On October 12, 2016 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported strategic leadership appointments to support the advancement of its portfolio of DNA-based cancer immunotherapies and infectious disease vaccines (Press release, Inovio, OCT 12, 2016, View Source;to-Advance-its-DNA-Immunotherapy-Product-Portfolio/default.aspx [SID:SID1234515766]). Inovio has an extensive pipeline of clinical-stage cancer immunotherapies highlighted by VGX-3100, which is entering phase III this year; and DNA vaccines in development for Zika, MERS and HIV, among others.

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Inovio adds two oncologists and a plasmid manufacturing expert reporting to Inovio’s Chief Medical Officer, Dr. Mark Bagarazzi:

Dr. Ildiko Csiki will serve Inovio as Vice President, Clinical Development, Oncology, responsible for advancing Inovio’s cancer programs. Prior to joining Inovio, Dr. Csiki had been clinical lead and senior director of clinical research at Merck & Co. where she guided Merck’s global solid tumor development program and was lead for several registration studies. Dr. Csiki also served as GSK’s director of clinical development and lead physician for the follicular lymphoma program. Dr. Csiki earned her MD and PhD degrees from Vanderbilt University School of Medicine and her BS in Biology and BA in Psychology from the University of Arkansas.

Dr. Jeffrey Skolnik, Vice President, Clinical Development, Oncology, will also direct Inovio’s cancer immunotherapy programs. Dr. Skolnik was previously vice president of clinical research at TetraLogic Pharmaceuticals, where he oversaw all global clinical assets. He also served as a medical director at GSK and AstraZeneca. Dr. Skolnik earned his MD at New York University, with honors in pathology, and his undergraduate degree from the University of Pennsylvania.

Robert J. Juba Jr. has been promoted to Vice President, Biological Manufacturing and Clinical Supply Management, and is responsible for ensuring the provision of Inovio’s SynCon plasmid DNA therapeutic and prophylactic vaccine candidates for clinical use. He has 22 years of experience in the pharmaceutical industry managing cGMP processes and operations, with extensive technical expertise in bacterial vaccine manufacturing. He led plasmid manufacturing at VGXI, Inc. and held several positions at Merck in bulk vaccine manufacturing operations and strategy. He holds Masters and BS degrees in Chemical Engineering from the Massachusetts Institute of Technology.
Inovio has also bolstered its manufacturing and business development functions with two additional staff reporting to Dr. Niranjan Sardesai, Inovio’s Chief Operating Officer:

Daniel Jordan will serve as Inovio’s Vice President, Device Manufacturing Operations. Previously he was vice president of U.S. and Canadian operations at Verisk Analytics, a 3M company. He has over 25 years of medical device manufacturing operations experience in early growth to mature organizations. Most recently he served as executive director of global operations at Teleflex Medical, a diversified medical device manufacturer. He earned an MBA in Finance from Weber University and a BS in Business Management at San Diego State University.

Dr. Paul Stead, Inovio’s Vice President, Business Development, will lead business development and partnering activities. He was vice president, business development at Nimbus Therapeutics, a company developing novel treatments for metabolic and immunological diseases, and oncology. For more than 20 years he served GSK in roles of increasing responsibility including business development, competitive intelligence and discovery chemistry. He holds an MBA from Lehigh University, a PhD in pharmaceutical sciences from the University of Nottingham, and a BS in Pharmacy from the University of Bath.
Dr. J. Joseph Kim, Inovio’s President & CEO, said, "We welcome these talented and experienced technical and business leaders to Inovio as we work to bring new breakthrough cancer medicines and vaccines to patients. It is gratifying that Inovio’s corporate culture, validated platform, and important product pipeline are attracting such accomplished executives to help us execute our product development and commercialization strategy."

