenter: Matthew S. Davids, MD, Dana Farber Cancer Institute, Boston, MA

Title: Preliminary Results from a Phase I Dose Escalation Trial of Ruxolitinib and the PI3Kδ Inhibitor TGR-1202 in Myelofibrosis
Abstract Number: 1125
Oral Session: 634. Myeloproliferative Syndromes: Clinical: Clinical Trials with JAK Inhibitors
Date and Time: Monday, December 5, 2016; 4:30 PM – 6:00 PM PT
Presentation Time: 5:00 PM PT
Location: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 15-17
Presenter: Tamara Kay Moyo, MD, PhD, Vanderbilt-Ingram Cancer Center, Nashville, TN
Posters Presentations:

Title: Modulation of T Cell Compartment in a Preclinical CLL Murine Model By a Selective PI3K Delta Inhibitor, TGR-1202
Abstract Number: 3236
Session: 642. CLL: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 4, 2016 6:00 PM – 8:00 PM PT
Location: San Diego Convention Center, Hall GH
Presenter: Kamira K. Maharaj, BS, Moffit Cancer Center, Tampa, FL

Title: Combination of Ublituximab, TGR-1202, and Bendamustine Demonstrates Significant Activity in Patients with Advanced DLBCL and Follicular Lymphoma
Abstract Number: 4197
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III
Date and Time: Monday, December 5, 2016; 6:00 PM-8:00 PM PT
Location: San Diego Convention Center, Hall GH
Presenter: Matthew A. Lunning, DO, University of Nebraska Medical Center, Omaha, NE

Title: A Phase I Trial of TGR-1202, a Next Generation Once-Daily PI3Kδ Inhibitor, in Combination with Brentuximab Vedotin, in Patients with Relapsed/Refractory Hodgkins Lymphoma
Abstract Number: 4146
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster III
Date and Time: Monday, December 5, 2016; 6:00 PM-8:00 PM PT
Location: San Diego Convention Center, Hall GH
Presenter: Rod Ramchandren, MD, Karmanos Cancer Center, Detroit, MI
A copy of 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.

On December 2, 2016 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 58th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), being held in San Diego, California, from December 3-6, 2016 (Press release, Spectrum Pharmaceuticals, DEC 2, 2016, View Source [SID1234516892]).

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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

The following are key PTCL-related abstracts being presented at the ASH (Free ASH Whitepaper) meeting:

Abstract # Type Title First Author
Date/Time
Location
4149 Poster Case Match Control Analysis of Propel Reveals Survival Advantage for Patients with Relapsed/Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL) Treated with Pralatrexate O’Connor
Monday, Dec 5,
6:00 PM-8:00 PM
Hall GH
4150 Poster Differential Outcome of Patients with Primary Refractory Vs. Relapsed Peripheral T-Cell Lymphoma: Analysis from a Prospective Multicenter US Cohort Study Lansigan
Monday, Dec 5,
6:00 PM-8:00 PM
Hall GH
1824 Poster The Pralatrexate – Romidepsin Doublet: A Well Tolerated and Highly Effective Combination for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Amengual
Saturday, Dec 3,
5:30 PM-7:30 PM
Hall GH

The following key ZEVALIN (ibritumomab tiuxetan)-related abstract will be presented at the ASH (Free ASH Whitepaper) conference:

Abstract # Type Title First Author Location
1793 Poster Short Course of Bendamustine and Rituximab Followed By 90Y-Ibritumomab Tiuxetan in Patients with Chemotherapy-Naive Follicular Lymphoma (FOL-BRITe): Final Report of Response Rates and Progression Free Survival Costa
Saturday, Dec 3,
5:30 PM-7:30 PM
Hall GH

On December 1, 2016 Unum Therapeutics, a clinical stage biopharmaceutical company developing a universal cellular immunotherapy to treat multiple cancers, reported that the Company has been selected for two poster presentations on its Antibody-Coupled T-cell Receptor (ACTR) platform at the 58th ASH (Free ASH Whitepaper) Annual Meeting, which is being held in San Diego, California, December 3-6, 2016 (Press release, Unum Therapeutics, DEC 1, 2016, View Source [SID1234516896]).
​
In addition, Dr. Michelle Poon of the NUH in Singapore, will be presenting initial results of an ongoing Investigator Sponsored Trial using autologous T-cells with ACTR transiently expressed through mRNA electroporation in combination with rituximab in patients with relapsed/refractory CD20+ B-cell Non Hodgkin lymphoma (B-NHL) (ATTCK20; ClinicalTrials.gov No. NCT02315118). Following the initial results of this ongoing trial, Unum recently announced the initiation of a clinical trial for patients with relapsed/refractory CD20+ B-NHL in which ACTR is durably expressed through viral delivery in autologous T-cells (ACTR087; ClinicalTrials.gov No. NCT02776813).
​
Presentation Details:
​
Presentation Title: Targeting CD20+ Relapsed Refractory B-Cell Lymphoma with ACTR087, Antibody-Coupled T-Cell Receptor (ACTR) Engineered Autologous T-Cells, in Combination with Rituximab
Presenter: Heather A. Huet, Senior Director of Drug Discovery, Unum Therapeutics
Presentation Date: Sunday, December 4, 2016
Presentation Time: 6:00 p.m.‐8:00 p.m.
Room: Hall GH (San Diego Convention Center)
Session: 801. Gene Therapy and Transfer: Poster II
Abstract Number: 3512
​
Presentation Title: ACTR Platform as an Adaptable, Universal T-Cell Therapy That Can Target Multiple Tumor Antigens to Overcome Antigen Escape
Presenter: Greg Motz, Senior Scientist, Unum Therapeutics
Presentation Date: Sunday, December 4, 2016
Presentation Time: 6:00 p.m.‐8:00 p.m.
Room: Hall GH (San Diego Convention Center)
Session: 703. Adoptive Immunotherapy: Poster II
Abstract Number: 3362
​
Presentation Title: A First-in-Human Study of Autologous T Lymphocytes with Antibody-Dependent Cell Cytotoxicity (ADCC) in Patients with B-Cell Non-Hodgkin Lymphoma (NHL)
Presenter: Michelle Poon, MD Senior Consultant, Department of Hematology-Oncology,
National University Cancer Institute, Singapore (NCIS)
Presentation Date: Sunday, December 4, 2016
Presentation Time: 6:00 p.m.‐8:00 p.m.
Room: Hall GH (San Diego Convention Center)
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster II
Abstract Number: 3031
​
The posters will be posted on Unum’s website following the presentations.
​
About Antibody-Coupled T-Cell Receptor (ACTR) Technology and ACTR087
Unum’s proprietary ACTR is a chimeric protein that combines components from receptors normally found on two different human immune cell types – natural killer (NK) cells and T-cells – to create a novel cancer cell killing activity. T-cells bearing the ACTR receptor protein can be directed to attack a tumor by combining with a monoclonal antibody that binds antigens on the cancer cell surface.
​
In contrast to other T-cell therapy approaches for cancer that are limited to a single cancer cell surface target and, therefore, treat a narrow set of tumors, Unum’s approach is not restricted by a specific tumor cell antigen and, thus, may have applications for treating many different types of cancers when combined with the right antibody.
​
Unum is developing ACTR in combination with a range of tumor-targeting antibodies for use in both hematologic and solid tumor indications. ACTR087, Unum’s most advanced product candidate, combines Unum’s proprietary ACTR, with rituximab, an anti-CD20 antibody. The ACTR087 study will be the first clinical trial using a viral vector to permanently insert the ACTR gene into the genome of patient T-cells.

