On September 11, 2019 Biogen Inc. (Nasdaq:BIIB) reported it will report third quarter 2019 financial results Tuesday, October 22, 2019, before the financial markets open (Press release, Biogen, SEP 11, 2019, View Source [SID1234539468]).

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Following the release of the financials, the Company will host a live webcast with Biogen management from 8:00-9:00 am ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website.

On September 11, 2019 Q BioMed, Inc. (OTCQB: QBIO) and Chemveda Life Sciences are very pleased to announce that after the recent successful chemical synthesis of a unique natural compound that has shown remarkable efficacy as a potential chemotherapy for the treatment of liver cancer, the two companies have formalized a collaboration to continue the work and to scale-up manufacturing of cGMP product for planned pre-clinical testing and clinical trials (Press release, Q BioMed, SEP 11, 2019, View Source [SID1234539451]).

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Since February 2017, Q BioMed and Chemveda have been engaged in a joint research program to synthesize uttroside B and several other derivatives. The goal of the program is to study their potential use in clinical trials for the treatment of hepatocellular carcinoma (liver cancer) as well as other cancers. The original compound was isolated and characterized from the leaves of Solanum nigrum Linn, a plant widely used in traditional medicines.

In a Scientific Reports study, researchers showed that in animal models, uttroside B was ten times more cytotoxic to the HepG2 liver cancer cell line than sorafenib, the only drug approved by the Food and Drug Administration for liver cancer at the time and the current first line treatment for hepatocellular carcinoma. Uttroside B drastically reduced tumors in mice bearing human liver cancer xenografts. In addition, in pre-clinical experiments, uttroside B induced cytotoxicity in all liver cancer cell lines and researchers were able to confirm its biological safety, both by in vitro and in vivo studies. Q BioMed is awaiting confirmatory cell line efficacy data from the synthesized drug product and its derivatives.

Denis Corin, Q BioMed CEO said, "Chemveda has been an excellent partner in this program, both in terms of execution and problem solving, and we look forward to the next phase as we advance this promising molecule and others towards the clinic."

Bheema Paraselli, Chemveda’s President & CEO said, "Since its inception in early 2017 we have been very interested in this research given to the novelty of its clinical end-point & nobility of this approach. What helped us cut through the initial uncertainty and risks surrounding the milestone approach was our stringent due-diligence, attention to detail, and tailored scientific approach. We are very thankful to Q BioMed for being of tremendous help."

Under the Agreement and depending upon reaching certain milestones, Q BioMed have agreed to pay Chemveda a combination of cash and stock and capped royalty on net sales of any and all drug product(s) resulting from the collaboration. Subject to the terms of the Agreement, Chemveda shall have the first right of refusal and, if exercised, the exclusive right to manufacture any products developed as a result of the program for pre-commercial and commercial production.

Chemotherapeutic options for liver cancer are limited, and the prognosis of patients remains challenging. According to the Centers for Disease Control and Prevention, it is the second most common cause of cancer deaths worldwide, claiming approximately 750,000 lives each year. In the US, the American Cancer Society estimates that 42,000 people will be diagnosed with liver cancer in 2019 and that 32,000 will die from the disease this year. Liver cancer incidence has more than tripled since 1980 and deaths in the US have increased 56% since 2003.

The uttroside B technology is covered by a provisional patent application. To see the full Scientific Reports study, go to:View Source

Please visit www.QBioMed.com for more information on our various pipeline products.

On September 11, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that clinical data on its investigational anti-PD-1 antibody tislelizumab, its investigational BTK inhibitor zanubrutinib, and its investigational PARP inhibitor pamiparib, will be presented in seven oral presentations and four poster presentations at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (CSCO), taking place September 18-22, 2019 in Xiamen, China (Press release, BeiGene, SEP 11, 2019, View Source [SID1234539469]).

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Oral Presentations:

Title: Tislelizumab in Chinese Patients with Non-Small Cell Lung
Cancer (NSCLC) and Nasopharyngeal Carcinoma (NPC)
Session: Lung Cancer Session 1
Date: Thursday, September 19
Time: 11:20 – 11:25
Location Auditorium, Level 1
Presenter Qing Zhou, M.D., Ph.D., Guangdong Provincial People’s Hospital

Title: Tislelizumab for Relapsed/Refractory Classical Hodgkin
Lymphoma: Updated Follow-up Efficacy and Safety Results
from a Phase 2 Study
Session: Innovative Drug Clinical Data Session 1
Date: Thursday, September 19
Time: 14:30 – 14:40
Location Strait Hall, Level 2
Presenter: Yuqin Song, M.D., Ph.D., Beijing Cancer Hospital

Title: Tislelizumab in Chinese Patients with Melanoma, Urothelial
Carcinoma (UC), and Renal Cell Carcinoma (RCC)
Session: Kidney Cancer Session 4
Date: Thursday, September 19
Time: 16:35 – 16:40
Location Conference Room 2A, Level 2
Presenter: Lili Mao, M.D., Ph.D. Beijing Cancer Hospital

Title: Tislelizumab in Chinese Patients with Esophageal Cancer
(EC), Gastric Cancer (GC), Hepatocellular Carcinoma (HCC),
and Microsatellite Instability-High/Mismatch Repair Deficient
(MSI-H/dMMR) Tumors
Session: Advanced Gastric Cancer Session 3
Date: Friday, September 20
Time: 11:24 – 11:36
Location Banquet Hall 1, Level 2
Presenter: Lin Shen, M.D., Ph.D., Beijing Cancer Hospital

