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RedHill Biopharma Announces YELIVA™ (ABC294640) Poster Presentation at the 2016 EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium

On November 21, 2016 RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported the presentation of a poster relating to YELIVA (ABC294640), the Company’s proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, at the 2016 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium, on November 29, 2016, in Munich, Germany (Press release, RedHill Biopharma, NOV 21, 2016, View Source [SID1234516722]).

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The poster, entitled ‘Antitumor and Anti-Inflammatory Effects of the Sphingosine Kinase-2 Inhibitor ABC294640 in Combination with Radiation,’ was authored by scientists from Apogee Biotechnology Corporation ("Apogee"), the original developers of YELIVA.

By inhibiting the SK2 enzyme, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid signaling molecule that promotes cancer growth and pathological inflammation.

RedHill is pursuing and evaluating, with YELIVA, multiple clinical programs in oncology, inflammatory and gastrointestinal indications, as well as potential collaboration opportunities with larger pharmaceutical companies to evaluate YELIVA as an add-on therapy to their existing oncology treatments.

Results from a Phase I study with YELIVA in patients with advanced solid tumors confirmed that the study, conducted at the Medical University of South Carolina Hollings Cancer Center (MUSC), successfully met its primary and secondary endpoints, demonstrating that the drug is well-tolerated and can be safely administered to cancer patients at doses that provide circulating drug levels that are predicted to have therapeutic activity.

A Phase II study with YELIVA for the treatment of advanced hepatocellular carcinoma (HCC) was initiated at MUSC Hollings Cancer Center. The study protocol is under FDA review and enrolment is expected to begin by year end 2016. The study is supported by a $1.8 million grant from the National Cancer Institute (NCI) awarded to MUSC and is intended to fund a broad range of studies on the feasibility of targeting sphingolipid metabolism for the treatment of a variety of solid tumor cancers, with additional funding from RedHill.

A Phase Ib/II study with YELIVA for the treatment of refractory or relapsed multiple myeloma was initiated at Duke University Medical Center. The study is supported by a $2 million grant from the NCI Small Business Innovation Research Program (SBIR) awarded to Apogee, in conjunction with Duke University, with additional support from RedHill.

A Phase I/II clinical study evaluating YELIVA in patients with refractory/relapsed diffuse large B-cell lymphoma was initiated at the Louisiana State University Health Sciences Center in New Orleans in June 2015 and was recently amended to address overall recruitment prospects. The study, which will now also include Kaposi sarcoma patients, is expected to resume by the end of 2016, pending regulatory approval. The study is supported by a grant from the NCI, as well as additional support from RedHill.

A Phase Ib study to evaluate YELIVA as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy is planned to be initiated in the first quarter of 2017.

The ongoing studies with YELIVA (ABC294640) are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

About YELIVA (ABC294640):
YELIVA (ABC294640) is a Phase II-stage, proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anti-cancer and anti-inflammatory activities. RedHill is pursuing with YELIVA multiple clinical programs in oncology, inflammatory and gastrointestinal indications. By inhibiting the SK2 enzyme, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid signaling molecule that promotes cancer growth and pathological inflammation. SK2 is an innovative molecular target for anticancer therapy because of its critical role in catalyzing the formation of S1P, which is known to regulate cell proliferation and activation of inflammatory pathways. YELIVA was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI and radioprotection models, as well as the ABC-101 Phase I clinical study in cancer patients with advanced solid tumors. The development of YELIVA was funded to date primarily by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including the U.S. National Cancer Institute, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Defense and the FDA Office of Orphan Products Development.

ImmunoCellular Therapeutics Reports Updated Immune Monitoring Data from ICT-107 Phase 2 Trial in Newly Diagnosed Glioblastoma at the Society for Neuro-Oncology Annual Meeting 2016

On November 21, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT:IMUC) reported the presentation of updated immune monitoring data from the phase 2 trial of ICT-107 in patients with newly diagnosed glioblastoma (Press release, ImmunoCellular Therapeutics, NOV 21, 2016, View Source [SID1234516718]). Also presented were updated long-term survival data from the phase 1 trial of ICT-107. ICT-107 is a dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. ICT-107 is currently being tested in a phase 3 registration trial in patients with newly diagnosed glioblastoma. The updated phase 1 and phase 2 data were presented in two oral sessions on Friday, November 18th, at the 21st Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology, held in Scottsdale, AZ.

