Illumina to Announce First Quarter 2018 Financial Results on Tuesday, April 24, 2018

On April 10, 2018 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for first quarter 2018 following the close of market on Tuesday, April 24, 2018 (Press release, Illumina, APR 10, 2018, View Source [SID1234525252]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time), Francis deSouza, President and Chief Executive Officer, and Sam Samad, Senior Vice President and Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, April 24, 2018. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 800-708-4539, or 1-847-619-6396 outside North America, both with passcode 46755682.

A replay of the conference call will be available from 4:30 pm Pacific Time (7:30 pm Eastern Time) on April 24, 2018 through May 1, 2018 by dialing 888-843-7419, or 1-630-652-3042 outside North America, both with passcode 46755682.

Asana BioSciences Announces Presentations of ASN003 (BRAF/PI3K inhibitor) and ASN007 (ERK1/2 inhibitor) at the American Association for Cancer Research Annual Meeting

On April 10, 2018 Asana BioSciences, LLC, an oncology focused, clinical stage biopharmaceutical company, reported that it will present updates for two of its lead molecules in clinical development at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held in Chicago, IL, April 14-18, 2018 (Press release, Asana BioSciences, APR 10, 2018, View Source [SID1234525253]).

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The presentation details are as follows:

1. ASN003, a novel highly selective BRAF and PI3K dual inhibitor: Phase I PK/PD results in patients with advanced solid tumors.

Authors: D. Rasco1, N. Lakhani2, R. Sullivan3, M. Mita4, J. Shah5, H. Usansky5, S. Reddy5, N. S. Rao5, L. Denis5, K. Flaherty3, Anthony Tolcher6. 1START Med. Oncology, San Antonio, TX; 2START Med. Oncology, Grand Rapids, MI; 3MGH, Boston, MA; 4Cedars Sinai Med. Oncology, Los Angeles, CA; 5Asana BioSciences, Lawrenceville, NJ, 6NEXT Oncology, San Antonio, TX.
Session: PO.CT01 – Phase I Clinical Trials 1; Section 42
Abstract: #CT019 / 12
Date/Time: Sunday, April 15 at 1:00pm – 5:00pm

2. Strong antitumor activity of ASN007, an oral ERK1/2 inhibitor, in PDX tumor models with MAP kinase pathway alterations including KRAS mutations.

Authors: Sanjeeva P. Reddy, Niranjan S. Rao, Roger A. Smith, Scott K. Thompson, Sarper
Toker. Asana BioSciences, Lawrenceville, NJ.
Session: PO.ET06.10 – Canonical Targets 2; Section 36
Abstract: #5783 / 9
Date/Time: Wednesday, April 18 at 8:00am – 12:00pm

ASN003 is a potent and highly selective inhibitor of both B-RAF and PI3 kinases. RAS-RAF-MEK and PI3K-AKT-mTOR are two major pathways involved in tumor cell signaling and growth. Components of these pathways are frequently mutated in a broad range of tumors. Selective BRAF inhibitors induce dimerization of RAF proteins, leading to paradoxical activation of the RAF-MEK-ERK cascade. This activation is a major limitation for the clinical use of selective RAF inhibitors, as it leads to resistance and results in side effects in the skin limiting their use in patients with BRAF mutant tumors. In addition, elevated signaling through the PI3K/AKT pathway, with or without concomitant MAPK reactivation, represents an alternative path to resistance to BRAF inhibitors. ASN003 demonstrates broad anti-proliferative activity in tumor cell lines and strong tumor growth inhibition in tumor xenograft models, including BRAF inhibitor resistant models. ASN003 is currently in Phase I clinical development in patients with advanced solid tumors, including melanoma, colorectal cancer and non-small cell lung cancer (clinicaltrials.gov NCT02961283). ASN003 is well tolerated and shows the potential to be developed as a monotherapy or in combination with checkpoint inhibitors or other standard of care.

