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 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 (Press release, GlycoMimetics, NOV 29, 2018, View Source [SID1234531706]). GlycoMimetics management will review additional posters from the ASH (Free ASH Whitepaper) meeting.

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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 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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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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 Tocagen Inc. (Nasdaq: TOCA), a late clinical-stage, cancer-selective gene therapy company and NRG Oncology, a member of the National Cancer Institute’s (NCI) National Clinical Trial Network (NCTN), reported that the NCI Cancer Therapy and Evaluation Program (CTEP) Brain Malignancies Steering Committee has approved a concept to develop a clinical trial utilizing the investigational therapeutic regimen Toca 511 (vocimagene amiretrorepvec) & Toca FC (flucytosine, extended-release) for the treatment of patients with newly diagnosed glioblastoma (GBM) (Press release, Tocagen, NOV 29, 2018, View Source;p=RssLanding&cat=news&id=2378701 [SID1234531707]).

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NRG Oncology, as one of the four adult group members of the NCI NCTN, conducts practice-defining, multi-institutional Phase 2 and 3 trials funded primarily by the NCI. The proposed Phase 2/3 trial (NRG-BN006) is expected to begin enrollment in 2019 and will be conducted by NRG Oncology under its NCI-funded grant, with Tocagen supplying investigational drug and supplemental financial support. Additional information about the trial will be provided in 2019.

Standard of care (SOC) for newly diagnosed GBM, the most common and deadly form of primary malignant brain tumor, involves surgical removal of as much of the tumor as possible followed by radiation therapy and temozolomide with use of tumor treating fields in a select group of patients. The proposed NRG-BN006 trial is designed to assess the benefit of adding Toca 511 & Toca FC to chemotherapy and radiation compared to SOC alone.

"The Brain Tumor Committee at NRG Oncology elected to conduct and sponsor the Toca 511 & Toca FC clinical trial in patients with newly diagnosed GBM based on the merits of published clinical data, which show extended overall survival compared to historical controls, durable complete responses and a favorable safety profile in patients with recurrent high grade glioma along with preclinical data that support a novel immune-activating mechanism of action, synergy with radiation therapy and additive efficacy in combination with temozolomide," said Minesh P. Mehta, chair of the Brain Tumor Committee at NRG Oncology.

Added Manmeet Ahluwalia, Principal Investigator of the proposed study, "Glioblastoma remains a very high unmet need and there is excitement among the NRG Oncology membership to explore the potential of Toca 511 & Toca FC to enhance standard treatment to achieve greater tumor response and extend survival of patients with this aggressive type of cancer."

Tocagen is currently studying Toca 511 & Toca FC for the treatment of recurrent high grade glioma (HGG) in the ongoing Phase 3 trial (Toca 5) which has enrolled approximately 400 patients, equally randomized to receive either Toca 511 & Toca FC or standard of care. Across three ascending-dose Phase 1 trials, Tocagen has treated 127 patients with recurrent HGG with Toca 511 & Toca FC. In these trials, Tocagen observed potential benefits, including ongoing durable complete responses, extended overall survival and a favorable safety profile. The proposed NRG-BN006 trial will be the first clinical trial of the Toca 511 & Toca FC regimen in the newly diagnosed GBM setting.

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.