Bio-Thera Solutions Announces BAT8001 (HER2-ADC) and BAT8003 (Trop2-ADC) Poster Presentations at the 2018 San Antonio Breast Cancer Symposium

On November 29, 2018 Bio-Thera Solutions, a clinical-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, reported the company will present two posters at the 2018 San Antonio Breast Cancer Symposium (SABCS) taking place December 4 – 8, 2018 in San Antonio, Texas (Press release, BioThera Solutions, NOV 29, 2018, View Source [SID1234531722]).

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The first poster, entitled "BAT8001, a potent anti-HER2 antibody-drug conjugate with a novel stable linker for the treatment of HER2-positive breast cancer," will present preclinical data that highlight advantages of BAT8001 as a potential treatment for breast cancer patients. An abstract of the presentation is currently available on SABCS website.

Presentation details are as follows:

Poster Session: Treatment: Her2-targeted therapy

Session Date and Time: Saturday, December 8, 7:00 am – 9:00 am

Location: Poster Area/Exhibition Hall

Poster Board Number: P6-17-39

The second poster, entitled "BAT8003, a potent anti-Trop-2 antibody-drug conjugate, for the treatment of Trop-2 positive Triple Negative Breast Cancer," will present preclinical data that highlight advantages of BAT8003 as a potential treatment for triple negative breast cancer patients. An abstract of the presentation is currently available on SABCS website.

Presentation details are as follows:

Poster Session: Treatment: Novel Targets and Targeted Agents

Session Date and Time: Saturday, December 8, 7:00 am – 9:00 am

Location: Poster Area/Exhibition Hall

Poster Board Number: P6-20-16

About BAT8001

BAT8001 is an investigational HER2-ADC being evaluated in multiple tumor types. HER2 is a naturally occurring receptor that is overexpressed in many types of cancer, including breast cancer and gastric cancer. BAT8001 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. BAT8001 is currently being evaluated in a Phase 3 clinical trial for the treatment of metastatic breast cancer patients (more information on the trial is available at View Source (CTR20180157)). The BAT8001 clinical study program will expand beyond metastatic breast cancer to other HER2-positive cancers, including gastric cancer, over the next 12 months.

About BAT8003

BAT8003 is an investigational Trop-2-ADC being evaluated in multiple tumor types. Trop-2 is a naturally occurring receptor that is overexpressed in many types of cancer, including triple negative breast cancer and gastric cancer. BAT8003 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. A Phase 1 clinical trial evaluating the pharmacodynamics and safety of BAT8003 is scheduled to begin in 2019Q1.

About Antibody-Drug Conjugates

Antibody-drug Conjugates or ADCs are designed to harness the targeting ability of monoclonal antibodies (mAbs) to deliver cytotoxic agents selectively to tumor cells by linking the monoclonal antibody and cytotoxic agent through a chemical linker. An ideal ADC consists of: 1) a highly selective mAb for a tumor-associated antigen that has little or no expression on normal cells, 2) a potent cytotoxic agent designed to induce target cell death after being internalized in the tumor cell and released and 3) a chemical linker that is stable in circulation but releases the cytotoxic agent in target cells. By selectively delivering a cytotoxic agent directly inside a tumor cell, ADCs increase the safety and tolerability of the cytotoxic agent relative to giving the cytotoxic agent systemically to the patient.

Athenex Announces Licensing Agreement with PharmaEssentia for Rights to Oradoxel (Oral Docetaxel) in Certain Asian Territories

On November 29, 2018 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has entered into an agreement with PharmaEssentia Corporation (Taipei Exchange:6446) to license the rights to develop and commercialize Athenex’s Oradoxel in Taiwan, Singapore and Vietnam (Press release, Athenex, NOV 29, 2018, View Source;p=RssLanding&cat=news&id=2378678 [SID1234531705]). The existing licensing agreement for Oraxol (oral paclitaxel) and Oratecan (oral irinotecan) with PharmaEssentia is being expanded to account for additional considerations, including milestone payments, for Oradoxel (oral docetaxel). In December 2013, Athenex and PharmaEssentia entered into a license agreement, pursuant to which PharmaEssentia was granted a license to develop and commercialize Oraxol and Oratecan in Taiwan and Singapore. The agreement was amended in December 2016 to also include Vietnam in the territories covered by the license.

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Under the terms of the expanded agreement, which includes Oradoxel, Athenex will receive a cash payment as well as the potential to receive additional milestone payments for certain development and regulatory milestones of Oradoxel in the territories. PharmaEssentia will be responsible for all activities and expenses relating to clinical development, regulatory approval, and commercialization of Oradoxel in the territories.

Docetaxel is an anti-cancer chemotherapeutic agent that is used widely in the treatment of breast, prostate, gastric, head and neck, and lung cancers. Oradoxel is an oral formulation of Docetaxel combined with HM30181A, a novel gastrointestinal tract specific P-glycoprotein pump inhibitor. Oradoxel is currently in Phase I clinical studies in the U.S. and New Zealand, and is ready to advance to Phase II with studies expected to begin in the first half of 2019.

