On January 29, 2018 Ipsen (Euronext: IPN; ADR: IPSEY) reported that Sotirios
G. Stergiopoulos, MD, has been appointed as Chief Medical Officer (Press release, Ipsen, JAN 29, 2018, View Source [SID1234523600]).

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Dr Stergiopoulos joined Ipsen in January 2017 as Senior Vice President, Head of Global Medical Affairs (GMA) and will retain this
position in addition to the role as the new Chief Medical Officer within the company. Dr Stergiopoulos reports to Alexandre Lebeaut, MD, Executive Vice-President R&D and Chief Scientific Officer.

Dr Lebeaut commented, "Sotirios has extensive experience in directing global medical affairs
strategies and a strong expertise in oncology drug development that includes chemotherapy,
immunology drugs and targeted agents across various tumor indications. We are delighted to appoint
him to an expanded role through which he will make the voice of the patient heard at the highest levels
of the organization and represent the company externally as its primary medical representative."

Prior to joining Ipsen, Sotirios was Vice President, Head of Global Medical Affairs Oncology at Baxalta (now Shire, Cambridge, MA), Executive Medical Director Oncology US Medical Affairs at Celgene Corporation (Summit, NJ), Senior Global Brand Medical Director Oncology at Novartis Pharmaceuticals (East Hanover, NJ) and Director Medical Affairs Oncology at Bayer Healthcare
(Montville, NJ).

Dr. Stergiopoulos added, "I am delighted to take on this leading role at Ipsen. This is an exciting
time for Ipsen with significant growth and evolution. Together with our experienced leadership team,
I look forward to helping our company continue to bring innovative new medicines to our patients."

Dr. Stergiopoulos is a physician executive with significant experience in the Pharmaceutical/Biotech industry, especially in Oncology. He has held appointments as an Attending Physician and trainee in institutions such as Albert Einstein College of Medicine, Harvard Medical School and the National Institutes of Health. He holds a Masters in Biotechnology Enterprise and Entrepreneurship (MBEE) from The Johns Hopkins University and a Medical Degree from Poznan University of Medical
Sciences (Poland). Sotirios is a Fellow of the American College of Physicians, the New York Academy of Medicine as well as the Royal Society of Medicine (UK). He is also a Member of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
In October 2017 Dr. Stergiopoulos was appointed President of the Board of Governors for the Accreditation Council for Medical Affairs (ACMA); a body whose mission is to establish, certify, and maintain the competencies of qualified medical and scientific professionals who have a focus in Medical Affairs within the pharmaceutical & biotechnology industries.

On January 29, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that it will host a Key Opinion Leader (KOL) Event in New York on Tuesday, February 6th from 8-10:30 AM EDT (Press release, Pieris Pharmaceuticals, JAN 29, 2018, View Source [SID1234523614]).

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The KOL event will feature world-class thought leaders in immuno-oncology and respiratory diseases, followed by a company presentation. The event will include presentations from:

Michael A. Curran, PhD, Assistant Professor in the Department of Immunology and Scientific Director of the Oncology Research for Biologics and Immunotherapy Translation (ORBIT) platform at MD Anderson Cancer Center.
David H. Ilson, MD PhD, Medical Oncologist and Attending Physician at Memorial Sloan Kettering Cancer Center and Professor at Weill Cornell Medical College.
Gary Anderson, PhD, FThorSoc, FERS, Professor in the Medical Faculty at the University of Melbourne and Director of the Centre for Lung Health Research.
Bruce Levy, MD, Parker B. Francis Professor of Medicine at Brigham and Women’s Hospital and the Chief of the Pulmonary and Critical Care Division.
The event will be accessible via a live webcast through this link beginning at 8am on February 6th.

In-person attendance is by invitation only. For more information please contact Clayton Robertson at [email protected].

On January 29, 2018 Lee’s Pharm and Sorrento Therapeutics reported that the Chinese authorities have approved China Oncology Focus Limited (COF, an affiliate of Lee’s Pharmaceutical Holdings Limited, Hong Kong Stock Symbol: 0950.HK) to proceed with the clinical trials for ZKAB001, an anti-PD-L1 monoclonal antibody exclusively licensed to COF for Greater China territories, by Sorrento Therapeutics (Press release, Sorrento Therapeutics, JAN 29, 2018, View Source [SID1234532254]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The investigation sites will be:

Beijing Cancer Hospital
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Wuhan Union Hospital
Shanghai Sixth People’s Hospital
The trials will be anticipated to use a 3+3 design with 5mg/kg, 10mg/kg and 15mg/kg dosing regimens. Once the Maximum Tolerated Dose (MTD) has been established, additional patients are expected to be recruited in an expanded Phase 1 protocol. Clinical data from these studies could be available by the end of the year 2019, and positive results could lead to conditional approval of the antibody prior to a confirmatory Phase 3 study.

