On January 24, 2020 Allergan plc (NYSE: AGN) reported that its Board of Directors has declared a cash dividend of $0.74 per ordinary share for the first quarter of 2020 (Press release, Allergan, JAN 24, 2020, View Source [SID1234553535]). The dividend will be paid on March 13, 2020 to shareholders of record at the close of business on February 14, 2020.

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On January 24, 2020 Sun BioPharma, Inc. (OTCQB: SNBP), a clinical-stage biopharmaceutical company developing disruptive therapeutics for the treatment of people with pancreatic cancer, reported initial Phase 1 clinical data for SBP-101, which was presented in a poster session at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Gastrointestinal Cancers Symposium (Press release, Sun BioPharma, JAN 24, 2020, View Source [SID1234553533]). SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI), a metabolic pathway of critical importance in cell function in multiple tumor types. Based upon the study data presented today, the adverse event profile of SBP-101 at the optimal dose level was manageable and an expansion study in patients with pancreatic ductal adenocarcinoma (PDA) is planned to begin during the second quarter of 2020.

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"We are excited about the early results from this Phase 1 trial, which suggest improved activity of SBP-101 in combination with gemcitabine and nab-paclitaxel, along with a tolerable adverse event profile," said Dr. Dusan Kotasek, Director, Clinical Research at Adelaide Cancer Centre and a key Principal Investigator in both the monotherapy and combination therapy studies of SBP-101. "Pancreatic ductal adenocarcinoma is an area of incredibly high unmet medical need, and by evaluating SBP-101 with the current standard of care, we hope to be able to offer patients an improved therapeutic option."

Preliminary Results Demonstrate Tolerability and Clinical Activity in Metastatic Treatment-Naïve Patients

As of the data cut off date of January 4, 2020, the addition of SBP-101 to the combination of gemcitabine plus nab-paclitaxel did not increase the frequency of grade 3/4 hematologic adverse events, peripheral neuropathy, nausea or diarrhea when compared to historical control data for patients who were treated with gemcitabine plus nab-paclitaxel. The most common adverse events (all grades) attributed to treatment with SBP-101 were fatigue, elevated LFTs, and injection site pain.

The most common grade 3/4 adverse event was elevation in liver function tests, which in most cases was asymptomatic, and in all cases reversed when SBP-101 was interrupted and decreased or discontinued.

Study results in evaluable subjects enrolled in the two highest dose cohorts (N=13) demonstrated an overall response rate (ORR) of 62%, including 8 partial responses (PRs). The disease control rate (DCR) was 85% by RECIST criteria. Eleven subjects in those cohorts (69%, N=16) saw a maximum decrease in CA 19-9 of more than 60%. As of January 4, 2020, 8 of 16 subjects remained on study. Median duration of response, progression free survival and overall survival had not been reached.

Phase 1a/1b Trial Design

This ongoing multicenter, open label, Phase 1 trial enrolled 20 patients with pancreatic ductal adenocarcinoma (PDA) across three dose cohorts. Study participants received a subcutaneous dose of SBP-101 at 0.2, 0.4 or 0.6 mg/kg on days 1-5 of each 28-day cycle, in addition to intravenous doses of 1000 mg/m2 of gemcitabine and 125 mg/m2 of nab-paclitaxel on days 1, 8 and 15. The goal of this study was to determine a recommended dose of SBP-101 for further development. Endpoints include safety, tolerability, and pharmacokinetics, in addition to early measures of efficacy including ORR as measured by RECIST, and CA19-9 levels. Based upon preliminary safety and efficacy signals, the protocol was amended to follow subjects for progression-free survival (PFS) and overall survival (OS).

Poster Presentation Information

Efficacy of SBP-101, in combination with gemcitabine and nab-paclitaxel, in first-line treatment of metastatic pancreatic ductal adenocarcinoma.
Friday, January 24, 2020, 12:00 PM to 1:30 PM and 4:30 PM to 5:30 PM
Abstract 710, Board K21
Poster Session B: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer
American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Gastrointestinal Cancers Symposium

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI), a metabolic pathway of critical importance in multiple tumor types. Sun BioPharma licensed SBP-101 from the University of Florida Research Foundation in 2011. The molecule has been shown to be a highly effective tumor growth inhibitor in preclinical studies of human pancreatic cancer models, demonstrating superior and complementary activity to existing FDA-approved chemotherapy agents. SBP-101 has demonstrated activity against primary and metastatic disease in clinical trials of patients with pancreatic cancer. The safety data and PMI profile observed in Sun BioPharma’s previously completed first-in-human dose escalation study of SBP-101 provides support for evaluation of SBP-101 in combination with current standard pancreatic cancer treatment.

On January 24, 2020 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that it will host a webcast at 11am (CET) on Monday, January 27th 2020 where CEO Jakob Lindberg will present and explain melflufen’s mechanism of action (Press release, Oncopeptides, JAN 24, 2020, View Source [SID1234553532]).

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Conference call for investors, analysts and the media, Monday, January 27th 2020, at 11 (CET).