On October 12, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that five clinical sites in Europe have been activated and are open for patient enrollment in the Company’s FOCUS Phase 3 clinical trial for patients with hepatic dominant ocular melanoma (the FOCUS Trial) (Press release, Delcath Systems, OCT 12, 2016, View Source;p=RssLanding&cat=news&id=2211160 [SID:SID1234515764]). The sites are the first centers in Europe to begin enrolling patients in the FOCUS Trial. One center, Charité University Hospital in Berlin, Germany, has treated its first patient. Delcath now has 13 centers in the U.S. and Europe open for patient recruitment, and expects up to 30 centers will participate in the FOCUS Trial.

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The following highly-accredited European centers are now open for patient enrollment:

Austria

University Hospital, Graz
Germany

Charité University Hospital, Berlin
University Hospital, Marburg
University Hospital, Regensburg
United Kingdom

University Hospital Southampton
"We are pleased to add these highly respected European cancer centers to our FOCUS Trial," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath. "This expansion allows Delcath to work with the some of Europe’s top universities and institutes while providing some of Europe’s leading clinicians with first-hand knowledge of our therapy, which will continue to be of great value as we expand our commercial footprint for CHEMOSAT as a treatment for ocular melanoma in Europe."

About the FOCUS Trial

The FOCUS Trial is a global Phase 3 clinical study evaluating the safety, efficacy and pharmacokinetic profile of the Company’s Melphalan/HDS system versus best alternative care in 240 patients with ocular melanoma liver metastases. The FOCUS Trial’s primary endpoint is a comparison of overall survival between the two study arms; secondary and exploratory endpoints include progression-free survival, overall response rate and quality-of-life measures. The FOCUS Trial is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that, if met, would support the submission for regulatory approval of Melphalan/HDS.

On October 12, 2016 Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) reported each company has entered into collaboration agreements with Abbott (NYSE: ABT), a leader in diagnostic technologies, to develop and commercialize companion diagnostic tests on Abbott’s m2000 RealTime System to identify isocitrate dehydrogenase (IDH) mutations in acute myeloid leukemia (AML) patients (Press release, Celgene, OCT 12, 2016, View Source [SID:SID1234515761]). Celgene is currently developing enasidenib (AG-221/CC-90007), an IDH2 mutant inhibitor, for the treatment of patients with relapsed or refractory AML who have an IDH2 mutation. Agios is developing AG-120, an IDH1 mutant inhibitor, for the treatment of patients with relapsed or refractory AML who have an IDH1 mutation.

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IDH1 and IDH2 mutations occur in approximately 20% of AML patients. An article published online this week in the journal Leukemia (Medeiros, Leukemia 2016) concluded that advances in the understanding of the genetics underlying myeloid malignancies are driving an era of development for targeted treatments such as IDH mutant inhibitors. The authors recommend that IDH mutational analysis should become part of the routine AML diagnostic workup and repeated at relapse to identify patients who may be eligible for targeted investigational treatments currently under clinical study.

"AML is a complex and heterogeneous disease, making it difficult to treat," said Han Myint, M.D., Vice President, Global Medical Affairs, Myeloid for Celgene. "IDH mutations lead to aberrant DNA methylation, causing a block in myeloid differentiation that leads to disease progression. Molecular profiling is important to identify genomic mutations which may have prognostic and potential treatment implications for patients with AML."

Abbott’s m2000rt RealTime System, is a polymerase chain reaction (PCR) instrument designed to enable clinical laboratories to automate PCR and results analysis, simplifying the complex and manual steps often associated with molecular diagnostics. Both Celgene and Agios have incorporated this screening into clinical trial designs, including the recently initiated Phase 3 IDHENTIFY trial comparing enasidenib with conventional therapy in older patients with an IDH2 mutation and relapsed or refractory AML (NCT02577406).

"The field of personalized medicine is advancing at a rapid pace for a broad range of medical conditions, especially within hematology-oncology," said Chris Bowden, M.D., chief medical officer at Agios. "Our collaboration with Abbott will provide a test to help identify AML patients with IDH mutations who are in need of treatment options."

The m2000 system has not been FDA cleared or approved for use with enasidenib or AG-120.

Enasidenib and AG-120 have not been approved for any use in any country.