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.

On September 27, 2018 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (NASDAQ: EGRX) reported that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will present at the Cantor Global Healthcare Conference as follows (Press release, Eagle Pharmaceuticals, SEP 27, 2018, View Source [SID1234529679]):

Date: Wednesday, October 3, 2018
Time: 9:10 a.m. Eastern Daylight Time
Location: Intercontinental New York Barclay Hotel, NYC
Webcast: View Source

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The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company’s website at www.eagleus.com, under the Investors + News Section.

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 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.

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)

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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."