ASN007 is a potent inhibitor of the extracellular-signal-regulated kinases, ERK1 and ERK2 (ERK1/2), key players in the RAS/RAF/MEK (MAPK) signaling pathway. This pathway is frequently hyper-activated in a wide range of cancers through mutations in upstream targets such as BRAF and RAS proteins. Inhibition of ERK1/2 offers a promising therapeutic strategy for such cancers. ASN007 shows potent and selective anti-proliferative activity in cancer cell lines that are driven by the MAPK-pathway, including RAS mutant cell lines. Furthermore, ASN007 demonstrates strong inhibition of tumor growth in multiple BRAF and KRAS mutant patient-derived and cell-line-derived xenograft models, including those that are resistant to BRAF and MEK inhibitors. ASN007 is currently in Phase I clinical development in patients with advanced solid tumors, including melanoma, colorectal cancer, non-small cell lung cancer and pancreatic cancer (clinicaltrials.gov NCT03415126).

TARIS® Announces Late-Breaking Poster Presentation at American Association of Cancer Research Annual Meeting

On April 9, 2018 -TARIS reported that it will present a late-breaking poster related to TAR-200 (GemRIS), the company’s lead clinical program in bladder cancer, at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 14-18, 2018 in Chicago (Press release, TARIS Biomedical, APR 9, 2018, View Source [SID1234525235]).

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Poster presentation details are as follows:

Poster Title: Significant cytotoxic and immumomodulatory effects of continuous low dose intravesical gemcitabine in rodent bladder tumor models
Poster Number:

LB-122
Session Title:

LBPO.IM01 – Late-Breaking Research: Immunology 1
Session Date:

April 16, 2018, 8:00 AM – 12:00 PM, Poster Section 45, Board #19

About Muscle Invasive Bladder Cancer

Bladder cancer is the fifth most common neoplasm in industrialized countries, affecting roughly 2.7 million people worldwide. In the United States, there were an estimated 79,000 new cases and nearly 17,000 deaths in 2017; Muscle Invasive Bladder Cancer (MIBC) accounts for 20-25% of the newly diagnosed cases and the majority of disease-related mortality.

While some potentially curative treatments, including surgical organ removal and chemoradiation, are available, 40% or more of patients with MIBC are unfit to undergo these morbid procedures, or opt to not receive them.i Available treatment options for these patients are limited to palliative care.

About TAR-200 (GemRIS)

TAR-200 is TARIS’s lead investigational program in bladder cancer, and is designed to release the chemotherapeutic agent gemcitabine continuously in the bladder for multiple weeks.

CEL-SCI Corporation to Present at The MicroCap Conference

On April 9, 2018 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy biopharmaceutical company, reported that Geert Kersten, Chief Executive Officer, will present a corporate overview at The MicroCap Conference on Tuesday, April 10th at 10 a.m. Eastern time (Press release, Cel-Sci, APR 9, 2018, View Source [SID1234525236]). The conference will be held April 9-10, 2018 at the Essex House in New York City.

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CEL-SCI Corporation to present at The MicroCap Conference

About The MicroCap Conference

The MicroCap Conference is an exclusive event dedicated to connecting high-performing small and microcap companies with committed investors. It is an opportunity to be introduced to and speak with management at some of the most attractive companies, learn from various expert panels, and network with other small and microcap investors.

FDA Accepts New Drug Application for Duvelisib and Grants Priority Review

On April 9, 2018 Verastem, Inc. (NASDAQ:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for its lead product candidate duvelisib (Press release, Verastem, APR 9, 2018, View Source [SID1234529549]). Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for which Verastem is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). The FDA target action date is October 5, 2018.

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"Obtaining Priority Review in the U.S. for duvelisib marks another important milestone for Verastem and speaks to the unmet need in relapsed/refractory CLL/SLL and FL and the urgency to identify effective therapies to treat these patients," said Robert Forrester, President and Chief Executive Officer of Verastem. "As an orally administered therapy, we believe duvelisib will provide an important treatment option for patients with CLL/SLL and FL, and for the physicians who treat them. We look forward to working with the FDA during the review process. We are continuing our commercial preparations for duvelisib to execute the launch promptly in the U.S. if approved. In parallel, we are exploring ex-U.S. partnering opportunities for duvelisib and plan to file a European Marketing Application towards the end of the year."

Priority Review is granted by the FDA to drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. Duvelisib has received Fast Track Designation from the FDA for patients with CLL who have received at least one prior therapy and for patients with FL who have received at least two prior therapies. In addition, duvelisib received orphan drug designation in the United States and the European Union for patients with CLL, SLL and FL.

About Duvelisib

Duvelisib is a first-in-class investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints and the FDA is reviewing a New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL). Duvelisib is also being developed by Verastem for the treatment of peripheral T-cell lymphoma (PTCL), which has Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.