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On December 1, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported a data update on the first two cohorts of the company’s Phase I clinical study of CLR 131 in patients with relapsed or refractory multiple myeloma (Filing, 8-K, Cellectar Biosciences, DEC 1, 2016, View Source [SID1234516868]).

The clinical benefit rate for this study is 80 percent despite patients receiving an average of four prior treatments, including stem cell transplant and triple drug combinations. The patients in Cohort 1 received a single 12.5 mCi/m2 dose and patients in Cohort 2 received a single 18.75 mCi/m2 dose. At this time, Cohort 1 and Cohort 2 patients have demonstrated post treatment median survival of 11.9 months and 4.9 months, respectively. The median survival for all evaluable patients in both cohorts continues to increase and will be followed to determine overall survival benefit. Currently, the median overall survival (mOS) for each cohort is not yet evaluable. All evaluable patients in the clinical study experienced progression free survival (PFS). In Cohort 1, patients averaged 88.5 days of PFS. While patients in Cohort 2 have already achieved an average PFS of 127 days, the average PFS in Cohort 2 continues to increase as one of the four patients is still experiencing PFS. It is important to note that overall survival of 11.9 months and PFS of 127 days in this heavily pretreated patient population is better than or equivalent to that reported by several recently approved multiple myeloma drugs.

"The efficacy observed with CLR 131 at the 12.5 and 18.75 mCi/m2 single dose compares favorably to drugs recently approved for relapsed or refractory multiple myeloma. We believe that the 18.75 mCi/m2 dose could represent an acceptable single dose or multi-dose regimen for future studies," said Jim Caruso, president and CEO of Cellectar Biosciences. "Combined with its clean safety profile, we are optimistic regarding the potential of CLR 131 and look forward to seeing results from our recently initiated Cohort 3 at a single 25mCi/m2 dose."

An evaluation of adverse events between Cohort 1 and Cohort 2 reveal a similar profile. Patients in Cohort 1 experienced an average of 4.75 adverse events per patient while patients in Cohort 2 experienced an average of 4.25 events per patient. The median severity grade of the adverse events in both cohorts was 2.0 (mild to moderate), as graded by the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE).

In the multi-center, open label Phase I dose escalation study, CLR 131 was administered as a single dose, 30-minute intravenous infusion on Day 1 with 40 mg dexamethasone orally weekly for 12 weeks. The primary study objective is to characterize the safety and tolerability of CLR 131 with and without dexamethasone in patients with relapsed and/or refractory multiple myeloma. Secondary study objectives include establishment of a recommended Phase II dose, both with and without dexamethasone, as well as an assessment of therapeutic activity, including progression-free survival (PFS) and additional efficacy endpoints.

Dose-escalation in this study uses a minimally modified, standard 3+3 schema with dose-limiting toxicities (DLTs) assessed through day 85 post-infusion. Each cohort consisted of four evaluable patients (three men, one woman in Cohort 1 and two men, two women in Cohort 2). Patients in both cohorts received an average of 4 prior treatments. All patients received and were relapsed or refractory to proteasome inhibitors and immunomodulatory drugs prior to enrollment, and all patients had received triple combination therapy as a single line of therapy at least once. One patient in Cohort 1 and three in Cohort 2 received autologous stem cell transplantation and three Cohort 1 patients and one Cohort 2 patient each received the latest approved drugs for multiple myeloma prior to enrollment. Patient’s ages range between 55-76 (Cohort 1) and 55-85 (Cohort 2) and averages were essentially identical at 68 and 69 years of age, respectively.

The company is currently enrolling patients into the study’s third cohort at a single 25 mCi/m2 dose and plans to provide an additional data update in the first half of 2017.

About CLR 131

CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)

Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma

Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

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