On November 29, 2018 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the launch of two novel products to deliver actionable insights on a wide range of blood cancers: a new workflow for the QIAGEN Clinical Insight (QCI) Interpret bioinformatics solution for hematological malignancies, and the new QIAact Myeloid DNA UMI Panel for use in myeloid neoplasm research as a Sample to Insight workflow on QIAGEN’s GeneReader NGS System (Press release, Qiagen, NOV 29, 2018, View Source [SID1234531726]).

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QIAGEN is a leader in molecular testing for blood cancers with its ipsogen portfolio of molecular assays, most of which are CE-marked for in vitro diagnostic use. In addition, QIAGEN supplies a very broad portfolio of solutions for research into blood cancers. The company also has a broad intellectual property estate in genes related to blood cancers. These new solutions represent very exciting extensions of this leading blood cancer testing franchise, adding to the complete set of oncology solutions available from QIAGEN.

QIAGEN will highlight these additions to its portfolio at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting and Exposition from December 1-4, 2018, in San Diego. QIAGEN solutions are featured in a number of research studies being presented at ASH (Free ASH Whitepaper) 2018.

On November 29, 2018 Cellerant Therapeutics, Inc., a clinical-stage company developing innovative immunotherapies for hematologic malignancies and other blood-related disorders, presented additional results from its randomized controlled Phase 2 clinical trial of romyelocel-L (human myeloid progenitor cells, formerly referred to as CLT-008), an off-the-shelf cell therapy which does not require HLA matching intended to prevent bacterial and fungal infections during neutropenia (Press release, Cellerant Therapeutics, NOV 29, 2018, View Source [SID1234531725]). Neutropenia is a serious side effect of myelosuppressive chemotherapy that leaves patients at high risk of serious, potentially life-threatening infections. The Phase 2 trial was conducted in patients aged 55 years or older newly diagnosed with acute myeloid leukemia (AML) who received either "7+3" (cytarabine and an anthracycline) or "HiDAC" (high-dose Ara-C based chemotherapy) induction chemotherapy. Results of the Phase 2 study for the pooled and 7+3 cohorts were presented previously and showed that romyelocel-L significantly reduced the incidence of serious infections and the number of days in hospital compared to control. The results from the HiDAC cohort, which are broadly in line with the pooled and 7+3 cohort results, will be presented on Saturday, December 1 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego.

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"AML patients who receive HiDAC induction therapy experience severe and prolonged neutropenia and thus are at high risk of infection and infection-related morbidity and mortality. These results show that romyelocel-L could meaningfully benefit AML patients by enabling them to receive optimal therapy and potentially increasing survival rates," said Dr. Farhad Ravandi, Janiece and Stephen A. Lasher Professor of Medicine at the University of Texas MD Anderson Cancer Center and one of the Phase 2 study’s principal investigators.

"Cellerant is excited to advance romyelocel-L to a pivotal Phase 3 trial in de novo AML patients receiving 7+3 induction therapy. Most AML treatments, including the newly approved therapies, cause Grade 3 or higher neutropenia leading to serious infections," added Ram Mandalam, President and CEO of Cellerant.

In the Phase 2 trial, patients were randomized to receive either romyelocel-L plus granulocyte colony stimulating factor (G-CSF) (the treated group) or G-CSF alone (the control group). Romyelocel-L was administered on Day 9, two days after the last dose of chemotherapy and G-CSF was administered on Day 14. The biological effect of romyelocel-L is expected to be observed starting on Day 15, which is when romyelocel-L derived neutrophils are likely to begin circulating.

In the HiDAC cohort, over the time period Day 15-28, the incidence of serious infection was 82% less in the treated group compared to the control group (p=0.03) and the total number of days in hospital was 3.1 days less for the treated group than the control group (p=0.03). There were no safety concerns and the incidence of serious adverse events was similar in the treated group compared to the control group.

Presentation details:
ASH Poster #1407: Ravandi, et al., Evaluation of Romyelocel-L Myeloid Progenitor Cells to Decrease Infections in De Novo AML Patients Receiving High-dose Ara-C-based Induction Therapy.

Session Name: 613. Acute Myeloid Leukemia: Clinical Studies: Poster I
Date: Saturday, December 1, 2018
Presentation Time: 6:15 PM – 8:15 PM
Location: San Diego Convention Center, Hall GH

Presenting author: Dr. Farhad Ravandi, University of Texas MD Anderson Cancer Center.

On November 29, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that it will host and webcast an investor/analyst meeting and update at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, on December 3 at 6 a.m. PT. Daniel J. DeAngelo, MD, PhD, Director of Clinical and Translational Research, Adult Leukemia Program, Dana-Farber Cancer Institute/Brigham and Women’s Hospital, Associate Professor of Medicine, Harvard Medical School, who served as lead investigator of the GlycoMimetics’ recently completed Phase 1/2 clinical trial of uproleselan in acute myeloid leukemia patients, will recap and provide perspective on his December 2 oral presentation at the ASH (Free ASH Whitepaper) meeting, highlighting the trial’s findings. GlycoMimetics management will review additional posters from the ASH (Free ASH Whitepaper) meeting (Press release, GlycoMimetics, NOV 29, 2018, View Source [SID1234531724]).

