On December 4, 2017 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported positive overall survival data from the long-term follow-up part of the Phase 2a trial of BL-8040 for the treatment of relapsed or refractory acute myeloid leukemia (r/r AML) (Press release, BioLineRx, DEC 4, 2017, View Source;p=RssLanding&cat=news&id=2320793 [SID1234522347]). The results demonstrate that the combination of BL-8040 with high-dose Ara-C (HiDAC) in this difficult-to-treat patient population significantly improved overall survival, compared with historical data of HiDAC monotherapy.

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The long-term survival results from the Phase 2a study derive from the expansion phase of the study, which included 16 patients (out of 42 total patients enrolled in the study). Participants were treated with BL-8040 as a monotherapy for two days, followed by a combination of BL-8040 and HiDAC for 5 days. The mean follow-up time was 338 days (29-853 days). BL-8040 in combination with HiDAC was found to be safe and well tolerated, and the response rate was 38% (6/16). Median overall survival was 11.1 (1-28) months, the estimated one-year survival rate was 37.5% and the estimated two-year survival rate was 28.5%, compared to historical data for patients treated only with HiDAC showing overall survival of approximately 6.1 months. Furthermore, the subset of patients exhibiting a response showed prolonged overall survival, with estimated one-year and two-year survival rates of 60%. Median overall survival for this group could not be calculated, since only two of these patients have relapsed.

The Phase 2a study assessed the efficacy of BL-8040, as a single agent and in combination with HiDAC, for the treatment of r/r AML. The majority of patients in the study were heavily pre-treated, and the treated patient population included patients who had relapsed following allogeneic stem-cell transplantation, as well as secondary AML patients – both conditions which represent difficult-to-treat populations with poor prognoses. Top-line results from the full study (n=42) were previously reported in March 2016, and showed an overall response rate (CR+CRi) of 38%, compared with historical data relating to HiDAC of approximately 20%.

Philip Serlin, Chief Executive Officer of BioLineRx, commented, "We are very pleased from the long-term follow-up results of this study, which continue to demonstrate the robust anti-leukemic activity of BL-8040 and show that combined treatment with HiDAC not only increases the response rate, but also increases overall survival time compared to historical data. We will continue to monitor the overall long-term survival of patients in this study, as we progress in the execution of our two other important studies in AML – our Phase 2a study in maintenance AML, which is part of our collaboration with Genentech, and our Phase 2b study in consolidation AML. The promising survival and response results we have seen in the r/r AML study, along with the future data readouts from the additional studies we’re currently running in this disease, have the potential to make BL-8040 a key player in the AML setting."

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On December 4, 2017 Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the appointment of Prof. Stéphane Depil, MD, PhD, to the role of Senior Vice President Research & Development and Chief Medical Officer (Press release, Cellectis, DEC 4, 2017, View Source [SID1234522366]). Prof. Depil’s responsibilities include bringing Cellectis’ product candidates to clinical-stage development, strategic and operational management of all therapeutic activities, and supervising research and development projects for the Company. Stéphane Depil will keep academic and research activities as adjunct Professor at Léon Bérard Cancer Center & University Claude Bernard Lyon 1, France.

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"Stéphane Depil’s deep medical, academic, and clinical regulatory oncology experience – specifically in R&D for all phases within the pharmaceutical, biotechnology, and clinical research spaces – will be invaluable as he leads Cellectis’ strategy and promotes awareness of the breakthrough work that we are doing as a leader and innovator in the gene-editing field," said Dr. André Choulika, Cellectis CEO. "His strategic alliance-building, collaboration skills, understanding of the global environment with oncological clinical research, and firsthand experience running a pharma company all add a great degree of ability and depth to our leadership team. This will be tremendously advantageous as Cellectis continues its efforts to cure cancer with our off-the-shelf gene-edited CAR T-cell product candidates."

Prof. Depil is a board-certified physician in hematology, with over 15 years of experience in oncology clinical development, both in hospital / university and pharmaceutical companies. Prior to joining the Léon Bérard Cancer Center & Cancer Research Center of Lyon, France as Medical Director of the Cancer Immunotherapy Program, he served as Chief Executive Officer at Netris Pharma, where he was responsible for the management of an oncology startup and preclinical development of a first-in-class monoclonal antibody in Phase I. Prior to Netris, Stéphane Depil worked at Servier for 8 years in a variety of roles, including Director of Oncology Research and Development, where he managed 20 programs: 5 in the clinic, 7 at late preclinical stages, and 8 at early preclinical stages. He also directly supervised over 100 licensing opportunities.

"As we are at a transformative moment in history with CAR T-cell therapy, Cellectis is harnessing the power of gene editing to improve patients’ lives through the allogeneic approach," added Prof. Depil. "As such, Cellectis is well-positioned to make its mark with the Company’s unique pioneering approach, and I look forward to joining the team at this pivotal time. This is an unprecedented era of biopharmaceutical innovation to develop next-generation therapeutics that will transform patient care as we know it today."

On December 4, 2017 Radius Health, Inc. (Nasdaq:RDUS), reported that it will present data from multiple clinical and pre-clinical studies of elacestrant, an oral selective estrogen degrader, in ER-positive breast cancer at the San Antonio Breast Cancer Symposium Meeting December 5-9, 2017 at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, Radius, DEC 4, 2017, View Source [SID1234522365]).