The ICT-107 phase 2 trial was a randomized, double-blind, placebo-controlled phase 2 study of the safety and efficacy of ICT-107 in patients with newly diagnosed glioblastoma following resection and chemoradiation. ICT-107 is an intradermally administered autologous immunotherapy consisting of the patient’s own dendritic cells pulsed with six synthetic tumor-associated antigens: AIM-2, MAGE-1, TRP-2, gp100, HER-2, IL-13Rα2. The placebo control consisted of the patient’s unpulsed dendritic cells. The data from the phase 2 trial indicated a survival advantage in the ICT-107 treated group compared to the control group. The data also showed an association between immune response and survival, especially in HLA-A2 positive (HLA-A2+) patients, which is the target patient population for the ongoing phase 3 registration trial.

The updated immune response data from the phase 2 trial showed that treatment with ICT-107 resulted in the development of a measurable anti-tumor T cell response in some patients, which was associated with survival. Patients that developed the anti-tumor T cell response which was measurable by both ELISpot (to detect viable T cells capable of binding to a target antigen) and multimer testing (to detect T cell binding with higher sensitivity than ELISpot) had improved survival. The data demonstrated that immuno-monitoring can provide an early indication of patients responding to immunotherapy. In the current ongoing phase 3 registration trial of ICT-107, ImmunoCellular plans to perform immuno-monitoring to support the trial.

The data were presented at SNO by Steven J. Swanson, PhD, Senior Vice President, Research, ImmunoCellular Therapeutics, in a presentation titled, "Categorizing immune responders with fusion metrics and simulation for association to survival and progression-free survival with immune response in HLA-A2+ patients with GBM from a phase 2 trial of dendritic cell (DC) immunotherapy (ICT-107)."

Dr. Swanson commented: "ICT-107 is designed to deliver therapeutic benefit by stimulating the patient’s immune system to attack tumor tissue. A first indicator that the immunotherapeutic is active is the production of tumor-specific T cells by the patient. In our SNO presentation, we described our ability to more clearly interpret the immune-monitoring data from the phase 2 trial. The ability to accurately identify negative and positive responses enabled us to better understand which of the patients in our trial generated T cells capable of attacking the tumor. We determined that patients with a T cell response measureable in both the ELIspot assay and through multimer analysis achieved longer survival as compared with patients who did not show a positive response. These data should enable us to better interpret the results of our ongoing phase 3 trial."

Andrew Gengos, ImmunoCellular Chief Executive Officer, said: "The phase 2 trial immune monitoring results indicate that patients who mount a T cell response appear to have improved survival over those without a detectable response. In designing the phase 3 trial, we have made important changes in the protocol to potentially enhance the immune response in ICT-107 treated patients with the goal of optimizing the potential survival outcomes in the trial."

Data from the phase 1 trial of ICT-107 were presented by Surasak Phuphanich, MD, Department of Neurology, Cedars-Sinai in Los Angeles, in a presentation titled "Ten-year follow up with long term remission in patients with newly diagnosed glioblastoma (GBM) treated with ICT-107 vaccine (phase 1)." The phase 1 open-label, single institution trial, which was completed in 2010, included 16 evaluable patients with newly diagnosed glioblastoma. Results of the study were initially published in 2012 (Cancer Immunol Immunother).

Updated survival data presented by Dr. Phuphanich at the 2016 SNO meeting showed that 19% of patients had long-term remission of greater than 8 years, with the longest remission being 9.6 years. Also, 38% of patients demonstrated long-term survival of greater than 8 years, with the longest survivor greater than 10.2 years. Immune response data showed a correlation between survival and cancer-stem-associated expression, and a trend toward greater CD8 T cell cytokine responses in long-term survivors.

ICT-107 Phase 3 Registration Trial Underway

The ongoing phase 3 registrational trial of ICT-107 is designed as a randomized, double-blind, placebo-controlled study of HLA-A2+ subjects, which is being conducted at about 120 sites in the US, Canada and the EU, with plans to randomize at least 500 patients with newly diagnosed glioblastoma. The primary endpoint in the trial is overall survival. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups.

For patients, families and physicians seeking additional information about the ICT-107 phase 3 trial, please consult www.clinicaltrials.gov.

About ImmunoCellular Therapeutics, Ltd.

Onxeo Announces 9th Positive DSMB Recommendation to Continue Livatag® ReLive Phase III Trial in HCC

On November 21, 2016 Onxeo S.A. (Euronext Paris, Nasdaq Copenhagen: ONXEO), a biopharmaceutical company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, reported that the company has received the 9th unanimous recommendation from the Data Safety Monitoring Board (DSMB), an independent European board of experts that monitors the safety of the Livatag Phase III trial, "ReLive", to continue the study without modification (Press release, Onxeo, NOV 21, 2016, View Source [SID1234516731]).

