On November 1, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that it plans to issue its third quarter 2018 financial results before the open of the U.S. financial markets on Thursday, November 08, 2018 (Press release, Selecta Biosciences, NOV 1, 2018, View Source [SID1234530528]). The management team also plans to provide an update on the development strategy for SEL-212, the company’s lead product candidate for the treatment of chronic severe gout, including plans to conduct a head-to-head clinical trial of SEL-212 compared to the current FDA-approved uricase therapy, Krystexxa.

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At 8.30 a.m. ET that day, Selecta Biosciences will host a conference call via live webcast to discuss these results and provide a corporate update. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10124090.

On November 1, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported it will release its unaudited financial results for the quarter ended September 30, 2018 on Thursday, November 8, 2018, before the US markets open (Press release, BioLineRx, NOV 1, 2018, View Source;p=irol-newsArticle&ID=2374740 [SID1234530544]).

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The Company will host a conference call on Thursday, November 8, 2018 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until November 10, 2018; please dial +1-888-326-9310 from the U.S. or +972-3-925-5925 internationally.

On November 1, 2018 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it will present data from three accepted abstracts related to MEI Pharma’s clinical stage drug development programs at the 2018 ASH (Free ASH Whitepaper) Annual Meeting to be held December 1-4, 2018 in San Diego (Press release, MEI Pharma, NOV 1, 2018, View Source [SID1234530572]).

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Study investigators will present updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma and other indolent B-cell malignancies, as well as results from a preclinical study demonstrating that voruciclib and venetoclax synergistically induce apoptosis in acute myeloid leukemia (AML) cells in vitro. The third abstract will present data from the pracinostat program, being developed in partnership with Helsinn Healthcare, SA, and will highlight an interim analysis of pracinostat in an ongoing Phase 2 study evaluating patients with high/very high-risk myelodysplastic syndrome (MDS).

"Data reported at the ASH (Free ASH Whitepaper) Annual Meeting this year continue to highlight the depth of our clinical pipeline and the progress across multiple programs, each with its own distinct mechanisms for targeting cancer biology," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Notably, the ME-401 data to be reported is supportive of our approach to evaluate both a continuous and intermittent dosing schedule in our Phase 2 study planned to start around year-end in an effort to maximize the utility of the candidate as both a single agent or in combination with other therapies."

Dr. Gold continued: "We also look forward to highlighting the preclinical data demonstrating that our CDK9 inhibitor candidate, voruciclib, synergistically enhances cancer cell death when combined with venetoclax in AML cells in vitro, adding to earlier data showing similar synergies in CLL and DLBCL preclinical models. These results are supportive of possible future studies evaluating voruciclib in combination with venetoclax in relapsed AML."

Poster Presentations at ASH (Free ASH Whitepaper) 2018

Title: Preliminary Safety and Efficacy Results with an Intermittent Schedule of the PI3K delta Inhibitor ME-401 Alone or in Combination with Rituximab for B-Cell Malignancies
Date & Time: December 2, 2018, 6:00 p.m. – 8:00 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 115670
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
Author: Andrew D. Zelenetz, M.D., Ph.D., Medical Director, Quality Informatics at Memorial Sloan Kettering Cancer Center

Title: Voruciclib, an Oral, Selective CDK9 Inhibitor, Enhances Cell Death Induced by the Bcl-2 Selective Inhibitor Venetoclax in Acute Myeloid Leukemia
Date & Time: December 1, 2018, 6:15 p.m. – 8:15 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 118372
Session: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster I
Author: Daniel A. Luedtke, BS, Wayne State University School of Medicine, Cancer Biology Graduate Program

Title: Planned Interim Analysis of a Phase 2 Study Evaluating the Combination of Pracinostat, a Histone Deacetylase Inhibitor (HDACi), and Azacitidine in Patients with High/Very High-Risk Myelodysplastic Syndrome (MDS)
Date & Time: December 3, 2018, 6:00 p.m. – 8:00 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 112741
Session: 637. Myelodysplastic Syndromes—Clinical Studies: Poster III
Author: Michael Keng, M.D., University of Virginia School of Medicine, Assistant Professor

Abstracts featured as part of the ASH (Free ASH Whitepaper) 2018 program may be found at: View Source

On November 1, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported publication of an abstract on pelareorep to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition taking place December 1-4 in San Diego, California (Press release, Oncolytics Biotech, NOV 1, 2018, View Source [SID1234530637]).

