On March 12, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that data from the Phase 2 multicenter trial evaluating ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis (RMS) has been selected for presentation at the upcoming American Academy of Neurology (AAN) annual meeting, to be held May 4 – 10, 2019 in Philadelphia, Pennsylvania (Press release, TG Therapeutics, MAR 12, 2019, View Source [SID1234534250]). Final data from the core Phase 2 trial has been previously presented, most recently at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual meeting in Dallas, TX. In addition to highlighting the final Phase 2 data, the AAN presentation plans to include data from the open label extension (OLE), a trial made available to any patient who completed the core Phase 2 trial allowing them to continue treatment with ublituximab.

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The abstract is available online and can be accessed via the below link or on the AAN meeting website at www.aan.com.

Presentation Details:

Title:Open Label Extension (OLE) of Phase 2 Multicenter Study of Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb) in Patients with Relapsing Forms of Multiple Sclerosis (RMS)
— Presentation Date & Time:Tuesday May 7, 2019, 5:30 PM – 6:30 PM ET
— Session Title: Poster Session P3: MS Clinical Trials and Therapeutic Research
— Presenter:Edward Fox, MD, PhD, Central Texas Neurology Consultants, Round Rock, TX
— Location:Pennsylvania Convention Center
— Abstract Number: 2055
These data support the ongoing, fully enrolled, international Phase 3 program evaluating ublituximab for the treatment of RMS. The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, are being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and are being led by Lawrence Steinman, MD, of Stanford University.

On March 12, 2019 Bio-Path Holdings, Inc., (Nasdaq: BPTH) (Bio-Path), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it has entered into definitive agreements with several healthcare focused institutional investors for the issuance and sale in a registered direct offering of 712,910 shares of its common stock, at a purchase price of $25.95 per share, for aggregate gross proceeds of approximately $18.5 million (Press release, Bio-Path Holdings, MAR 12, 2019, View Source [SID1234534269]). The offering is expected to close on or about March 14, 2019, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Bio-Path currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

The shares of common stock described above are being offered and sold by Bio-Path pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-215205), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (SEC) on January 9, 2017. The offering of the shares of common stock will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On March 12, 2019 Dong-A ST Co., Ltd. (170900: Korea SE), the Korean pharmaceutical company, and Beactica AB, the Swedish drug discovery company, reported an expansion of their research and licensing agreement (Press release, Dong-A ST, MAR 12, 2019, View Source [SID1234535724]). The collaboration – which was initiated in October 2016 – is now expanded with an aim to jointly identify and develop novel small molecules targeting a protein–protein interaction of therapeutic relevance for immuno-oncology. The partnership further builds on Beactica’s unique early-stage lead generation capabilities and Dong-A ST’s strengths in the pharmacological proof of novel target concepts as well as downstream pre-clinical and clinical development of new therapeutic agents.

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Under the terms of the additional agreement, Dong-A ST will gain exclusive global rights for the further development and commercialization of compounds discovered. In return, Beactica is eligible to receive research funding as well as milestone payments for certain research, preclinical, clinical and regulatory achievements as well as royalties on commercial sales of the products resulting from the partnership. Beactica is also entitled to a revenue share from any related future licensing activities by Dong-A ST. Full financial details remain undisclosed.

"The collaboration between Dong-A ST and Beactica brings together our complementary strengths and establishes a powerful platform for the discovery and development of next generation anti-cancer therapeutics" said Mr Daesik Eom, Chairman and CEO of Dong-A ST. "Beactica’s capabilities and expertise accelerates the advancement of Dong-A ST’s oncology pipeline and will enhance Dong-A ST’s global competitiveness in the pharmaceutical industry."

"Following recent success in our collaboration we are pleased with Dong-A’s confidence and trust to expand this partnership into new target areas." said Dr Per Källblad, CEO of Beactica. "As a long-term strategic partner we are proud to have delivered valuable contributions to Dong-A’s research and look forward to a continued successful collaboration."

On March 12, 2019 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Guardant Health, MAR 12, 2019, View Source [SID1234534251]).

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Recent Highlights

Revenue of $32.9 million for the fourth quarter and $90.6 million for the full year of 2018, representing 64% and 82% increases, respectively, over the corresponding periods of 2017

NILE study, a head-to-head comparison of the Guardant360 assay to standard-of-care tissue testing met its primary endpoint, detecting a similar number of targetable biomarkers in NSCLC patients, which supports utilization of Guardant360 testing ahead of tissue testing

Launched the LUNAR assay to academic and biopharmaceutical researchers to support investigation of clinical applications, including for residual disease/recurrence monitoring and early detection

Announced an agreement with AstraZeneca to support the development of the Guardant360 and GuardantOMNI assays for use as companion diagnostics for Tagrisso and Imfinzi, respectively
"During 2018, we made important headway on key initiatives and are continuing to see strong adoption of our liquid biopsy platform, which has driven increased revenue of more than 80 percent over the prior year," said Helmy Eltoukhy, PhD, Chief Executive Officer. "We believe the recent NILE readout is an important catalyst supporting a blood-first paradigm for first-line use of Guardant360 testing for treatment selection ahead of tissue testing, offering lung cancer patients improved care with a faster time to treatment."

"In addition, we are encouraged by the progress we are making with our LUNAR program and look forward to presenting pilot LUNAR data at the AACR (Free AACR Whitepaper) conference next month. As a result of these developments, we are ramping up investment to accelerate our research and development efforts toward earlier cancer detection," continued Dr. Eltoukhy.

On March 12, 2019 bluebird bio, Inc. presented an Investor presentation (Press release, bluebird bio, MAR 12, 2019, View Source [SID1234534273]).

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