On May 16, 2018 BioLineRx Ltd. (NASDAQ: BLRX)(TASE: BLRX)(BLRX) , a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that the European Patent Office (EPO) has issued a Decision to Grant a patent claiming the use of BL-8040 with cytarabine, a chemotherapeutic agent, for the treatment of acute myeloid leukemia (AML) (Press release, BioLineRx, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349350 [SID1234526683]).

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This patent will be valid through March 2034, with the option of up to five years’ patent term extension. Member patents were also granted in Japan and Hong Kong. Additional corresponding patent applications are pending in China (a Notice of Acceptance was received), Israel (a Notice of Acceptance was received), the United States, India, Korea, Mexico, Brazil, Canada and Australia.

"The long-term patent exclusivity we have received from the European Patent Office for BL-8040 in combination with cytarabine provides us with significant additional patent protection in AML, one of BL-8040’s key indications," said Philip A. Serlin, Chief Executive Officer of BioLineRx. "In this regard, we are moving forward in full force with two ongoing trials in the AML space – a Phase 2b in consolidation AML and a Phase 1b/2 in maintenance AML, in addition to the continued follow-up on encouraging overall survival results shown in our recently completed relapsed/refractory AML study."

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 May 16, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that seven abstracts highlighting progress in the Rubraca preclinical research and clinical development program will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5 in Chicago (Press release, Clovis Oncology, MAY 16, 2018, View Source [SID1234526702]).

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The accepted abstracts include additional data from the phase 3 ARIEL3 clinical trial, as well as summaries of ongoing preclinical research and multiple clinical trials in which Rubraca is being studied as monotherapy and in combination in cancer types including ovarian, bladder, prostate and breast cancers.

"Rubraca has demonstrated its ability to reduce the risk of disease progression following platinum-based chemotherapy for women with advanced ovarian cancer, and our team is dedicated to fully exploring the potential of this molecule as a new treatment option for patients being treated for other cancer types where PARP inhibitors have shown encouraging results," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to sharing updates on the progress of our clinical development program at ASCO (Free ASCO Whitepaper) 2018."

The four Clovis Oncology-sponsored abstracts accepted for presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting comprise:

Abstract TPS4592 (Poster 415a) – ATLAS: A phase 2, open-label study of rucaparib in patients (pts) with locally advanced or metastatic urothelial carcinoma (mUC).

Presenter: Petros Grivas, MD, PhD, University of Washington
Session: Genitourinary (Nonprostate) Cancer
Date/Time: Saturday, June 2, 8:00 -11:30 a.m. CT
Location: Hall A
Abstract 5537 (Poster 264) – Evaluation of rucaparib in platinum-sensitive recurrent ovarian carcinoma (rOC) in patients (pts) with or without residual bulky disease at baseline in the ARIEL3 study.

Presenter: Carol Aghajanian, MD, Memorial Sloan Kettering Cancer Center
Session: Gynecologic Cancer
Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
Location: Hall A
Abstract 5545 (Poster 272) – Exploratory analysis of percentage of genomic loss of heterozygosity (LOH) in patients with platinum-sensitive recurrent ovarian carcinoma (rOC) in ARIEL3.

Presenter: Ana Oaknin, MD, PhD, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO)
Session: Gynecologic Cancer
Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
Location: Hall A
Abstract 5582 (Poster 309) – Efficacy and immune modulation of the tumor microenvironment with the combination of the PARP inhibitor rucaparib and CD122-biased agonist NKTR-214.

Presenter: Andrew Simmons, PhD, Clovis Oncology
Session: Gynecologic Cancer
Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
Location: Hall A
Additionally, three additional collaborator and investigator sponsored abstracts investigating Rubraca in metastatic breast and prostate cancers are also being presented:

Abstract TPS1112 (Poster 187a) – An open-label, phase II study of rucaparib, a PARP inhibitor, in HER2- metastatic breast cancer patients with high genomic loss of heterozygosity.

Presenter: Anne Patsouris, Institute of West Cancerology Paul Papin
Session: Breast Cancer – Metastatic
Date/Time: Saturday, June 2, 8:00-11:30 a.m. CT
Location: Hall A
Abstract TPS5095 (Poster 317b) – Phase II trial of rucaparib (without ADT) in patients with metastatic hormone-sensitive prostate cancer harboring germline DNA repair gene mutations (TRIUMPH).

