Spectrum Pharmaceuticals Announces Dr. Francois Lebel as Chief Medical Officer

On October 18, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported the appointment of Francois Lebel, M.D., F.R.C.P.C. as Chief Medical Officer, effective November 5, 2018 (Press release, Spectrum Pharmaceuticals, OCT 18, 2018, View Source [SID1234530082]).

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"Dr. Lebel is an accomplished leader and has deep expertise in biopharmaceuticals with an emphasis in oncology drug development," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Given his qualifications, we believe Dr. Lebel will add significant value to Spectrum and our clinical programs. We have several near-term milestones and priorities including expanding the development of poziotinib in broader patient populations, gaining regulatory clarity for breakthrough designation on poziotinib, and filing the ROLONTIS BLA in the fourth quarter."

Dr. Lebel will be responsible for leading the Spectrum clinical program which includes directing the clinical research staff, overseeing the company’s ongoing clinical trials, and regulatory submissions. He will also direct clinical development strategies, life-cycle management, relationships with regulatory bodies and provide strategic counsel on all business development activities.

"It is a great time to have the opportunity to lead the medical and scientific organization at Spectrum ahead of multiple FDA submissions," said Francois Lebel, M.D., F.R.C.P.C, Chief Medical Officer of Spectrum Pharmaceuticals. "In evaluating Spectrum’s pipeline drugs, I have been very impressed with the robust clinical data, especially the recently released poziotinib data in heavily pretreated lung cancer patients who have very few options. I plan to aggressively expand the utility of this targeted therapy in areas of high unmet medical need. I look forward to leading Spectrum into a new era in medical and clinical development with the goal of significantly advancing patient care in oncology."

Dr. Lebel brings nearly 30 years of clinical leadership experience within the biopharmaceutical industry. He has designed and managed global medical organizations to deliver results, enhance productivity and practice sound risk management. Most recently, he served as the Executive Vice President of Research & Development, Chief Medical Officer at ZIOPHARM Oncology. He also held various leadership roles including Vice President of Research & Development at Baxter International and Global Head of Medical and Scientific Affairs at MedImmune. In the last 25 years, he provided strategic leadership on eight NDA/BLAs in various therapeutic areas and on a number of mergers and acquisitions. Dr. Lebel has broad and deep experience in oncology drug development, medical affairs, regulatory and pharmacovigilance acquired through various roles of increasing responsibilities at Chiron (Novartis), Warner-Lambert (Pfizer) and Burroughs Wellcome (GSK). He received his medical degree from the University of Ottawa, Canada, and he completed his post graduate training at McGill University and Harvard Medical School. He is Board Certified in Internal Medicine and a fellow of the Royal College of Physicians of Canada.

Biocure Announces: Breakthrough Pre-Clinical Trial Results for CAR-T Cells Treatment of Acute Leukemia

On October 18, 2018 Biocure Technology Inc. (CSE: CURE) (OTCQB: BICTF) (the "Company" or "Biocure") reported the successful results of the Pre-Clinical Trial of safety and toxicity of CAR-T cells based treatment for Acute Lymphocytic Leukemia (Press release, Biocure Technology, OCT 18, 2018, View Source [SID1234628760]).

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This is the first breakthrough milestone achieved in Korea and serves as a pre-requisite by Korea FDA (KFDA) for proceeding to an IND (Investigation of a New Drug) application.

The trial results demonstrated a complete remission of the cancerous cells within 7 and 28 days from the injection of reengineered CAR-T cells into a mouse. The study further showed encouraging results as no toxicity symptoms have risen from the high-volume injection. Company believes these to be strong indicators for the next phase clinical trials.

CAR-T cells are a novel form of potential treatment for cancer by "enlisting" and strengthening the power of a patient’s own immune system to attack cancerous tumors. T-Cells are the fundamental protection agent of the human immune system and plays a critical role in orchestrating the immune response and killing cells infected by pathogens.

CAR-T cells immunotherapy essentially "trains" or "engineers" T-Cells to recognize specific cancer related proteins or antigens (CD19 in this case) and thus attach themselves to that cancer cell and destroy it specifically without harming healthy cells. The T-Cells are taken from the patient’s own blood, being reengineered (or "trained") and reintroduced back into the body with their new abilities to fight specific cancerous cells. The "training" entails a production of new receptors on the T-Cell surface that now will enhance the T-Cell with the ability to recognize/attach itself to the cancerous cell’s surface proteins/antigens. These new T-Cell receptors are called "Chimeric Antigen Receptors" or CARs in short which coined the industry name of this novel treatment to "CAR-T".