Title: Safety and Efficacy in Patients with Long-Term Exposure
(LTE) to Tislelizumab, an Investigational Anti-PD-1 Antibody,
in a First-in-Human Phase 1 Study
Session: Immuno-Oncology Session 3
Date: Friday, September 20
Time: 11:54 – 12:00
Location Hall 1G, Level 1
Presenter Chia-Jui Yen, M.D., Ph.D., National Cheng Kung University Hospital

Title: Tislelizumab Plus Chemotherapy as First-Line Treatment for
Chinese Patients with Lung Cancer
Session: Lung Cancer Session 3
Date: Saturday, September 21
Time: 11:38 – 11:44
Location Auditorium, Level 1
Presenter: Zhijie Wang, M.D., Ph.D., Cancer Hospital, Chinese Academy of Medical Sciences

Title: Tislelizumab in Combination with Chemotherapy as
Treatment for Chinese Patients with Esophageal Squamous
Cell Carcinoma (ESCC)
Session: Innovative Drug Clinical Data Session 1
Date: Saturday, September 21
Time: 14:30 – 14:40
Location Banquet Hall 2, Level 2
Presenter: Ru Jia, M.D., The Fifth Medical Center, General Hospital of the People’s Liberation Army

Poster Presentations:

Title: Dose Escalation of Pamiparib in Chinese Patients with High-
Grade Non-Mucinous Ovarian Cancer (HGOC) or Advanced
Triple-Negative Breast Cancer (TNBC)
Board #: P-36
Date: Thursday, September 19
Time: Afternoon
Location: Strait Hall Poster Area, Level 2
Presenter: Xiyan Mu, M.D., BeiGene

Title: Zanubrutinib for Patients with Relapsed or Refractory
Chronic Lymphocytic Leukemia or Small Lymphocytic
Lymphoma
Board #: P-45
Date: Friday, September 20
Time: Morning
Location: Strait Hall Poster Area, Level 2
Presenter: Meng Ji, M.D., BeiGene

Title: Zanubrutinib, a Highly Specific BTK Inhibitor in Chinese
Patients with Relapsed/Refractory B-cell Malignancies:
Follow-up Report of a Phase 1 Trial in China
Board #: P-46
Date: Friday, September 20
Time: Morning
Location: Strait Hall Poster Area, Level 2
Presenter: Chenmu Du, M.D., BeiGene

Title: The molecular binding mechanism of tislelizumab, an
investigational anti-PD-1 antibody, is differentiated from
pembrolizumab and nivolumab
Board #: P-60
Date: Friday, September 20
Time: Morning
Location: Strait Hall Poster Area, Level 2
Presenter: Ye Liu, Ph.D., BeiGene

On September 11, 2019 Zetagen Therapeutics, a private, US-based biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported its award of $225,000 USD from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health (NIH) (Press release, Zetagen Therapeutics, SEP 11, 2019, View Source [SID1234643689]). The grant will be used for a Phase I validation study of a novel, surgical implant for use with the Company’s small-molecule ZetaFuse. The implant is designed to repair damaged bone through stem cell activation.

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"We are extremely pleased to be recognized by the NIAMS, allowing us to enter our next phase of research," said Joe C. Loy, CEO of Zetagen Therapeutics, Inc. "This study further builds on our earlier validation studies, allowing us to now focus on how to successfully repair damaged bone by activating the body’s own stem cells – something which can potentially be applied beyond osteolytic cancers to other orthopedic interventions."

The NIAMS grant is part of the Small Business Innovation Research Program (SBIR), a three phase award system created by the Federal Government for small businesses to engage in research and development that has the potential for commercialization and public benefit. Zetagen exclusively-licensed its platform technology from the State University of New York in 2016.

On September 11, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed therapy (third-line disease) (Press release, Puma Biotechnology, SEP 11, 2019, View Source [SID1234539435]). The FDA has informed the Company that it is not currently planning to hold an advisory committee meeting to discuss this application. The FDA confirmed that the review will have an action date of late April, 2020.

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"The FDA’s acceptance of our sNDA marks another important regulatory milestone for my team," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "We look forward to working with the FDA during its review of this submission, which targets patients with HER2-positive metastatic breast cancer who have progressed on two or more prior treatments and who need additional treatment options."

Neratinib was originally approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as NERLYNX tablets. In September 2018 NERLYNX was granted marketing authorization by the European Commission for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy.

The sNDA is supported by the results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine versus Tykerb (lapatinib) plus capecitabine in patients with third-line HER2-positive metastatic breast cancer.

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

About NALA

The NALA trial is a randomized controlled Phase III trial of neratinib plus capecitabine versus Tykerb (lapatinib) plus capecitabine in patients with third-line HER2-positive metastatic breast cancer. The trial enrolled 621 patients who were randomized (1:1) to receive either neratinib plus capecitabine or lapatinib plus capecitabine. The trial was conducted globally at sites in North America, Europe, Asia-Pacific and South America. The co-primary endpoints of the trial are centrally confirmed progression free survival (PFS) and overall survival (OS). An alpha level of 1% was allocated to the PFS and 4% allocated to OS. The study was to be considered positive if either of the co-primary endpoints was positive. Puma reached agreement with the FDA under a Special Protocol Assessment (SPA) for the design of the Phase III clinical trial and the European Medicines Agency (EMA) also provided follow-on scientific advice (SA) consistent with that of the FDA regarding the Company’s Phase III trial design and endpoints used in the trial.