On December 3, 2019, Aeglea BioTherapeutics presented the corporate presentation (Presentation, Aeglea BioTherapeutics, DEC 3, 2019, View Source [SID1234554280]).

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On December 3, 2019 Genomic Testing Cooperative, LCA (GTC) reported that they will be presenting data on their proprietary AI-based algorithms and RNA and DNA testing at the American Association of Hematology (ASH) (Free ASH Whitepaper) annual meeting (Press release, Genomic Testing Cooperative, DEC 3, 2019, View Source [SID1234553223]). In collaboration with multiple academic centers, GTC developed new approaches for the classification of diseases and prediction of response to combination therapy.

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Dr. Maher Albitar, GTC Chief Executive Officer and Chief Medical Officer, stated "Cancer is complex disease and requires complex biomarkers for predicting its behavior. RNA Sequencing provides a wealth of information that can be used for predicting clinical course and response to combination therapy. RNA sequencing data, when combined with mathematical algorithms, can provide reliable means to manage and treat cancer. GTC is committed to be the leader in innovation in developing molecular biomarkers to help physicians select the proper combination therapy for their patients."

Highlights of GTC presentations include:
-Targeted next generation sequencing (NGS) of RNA is reliable and practical for routine clinical testing.

-RNA sequencing data when used with AI or Bayesian statistics can provide powerful means for predicting clinical behavior and response to combination therapy

-Testing for mutations using RNA may provide a new paradigm for better characterizing and monitoring of cancers

-Liquid biopsy provides important clinical information in patients with acute myeloid leukemia.

The following is a list of studies that will be presented by GTC and its collaborators at ASH (Free ASH Whitepaper):
1) 2891-Title: "Cell of Origin Classification of DLBCL Using Targeted NGS Expression Profiling and Deep Learning"

Collaborators: University of Texas MD Anderson Cancer Center, Houston, TX; University of California, Irvine, CA; University Hospital Basel, Basel, Switzerland; University of Verona, Verona, Italy; Columbia University Medical Center, New York, NY; Aalborg University Hospital, Aalborg, Denmark; Well Cornell Medical College, New York, NY; Cleveland Clinic, Cleveland, OH; San Raffaele Scientific Institute, Milano, Italy; San Raffaele Hospital, Milan, Italy; Odense University Hospital, Odense, Denmark; Instituto de Investigación Marqués De Valdecilla, Santander, Spain; University Hospital Nijmegen, Nijmegen, NLD; Houston Methodist Hospital, Houston, TX; Lerner Research Institute, Cleveland Clinic, Cleveland, OH.

2) 2730-Title: "Higher Stability of Mutant IDH1/2 mRNA As Compared to Wild-Type mRNA in Patients with Acute Myeloid Leukemia"

Collaborators: Departments of Leukemia, Stem Cell Transplantation, and Hematopathology, UT MD Anderson Cancer Center, Houston, TX

3) 1314-Title: "Expression Profiling of mRNA By Next Generation Sequencing and the Development of Algorithm for Predicting Response in Acute Myeloid Leukemia"

Collaborators: Department of Computer Science, Georgia Southern University, Savannah, Georgia;
Departments of Leukemia, Stem Cell Transplantation, and Hematopathology, UT MD Anderson Cancer Center, Houston, TX

4) 1499-Title: Higher Stability of Mutant mRNA As Compared to Wild-Type mRNA in Diffuse Large B-Cell Lymphoma

Collaborators: University of Texas MD Anderson Cancer Center, Houston, TX; University of California, Irvine, CA; University Hospital Basel, Basel, Switzerland; University of Verona, Verona, Italy; Columbia University Medical Center, New York, NY; Aalborg University Hospital, Aalborg, Denmark; Well Cornell Medical College, New York, NY; Cleveland Clinic, Cleveland, OH; San Raffaele Scientific Institute, Milano, Italy; San Raffaele Hospital, Milan, Italy; Odense University Hospital, Odense, Denmark; Instituto de Investigación Marqués De Valdecilla, Santander, Spain; University Hospital Nijmegen, Nijmegen, NLD; Houston Methodist Hospital, Houston, TX; Lerner Research Institute, Cleveland Clinic, Cleveland, OH.

