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Tocagen to Participate in Four Investor Conferences in October

On September 27, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that members of the leadership team will present at the following upcoming investor conferences in New York City (Press release, Tocagen, SEP 27, 2018, View Source;p=RssLanding&cat=news&id=2369348 [SID1234529674]):

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Tuesday, October 2, 10:30 a.m. ET
Ladenburg Thalmann 2018 Healthcare Conference
Presenter: Chief Executive Officer Marty Duvall

Wednesday, October 3, 8:00 a.m. ET
Cantor Global Healthcare Conference
Presenter: Chief Executive Officer Marty Duvall

Wednesday, October 3, 9:00 a.m. ET
Leerink Roundtable Series: Rare Disease & Oncology
Presenters: Chief Financial Officer Mark Foletta and Chief Medical Officer Asha Das, M.D.

Tuesday, October 9, 3:45 p.m. ET
Chardan Capital Markets 2nd Annual Genetic Medicines Conference
Presenter: Chief Executive Officer Marty Duvall

The live audio webcasts from the conferences and subsequent replay may be accessed by visiting the "Events & Presentations" page in the investors section of Tocagen’s website. The webcasts will be available shortly after conclusion of the presentation and archived on the company’s website for 90 days following the presentation.

ISA Pharmaceuticals Reports Publication of Favorable Phase 2 Results of ISA101 plus Nivolumab in JAMA Oncology

On September 27, 2018 ISA Pharmaceuticals B.V., a clinical-stage immuno-oncology company, reported the publication of the results of a Phase 2 combination trial with ISA’s synthetic long-peptide (SLP) HPV-16 vaccine ISA101 and nivolumab, a monoclonal antibody and PD-1 checkpoint inhibitor (NCT02426892) (Press release, ISA Pharmaceuticals, SEP 27, 2018, View Source [SID1234529663]). The open-label trial in patients with HPV-16 associated cancers demonstrated safety and efficacy, resulting in an improved survival as compared to historical nivolumab monotherapy results. It was conducted by MD Anderson Cancer Center in collaboration with ISA Pharmaceuticals and Bristol-Myers Squibb. The results are published in JAMA Oncology today (doi:10.1001/jamaoncol.2018.4051; View Source)

The trial included 24 patients with incurable HPV16-positive cancers; 22 of whom had oropharyngeal cancer, a subtype of head and neck cancer. All patients had received prior cytoreductive therapy for advanced disease. Patients received ISA101 on days 1, 22 and 50. Nivolumab was administered i.v. every 2 weeks as of day 8 for up to one year. The primary objective was assessment of efficacy defined as overall response rate (ORR) by RECIST v. 1.1. Secondary objectives were assessment of safety, tolerability, HPV-specific immune responses, progression-free survival (PFS), and overall survival (OS). The combination of ISA101 and nivolumab was very well-tolerated. Overall response rate was 33% (8/24); all responses occurred in the patients with oropharyngeal cancer. The one-year and median survival rates are estimated at 70% and 17.5 months, respectively.

"These are promising results when compared to historical data with nivolumab monotherapy in HPV-related oropharynx cancer, albeit this was a small single arm trial with a heterogeneous patient population," said Bonnie Glisson, MD, Professor at The University of Texas MD Anderson Cancer Center and Principle Investigator of the trial. "These findings support our hypothesis that induction of a heightened HPV-specific immune response with vaccine augments the proportion of patients benefiting from CPB therapy and clearly merit confirmation in a randomized trial."

"We are very pleased with the results," said Kees Melief, CSO of ISA Pharmaceuticals, "The data not only add to a growing body of evidence that the future of cancer treatment lies in combination therapy addressing multiple targets and mechanisms, but they also demonstrate that ISA’s SLP vaccines may be an important cornerstone of this approach. In a trial combining ISA101 with standard-of-care chemotherapy in cervical cancer patients it has been shown that this approach leads to a stronger, vaccine-induced HPV16-specific immune response. Moreover, this combination appears to be associated with improved clinical outcome. The latest data suggest that the efficacy of anti-PD-1 therapy can be augmented by vaccination, thereby stimulating a larger repertoire of tumor-specific T cells. As a next step, we will conduct a randomized trial to confirm these findings."

"The outcome of this trial is an important confirmation of our therapeutic approach," said Gerben Moolhuizen, CEO of ISA Pharmaceuticals, "We look forward to initiating further clinical trials combining our SLP vaccines with other cancer therapeutics."

Aptose Biosciences and CrystalGenomics Announce Issuance of European Patent for CG-806

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.

"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).

INSYS Therapeutics to Present at 2018 Cantor Global Healthcare Conference

On September 27, 2018 INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, reported that Saeed Motahari, president and chief executive officer, and Andy Long, chief financial officer, will present at the upcoming 2018 Cantor Global Healthcare Conference as follows (Press release, Insys Therapeutics, SEP 27, 2018, View Source [SID1234529647]):

Date: Tuesday, Oct. 2, 2018
Time: 1:05 p.m. Eastern Time
Location: New York, N.Y.
The presentation will be webcast live at the aforementioned time, and archived for 90 days thereafter, via the Investors section of company’s website at View Source, under Presentations & Events. Accessible at the same webpage, the presentation slides will be available during and after the conference.

CytoSen Therapeutics Receives FDA’s Favorable Response to Pre-IND Meeting Package for Phase 2 Study in AML

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.

"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.