"We are proud to announce the acceptance of the IND for our anti-PD-L1 antibody ZKAB001. It’s further evidence for COF continued commitment to addressing high unmet oncology needs by bringing new effective immuno-oncology therapies to the Chinese market. Throughout the IND-enabling activities and the extensive IND review process by the Chinese FDA, the COF team has worked closely and efficiently with Sorrento colleagues. In the landscape of anti-PD-L1 therapies in China, we believe our program is part of the first wave of immune checkpoint inhibitors. Encouraged by our impressive preclinical data, we are excited about evaluating our immunotherapy and addressing unmet medical needs of cancer patients in the Greater China region. Based on this highly productive first joint project, we look forward to potentially expanding our partnership with Sorrento," said Dr. Xiaoyi (Benjamin) Li, Chief Executive Officer and Executive Director of COF.

"We believe COF’s progress in the development of cancer therapeutics for the Greater China market utilizing our G-MAB library of fully human antibodies is a testimony of the value of Sorrento’s comprehensive portfolio of immuno-oncology platform technologies and products acquired and developed over the years," stated Dr. Henry Ji, Chairman and CEO. "Although our own internal resources are currently focused on the development of CAR-T platforms and programs, we think we have shown success in collaborations and out-licensing of other therapeutic assets to a number of strategic partners. COF’s success in developing ZKAB001 could lead to milestone and royalty payments to Sorrento."

About ZKAB001 (anti-PD-L1 monoclonal antibody)

ZKAB001 is a fully human anti-PD-L1 monoclonal antibody (mAb), an immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting Natural Killer (NK) cells and other effector cells against the tumor potentially further strengthening the anti-tumor effect of the antibody. It was licensed from Sorrento Therapeutics, Inc. (SRNE) to COF in Q4 2014.

On January 29, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported that its Chief Medical Officer, Dr. Mark Kowalski, will present "Leveraging Synthetic Lethality to Enhance Clinical Trials with SRA737, a Next-Generation Chk1 Inhibitor" at the DNA Damage Response Therapeutics Summit in Boston, MA (Press release, Sierra Oncology, JAN 29, 2018, View Source [SID1234523616]). The presentation is scheduled for 2:15 pm Eastern Time (ET) on February 1, 2018.

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Sierra Oncology is a key sponsor of the DNA Damage Response Therapeutics Summit, which will gather leading stakeholders from across drug development over two days to discuss how to therapeutically exploit synthetic lethal interactions for targeted cancer therapy. This is the first industry-dedicated meeting focused on identifying the next generation of DNA damage response therapeutics, achieving efficacy across a range of contexts, optimizing synthetic lethal screening techniques and exploiting key targets of mechanisms of resistance.

On January 26, 2018 The U.S. Food and Drug Administration reported the approval of Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs) (Press release, US FDA, JAN 26, 2018, View Source [SID1234523587]). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.

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"GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing," said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "This approval provides another treatment choice for patients with these rare cancers. It also demonstrates how the FDA may consider data from therapies that are used in an expanded access program to support approval for a new treatment."

GEP-NETs can be present in the pancreas and in different parts of the gastrointestinal tract such as the stomach, intestines, colon and rectum. It is estimated that approximately one out of 27,000 people are diagnosed with GEP-NETs per year.

Lutathera is a radioactive drug that works by binding to a part of a cell called a somatostatin receptor, which may be present on certain tumors. After binding to the receptor, the drug enters the cell allowing radiation to cause damage to the tumor cells.

The approval of Lutathera was supported by two studies. The first was a randomized clinical trial in 229 patients with a certain type of advanced somatostatin receptor-positive GEP-NET. Patients in the trial either received Lutathera in combination with the drug octreotide or octreotide alone. The study measured the length of time the tumors did not grow after treatment (progression-free survival). Progression-free survival was longer for patients taking Lutathera with octreotide compared to patients who received octreotide alone. This means the risk of tumor growth or patient death was lower for patients who received Lutathera with octreotide compared to that of patients who received only octreotide.

The second study was based on data from 1,214 patients with somatostatin receptor-positive tumors, including GEP-NETS, who received Lutathera at a single site in the Netherlands. Complete or partial tumor shrinkage was reported in 16 percent of a subset of 360 patients with GEP-NETs who were evaluated for response by the FDA. Patients initially enrolled in the study received Lutathera as part of an expanded access program. Expanded access is a way for patients with serious or immediately life-threatening diseases or conditions who lack therapeutic alternatives to gain access to investigational drugs for treatment use.

Common side effects of Lutathera include low levels of white blood cells (lymphopenia), high levels of enzymes in certain organs (increased GGT, AST and/or ALT), vomiting, nausea, high levels of blood sugar (hyperglycemia) and low levels of potassium in the blood (hypokalemia).

Serious side effects of Lutathera include low levels of blood cells (myelosuppression), development of certain blood or bone marrow cancers (secondary myelodysplastic syndrome and leukemia), kidney damage (renal toxicity), liver damage (hepatotoxicity), abnormal levels of hormones in the body (neuroendocrine hormonal crises) and infertility. Lutathera can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception. Patients taking Lutathera are exposed to radiation. Exposure of other patients, medical personnel, and household members should be limited in accordance with radiation safety practices.

Lutathera was granted Priority Review, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition. Lutathera also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.