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The investor/analyst event will be webcast beginning at 6:15 a.m. PT. The dial-in number for the event is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 9779654. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

Investors/analysts are requested to pre-register for the private in-person event at [email protected]. The event will be held at Hard Rock Hotel San Diego in the Celebrate Room, 207 Fifth Avenue, San Diego. On-site inquiries will be handled by Shari Annes, (650) 888-0902, by text or phone.

On November 29, 2018 Triumvira Immunologics, Inc. (Triumvira), reported the upcoming presentation of key preclinical data at the American Society of Hematology (ASH) (Free ASH Whitepaper) 60th Annual Meeting and Exposition December 1-4, 2018 in San Diego, CA (Press release, Triumvira Immunologics, NOV 29, 2018, View Source [SID1234531723]). The data will be presented during a poster presentation on Sunday, December 2, and a podium presentation on Monday, December 3.

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"We continue to expand our knowledge base on the promise of our proprietary T cell Antigen Coupler (TAC) technology in different tumor types," commented Andreas Bader, Ph.D., Triumvira’s Senior Vice President of R&D. "The presentations will focus on experiments using T cells genetically engineered with TACs directed against either CD19 or BCMA antigen, demonstrating robust cell-killing and anti-tumor efficacy in preclinical models of hematological malignancies with no detectable side effects."

Podium Presentation Title:

T Cells Engineered with a Novel Chimeric Receptor Demonstrate Durable In Vivo Efficacy Against Disseminated Multiple Myeloma

Publication Number: 962; Session Name: 703. Adoptive Immunotherapy: Preclinical Studies to Improve Safety and Efficacy of CAR-T Cells; Presentation Date/Time: Monday, December 3, 2018: 4:30 – 6:00 PM PST

Presenter: Ksenia Bezverbnaya, McMaster University

Poster Title:

T Cells Engineered with T Cell Antigen Coupler (TAC) Receptors for Haematological Malignancies

Publication Number: 3267; Session Name: 653. Myeloma: Therapy, excluding Transplantation: Poster II; Presentation Date/Time: Sunday, December 2, 2018: 6:00 PM – 8:00 PM PST

Presenter: Dr. Christopher Helsen, Director of Research & Development, and Head of Platform Development, Triumvira Immunologics.

On November 29, 2018 Bio-Thera Solutions, a clinical-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, reported the company will present two posters at the 2018 San Antonio Breast Cancer Symposium (SABCS) taking place December 4 – 8, 2018 in San Antonio, Texas (Press release, BioThera Solutions, NOV 29, 2018, View Source [SID1234531722]).

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The first poster, entitled "BAT8001, a potent anti-HER2 antibody-drug conjugate with a novel stable linker for the treatment of HER2-positive breast cancer," will present preclinical data that highlight advantages of BAT8001 as a potential treatment for breast cancer patients. An abstract of the presentation is currently available on SABCS website.

Presentation details are as follows:

Poster Session: Treatment: Her2-targeted therapy

Session Date and Time: Saturday, December 8, 7:00 am – 9:00 am

Location: Poster Area/Exhibition Hall

Poster Board Number: P6-17-39

The second poster, entitled "BAT8003, a potent anti-Trop-2 antibody-drug conjugate, for the treatment of Trop-2 positive Triple Negative Breast Cancer," will present preclinical data that highlight advantages of BAT8003 as a potential treatment for triple negative breast cancer patients. An abstract of the presentation is currently available on SABCS website.

Presentation details are as follows:

Poster Session: Treatment: Novel Targets and Targeted Agents

Session Date and Time: Saturday, December 8, 7:00 am – 9:00 am

Location: Poster Area/Exhibition Hall

Poster Board Number: P6-20-16

About BAT8001

BAT8001 is an investigational HER2-ADC being evaluated in multiple tumor types. HER2 is a naturally occurring receptor that is overexpressed in many types of cancer, including breast cancer and gastric cancer. BAT8001 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. BAT8001 is currently being evaluated in a Phase 3 clinical trial for the treatment of metastatic breast cancer patients (more information on the trial is available at View Source (CTR20180157)). The BAT8001 clinical study program will expand beyond metastatic breast cancer to other HER2-positive cancers, including gastric cancer, over the next 12 months.

About BAT8003

BAT8003 is an investigational Trop-2-ADC being evaluated in multiple tumor types. Trop-2 is a naturally occurring receptor that is overexpressed in many types of cancer, including triple negative breast cancer and gastric cancer. BAT8003 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. A Phase 1 clinical trial evaluating the pharmacodynamics and safety of BAT8003 is scheduled to begin in 2019Q1.

About Antibody-Drug Conjugates

Antibody-drug Conjugates or ADCs are designed to harness the targeting ability of monoclonal antibodies (mAbs) to deliver cytotoxic agents selectively to tumor cells by linking the monoclonal antibody and cytotoxic agent through a chemical linker. An ideal ADC consists of: 1) a highly selective mAb for a tumor-associated antigen that has little or no expression on normal cells, 2) a potent cytotoxic agent designed to induce target cell death after being internalized in the tumor cell and released and 3) a chemical linker that is stable in circulation but releases the cytotoxic agent in target cells. By selectively delivering a cytotoxic agent directly inside a tumor cell, ADCs increase the safety and tolerability of the cytotoxic agent relative to giving the cytotoxic agent systemically to the patient.