The nine consecutive positive DSMB recommendations reinforce the acceptable safety profile of Livatag. The ReLive study is an ongoing international, randomized Phase III trial designed to evaluate the efficacy of intravenous (IV) administration of Livatag in patients with advanced hepatocellular carcinoma (HCC) after failure or intolerance to sorafenib. The study plans to enroll a total of 400 patients across approximately 90 sites. To date, more than 90% of the patients have been randomized in the study. The DSMB reviews the safety data of the treated patients in the study, totaling more than 900 infusions of Livatag.

"As we are approaching complete randomization in the ReLive study, we are, once again, encouraged by the DSMB’s positive recommendation which confirmed the acceptable safety profile of Livatag as regards to unexpected safety events. Enrolment is well on track and we should reach the 400 patients in the coming weeks, which comforts us in our planning of preliminary data announcement mid-2017. Livatag’s potential to address the unmet medical need for HCC patients combined with the drug’s favorable safety profile is a significant cornerstone in Onxeo’s mission to develop innovative medicines for patients, providing patients with new therapeutic options, and a significant catalyst for the company value," said Judith Greciet, CEO of Onxeo.

As per study protocol, the DSMB meets twice a year since study initiation to review the safety data of the ReLive trial and subsequently issues recommendations on the conduct of the study.

Celyad announces the approval to initiate its NKR-2 CAR-T Clinical Trial in Belgium

On November 21,2016 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, reported the approval in Belgium to initiate the THINK clinical trial (Press release, Celyad, NOV 21, 2016, View Source [SID1234516730]). THINK is the second clinical trial of its NKR-2 product candidate, a CAR-T cell therapy using NKG2D ligands as a target, to evaluate safety and efficacy in seven cancer indications including both solid and hematological malignancies.

THINK (THerapeutic Immunotherapy with NKR-2) is a multinational open-label Phase Ib study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 T-cells in seven, refractory cancers including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma).

This trial will be conducted in the US and in Europe. It contains a dose escalation and an extension stage. The dose escalation will be conducted in parallel in the solid tumor and in the liquid cancer groups, while the extension phase will evaluate in parallel each tumor independently.

The dose escalation design will include three dose levels adjusted to body weight: up to 3×108, 1×109 and 3×109 NKR-2 T-cells. At each dose, the patients will receive three successive administrations, two weeks apart, of NKR-2 T-cells at the specified dose. The dose escalation part of the study will enroll up to 24 patients while the extension phase would enroll 86 additional patients.

The seven indications evaluated in the THINK trial were selected based on evidence generated in the pre-clinical settings and in the first study recently completed (a Phase I single injection, dose escalation study evaluating NKR-2 T-cells in 12 patients suffering from Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM) at Dana Farber Cancer Institute in Boston, MA, USA).

Dr. Christian Homsy, CEO of Celyad commented: "We are extremely happy to be able to start this next phase of the clinical development program of NKR-2, building on the successful outcome of the single dose, dose escalation trial, to be presented at ASH (Free ASH Whitepaper). We now look forward to treating the first patients in Belgium, and to receiving FDA clearance to initiate the trial at our US-based sites."

Dr. Frédéric Lehmann, VP Clinical Development and Medical Affairs at Celyad added: "We are excited to initiate this multiple tumor study with key cancer institutions in Belgium. While immunotherapy is rapidly transforming the treatment of patients with cancer, there remains a significant unmet medical need for more effective therapies. It is our hope that Celyad’s NKR-2 T-cells have the potential to be truly disruptive in the way we treat cancer and this study is one more step towards that goal."

CEL-SCI SUBMITS RESPONSE TO FDA IN CONNECTION WITH PARTIAL CLINICAL HOLD ON PHASE 3 CLINICAL TRIAL

On November 21, 2016 -CEL-SCI Corporation (NYSE MKT: CVM) reported that it has submitted its response to the U.S. Food and Drug Administration (FDA) regarding the previously announced partial clinical hold of CEL-SCI’s Phase 3 clinical trial of its investigational drug Multikine* (Leukocyte Interleukin, Injection) in patients with squamous cell carcinoma of the head and neck (Press release, Cel-Sci, NOV 21, 2016, View Source [SID1234516728]).