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The abstract, authored by Craig C. Hofmeister, Acting Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine, et al., is titled "Oncolytics Virus Replication Using Pelareorep (Reolysin) and Carfilzomib in Relapsed Myeloma Patients Increases PD-L1 Expression with Clinical Responses".

Because immune checkpoint inhibitors can only be effective when tumors express checkpoints such as PD-L1, an industry-wide effort is underway to identify agents that can upregulate the checkpoints on checkpoint-naked tumor cells. The abstract outlines a two-part study that demonstrated an increase in viral infection, viral replication and PD-L1 expression on the surface of myeloma cells for patients undergoing treatment with pelareorep in combination with carfilzomib (Kyprolis), a proteasome inhibitor, while carfilzomib alone has not been shown to induce PD-L1 expression. In part one of the study, six carfilzomib-sensitive patients showed reovirus infection and replication in the post-treatment bone marrow aspirates. In part two of the study, seven carfilzomib-refractory patients were enrolled, and of the three patients processed to date, reovirus infection was detected in myeloma cells of two patients and endothelial cells of one patient.

"With two very good partial responses and two partial responses, the results demonstrate an objective response at the recommended dose, as well as increased viral infection and viral replication," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "Most notably, in these myeloma patients receiving a proteasome inhibitor, systemically delivered pelareorep led to increases in PD-L1 expression, making pelareorep an ideal candidate to use in combination with this drug class."

The complete abstract can be found online at View Source Full details from the poster presentation will be announced after it is presented.

Presentation Number: 2655
Title:
Oncolytics Virus Replication Using Pelareorep (Reolysin) and Carfilzomib in Relapsed Myeloma Patients Increases PD-L1 Expression with Clinical Responses
Date: Sunday, December 2
Lecture Time: 6:00 p.m. PT – 8:00 p.m. PT
Location: San Diego Convention Center, Hall GH
Speakers: Craig Hofmeister
Session:
605. Molecular Pharmacology, Drug Resistance—Lymphoid and Other Diseases: Poster II

About Pelareorep
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 and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On November 1, 2018 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported that new translational data for NiCord, an investigational cell therapy in Phase 3 clinical development for allogeneic stem cell, or bone marrow, transplant, will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting, which is being held December 1-4 in San Diego, CA (Press release, Gamida Cell, NOV 1, 2018, View Source [SID1234530653]).

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Details about the poster presentation are as follows:
Presentation Time: Saturday, December 1, 2014, 6:15 p.m. – 8:15 p.m. PT
Title: Rapid and Robust CD4+ and CD8+ T-, NK-, B- and Monocyte Cell Reconstitution after Nicotinamide-Expanded Cord Blood Transplantation
Abstract Number: 2123
Lead Author: Jaap Jan Boelens, M.D., Ph.D., Pediatric Blood and Marrow Transplantation Program, University Medical Center Utrecht, Utrecht, Netherlands
Location: San Diego Convention Center, Hall GH

About NiCord
NiCord, the company’s lead clinical program, is under development as a universal bone marrow transplant solution for patients with high-risk hematologic malignancies. NiCord has demonstrated improved efficacy over standard cord blood, including fewer bacterial and fungal infections and a reduction in duration of hospital stays. NiCord has been granted breakthrough status by the U.S. Food and Drug Administration, making it the first bone marrow transplant alternative to receive this designation. It has also received U.S. and EU orphan drug designation. A Phase 3 study evaluating NiCord in patients with leukemia and lymphoma is ongoing in the United States, Europe and Asia (NCT02730299). For more information on NiCord clinical trials, please visit www.clinicaltrials.gov.