Onconova Therapeutics Announces Presentations at the 15th International Symposium on Myelodysplastic Syndromes (MDS 2019) in Copenhagen, Denmark

On May 6, 2019 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported that five posters related to the Company’s lead product candidate, rigosertib, were accepted for presentation at the 15th International Symposium on Myelodysplastic Syndromes taking place May 8-11, 2019 at the Tivoli Hotel & Congress Center in Copenhagen, Denmark (Press release, Onconova, MAY 6, 2019, View Source [SID1234535757]).

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Dr. Ric Woodman, CMO of Onconova, will be attending the Symposium and available to meet with interested parties.

DETAILS OF THE POSTERS:

1) PHASE II STUDY OF ORAL RIGOSERTIB COMBINED WITH AZACITIDINE IN PATIENTS WITH HIGHER-RISK MYELODYSPLASTIC SYNDROMES (MDS)
Abstract: MDS19-0216
May 8 – May 11, Room Vandsalen
Presenter: Lewis R. Silverman, MD
Tisch Cancer Institute, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY

2) RIGOSERTIB /AZACITIDINE MODULATES INNATE IMMUNE SIGNALING AND HEMATOPOIETIC GENE PATHWAYS WHEN SEQUENCED IN VITRO, IN THE MYELODYSPLASTIC SYNDROME (MDS)
Abstract: MDS19-0201
May 8 – May 11, Room Vandsalen
Presenter: Lewis R. Silverman, MD
Tisch Cancer Institute, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY

3) EMERGENCE OF PTPN11 MUTATIONS IS ASSOCIATED WITH CLINICAL RESISTANCE TO RIGOSERTIB AND AZACITIDINE IN PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
Abstract: MDS19-0195
May 8 – May 11, Room Vandsalen
Presenter: Lewis R. Silverman, MD
Tisch Cancer Institute, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY

4) UTILITY OF ADAPTIVE TRIAL DESIGN IN HIGHER-RISK MYELODYSPLASTIC (HR-MDS) SYNDROMES IN A PHASE 3 TRIAL OF INTRAVENOUS RIGOSERTIB: INSPIRE TRIAL
Abstract: MDS19-0211
May 8 – May 11, Room Vandsalen
Presenter: Aref Al-Kali, MD
Mayo Clinic, Hematology, Rochester, MN

5) EX VIVO RESPONSE PROFILING OF RIGOSERTIB IDENTIFIES DISTINCT CLASSES OF RESPONDERS IN ELODYSPLASTIC SYNDROME
Abstract: MDS19-0200
Presenter: Marianne Santaguida, PhD, Director of Scientific Partnerships
Notable Labs, Foster City, CA

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress to the development of acute leukemia.

QIAGEN Reports Results for First Quarter of 2019 and Announces Plans for New $100 Million Share Repurchase Program

On May 6, 2019 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results of operations for the first quarter of 2019, meeting its outlook for net sales growth at constant exchange rates, or CER, and exceeding the outlook for adjusted earnings per share at CER while driving global expansion of its Sample to Insight portfolio of molecular testing solutions (Press release, Qiagen, MAY 6, 2019, View Source [SID1234535775]).

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"Our performance for the first quarter of 2019 was in line with our outlook for solid sales growth and continued improvements in profitability. QIAGEN is reaffirming the full-year outlook set for this year," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "We have made significant progress in 2019 on advancing our portfolio of differentiated Sample to Insight solutions and are looking forward to delivering on its value."

"We are well positioned to achieve our goals for full-year sales growth, and to deliver faster growth particularly in the second half of 2019 given the success of our growth initiatives as well as the soon anticipated U.S. approval of the QIAstat-Dx system for multiplex syndromic testing. Our QuantiFERON latent TB test grew in line with the 2019 sales target range in the first quarter of 2019, and we announced additional automation options for this important contributor in the global fight against tuberculosis. We also expanded our portfolio of solutions for next-generation sequencing, which remains on track to achieve $190 million of sales in 2019 compared to $140 million in 2018, with the launch of new liquid biopsy and gene panels integrated with QIAGEN bioinformatics solutions. The launch of two new fully integrated molecular testing solutions – QIAstat-Dx and NeuMoDx for integrated molecular laboratory testing – are progressing well in Europe, are receiving a very positive acceptance and we are ready to capture share gains and growth opportunities in their very large target markets. Our teams are developing a broad range of tests to further expand the utility of these novel systems. In Precision Medicine, we are pleased by the breakthrough U.S. regulatory approval for a new therascreen companion diagnostic that tests for variants of the biomarker FGFR to help guide treatment decisions for patients with urothelial cancer. We are moving ahead with the transformation of QIAGEN and are continuing to execute on a strategy to maximize the value of this differentiated portfolio of molecular testing solutions along the continuum from Life Sciences research to Molecular Diagnostics."

