Anixa Biosciences to Present Latest Prostate Cancer Data at the 2019 American Association for Cancer Research (AACR) Annual Meeting

On February 28, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it will present data in an oral minisymposium presentation from its study utilizing Anixa’s artificial intelligence (AI) driven early cancer detection technology (Press release, Anixa Biosciences, FEB 28, 2019, View Source [SID1234533867]). The presentation will be made at the 2019 annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Atlanta, Georgia. The meeting will be held March 29–April 3, 2019 and will be attended by world leading experts across the field of cancer research. All abstracts are currently available to view by registered attendees on the online itinerary planner.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oral Minisymposium Presentation:

Abstract Control Number: 598
Title: Using machine learning to predict the risk of either having an aggressive form of prostate cancer (PCa) or lower grade PCa/benign prostatic hyperplasia (BPH) based upon the flow cytometry immunophenotyping of myeloid-derived suppressor cells (MDSCs) and lymphocyte cell populations
Presenter: George A. Dominguez, PhD – Senior Clinical Research Scientist
Session Title: Biomarkers for Early Detection and Biologic Assessment of Cancer
Session Start: Sunday March 31, 2019 3:00 PM ET
Session End: Sunday March 31, 2019 5:00 PM ET

The presentation will focus on the continuing research progress of Anixa’s AI technology that combines the fields of flow cytometry with artificial intelligence featuring new data and insights into its application for early prostate cancer detection.

"We are pleased to be giving an oral presentation at this AACR (Free AACR Whitepaper) symposium focusing on early detection of cancer," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences.

American Association for Cancer Research (AACR) (Free AACR Whitepaper)
The American Association for Cancer Research (AACR) (Free AACR Whitepaper) (www.aacr.org) is a 501(c)(3) public charity headquartered in Philadelphia, PA. The mission of the AACR (Free AACR Whitepaper) is to prevent and cure cancer through research, education, communication and collaboration. Through its programs and services, the AACR (Free AACR Whitepaper) fosters cancer research and related biomedical science; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer causes, prevention, diagnosis and treatment throughout the world.

Synlogic to Present at Investor Conferences in March

On February 28, 2019 Synlogic(Nasdaq:SYBX) reported that Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer, will present at the following upcoming investor conferences (Press release, Synlogic, FEB 28, 2019, View Source [SID1234533866]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Chardan’s 1st Annual Microbiome Medicines Summit at 2:05pm ET on Thursday, March 7, 2019, in New York City.
Cowen and Company 39th Annual Health Care Conference at 11:20 am ET, on Monday, March 11, 2019, in Boston.
Live webcasts of the presentations can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. Archived copies of the webcasts will be available on the Synlogic website for approximately 30 days after the event.

Amgen Highlights Progress Of Innovative Early Oncology Pipeline With New Data At AACR 2019

on February 28, 2019 Amgen (NASDAQ:AMGN) reported that new data from its early-stage oncology pipeline will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, March 29 – April 3, 2019 (Press release, Amgen, FEB 28, 2019, View Source;p=RssLanding&cat=news&id=2389545 [SID1234533864]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"At Amgen, we are searching for and finding answers to incredibly complex questions to advance care and improve lives for cancer patients," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "In a significant milestone in the oncology community, we will share the latest preclinical data from our KRASG12C inhibitor, AMG 510. KRAS has eluded targeting despite more than 30 years of industry and academic research. Our program is the first to reach the clinical stage, which will evaluate its potential against a target that is easily identifiable and present in a wide range of solid tumors."

For the first time, preclinical data will be presented on AMG 510, a first-in-class investigational KRAS­G12C inhibitor being evaluated for the treatment of solid tumors. Data at the meeting will also showcase Amgen’s novel bispecific T cell engager (BiTE) platform, including preclinical data evaluating the use of AMG 757, a DLL3-targeted BiTE molecule, in resistant subtypes of melanoma. Additional research to be presented will include preclinical data evaluating the use of Amgen’s intravenous investigational MCL-1 inhibitor, AMG 176, in combination with standard of care therapies in acute myeloid leukemia.

A complete listing of abstracts can be found on the AACR (Free AACR Whitepaper) website. Notable abstracts of interest include:

KRASG12C Inhibition:

Discovery of AMG 510: A Noval Covalent Inhibitor of KRASG12C, Now in a Phase 1 Clinical Trial for Patients with Solid Tumors Harboring the KRAS P.G12C Allele
Oral Presentation, Sunday, March 31 from 4:28-4:52 p.m. ET in Georgia World Congress Center, Building A, Level 3, Room A305
Discovery and In Vitro Characterization of AMG 510, a Potent and Selective Covalent Small Molecule Inhibitor of KRASG12C
Abstract #4484, Oral Presentation, Tuesday, April 2 from 3-5 p.m. ET in Georgia World Congress Center, Building C, Level 3, Georgia Ballroom 3
Discovery of AMG 510, a First-In-Human Covalent Inhibitor of KRASG12C for the Treatment of Solid Tumors
Abstract #4455, Oral Presentation, Tuesday, April 2 from 3-5 p.m. ET in Georgia World Congress Center, Building B, Level 2, Room B206
In Vivo Characterization of AMG 510, A Potent and Selective KRASG12C Covalent Small Molecule Inhibitor in Preclinical KRASG12C Cancer Models
Abstract #3090/24, Poster Presentation, Tuesday, April 2 from 8 a.m.-noon ET in Georgia World Congress Center, Exhibit Hall B, Section 14
BiTE Antibody Construct:

Melanoma Subtypes that Emerge During Adaptive Resistance to Therapy are Targets for Bispecific T Cell Engager (BiTE) Antibody Constructs Directed to CDH19 And DLL3
Abstract #553/17, Poster Presentation, Sunday, March 31 from 1-5 p.m. ET in Georgia World Congress Center, Exhibit Hall B, Section 23
Evaluation of Mesothelin BiTE Antibody Constructs in Models of Pancreatic Ductal Adenocarcinoma
Abstract #1561/30, Poster Presentation, Monday, April 1 from 8 a.m.-noon ET in Georgia World Congress Center, Exhibit Hall B, Section 25
Additional Preclinical Data:

AMG 176 Exhibits Robust Antitumor Activity in Combination with Standard of Care Agents in Models of Acute Myeloid Leukemia
Abstract #2180/2, Poster Presentation, Monday, April 1 from 1-5 p.m. ET in Georgia World Congress Center, Exhibit Hall B, Section 14
CSF-1 Receptor-Mediated Macrophage Depletion Can Induce Immunomodulatory Resistance Mechanisms in Murine Tumor Models
Abstract #2803/19, Poster Presentation, Tuesday, April 2 from 8 a.m.-noon ET in Georgia World Congress Center, Exhibit Hall B, Section 3
About KRAS
The subject of more than three decades of research, RAS proteins make up the most frequently mutated gene family in human cancers.1,2 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.2 A specific mutation known as KRASG12C accounts for approximately 12 percent of all KRAS mutations across tumor types.3 Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.

About BiTE Technology
Bispecific T cell engager (BiTE) antibody construct is an innovative technology that can be engineered to target any tumor antigen expressed by any type of cancer. The protein molecules are designed to kill malignant cells using the patient’s own immune system by bridging T cells to tumor cells. BiTE antibody construct helps connect the T cells to the targeted cell, with the intent of causing T cells to inject toxins which trigger cancer cell death (apoptosis). Amgen is developing BiTE antibody constructs to uniquely (or specifically) target numerous hematologic malignancies and solid tumors.

About Amgen’s Commitment to Oncology
Amgen is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen’s supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.

Halozyme Announces FDA Approval Of Herceptin Hylecta™

On February 28, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that Genentech, a member of the Roche Group, has received approval from the U.S. Food and Drug Administration (FDA) for Herceptin Hylecta, a subcutaneous fixed-dose combination of trastuzumab and hyaluronidase-oysk (Press release, Halozyme, FEB 28, 2019, View Source [SID1234533861]). Herceptin Hylecta is approved for the treatment of certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease. Herceptin Hylecta is a co-formulation of trastuzumab with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE technology). Herceptin Hylecta is a ready-to-use formulation that can be administered in two to five minutes, compared to 30 to 90 minutes for intravenous trastuzumab.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are delighted that Herceptin Hylecta has been approved in the U.S. and that the potential for two- to five-minute administration time will now be available to patients in most of the major developed markets," said Dr. Helen Torley, president and chief executive officer. "Herceptin Hylecta is the third product co-formulated with ENHANZE to receive FDA approval, which represents an important achievement."

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

TG Therapeutics Announces Proposed Public Offering of Common Stock and Closing of $60.0 Million Venture Debt Financing

on February 28, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company dedicated to developing medicines for patients with B-cell mediated diseases, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, TG Therapeutics, FEB 28, 2019, View Source [SID1234533858]). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. TG Therapeutics intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, the Company announced that it has entered into a debt financing agreement for up to $60.0 million with Hercules Capital, Inc. (NYSE: HTGC), a leader in customizing debt financing for companies in the life sciences and technology-related markets. The first advance of $30.0 million was funded at closing. Two additional advances of $10.0 million may be drawn at the Company’s option, subject to certain clinical trial milestones, and the fourth advance of $10.0 million, is available through December 15, 2020 subject to the approval of Hercules.

The loan will mature on March 1, 2022. Payments under the loan are interest-only for a period of 18 months, followed by equal monthly installments of principal and interest thereafter. The interest-only period may be extended to 24 months contingent upon the Company achieving certain clinical development or fundraising milestones. In connection with the debt financing, the Company issued Hercules a warrant to purchase up to 147,058 of its common shares at an exercise price of $4.08 per share.

Further information with respect to the debt financing agreement with Hercules will be contained in a Current Report to be filed on Form 8-K by the Company with the Securities and Exchange Commission (the "SEC").

TG Therapeutics intends to use the net proceeds of the public offering and the debt facility to fund the ongoing development of ublituximab and umbralisib, for research and development activities and for general corporate purposes.

The public offering of common stock is being made pursuant to a shelf registration statement previously filed with the SEC on May 26, 2017 and declared effective by the SEC on June 13, 2017. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus related to the offering has been filed with the SEC and is available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus, when available, may also be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by e-mail at [email protected]

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