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Details for the abstracts related to elacestrant are below:

Abstract Title: Elacestrant, a novel oral selective estrogen receptor degrader (SERD), decreases tumoral 18F-FES uptake in a phase 1 study of ER+, HER2 -, advanced breast cancer patients
Poster Session 1 (P1-10-04)
Session Title: Treatment: New Drugs and Treatment Strategies
Session Date: Wednesday, 12/6/2017
Session Time: 5:00 PM — 7:00 PM
Location: Hall 1

Abstract Title: Elacestrant, oral selective estrogen receptor degrader (SERD) in patients with ER positive (ER+)/HER2- advanced breast cancer: Updated phase 1 efficacy, safety and pharmacodynamic results
Spotlight Session 5 (PD5-08)
Session Title: Endocrine Therapy: SERDS for metastatic ER+ breast cancer
Session Date: Thursday, 12/7/2017
Session Time: 5:00 PM — 7:00 PM
Location: Ballroom 1&2 – 3rd Level

Abstract Title: New oral SERD elacestrant (RAD1901) shows efficacy in breast cancer models harbouring ESR1 mutations and enhances the antiproliferative activity of mTORC1 and CDK4/6 inhibitors
Poster Session 4 (P4-04-09)
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: Friday, 12/8/2017
Session Time: 7:00 AM — 9:00 AM
Location: Hall 1

Abstract Title: Anti-tumor activity of elacestrant (RAD1901) in combination with alpelisib (BYL-719) in patient-derived xenograft models of ER+ breast cancer
Poster Session 4 (P4-04-14)
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: 12/8/2017
Session Time: 7:00 AM — 9:00 AM
Location: Hall 1

Abstract Title: Elacestrant (RAD1901) demonstrates anti-tumor activity in a fulvestrant-resistant PDX model
Poster Session 4 (P4-04-17)
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: 12/8/2017
Session Time: 7:00 AM — 9:00 AM
Location: Hall 1

Abstracts for the posters can be found on the SABCS website at View Source

Webcast Information

Radius will host an investor meeting and webcast on Thursday, December 7th to highlight the elacestrant data presented at SABCS and provide a company update at 8:00 p.m. CT / 9:00 p.m. ET.

The live webcast titled "Oncology Program Update from San Antonio Breast Cancer Symposium — 2017" will be available at View Source or by visiting the Investors section of Radius’ website at View Source

A replay of the webcast will be archived on Radius’ website for 30 days following the presentation.

About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once daily oral treatment for hormone-receptor positive breast cancer. Elacestrant is currently being investigated for potential use in women with advanced estrogen receptor positive, HER2 negative, breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.

Additional information on the clinical trial program of elacestrant (RAD1901) is available on www.clinicaltrials.gov.

On December 4, 2017 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a company focused on helping improve patient lives by providing high quality biologics manufacturing services to biotechnology and pharmaceutical companies, reported that it will report financial results for the second quarter of fiscal year 2018 ended October 31, 2017 on December 11, 2017 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Peregrine Pharmaceuticals, DEC 4, 2017, View Source [SID1234522364]). Peregrine’s senior management will discuss financial results for the second quarter and review recent corporate developments.

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To listen to the live webcast, or access the archived webcast, please visit: View Source
To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals call.

On December 4, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, also known as pelareorep, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn ‘cold’ tumors ‘hot’, reported that it will present at the Oncolytic Virotherapy Summit (Press release, Oncolytics Biotech, DEC 4, 2017, View Source [SID1234522363]). Dr. Matt Coffey, Oncolytics’ President and Chief Executive Officer, will present on Wednesday, December 6 at 11:00 a.m. ET as part of a panel presentation and then present specifically on pelareorep in a Clinical Case Study presentation at 2:30 p.m. ET on the same day. The conference takes place on December 5th, 6th and 7th in Miami, Florida.

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"The Oncolytic Virotherapy Summit offers us another opportunity to highlight our extensive experience with pelareorep in the clinic and to illustrate its ability to induce an inflamed tumor phenotype amongst our peers and for potential partners," said Dr. Coffey. "Our clinical experience with pelareorep has led us to favorable feedback from the FDA following our end-of-phase 2 meeting which helps us define a clear regulatory path in metastatic breast cancer and a single 400-patient phase 3 registration study. Our phase 3 protocol will be made available following evaluation and completion of discussions with clinical advisors, potential partners and the EMA."

The panel presentation: "How Can We Improve The Efficacy of Oncolytic Virotherapies?", also including management from PsiOxus Therapeutics, Vyriad and Replimune Group, will cover:

· Viral modulation of the tumor microenvironment
· Increasing the viral impact with activated immune responses
· Combination drug therapies to stimulate the immune response and prevent immunosuppression
· Viral delivery for largest impact
Dr. Coffey’s individual presentation: "Clinical Progress and Robust Safety Findings of Using Reovirus as an Immuno-Oncology Viral Agent to Treat Cancer", will highlight:

· The role of REOLYSIN in the activation of the immune system and the induction of an inflamed tumor phenotype in the tumor microenvironment
· Overall survival data from the Company’s randomized phase 2 metastatic breast cancer study
· The largest pooled safety database of any oncolytic virus
About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.