The conference call will also be streamed on the corporate website www.oncopeptides.com and via the link below.

View Source

The presentation will be available at:

www.oncopeptides.com / Investor Relations / Presentations / Presentation webcast melflufen mechanism-of-action/

For more information, please contact:
Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 70 853 72 92

This information was submitted for publication at 18.30 CET January 24, 2020.

About melflufen

Melflufen is a novel peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

On January 24, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage biopharmaceutical company pioneering a novel class of immunotherapies, reported that it will host a key opinion leader symposium on the role of survivin in cancer biology and DPX-Survivac’s potential as a targeted immunotherapeutic agent across a range of tumor types (Press release, IMV, JAN 24, 2020, View Source [SID1234553529]). The event will be held on Thursday, February 27, 2020 from 8:30 – 10:00 a.m. ET in New York, NY.

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The event will feature presentations by key opinion leaders, including:

Sally P. Wheatley, Ph.D., Assistant Professor, School of Life Sciences, University of Nottingham;

Jeannine Villella, D.O., FACOG, FACS, Chair of Gynecologic Oncology, Department of Obstetrics and Gynecology, Lenox Hill Hospital and NYU Winthrop Hospital; and

Oliver Dorigo, M.D, Ph.D., Associate Professor of Obstetrics and Gynecology, Stanford University Medical Center, Stanford University Medical Center.

Additionally, IMV management will provide a corporate update, including an overview of recent data from ongoing studies of DPX-Survivac, which is currently being evaluated in three Phase 2 studies in advanced ovarian cancer, relapsed/refractory diffuse large B-cell lymphoma and a basket of solid tumor indications. Topline results are expected from all three studies in 1H20.

A live webcast of the event will be available under "Events, Webcasts and Presentations" in the Investors section of IMV’s website and will be available for replay approximately two hours following the live event.

On January 24, 2020 University Hospitals Seidman Cancer Center reported that it treated its first patient in a new clinical trial to validate the groundbreaking effects of the poliovirus on glioblastoma (GBM), a deadly Grade IV cancer of the brain (Press release, University Hospitals, JAN 24, 2020, View Source [SID1234553527]).

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UH is the only Midwest site participating in this clinical trial, which was initiated at Duke Cancer Institute in Durham, NC. The original study, which ran from 2012-2017, was published in New England Journal of Medicine in July 2018 as well as highlighted on "60 Minutes" in 2015 and again in 2018. The study found that survival rates were significantly higher in glioblastoma patients who received an intratumoral infusion of a modified viral chimera combining the polio and rhinoviruses (PVSRIPO immunotherapy) compared to patients receiving standard treatment at the same institution.

"We are proud that University Hospitals was selected as one of a handful of top brain tumor centers such as the Massachusetts General Hospital and UCSF to participated in this Phase II clinical trial based on our expertise in immunotherapy and reputation for treating brain tumors," said Andrew E. Sloan, MD, FAANS, FACS, Director of the Brain Tumor and Neuro-Oncology Center and the Center of Excellence in Translational Neuro-Oncology at UH Seidman Cancer Center and the UH Neurological Institute. "We want to offer this treatment opportunity to patients with recurrent glioblastomas who want to pursue groundbreaking alternatives that may improve their chances of survival from the most challenging of brain cancers."

The 59-year-old man first enrolled in this trial suffered from glioblastoma that recurred after initial surgery and treatment. Following a biopsy to verify the progression of the brain tumor, Dr. Sloan placed a catheter into the tumor and the modified attenuated poliovirus was convected through the catheter into the tumor the next morning. Through this process, known as convection enhanced delivery (CED) and performed in the NeuroIntensive Care Unit at UH Cleveland Medical Center, the poliovirus attacks the tumor creating an anti-tumor immune response. The patient went home the next day.

"This trial uses a polio virus modified to specifically target a receptor (CD155) found only on tumor cells," Dr. Sloan said. "While it only kills a small number of tumor cells directly, the virus and the immune response it exerts exposes these tumor cells, which have been hiding from the immune system and creates a significant anti-tumor immune response that takes over and kills the rest of the tumor that the virus has not destroyed. Unlike the native polio virus, the modified virus does not attack neurons."

Traditionally, survival from a GBM is less than a year, and patients typically live less than six months after recurrence. The survival rate among those receiving PVSRIPO immunotherapy was 21 percent at 24 and 36 months, much higher than the 4 percent survival rate among historical controls treated at Duke, according to the article published in the New England Journal of Medicine on July 12, 2018.

Researchers at Duke first discovered that the poliovirus delivered directly into intracranial tumors was able to trigger a positive immune reaction, which led to a longer survival rate from the notoriously difficult-to-treat cancer. In Phase I of the clinical trial, doctors determined the correct dose of the virus to administer while mitigating side effects. In Phase II, researchers will compare outcomes in patients.

"The body has an amazing immunological memory," Dr. Sloan said. "If you’ve received the polio vaccine as a child, your immune system remembers that polio is a bad thing. The injection of the polio virus jump-starts the immune response, which in turn attacks the cancer."