Unum Therapeutics to Host First Quarter 2019 Financial Results Conference Call and Webcast on May 13, 2019 at 8:00 A.M. ET

On May 6, 2019 Unum Therapeutics Inc. (Nasdaq: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies to treat cancer using its novel T cell technology platforms, reported that the company will host a conference call and live audio webcast on Monday, May 13, 2019 at 8:00 a.m. ET to discuss financial results for the first quarter of 2019 (Press release, Unum Therapeutics, MAY 6, 2019, View Sourcenews-releases/news-release-details/unum-therapeutics-host-first-quarter-2019-financial-results" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-host-first-quarter-2019-financial-results" rel="nofollow">View Source [SID1234535734]). Unum management will also provide an update on the Company’s recent progress and upcoming milestones.

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Participants may access the conference call by dialing 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 1443149. To join the live webcast, please visit the investor relations section of the Unum Therapeutics website at View Source at least 10 minutes before the event begins.

A webcast replay will be available at the same location on the Unum Therapeutics website beginning approximately two hours after the event and will be archived for 90 days.

Onxeo Announces Treatment of First Patient in DRIIV-1b, a Phase 1b Clinical Trial of AsiDNA™ in Combination with Chemotherapy

On May 6, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported a new milestone in the clinical development of AsiDNA with the treatment of the first patient in DRIIV-1b, a phase 1b clinical study of AsiDNA, a first-in-class tumor DNA repair inhibitor, in combination with carboplatin and with carboplatin plus paclitaxel, in patients with solid tumors eligible to such treatments (Press release, Onxeo, MAY 6, 2019, View Source [SID1234535758]).

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DRIIV-1b is an extension of the DRIIV-1 (DNA Repair Inhibitor administered IntraVenously) phase 1 study currently being completed, in which AsiDNA, administered intravenously (IV) demonstrated its intratumoral activity by inducing a significant increase in its activity biomarkers in the tumor cells of patients, with a favorable safety profile at various active doses.

At the active dose of 600 mg, among the three patients included in the cohort, two patients with relapsed, multi-treated metastatic colorectal cancer were controlled with medical imaging, which showed no further disease progression after the second treatment cycle, and continued their treatment with AsiDNA for three months. The 600 mg active dose was considered to be optimal for further development of AsiDNA in combination with chemotherapy.

DRIIV-1b aims at showing the safety and efficacy of a 600 mg dose of AsiDNA in combination with carboplatin, and carboplatin plus paclitaxel, in up to 18 patients with solid tumors eligible for such treatments (lung, breast, ovarian or head and neck cancers, …). The efficacy of the combinations will be evaluated every six to eight weeks by medical imaging in accordance with RECIST criteria (Response evaluation criteria in solid tumors). The study will take place in Belgium, and initial results are expected in the second half of 2019.

Dr Nuria Kotecki of the Institute Jules Bordet in Brussels commented: "The «DDR» (DNA Damage Response) approach represents a particularly interesting alternative in cancer treatment. Indeed, combining AsiDNA, a tumor DNA repair inhibitor, with agents such as carboplatin, that causes breaks in that same DNA, is a very promising approach in terms of synergistic efficacy. On the basis of the safety profile of AsiDNA observed in monotherapy, this combination can be considered as we are looking for greater efficacy without aggravating the toxicity observed with chemotherapy. We are thrilled to start this DRIIV-1b study, which should enable us to confirm the preclinical and clinical results already obtained."

This first combination trial represents a major milestone in the clinical development of AsiDNA. Thanks to its highly differentiated mechanism of action, confirmed by exhaustive preclinical studies, the combination of AsiDNA with various anti-cancer treatments appears especially relevant to increase their efficacy and avoid the occurrence of resistance from tumors.

DRIIV-1b is the first combination study of AsiDNA by IV administration, aimed at confirming such synergistic efficacy on tumors for which the medical needs remain immense. Positive results from this study will represent a proof of the interest of AsiDNA combined with chemotherapy and will open the door to further clinical development of AsiDNA IV in a phase 2 program in one or several indications.

Olivier de Beaumont, Onxeo’s Chief Medical Officer, concluded: "This study marks the start of the clinical development of AsiDNA in combination with chemotherapy. The results, expected by the end of the year, will enable us to confirm the potential of our flagship product in indications with strong medical needs. Other combination studies are also being prepared to further support the growing interest in AsiDNA and its broad clinical potential. We are very pleased to be continuing our collaboration with Dr Nuria Kotecki, a clinical investigator already involved in the DRIIV-1 study, and we thank her for her help and support in this promising research program."

Gilead Sciences to Present at the Bank of America Merrill Lynch 2019 Health Care Conference on Tuesday, May 14

On May 6, 2019 Gilead Sciences, Inc. (Nasdaq: GILD) reported that Robin L. Washington, Gilead’s Executive Vice President and Chief Financial Officer, and John McHutchison, AO, MD, Gilead’s Chief Scientific Officer and Head of Research & Development, will participate in a fireside chat at the Bank of America Merrill Lynch 2019 Health Care Conference in Las Vegas on Tuesday, May 14 at 10:00 a.m. Pacific Time (Press release, Gilead Sciences, MAY 6, 2019, View Source [SID1234535838]).

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The audio portion of the fireside chat will be accessible live through the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the presentation to ensure adequate time for any software download that may be required to listen to the webcast. The replay will be available for 14 days following the presentation.