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]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"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 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it has entered into four collaboration agreements to evaluate the safety, tolerability and efficacy of Chi-Med’s surufatinib (HMPL-012 or sulfatinib) and fruquintinib in combination with checkpoint inhibitors (Press release, Hutchison China MediTech, NOV 29, 2018, https://www.chi-med.com/a181129/ [SID1234531708]). It is an important part of Chi-Med’s strategy to explore the potential synergies of its drug candidates in combination with other anti-cancer treatments. These four new immunotherapy collaborations add to our ongoing studies combining savolitinib, Chi-Med’s highly selective c-Met inhibitor, with AstraZeneca PLC’s checkpoint inhibitor, durvalumab (Imfinzi).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Today, Chi-Med is announcing the first steps to develop its vascular endothelial growth factor receptor ("VEGFR") inhibitors, surufatinib and fruquintinib, in combination with various programmed cell death protein-1 ("PD-1") monoclonal antibodies in several solid tumor settings:

A global collaboration to evaluate the combination of surufatinib with toripalimab (JS001), a PD-1 monoclonal antibody being developed by Shanghai Junshi Biosciences Co. Ltd.;
A global collaboration to evaluate the combination of fruquintinib with sintilimab (IBI308), a PD-1 monoclonal antibody being developed by Innovent Biologics (Suzhou) Co. Ltd.;
A collaboration in China to evaluate the combination of surufatinib with HX008, a PD-1 monoclonal antibody being developed by Taizhou Hanzhong Pharmaceuticals, Inc.; and
A collaboration in China to evaluate the combination of fruquintinib with genolimzumab (GB226), a PD-1 monoclonal antibody being developed by Genor Biopharma Co. Ltd.
The global market for angiogenesis inhibitors was over US$18 billion in 2017, based on their use in around 30 different tumor settings. Each of the agreements announced today will pursue different initial indications within the field of solid tumors.

"Recent innovations in solid tumor drugs have focused on targeted therapies and immunotherapies which, as monotherapies, have both provided improved patients outcomes," said Christian Hogg, Chief Executive Officer of Chi-Med. "We believe that the future of oncology treatments increasingly lies in combining therapies, utilizing multiple mechanisms of action ("MOA") to confront tumors. Our unique next-generation anti-angiogenesis VEGFR inhibitors, with high selectivity and tolerability, make them ideal candidates for such combinations with immunotherapy agents such as PD-1/L1 monoclonal antibodies to prolong and expand the benefits of these therapies to more patients."

Chi-Med’s proof-of-concept studies have already demonstrated the benefits of combinations with other kinase inhibitors or with chemotherapy.

Surufatinib (HMPL-012 or sulfatinib) is a novel, oral angio-immuno kinase inhibitor that inhibits VEGFR and fibroblast growth factor receptor (FGFR) which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R) which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. This dual angiogenesis-checkpoint inhibitor’s MOA may be very suitable for combination use with other immunotherapies. Surufatinib, as a monotherapy, is in late-stage clinical trials in China and began proof-of-concept clinical trials in the United States in July 2018.

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR. Its unique kinase selectivity has been shown to reduce off-target toxicity thereby allowing possible use in combination with other agents. It was first approved for colorectal cancer in China in September 2018. It is in several late-stage clinical trials for lung and gastric cancer, including in combination with chemotherapy such as paclitaxel (Taxol) and other kinase inhibitors such as gefitinib (Iressa), and is in a Phase I clinical trial in the United States.

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]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

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 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that Jigar Raythatha, CEO, will present at the BMO 2018 Prescriptions for Success Healthcare Conference at the Mandarin Oriental Hotel in New York at 10:40 AM on Wednesday, December 12 (Press release, Constellation Pharmaceuticals, NOV 29, 2018, View Source [SID1234531744]). A live audio webcast of the presentation and an archive for replay will be available on the Investor Relations section of Constellation’s website at View Source The audio webcast replay will be available for 90 days following the live presentation.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!