5) 2592-Title: Sequencing of Circulating Cell-Free DNA in Patients with AML Detects Clinically Significant Mutations Not Detected in Bone Marrow: The Role for Complementary Peripheral Blood and Bone Marrow Genomic Analysis

Collaborators: Departments of Leukemia, Genomic, and Hematopathology, UT MD Anderson Cancer Center, Houston, TX.

On December 3, 2019 Luye Pharma of Yantai reported that it has acquired Shandong Boan Biological, a company developing biosimilar products, at a price unofficially reported to be $205 million (Press release, Luye Pharma, DEC 3, 2019, View Source [SID1234551907]). Luye said the acquisition includes Boan’s drug portfolio, antibody screening platform, antibody manufacturing platform and related IP. Boan currently has 8 biosimilar drugs in development, three of them in clinical trials. Previously, Luye in-licensed four biosimilars from Boan, including biosimilars to Avastin, Prolia,Xgeva and Eylea. Luye said the molecules at at the IND stage in the US and/or Europe and/or Japan.

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On December 3, 2019 QBiotics Group Limited (QGL), a life sciences company developing novel anticancer and wound healing pharmaceuticals, reported that it has dosed its first patient in a Phase I/II clinical trial evaluating the optimal dosing and safety of its lead product, tigilanol tiglate, in patients with head and neck squamous cell carcinoma (HNSCC) (Press release, QBiotics, DEC 3, 2019, View Source [SID1234551905]).

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Dr Victoria Gordon, Managing Director and CEO of QBiotics, said, "We are delighted to announce the treatment of our first patient in our multi-site clinical study, which includes trial sites in Australia and India. Cancers of the head and neck rank as the sixth most common cancer diagnosed worldwide[1] with more than 2 million[2] new cases each year. The high rate of HNSCC is largely driven by tobacco use, and increased infection with human papillomavirus (HPV)."

Dr Gordon continued, "This study marks an important advancement for QBiotics’ oncology pharmaceutical. It follows our successful first-in-man QBC46-H01 study[3] in a range of solid tumours, which demonstrated patients with squamous cell carcinoma, the most common type of head and neck cancer, had encouraging tumour responses when treated with tigilanol tiglate."

Surgery and radiotherapy are currently the primary local treatments for HNSCC. However, these treatments can come with challenges such as damage to healthy tissue and impacting a person’s ability to breathe, hear, see, smell, swallow or taste as well as adversely affecting appearance. Better local therapies are therefore needed. Direct intratumoural injection with tigilanol tiglate may offer advantages as it directly targets tumour cells and reaches infiltrating cancer cells that can be missed by surgery. This approach limits exposure and damage to surrounding healthy tissues, reducing the risk of functional or cosmetic impairment. Intratumoural injection also offers the potential for reduced toxicity due to localised (target site) treatment, compared to systemic toxicity induced by chemotherapeutic agents.

The Phase I/II open label "QBC46-H03" study, is a dose escalation study in patients with HNSCC aimed at determining the maximum tolerated dose (MTD) and recommended dose level for further studies. The study will also investigate safety, tolerability and tumour response following a single or multiple (two to three) doses of tigilanol tiglate. It will enrol up to 40 patients from the Tata Medical Centre in Kolkata, the Tata Memorial Hospital in Mumbai, the Princess Alexandra Hospital in Brisbane, and other clinical sites in Australia.

On December 3, 2019 Proteostasis Therapeutics, Inc. (NASDAQ: PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing, reported that Proteostasis management will present at the Piper Jaffray 31st Annual Healthcare Conference on Thursday, December 5, 2019 at 11:00 a.m. ET at the Lotte New York Palace (Press release, Proteostasis Therapeutics, DEC 3, 2019, View Source [SID1234551904]).

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A live audio webcast of the Piper Jaffray conference presentation will be available on the Investor Events page in the Investors & Media section of the Company’s website, www.proteostasis.com. A replay of the webcast will be available on the Company’s website following the presentation.