On November 30, 2018 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) and NeoGenomics, Inc. (NASDAQ: NEO) reported a master service agreement to accelerate the availability of innovative companion diagnostics that enable precision medicine for cancer patients (Press release, Qiagen, NOV 30, 2018, View Source [SID1234531758]). The partnership between QIAGEN and NeoGenomics, a leading provider of cancer-focused genetic testing services, will ensure Day-One patient access to FDA-approved molecular tests paired with newly approved drugs for cancer.

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Building on the U.S. Food and Drug Administration’s modernized regulatory approach to advanced diagnostics, especially next-generation sequencing (NGS) tests, the collaboration with NeoGenomics will allow QIAGEN and pharmaceutical partners to streamline the development and launch of targeted drugs and companion diagnostics to guide treatment decisions. The partnership offers flexible pathways leading to introduction of FDA-approved companion diagnostics simultaneously with launch of new therapies.

QIAGEN and NeoGenomics will discuss their efforts to expedite access for precision medicine solutions at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting and Exposition from December 1-4, 2018, in San Diego.

"As a leading provider of oncology testing for both clinical trials and patient care, NeoGenomics is uniquely positioned to assist pharmaceutical and biotech companies to develop and commercialize companion diagnostic tests. Our collaboration with QIAGEN will ensure that patients have access to the most advanced companion diagnostics to target new cancer medicines, as soon as those medicines are approved. We are excited to work with QIAGEN to deploy cutting edge technologies to remain at the forefront of precision medicine" said Douglas M. VanOort, Chairman and CEO of NeoGenomics.

"We are excited to collaborate with NeoGenomics to ensure immediate availability of QIAGEN companion diagnostics during clinical trials and upon approval by the FDA, supporting synchronized launches of new oncology drugs, to make a difference for patients," said Peer Schatz, CEO of QIAGEN. "Together with our Pharma partners, we are now planning to provide investigational use only (IOU) tests to NeoGenomics and other labs, enabling them to verify, set up and run our companion diagnostics in clinical trials and in anticipation of regulatory approval. The companion diagnostic services can be promoted by NeoGenomics through their national commercial teams starting with their FDA approval, facilitating the rapid adoption of innovative targeted therapies which can deliver meaningful benefits to patients. We look forward to discussing this approach further at ASH (Free ASH Whitepaper) 2018, and demonstrating our rapidly evolving Sample to Insight solutions to the world’s top hematology and oncology experts."

NeoGenomics has a national footprint and broad customer reach in cancer-related genetic testing services and one of the most comprehensive oncology-focused test menus. The master service agreement provides a flexible framework with multiple options for co-development, verification, setup, and launch of new companion diagnostics, including next-generation sequencing tests, for biomarker profiling paired with new targeted drugs.

As QIAGEN collaborates with pharma and biotech partners, co-development progresses from drug discovery and creation of a biomarker test, to clinical development evaluating the proposed drug and test, to validation for clinical use and then commercialization of the new drug and companion diagnostic. Commercial alignment and launch readiness for companion diagnostics at the time of drug approval have become increasingly important for QIAGEN´s pharmaceutical partners. For more information, please visit View Source

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.