Dr. Kochung Lin, Chief Executive Officer of PharmaEssentia, commented, "We are excited with the encouraging results so far from clinical trials of Athenex’s Orascovery drug candidates, particularly Oraxol. The potential of oral chemotherapy drugs to improve efficacy and safety, and improve patients’ quality of life, cannot be overstated. Athenex has generated promising Phase I data with both Oratecan and Oradoxel, and we are pleased to participate in the development of these exciting products in Taiwan, Singapore and Vietnam to help realize the full potential of this platform. We have been impressed by the Athenex team in their execution and are delighted to continue and expand our excellent partnership with the addition of Oradoxel."

Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex, stated, "This agreement builds on our longstanding relationship with PharmaEssentia. PharmaEssentia has demonstrated strong commitment to cancer drug research and development, and we are confident they have the capabilities for successfully delivering Oradoxel to patients in the licensed territories."

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

Triumvira Immunologics Announces Presentation of Key Preclinical Data on TAC Technology at American Society of Hematology

On November 29, 2018 Triumvira Immunologics, Inc. (Triumvira), reported the upcoming presentation of key preclinical data at the American Society of Hematology (ASH) (Free ASH Whitepaper) 60th Annual Meeting and Exposition December 1-4, 2018 in San Diego, CA (Press release, Triumvira Immunologics, NOV 29, 2018, View Source [SID1234531723]). The data will be presented during a poster presentation on Sunday, December 2, and a podium presentation on Monday, December 3.

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"We continue to expand our knowledge base on the promise of our proprietary T cell Antigen Coupler (TAC) technology in different tumor types," commented Andreas Bader, Ph.D., Triumvira’s Senior Vice President of R&D. "The presentations will focus on experiments using T cells genetically engineered with TACs directed against either CD19 or BCMA antigen, demonstrating robust cell-killing and anti-tumor efficacy in preclinical models of hematological malignancies with no detectable side effects."

Podium Presentation Title:

T Cells Engineered with a Novel Chimeric Receptor Demonstrate Durable In Vivo Efficacy Against Disseminated Multiple Myeloma

Publication Number: 962; Session Name: 703. Adoptive Immunotherapy: Preclinical Studies to Improve Safety and Efficacy of CAR-T Cells; Presentation Date/Time: Monday, December 3, 2018: 4:30 – 6:00 PM PST

Presenter: Ksenia Bezverbnaya, McMaster University

Poster Title:

T Cells Engineered with T Cell Antigen Coupler (TAC) Receptors for Haematological Malignancies

Publication Number: 3267; Session Name: 653. Myeloma: Therapy, excluding Transplantation: Poster II; Presentation Date/Time: Sunday, December 2, 2018: 6:00 PM – 8:00 PM PST

Presenter: Dr. Christopher Helsen, Director of Research & Development, and Head of Platform Development, Triumvira Immunologics.

GlycoMimetics to Host 2018 Investor/Analyst Meeting at 60th ASH Annual Meeting on December 3, 2018

On November 29, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that it will host and webcast an investor/analyst meeting and update at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, on December 3 at 6 a.m. PT. Daniel J. DeAngelo, MD, PhD,Director of Clinical and Translational Research, Adult Leukemia Program, Dana-Farber Cancer Institute/Brigham and Women’s Hospital, Associate Professor of Medicine, Harvard Medical School, who served as lead investigator of the GlycoMimetics’ recently completed Phase 1/2 clinical trial of uproleselan in acute myeloid leukemia patients, will recap and provide perspective on his December 2 oral presentation at the ASH (Free ASH Whitepaper) meeting, highlighting the trial’s findings (Press release, GlycoMimetics, NOV 29, 2018, View Source [SID1234531706]). GlycoMimetics management will review additional posters from the ASH (Free ASH Whitepaper) meeting.

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The investor/analyst event will be webcast beginning at 6:15 a.m. PT. The dial-in number for the event is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 9779654. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

Investors/analysts are requested to pre-register for the private in-person event at [email protected]. The event will be held at Hard Rock Hotel San Diego in the Celebrate Room, 207 Fifth Avenue, San Diego. On-site inquiries will be handled by Shari Annes, (650) 888-0902, by text or phone.

GlycoMimetics to Host 2018 Investor/Analyst Meeting at 60th ASH Annual Meeting on December 3, 2018

On November 29, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that it will host and webcast an investor/analyst meeting and update at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, on December 3 at 6 a.m. PT. Daniel J. DeAngelo, MD, PhD, Director of Clinical and Translational Research, Adult Leukemia Program, Dana-Farber Cancer Institute/Brigham and Women’s Hospital, Associate Professor of Medicine, Harvard Medical School, who served as lead investigator of the GlycoMimetics’ recently completed Phase 1/2 clinical trial of uproleselan in acute myeloid leukemia patients, will recap and provide perspective on his December 2 oral presentation at the ASH (Free ASH Whitepaper) meeting, highlighting the trial’s findings. GlycoMimetics management will review additional posters from the ASH (Free ASH Whitepaper) meeting (Press release, GlycoMimetics, NOV 29, 2018, View Source [SID1234531724]).

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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

                  Schedule Your 30 min Free Demo!

The investor/analyst event will be webcast beginning at 6:15 a.m. PT. The dial-in number for the event is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 9779654. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

Investors/analysts are requested to pre-register for the private in-person event at [email protected]. The event will be held at Hard Rock Hotel San Diego in the Celebrate Room, 207 Fifth Avenue, San Diego. On-site inquiries will be handled by Shari Annes, (650) 888-0902, by text or phone.