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 2, 2016 PIQUR Therapeutics AG, a Swiss clinical-stage pharmaceutical company, reported that
the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to PIQUR’s lead compound PQR309 for the treatment of primary central nervous system lymphoma (PCNSL) (Press release, PIQUR Therapeutics, DEC 2, 2016, View Source [SID1234527272]).

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PCNSL is a very rare and aggressive form of lymphoma involving brain and its linings, eyes or spinal cord. The disease affects less than 1 person in 100,000 in the USA with approximately 7,500 new cases reported annually in the USA, Europe and Japan. Treatment options available for PCNSL are limited, and the prognosis with current therapies is poor.

"We are very pleased to receive FDA orphan drug designation for PQR309 in PCNSL. This is an important regulatory milestone for the company and a significant step towards the clinical advancement of PQR309," said Dr. Ruggero Della Bitta, Chief Medical Officer of PIQUR. "This represents an important step towards addressing a high unmet medical need and bringing a potential treatment to those with this rare and life-threatening disease."

The Orphan Drug Designation Program, administered by the FDA’s Office of Orphan Products Development, is intended to encourage companies to develop therapeutics for diseases that affect fewer than 200,000 people in the USA. The designation provides the company several benefits and incentives, including assistance with clinical study design and drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, as well as a seven-year period of market exclusivity upon regulatory product approval.

About PQR309
PIQUR’s lead compound, PQR309, is an oral, brain-penetrant, dual inhibitor of the PI3K/mTOR pathway, which is activated in 60 – 80% of human cancers. Unlike most of its competitors, PQR309 crosses the blood-brain barrier, expanding its use to malignant diseases involving the brain. Preclinical and Phase 1 studies have shown PQR309 to have a favorable safety, tolerability and pharmacokinetic profile. In addition, PQR309 has shown both preclinical
activity in various tumor models and clinical activity in Phase 1 and 2 studies.

PQR309 is currently being investigated in five Phase 1 and 2 clinical studies in advanced solid tumors (NCT02483858), relapsed or refractory lymphoma (NCT02249429), relapsed or refractory PCNSL (NCT02669511) and progressive glioblastoma multiforme (NCT02850744). In addition, the PIQHASSO Phase 1/2b study investigates PQR309 in combination with Eisai’s Eribulin in metastatic HER2-negative and triple-negative breast cancer (NCT02723877).

On December 2, 2016 Surface Oncology, an immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that it will present preclinical data on its CD47 program at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Surface Oncology, DEC 2, 2016, View Source [SID1234516902]). The data demonstrate that SRF231, a fully human CD47 antibody, induces robust tumor cell phagocytosis and clearance, both alone and in combination with existing standard of care treatment.

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"These data highlight the strong anti-tumor activity of SRF231 in hematological disease models," said Vito Palombella, PhD, Chief Scientific Officer at Surface Oncology, "and further suggest that SRF231 has the potential to be the best-in-class CD47 antibody to help patients with a wide range of cancers."

CD47 is an important immune escape mechanism exploited by multiple tumor types, making it a target with broad therapeutic potential. CD47 acts as a macrophage checkpoint or "don’t eat me" signal that prevents cells from being eliminated by a macrophage-mediated process called phagocytosis.

The data presented at ASH (Free ASH Whitepaper) demonstrate that SRF231 enhances tumor cell phagocytosis alone and in combination with opsonizing antibodies (e.g., anti-CD20 Ab). SRF231 also leads to profound tumor growth inhibition in models of multiple myeloma and non-Hodgkin’s lymphoma.

Previously, Surface presented data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s annual meeting demonstrating that SRF231 binds with high affinity to CD47, stimulates phagocytosis of cancer cells in vitro, and has potent anti-tumor activity in multiple in vivo disease models. These data also demonstrate that SRF231 does not induce detectable hemagglutination or phagocytosis of red blood cells in vitro, a potentially important safety advantage. SRF231 is expected to enter clinical trials in 2017.

On December 1, 2016 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported that data from ongoing phase 1 trials of Endocyte’s SMDC EC1456 will be presented at the IASLC 17th World Conference on Lung Cancer on Wednesday, Dec. 7, at 2:30 P.M. CET (Press release, Endocyte, DEC 1, 2016, View Source [SID1234516879]). The conference will be held at the Messe Wien Exhibition & Congress Center in Vienna, Austria.

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The presentation will be available on Endocyte’s website following presentation at the conference.

Presentation is as follows:

Poster Presentation: Phase 1 Dose Escalation, Safety and Pharmacokinetic Study of the Folate Receptor-Targeted Small Molecule Drug Conjugate (SMDC) EC1456 in Advanced Cancer: Lung Cancer Patient Subset
When: Wednesday, December 7th, 2:30 p.m. – 3:45 p.m. CET, Hall B
Track: Advanced NSCLC
Presenter: Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore
About EC1456 and etarfolatide

EC1456 is an investigational therapeutic SMDC constructed of folic acid conjugated through a spacer and releasable linker system to a potent cytotoxic microtubule inhibitor, TubBH. The high affinity of the folic acid ligand for the FR allows for the active and specific targeting of EC1456 to FR-expressing cancer cells. The FR is highly expressed in several epithelial cancers (e.g. ovarian, NSCLC) but is expressed at low levels in most normal tissues.

Etarfolatide is an FR-targeted companion imaging agent being co-developed to characterize whole body FR expression in real time, to identify patients most likely to benefit from EC1456 therapy. EC1456 and etarfolatide are currently being evaluated in a phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT01999738).