On November 20, 2017 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that an abstract with partial results from the monotherapy portion of BL-8040’s Phase 2a COMBAT study in pancreatic cancer was accepted for presentation at the ASCO (Free ASCO Whitepaper) 2018 Gastrointestinal Cancers Symposium, to take place January 18-20, 2018 in San Francisco, CA (Press release, BioLineRx, NOV 20, 2017, View Source;p=RssLanding&cat=news&id=2317838 [SID1234522148]).

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The Phase 2a study, named the COMBAT study, is an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of the combination of BL-8040 and KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., (known as MSD outside the United States and Canada), in up to 30 subjects with metastatic pancreatic adenocarcinoma. The study is primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies. In addition, the study will evaluate multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity, for both BL-8040 as a monotherapy, as well as for the combination of BL-8040 and KEYTRUDA. The study is being conducted in the US, Israel and additional territories.

"We are very pleased that the abstract presenting our partial monotherapy results for the COMBAT study were accepted to this important clinical conference. Because of the embargo policy of the conference, we won’t be able to share the data by the end of the year, but rather disclose it in January 2018, when the abstracts are released," commented Philip Serlin, Chief Executive Officer of BioLineRx. "As for today, we can report that enrollment of the study has been completed and we are meeting our timelines for conclusion of the study and topline results by the second half of 2018. We are excited about the upcoming topline results in 2018, and continue to fully support our development plan in combination with immune checkpoint inhibitors".

In September 2016, BioLineRx announced the initiation of the COMBAT study, its first Phase 2a study for evaluating the clinical efficacy of BL-8040 in combination with KEYTRUDA, for the treatment of patients with metastatic pancreatic cancer who relapse to previous therapies. The COMBAT study is being conducted by BioLineRx under a collaboration agreement between BioLineRx and MSD, through a subsidiary, to support a Phase 2a study investigating BioLineRx’s BL-8040 in combination with KEYTRUDA in patients with metastatic pancreatic cancer.

BL-8040, BioLineRx’s lead oncology platform, is a CXCR4 antagonist that has been shown in several clinical trials to be a robust mobilizer of immune cells and to be effective at inducing direct tumor cell death. Additional findings in the field of immuno-oncology suggest that CXCR4 antagonists may be effective in inducing the infiltration of anti-tumor T cells into the tumor. Therefore, when combined with KEYTRUDA, which blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect tumor cells survival, BL-8040 has the potential to enable activated larger amount of T cells to better reach tumor cells in the fight against pancreatic cancer.

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 November 20, 2017 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), will present at the LD Micro Conference taking place December 5-7th in Los Angeles (Press release, Onconova, NOV 20, 2017, View Source [SID1234522181]). The Company’s CEO and President, Dr. Ramesh Kumar, will present and be available for one-on-one meetings.

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Presentation Details:

Date: Thursday, December 7th, 2017

Time: 9:00 am PST (12:00 pm EST)

Location: Luxe Sunset Boulevard Hotel, Los Angeles, California, Track 4

The presentation will be available on the Investors section of the Company’s website at: View Source

On November 20, 2017 Cellectis (Alternext: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the publication of a study in Molecular Therapy — Nucleic Acids describing the educated engineering of highly specific and efficient TAL nucleases (TALEN) targeting PD1, a key T-cell immune checkpoint (Press release, Cellectis, NOV 20, 2017, View Source;utm_medium=feed&utm_campaign=Feed%3A+cellectis+%28Cellectis+RSS+Feed%29#When:21:30:00Z [SID1234522174]).

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In this report, Anne-Sophie Gautron, Ph.D., Alexandre Juillerat, Ph.D., and their collaborators used a strategy developed by Cellectis to control TALEN targeting based on a proprietary technology leveraging the exclusion capacities of non-conventional RVDs. This approach allows combined disruptions of the desired TRAC and PDCD1 loci by TALEN while eliminating low frequency off-site processing. By adjusting a few RVDs, they provided a rapid and straightforward redesign of optimal TALEN combinations for multiplex gene editing. This approach can greatly benefit gene editing for therapeutic applications where high editing efficiencies need to be associated with maximal specificity and safety.

Anne-Sophie Gautron, Ph.D. Project leader Immunotherapy

Dr. Anne-Sophie Gautron, Ph.D., graduated in immunology from the University Pierre et Marie Curie/Pasteur Institute, Paris 6, France. After receiving her Ph.D. in immunology in 2009 from the University René Descartes, Paris 5, France, she joined the Neurology and Immunobiology departments at Yale University, Connecticut, where she studied the role of regulatory T-cells in inhibiting pathogenic Th1 and Th17-cell responses. In 2014, she joined the Early Discovery team of Cellectis in Paris, France, working on the development of the next generation of CAR T-cells for adoptive immunotherapy. In 2017, she joined the CAR development group to lead projects associated with the development of new CAR-expressing engineered T-cells for administration as "off-the-shelf" immunopharmaceuticals for cancer treatment.