The trial, first of its kind in the history of Korea, is a result of a wide Korean scientific collaboration. BioCure has performed the trial via its wholly owned subsidiary BiocurePharm in collaboration with Pharos Vaccine with the assistance of Osong Medical Innovation Foundations as the trial CRO (Contract Research Organization) and Croen Corp. who led the toxicity tests under GLP (Good Laboratory Practice) standards.

Biocure has successfully completed the safety test of a Biodistribution analysis study and toxicity study for single dose intravenous injection as per the Korea FDA guidelines. This milestone allows BioCure to advance into the actual production of anti-CD19 CAR-T Cell for a clinical trial.

The Company has already contracted CdmoGen Co. Ltd. and Master Cell Bank to produce a Lentiviral Vector under GMP standards necessary for advancing to the next stage of CAR-T Cell based clinical trials.

Agios to Webcast Conference Call of Third Quarter 2018 Financial Results on November 1, 2018

On October 18, 2018 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company will host a conference call and live webcast on Thursday, November 1, 2018 at 8:00 a.m. ET to report its third quarter financial results and other business highlights (Press release, Agios Pharmaceuticals, OCT 18, 2018, http://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-third-quarter-2018-financial [SID1234530260]).

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A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 5285068. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event

Bexion Pharmaceuticals, Inc. Represented at 15 th Annual BioNetwork Partnering Summit

On October 18, 2018 Bexion Pharmaceuticals, Inc., a clini cal stage biotechnology company focused on developing innovative cures for cancer, reported that Dr. Ray Takigiku, Founder and CEO of the Company presented recently at the 15 th Annual BioNetwork Partnering Summit, held in Laguna Nigel, CA from October 10 – 12, 2018 (Press release, Bexion, OCT 18, 2018, View Source [SID1234530294]). Chosen by the National Cancer Institute as part of its SBIR Investor Initiatives program, Bexion was among a select group of companies th at the N CI sponsored to present at this annual biotech industry financial partnering forum.

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Over 200 se nior decision makers in pharma and biotech deal making attend ed the conference to pursue relationships for partnerships and investment opportunities.

Dr. Takigiku presented the Bexion story to the audience and participated in numerous one to one meetings with pharma organizations.

About NCI SBIR Investor Initiatives Program

Through the Investor Initiatives Program, the National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Development Center connects NCI SBIR funded companies wi th potential investors and strategic partners to continue the research and commercialization efforts initially funded by NCI. Companies must apply and are selected by a panel of independent experts including over 50 Venture Capital organizations and potent ial strategic partners.

Delcath Announces Enrollment of First Patient in ALIGN Trial

On October 18, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that patient treatments have begun in the Company’s second global US registration trial investigating Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) in the treatment of patients with intrahepatic cholangiocarcinoma (ICC) (Press release, Delcath Systems, OCT 18, 2018, View Source;p=RssLanding&cat=news&id=2372259 [SID1234530000]).

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The University of Tennessee Health Science Center (UTHSC) in collaboration with Methodist University Hospital (MUH) and West Cancer Center (WCC) in Memphis, Tennessee have enrolled the trial’s first patient and treatments have begun by a team led by Dr. Evan S. Glazer. Dr. Glazer, a board certified surgical oncologist, is the principal investigator for the trial at the UTHSC/MUH/WCC location.

The trial, entitled A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma, (the ALIGN Trial) will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe.

"ICC is a deadly form of liver cancer, and the current treatment options have only shown very limited benefit," said Dr. Evan Glazer, "Our team is encouraged by the initial data available for Melphalan/HDS and are pleased to participate in this trial to explore this therapy’s potential as a new treatment option for these patients. We are most excited by the multi-disciplinary approach that this trial takes to help our patients."

"We are delighted to be working with Dr. Glazer and the team in Memphis to initiate The ALIGN Trial," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "In this orphan population where there exists a large unmet need, this trial provides us with a potential second pathway to commercial drug approval in the United States, and if successful we believe will be an important value driver for Delcath."