GT BIOPHARMA, INC. TO PRESENT AT BIOTECH SHOWCASE™ 2019

On December 20, 2018 GT Biopharma, Inc. (OTCQB: GTBP and Euronext Paris GTBP.PA) ("GT Biopharma" or the "Company"), an immuno-oncology biotechnology company focused on innovative treatments based on the Company’s proprietary NK-engager and Bispecific Antibody Drug Conjugate platforms, reported that Raymond W Urbanski, M.D., Ph.D., Chief Executive Officer and Chairman, will present at Biotech Showcase 2019 on Tuesday, January 8, 2019 at 11:30 AM PST in San Francisco, CA (Press release, GT Biopharma , DEC 20, 2018, View Source [SID1234539517]).

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As part of his presentation, Dr. Urbanski will provide a corporate update and discuss GT Biopharma’s pipeline of immuno-oncology products based off the Company’s proprietary Tri-specific Killer Engager (TriKE), Tetra-specific Killer Engager (TetraKE) and bi-specific Antibody Drug Conjugate (ADC) technology platforms.

The Company’s most advanced bi-specific ADC in development, GTB-1550, targets CD19+ and/or CD22+ hematological malignancies and is currently in the Phase 2 component of a Phase 1/2 Non-Hodgkin’s Lymphoma (NHL)/Acute Lymphocytic Leukemia (ALL) trial which is an open-label, investigator-led study. GT Biopharma expects to announce topline results from the Phase 2a trial of GTB-1550 in the first quarter of 2019.

Additionally, the Company recently announced its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) is now open and it is authorized to initiate a first-in-human Phase 1 study with GTB-3550 (formerly OXS-3550), its first-in-class (TriKE), for the treatment of acute myelogenous leukemia (AML), myelodysplatic syndrome (MDS) and mastocytosis. The study, which is expected to commence in the first half of 2019, will be led by Principal Investigator, Sarah A. Cooley, MD, MS, Associate Professor, Division of Hematology, Oncology and Transplantation at Masonic Cancer Center, University of Minnesota. The Company believes that GTB-3550 could serve as a relatively safe, cost-effective, and easy-to-use therapy for refractory/relapsed AML, high-risk MDS and advanced systemic mastocytosis and could also be combined with chemotherapy and/or other agents as frontline therapy thus targeting a much larger patient population.

In addition to the presentation, Dr. Urbanski will also be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please click here to visit the conference website.

A live audio webcast of the presentation will be available on the Events page of the Investors section of the Company’s website (www.gtbiopharma.com). A webcast replay will be accessible for 90 days following the live presentation.

NASH-Associated Liver Cancer Use Patent for EP4 Receptor Antagonists Approved in Canada

On December 20, 2018 AskAt reported that it received a notice of allowance dated December 11, 2018 from Canadian Intellectual Property Office (CIPO) in connection with the Application No. 3,000,237, Use of EP4 receptor antagonists for the treatment of NASH-associated liver cancer (Press release, AskAt, DEC 20, 2018, View Source [SID1234535042]).

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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

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Helix BioPharma Corp. Closes Second Tranche of Private Placement

On December 20, 2019 Helix BioPharma Corp. (TSX, FSE: "HBP") ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has closed a second tranche of a private placement financing for gross proceeds of CAD342,000 (Press release, Helix BioPharma, DEC 20, 2018, View Source [SID1234533057]). The Company expects to complete a third tranche of the private placement financing before the end of December.

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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

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The terms of the placement are for the purchase of units at $1.20 per unit. Each unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant will entitle the holder to purchase one common share at an exercise price of $1.50 and have an expiry of five years from the date of issuance. Helix intends to use the net proceeds of the private placement for working capital and research and development activities.

ACM Alpha Consulting Management AG provided financial advisory services to Helix in connection with the private placement.

XYNOMIC PHARMA ACQUIRES GLOBAL EXCLUSIVE RIGHTS TO PHASE 2 READY MTORC1/2 INHIBITOR FROM BOEHRINGER INGELHEIM

On December 20, 2018 Xynomic Pharmaceuticals, Inc. ("Xynomic"), a clinical stage US-China oncology drug development company, reported that it has been granted an exclusive, worldwide license to develop, manufacture and commercialize BI 860585, a phase 2 ready mTORC1/2 inhibitor, from Boehringer Ingelheim International GmbH ("Boehringer Ingelheim") (Press release, Xynomic Pharmaceuticals, DEC 20, 2018, View Source [SID1234532253]).

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BI 860585 is a potent and selective ATP-competitive mTOR serine/threonine kinase inhibitor. It has been tested in a phase 1 trial with 90 patients with advanced solid tumors as single agent, in combination with exemestane or paclitaxel. In this trial BI 860585 was well tolerated and disease control rates (partial response plus stable disease) were 20%, 28% and 58%, respectively.

Xynomic plans to initiate 2 clinical trials in the next 6-9 months, among which, one is a potentially pivotal phase 2 trial combining BI 860585 with a standard-of-care treatment against breast cancer and the other is a phase 1b trial combining BI 860585 with Xynomic’s XP-102 (formerly known as BI 882370) against colorectal cancer.

According to a press release by World Health Organization (WHO)’s International Agency for Research on Cancer dated September 12, 2018, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in women. In addition, colorectal cancer is the second most commonly diagnosed cancer and the third leading cause of cancer death in women and the third most commonly diagnosed cancer in men. According to IMS and iHealthcareanalyst, drugs treating these two malignancies are expected to generate annual revenue of approximately $25.4 billion by 2023.

Total payments of Xynomic associated with the licensing agreement, including an upfront payment, regulatory milestone payments and potential royalties, will be up to $800 million.

Constellation Pharmaceuticals to Present at J.P. Morgan Healthcare Conference

On December 20, 2018 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that Jigar Raythatha, CEO, will present at the J.P. Healthcare Conference at the Westin St. Francis Hotel in San Francisco at 4:00 PM PST/7:00 EST on Wednesday, January 9 (Press release, Constellation Pharmaceuticals, DEC 20, 2018, View Source [SID1234532221]). A live audio webcast of the presentation and an archive for replay will be available on the Investor Relations section of Constellation’s website at View Source The audio webcast replay will be available for 90 days following the live presentation.

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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

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