Syndax to Present at the International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer

On September 5, 2018 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that data from the PD-(L)1 refractory non-small cell lung cancer (NSCLC) cohort of ENCORE 601 will be presented at the upcoming International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC) being held September 23-26, 2018 in Toronto, Canada (Press release, Syndax, SEPT 5, 2018, View Source [SID1234529292]). ENCORE 601 is a Phase 1b/2 trial evaluating the efficacy and safety of entinostat, the Company’s class I selective HDAC inhibitor, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, across multiple cohorts of PD-(L)1 treatment-naïve and pre-treated cancers, including NSCLC, melanoma and microsatellite stable colorectal cancer.

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The accepted abstract is available on the World Conference on Lung Cancer website at View Source Updated data will be presented at the conference.

Presentation Details

Title: Efficacy/Safety of Entinostat (ENT) and Pembrolizumab (PEMBRO) in NSCLC Patients Previously Treated with Anti-PD-(L)1 Therapy
Presenter: Matthew D. Hellmann, M.D., Memorial Sloan Kettering Cancer Center
Track: Advanced NSCLC
Session: OA05 – Clinical Trials in IO
Presentation Number: OA05.01
Date and Time: September 24, 2018 1:30 – 1:40 PM ET

DiaMedica Therapeutics Announces the Appointment of Dr. Harry Alcorn Jr. as Chief Medical Officer

On September 5, 2018 DiaMedica Therapeutics Inc. (the "Company" and "DiaMedica") (TSX-V:DMA) (OTCQB:DMCAF) reported the recent appointment of Harry Alcorn Jr. Pharm.D. as Chief Medical Officer where he will oversee global clinical development and regulatory initiatives for DiaMedica (Press release, DiaMedica, SEP 5, 2018, View Source [SID1234529333]). Dr Alcorn has over 30 years of clinical research experience working with public and private biotech and pharmaceutical companies in studies of kidney diseases and diabetic, hepatic and cardiovascular patients. He has designed, authored and been a consultant to a multitude of companies in the industry on protocol development, clinical execution and regulatory guidance. He has served as Principal Investigator or Sub Investigator in over 450 clinical studies and has assisted many biotech and pharmaceutical companies in negotiating protocols and presenting results to the FDA. Dr. Alcorn has presented at numerous international meetings and industry seminars discussing the critical challenges in conducting patient studies.

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Prior to joining DiaMedica, Dr. Alcorn served as Chief Scientific Officer at DaVita Clinical Research (DaVita), a company that provides clinical research services for pharmaceutical and biotech companies. During this time, he also served on the Board of Directors for The Association of Clinical Pharmacology Units and on the Board of Directors of MedTox Laboratories. In 2000 Dr. Alcorn started the US Renal Network, the first organization to coordinate clinical trial sites for the conduct of kidney studies. Prior to DaVita he held the position of Executive Director and led the clinical trials at GalaGen Inc, a biopharmaceutical company developing therapeutics to target life-threatening and emerging pathogens.

Dr. Alcorn obtained his Bachelor of Pharmacy from Creighton University and his Doctor of Pharmacy from University of Nebraska Medical Center. He currently holds clinical faculty appointments with the University of Minnesota, Creighton University, University of Nebraska Medical Center, Virginia Commonwealth and the University of Colorado, Denver.

"We are thrilled that Harry is bringing to DiaMedica his strong industry and operational leadership at a time when we are preparing to initiate clinical research in patients with Chronic Kidney disease" commented Rick Pauls, President and CEO of DiaMedica. "His knowledge, experience in patient trials, along with his work as a subject matter expert for both industry and the FDA, complements our team."
I am very excited to join DiaMedica at this stage of its development," said Dr. Alcorn. "DiaMedica is leading the investigation of the KLK1 protein and has the opportunity to significantly improve the lives of patients suffering from chronic kidney disease and neurological disorders. I look forward to helping the company accelerate the development of DM199 for these patients."

About DM199

DM199 is a recombinant (synthetic) form of the human protein known as "KLK1". The KLK1 protein plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostacyclin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as chronic kidney disease, retinopathy, stroke, vascular dementia and treatment resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and DiaMedica is preparing to initiate a clinical study in patients with chronic kidney disease.

Moffitt Cancer Center and ITUS Corporation Announce Scheduling of Pre-IND Meeting with the FDA for their CAR-T Therapy

On September 5, 2018 ITUS Corporation (NASDAQ: ITUS) and its research partner, Moffitt Cancer Center, reported that a pre-IND meeting with the US FDA has been scheduled on Tuesday, October 16, 2018 (Press release, Anixa Biosciences, SEP 5, 2018, View Source [SID1234530493]). The meeting is to discuss numerous aspects of the planned clinical trial of their CAR-T therapy for ovarian cancer.

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Dr. Amit Kumar, CEO of ITUS stated, "We are pleased to be meeting with the FDA this fall, as anticipated. We have submitted pre-clinical data, as well as a series of questions, to the FDA. Coming out of this meeting, our goal is to have a good understanding of the design for the clinical trial in our Investigational New Drug (IND) application. Assuming the FDA does not require additional animal studies, we hope to file the IND application in early 2019, with human testing potentially beginning shortly thereafter."

Dr. Jose Conejo-Garcia, Co-head of Immunology at Moffitt Cancer Center, the inventor of the technology, and the Principal Investigator of the team developing the therapy, added, "We are heading towards the first in human trial of our hormone receptor based Chimeric Antigen Receptor T-cell technology, which internally we refer to as Chimeric Endocrine Receptor T-cell technology (CER-T). Our unique approach, could create a whole new platform for CAR-T that takes advantage of hormone-receptor combinations. To date CAR-T therapy has only shown efficacy in certain liquid tumors. We hope our approach will enable chimeric receptors expressed on T cells to work on the vastly larger numbers of solid tumors relative to hematological malignancies".

BeiGene to Present Data on Anti-PD-1 Antibody Tislelizumab at the IASLC 19th World Conference on Lung Cancer (WCLC) in Toronto

On September 5, 2018 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 it will present data on its investigational anti-PD-1 antibody tislelizumab at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC), which takes place September 23-26 in Toronto, Canada (Press release, BeiGene, SEPT 5, 2018, View Source;p=irol-newsArticle&ID=2366246 [SID1234529293]). Discovered by BeiGene, tislelizumab is being studied as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumors and hematologic cancers.

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Poster Presentations:

Title: Tislelizumab Combined with Chemotherapy as First-Line Treatment in Chinese Patients with Advanced Lung Cancer
Session 1: JCSE01 – Perspectives for Lung Cancer Early Detection
Location: Room 202 BD
Date: Sunday, September 23
Time: 07:30-11:15 EDT
Presenter: J. Wang

Poster: P1.04-36
Session 2: P1.04 Immuno-oncology
Date: Monday, September 24
Time: 16:45-18:00 EDT
Presenter: J. Wang

Title: Preliminary Results with Tislelizumab in Chinese Patients with Non-Small Cell Lung Cancer (NSCLC)
Poster: P2.04-29
Session: P2.04 Immuno-oncology
Date: Tuesday, September 25
Time: 16:45-18:00 EDT
Presenter: Y-L. Wu

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

Iovance Biotherapeutics, Inc., Corporate Presentation – September 2018.

On September 5, 2018 Iovance Biotherapeutics, Inc presented the Corporate Presentation (Presentation, Iovance Biotherapeutics, SEP 5, 2018, View Source [SID1234529316]).

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