Alexandre Juillerat, Ph.D. Innovation Team leader

Dr. Alexandre Juillerat, Ph.D., graduated in Chemistry from the University of Lausanne, Switzerland. After receiving in 2006 his Ph.D. in protein engineering from the École Polytechnique Fédérale de Lausanne (EPFL, Switzerland), he moved to the laboratory of Structural Immunology at the Institut Pasteur in Paris, France, performing structure-function studies on a major adhesin of plasmodium falciparum. In 2010, he joined the R&D department of Cellectis in Paris, France, working on the development and implementation of sequence specific designer nucleases including the transcription activator-like effector nucleases TALEN. He then joined the Cellectis facility based in New York, NY, USA, leading projects associated with the development of the T-cell chimeric antigen receptor (CAR) technology.

Fine and predictable tuning of TALEN gene editing targeting for improved T-cell adoptive immunotherapy

Anne-Sophie Gautron1,3, Alexandre Juillerat2,3, Valérie Guyot1, Jean-Marie Filhol1, Emilie Dessez1, Aymeric Duclert1, Philippe Duchateau1 and Laurent Poirot1.

1Cellectis SA, 8 rue de la croix Jarry, 75013 Paris, FRANCE

2Cellectis Inc, 430E, 29th street, NYC, NY 10016, USA

3These authors contributed equally to this work.

http://www.sciencedirect.com/science/article/pii/S2162253117302664?via=ihub

On November 20, 2017 Samsung Bioepis Co., Ltd. reported the European Commission’s (EC) marketing authorization of ONTRUZANT, a biosimilar referencing Herceptin (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer (Press release, Samsung Bioepis, NOV 20, 2017, View Source [SID1234522145]). ONTRUZANT is the first trastuzumab biosimilar to receive regulatory approval in Europe.

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The EC approval of ONTRUZANT applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. ONTRUZANT will be commercialized by MSD, which is known as Merck in the United States and Canada.

"Breast cancer remains the most common form of cancer affecting women. We hope ONTRUZANT will play an important role expanding patient access to trastuzumab across the region," said Christopher Hansung Ko, President & CEO of Samsung Bioepis. "Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry’s strongest biosimilar pipelines, so that more cancer patients and healthcare systems across Europe will benefit from biosimilars."

ONTRUZANT is the fourth biosimilar developed by Samsung Bioepis to receive EC marketing authorization. Samsung Bioepis has also received marketing authorizations for Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab).

PVS-RIPO, more commonly referred to as the re-engineered poliovirus, is the Sabin type 1 polio vaccine, genetically modified so it cannot harm or kill normal cells (Company Web Page, Istari Oncology, NOV 19, 2017, View Source [SID1234522139]).
We believe there are several important advantages of PVS-RIPO as an immunotherapy for cancer treatment:
The poliovirus receptor CD155 is expressed in virtually all solid cancers, as well as dendritic cells, macrophages and other immune cells.
PVS-RIPO infects and kills tumor cells that express CD155.
PVS-RIPO infection of immune cells facilitates induction of an antitumor immune response.
PVS-RIPO is the only oncolytic virus that is not destroyed by the Type 1 interferon response caused by these viruses.
Other oncolytic viruses kill or limit dendritic cells. PVS-RIPO stimulates dendritic cell activity and immune function.
Cancer patients who are immune to polio and have been boosted with the Salk vaccine experience a recall immune response upon intratumoral PVS-RIPO infusion.
For targeting glioblastoma, the vaccine is delivered by direct intratumoral delivery via convection-enhanced delivery (CED), which by-passes the blood-brain barrier and reduces systemic toxicity. CED is commonly used, and we believe it is reproducible in multiple centers. Less than 5% of the tumor volume needs to be injected to achieve high drug concentrations throughout the tumor. BrainLAB and Therataxis software allow highly accurate and reproducible drug distribution and injection accuracy.
The FDA granted PVS-RIPO Breakthrough Therapy Designation on May 10, 2016. Breakthrough Therapy Designation conveys all fast track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior FDA managers, and eligibility for rolling review and priority review.
The FDA also granted PVS-RIPO Orphan Drug designation for glioblastoma on May 26, 2016. Benefits of this designation include tax credits of 50% of the clinical drug testing cost awarded upon approval, waiver of NDA/BLA application fee, and seven years of data exclusivity upon approval (that is, it bars the FDA from approving any other application for the same drug for the same orphan disease or condition for seven years).

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