On February 28, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported the acceptance for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 of an abstract describing results of preclinical studies of tesetaxel, Odonate’s investigational, orally administered taxane (Press release, Odonate Therapeutics, FEB 28, 2019, View Source [SID1234533870]). These preclinical results indicate that, following oral administration, tesetaxel achieves brain concentrations that exceed concentrations required for tumor killing for a sustained period of time. This is in contrast to paclitaxel and docetaxel, the most commonly prescribed taxanes, which do not substantially cross the blood-brain barrier. New therapies are needed for patients with tumors that have metastasized to the brain from other organs, such as the breast or the lung, as well as patients with primary brain tumors. The AACR (Free AACR Whitepaper) Annual Meeting 2019 will be held March 29 – April 3, 2019 in Atlanta, Georgia. The abstract for this presentation was made publicly available yesterday and can be found on the AACR (Free AACR Whitepaper) Annual Meeting 2019 Itinerary Planner or by clicking the title below.

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Presentation Details:

Abstract 3078 (Poster Board #12): Tesetaxel, a novel, oral taxane, crosses intact blood-brain barrier (BBB) at therapeutically relevant concentrations
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 1
Session Date and Time:Tuesday, April 2, 20198:00 AM – 12:00 PM
Location:Georgia World Congress Center, Exhibit Hall B, Poster Section 14

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) assessed by the IRC and disease control rate (DCR) assessed by the IRC. To learn more, please visit www.contessastudy.com.

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.

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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.

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]):

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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.

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]).

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"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.

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.

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"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.