On September 27, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, will present at the 2018 Cantor Fitzgerald Global Healthcare Conference on Tuesday, October 2, 2018, at 1:05 p.m. Eastern Time (ET) (Press release, Veracyte, SEP 27, 2018, View Source [SID1234529633]).

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A live audio webcast of the presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On September 27, 2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), reported that the European Patent Office ("EPO") has issued European Patent No. EP2940014B1 for CG-806, a first-in-class, highly potent oral small molecule being developed for acute myeloid leukemia (AML), B cell and other hematologic malignancies (Press release, Aptose Biosciences, SEP 27, 2018, View Source [SID1234529656]). The granted patent claims various compounds, including the CG-806 compound, pharmaceutical compositions comprising the CG-806 compound, and uses for the treatment of various diseases, such as cancer. This European patent will be nationalized in, and cover, approximately forty European countries including the United Kingdom, France, Germany, Italy, Netherlands and Spain. The patent is expected to provide protection until the end of 2033.

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"This is a meaningful decision by the EPO and adds to the previously issued patents in the US and Japan for CG-806," stated Dr. William G. Rice, Chairman, President and Chief Executive Officer of Aptose. "We will continue to strengthen the patent portfolio through additional findings and applications."

About CG-806

CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors.

About CrystalGenomics

CrystalGenomics, Inc. is a commercial stage biopharmaceutical company focused in the structure-based drug discovery and development of novel therapeutics in unmet medical need areas of inflammation, oncology, and infectious disease. In addition to several drug programs in the R&D pipeline, the Company has an osteoarthritis drug on the market and, has recently added manufacturing and commercialization capabilities through multiple acquisitions. For more information, please visit: www.cgxinc.com or www.crystalgenomics.com. CrystalGenomics, Inc. is listed on KOSDAQ (083790).

On September 27, 2018 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that the independent Data and Safety Monitoring Board (DSMB) completed its second safety assessment of the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent GBM (Press release, VBI Vaccines, SEP 27, 2018, View Source [SID1234529675]). The DSMB reviewed the complete safety data from the fully enrolled, intermediate-dose patient cohort, and unanimously recommended the continuation of the study without modification.

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Following this recommendation, VBI has initiated enrollment in the high-dose arm of the study. One final, pre-specified DSMB review is expected to occur after completion of enrollment in the high-dose cohort, concluding the dose-escalation phase of the study.

"We are encouraged by the sustained clean safety profile of VBI-1901 as concluded by this second DSMB assessment," said Jeff Baxter, VBI’s President and CEO. "These positive safety reviews are critical milestones for the program and for patients diagnosed with this extremely aggressive tumor who currently have no effective treatment options. With active clinical study sites at the Columbia University Medical Center, Dana-Farber Cancer Institute, and Massachusetts General Hospital, we hope to complete enrollment in this high-dose cohort quickly and look forward to announcing initial immunologic data from the low- and intermediate-dose cohorts expected later this year."

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 28 patients with recurrent GBM:

Part A: Dose-escalation phase to define the safety, tolerability, and optimal dose level of VBI-1901 in recurrent GBM patients. This phase is expected to enroll up to 18 patients in three dose cohorts.
Part B: A subsequent extension of the optimal dose level, as defined in the dose escalation phase. This phase is expected to enroll an expanded cohort of approximately 10 additional patients.

VBI-1901 is administered intradermally and is adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), a potent adjuvant that mobilizes dendritic cell function. Patients in both phases of the study will receive vaccine every four weeks until tumor progression.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.

On September 27, 2018 CytoSen Therapeutics, a private biopharmaceutical company accelerating innovation in Natural Killer (NK) cell therapy, reported it has received a favorable response from the U.S. Food and Drug Administration ("FDA") to its pre-Investigational New Drug ("pre-IND") meeting package for the proposed Phase 2 trial of CytoSen’s adoptive NK cell therapy, CSTD002-NK, for the reduction of relapse in high risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in patients undergoing haploidentical hematopoietic stem cell transplantation (HSCT) (Press release, CytoSen Therapeutics, SEP 27, 2018, View Source [SID1234529634]). The FDA agreed that the Company’s pre-clinical studies, in combination with results from the clinical trial conducted at The University of Texas MD Anderson Cancer Center adequately support the Company’s proposed Phase 2 clinical trial. The FDA also deemed the proposed dose regimen, safety assessment and study endpoints as appropriate, and confirmed that interim results from the clinical study could be considered for a Regenerative Medicine Advanced Therapy (RMAT) designation.

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"We are pleased with the feedback and clarification we received from the FDA, which reinforces our clinical development strategy and serves as a critical next step to initiate our planned AML-transplant study," said Trent Carrier, Ph.D., CEO of CytoSen. "We look forward to commencing the trial in the first half of 2019."

CSTD002-NK is a high dose, adoptive haploidentical NK cell therapy expanded ex vivo using CytoSen’s patented nanoparticle platform. The proposed Phase 2 trial is CytoSen’s first clinical study utilizing the nanoparticle technology, which produces highly activated NK cells within a scalable manufacturing platform.

About CytoSen’s NK Cell Platform

Natural Killer cells play a significant role in the body’s innate immune response, circulating through the body to rapidly recognize and kill cancerous cells. CytoSen’s nanoparticle processing technology enables improved and sustained growth of high-dose NK cells that have potent anti-cancer cytotoxicity as well as increased expansion and activation capabilities. CytoSen’s lead clinical product, CSTD002-NK, is poised to initiate Phase 2 trial enrollment in the U.S. in the first half of 2019 as a best-in-class NK cell therapy for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in HSCT patients.

CytoSen’s technology platform is based on the work of Dean Lee, M.D., Ph.D., Co-Founder of CytoSen and Chair of CytoSen’s Scientific Advisory Board and Director of the Cellular Therapy and Cancer Immunotherapy Program for Nationwide Children’s Hospital’s Division of Hematology/Oncology/BMT and Center for Childhood Cancer and Blood Diseases, and Stefan Ciurea, M.D., Associate Professor, Department of Stem Cell Transplantation, MD Anderson Cancer Center. Data from Phase I/II clinical trials at MD Anderson demonstrated compelling results in treating AML, providing validation for CytoSen’s strategic clinical development program.

On September 27, 2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a Fortress Biotech (NASDAQ: FBIO) company, reported that James F. Oliviero, President and Chief Executive Officer of Checkpoint, will present a company overview at the Ladenburg Thalmann 2018 Healthcare Conference on Tuesday, October 2, 2018, at 2 p.m. EDT (Press release, Checkpoint Therapeutics, SEP 27, 2018, View Source [SID1234529734]). The conference will be held at the Sofitel New York in New York City.

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A live webcast of the presentation will be available on the Events page of the Investors & Media section of Checkpoint’s website: www.checkpointtx.com.