Presenter: Mark Christopher Markowski, MD, PhD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Session: Genitourinary (Prostate) Cancer
Date/Time: Saturday, June 2, 1:15-4:45 p.m. CT
Location: Hall A
Abstract TPS3126 (Poster 327b) – An open-label, phase 2 study of nivolumab in combination with either rucaparib, docetaxel, or enzalutamide in men with castration-resistant metastatic prostate cancer (mCRPC; CheckMate 9KD).

Presenter: Karim Fizazi, MD, PhD, Gustave Roussy
Session: Developmental Therapeutics—Immunotherapy
Date/Time: Monday, June 4, 8:00-11:30 a.m. CT
Location: Hall A
Clovis Oncology’s Rubraca posters will be available online at View Source as of the time they are presented at the meeting.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Rubraca is an unlicensed medical product outside of the U.S.

On May 16, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported that the Company will present on the design of its Phase 1 clinical trial of SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5, 2018 in Chicago (Press release, Syros Pharmaceuticals, MAY 16, 2018, View Source [SID1234526718]).

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The Phase 1 trial is currently enrolling advanced solid tumor patients in the dose-escalation portion of the trial, with planned expansion cohorts to further evaluate SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations. Syros expects to open the expansion phase of the trial in mid-2018 and to report data from the dose-escalation portion of the trial in the fourth quarter of 2018.

Details on the presentations are as follows:

Date & Time: Monday, June 4, 8:00 a.m. – 11:30 a.m. CDT
Presentation Title: Trial Design of a First-in-Human Phase 1 Evaluation of SY-1365, a First-in-
Class Selective CDK7 Inhibitor, with Initial Expansions in Ovarian and Breast Cancers
Session Title: Developmental Therapeutics—Clinical Pharmacology and Experimental
Therapeutics
Presenter: Geoffrey Shapiro, M.D., Ph.D., Dana-Farber Cancer Institute
Abstract Number: TPS2600
Location: McCormick Place, Hall A

On May 16, 2018 Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, reported that Chairman and CEO Brent Saunders will present at the Bernstein 34th Annual Strategic Decisions Conference in New York, NY (Press release, Allergan, MAY 16, 2018, View Source(1) [SID1234526735]). The presentation will begin at 10:00 a.m. Eastern Time on Wednesday, May 30, 2018.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source;. The webcast can also be accessed through the following URL: https://cc.talkpoint.com/bern0…

An archived version will be available within approximately 3 hours of the live presentation, and can be accessed at the same location for 180 days

On May 16, 2018 NanOlogy LLC, a clinical-stage pharmaceutical development company, reported it will present data from preclinical studies of inhaled NanoPac (submicron particle paclitaxel) showing prolonged retention of drug in lung tissue and significant tumor regression without adverse drug-related observations in an orthotopic animal model of non-small cell lung cancer (NSCLC) (Press release, NanOlogy, MAY 16, 2018, View Source [SID1234526907]).

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The data will be presented in an abstract entitled "NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model" during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Sunday, June 3rd, from 8:00 AM to 11:30 AM in Hall A of McCormick Place in Chicago.

An initial preclinical pharmacokinetic (PK) study examined the retention of NanoPac in rat lung tissue following a single inhalation via a nose-only exposure chamber. Data showed measurable amounts of drug in the lung at the end of the 14-day study with examined tissue being microscopically indistinguishable from normal lung tissue.

A preclinical study followed to examine the therapeutic effect of inhaled NanoPac using an orthotopic model of NSCLC. Histologic analysis revealed NanoPac achieved a significant decrease in primitive tumor cell population as well as significant tumor regression.

Gere diZerega, MD, VP of Medical Affairs, said, "In our initial PK study, inhaled NanoPac resulted in longer lung retention of drug at a higher concentration compared to systemically administered paclitaxel. The evidence seen in our preclinical PK and efficacy studies has given us the confidence to move forward with IND-enabling studies in preparation for clinical trials."

Lung cancer is by far the leading cause of cancer death according to the American Cancer Society with more than 154,000 deaths expected this year. More people die of lung cancer every year than breast, prostate, and colon cancers combined.

The preclinical lung cancer studies are in addition to an extensive clinical development program underway by NanOlogy. Local administration of NanoPac is also being evaluated in Phase 2 clinical trials for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. A clinical trial of NanoDoce (submicron particle docetaxel sterile suspension) is planned to begin in September for bladder cancer.

NanOlogy is also progressing a clinical trial of a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides NME-like advantages without the risk and timeline associated with new molecular entity drug development.