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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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 Alligator reported dosing in the first clinical phase I dose escalation study (ClinicalTrials.gov: NCT02379741) in April 2015 (Press release, Alligator Bioscience, OCT 12, 2016, View Source [SID1234538691]). The study was later expanded to include both intratumoral and intravenous dose escalation. An additional clinical phase I study (ClinicalTrials: NCT02829099) started dosing on 9 October 2016. The second study is sponsored by Janssen Research & Development, LLC and includes dose escalation with ADC-1013 (JNJ-64457107) administered intravenously. The Alligator sponsored trial continues to enroll patients for intratumoral dose escalation, while further enrollment for intravenous dose escalation will take part in the Janssen study.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Per Norlén CEO at Alligator says that "The start of the Janssen trial is very exciting. ADC-1013 now enters a phase of development where Janssen assumes responsibility for all future clinical studies."

For further information, please contact:
Per Norlén, CEO, e-mail: [email protected]
Rein Piir, VP Investor Relations, e-mail: [email protected]
Office number: +46 46 2864280

About ADC-1013
ADC-1013 is an agonistic fully human monoclonal antibody targeting CD40, an immuno-stimulatory receptor found on antigen-presenting cells such as dendritic cells. The functional activity of ADC-1013 has been investigated in human and murine in vitro models. In in vitro models, stimulation of CD40 on dendritic cells initiates a process leading to a dramatic increase in T effector cells attacking the tumor. In addition, it is believed that once a tumor-specific memory is established, it may lead to long-term immunity to the cancer. Alligator granted Janssen Biotech, Inc., an exclusive, worldwide license to ADC-1013 in an agreement entered in August 2015.

On October 11, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that five new clinical trial sites in the U.S. have been activated in the Company’s global FOCUS Phase 3 clinical trial for patients with hepatic dominant ocular melanoma (the FOCUS Trial) (Press release, Delcath Systems, OCT 11, 2016, View Source;p=RssLanding&cat=news&id=2210776 [SID:SID1234515730]). These accredited centers join several other prestigious centers as active participants in the FOCUS Trial. Currently, Delcath now has a total of 8 cancer centers in the U.S. open for patient enrollment in the FOCUS Trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The new participating centers are:

Ohio State University Comprehensive Cancer Center
MD Anderson Cancer Center
Thomas Jefferson University Sidney Kimmel Cancer Center
University of Chicago Comprehensive Cancer Center
University of Maryland Greenebaum Cancer Center
"We are pleased to add these respected cancer research institutions to our FOCUS Trial, and to expand the regional coverage available to patients in the U.S. with ocular melanoma liver metastases," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath. "Interest in the FOCUS Trial has been strong, and we expect to achieve our goal of activating approximately 30 centers in both the U.S. and Europe in the coming months."

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 11, 2016 Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company, reported a collaboration with the Children’s Research Institute to conduct a clinical study of ThermoDox, Celsion’s heat activated liposomal encapsulation of doxorubicin, in combination with magnetic resonance-guided high intensity focused ultrasound (MR-HIFU) to treat relapsed or refractory solid tumors in children and young adults (Press release, Celsion, OCT 11, 2016, View Source [SID:SID1234515733]). This investigator-sponsored Phase I clinical study is being partially funded by the National Institutes of Health and is expected to commence in the fourth quarter of 2016.

"Even with the use of intensive therapy, the prognosis for children diagnosed with metastatic sarcoma and recurrent solid tumors remains poor and has not improved over the past three decades," stated Dr. Nicolas Borys, Celsion’s chief medical officer. "Recent advances in the use of non-invasive MR-HIFU coupled with novel therapies such as ThermoDox have demonstrated the clear potential to overcome the challenges to treating pediatric malignancies by enabling safer, more tolerable targeted therapies with the potential to change cancer treatment paradigms."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The trial targeting treatment of childhood sarcomas will be carried out as a multi-disciplinary collaboration among Celsion, the research groups of Dr. AeRang Kim, MD, PhD at the Children’s National Medical Center – Department of Hematology/Oncology, and Dr. Brad Wood and Dr. Rosandra Kaplan at the National Institutes of Health.

"Celsion’s experience in combining ThermoDox with HIFU, a non-invasive next generation heating technology, supports this very important research in childhood cancers. From a safe dose, ThermoDox’s proven ability to deliver high concentrations of an effective chemotherapy directly to a heated tumor makes it an ideal candidate for a trial involving children and young adults," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "This study will further define ThermoDox’s potential in combination with ultrasound-induced hyperthermia, and highlight potential applications of ThermoDox in combination with a broad range of heating technologies that could address an even larger population of patients."

ThermoDox is currently in late stage clinical trials in primary liver cancer and recurrent chest wall breast cancer. It is positioned for use with multiple heating technologies, and has the potential for applications in the treatment of other forms of cancer including metastatic liver and non-muscle invading bladder cancers.

About ThermoDox
Celsion’s most advanced program is a heat-mediated, tumor-targeting drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox has the potential to address a broad range of cancers.

Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism, rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, ThermoDox is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream. In the second mechanism, when an external heating device heats tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and into the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area related to tumor invasion, supporting more precise drug targeting.

On October 11,2016 Kite Pharma, Inc. (Nasdaq:KITE) reported that it will hold an Investor Day on October 18, 2016 in New York where the company will share updates on its advancing pipeline of chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates, next generation research and development programs, and KTE-C19 launch readiness. The event and live webcast will begin at 12:00pm Eastern Time (Press release, Kite Pharma, OCT 11, 2016, View Source [SID:SID1234515737]). The live audio webcast can be accessed through the Events and Presentations section under the Investors tab of Kite’s website at www.kitepharma.com. Following the live audio webcast, a replay will be available on Kite’s website for approximately 30 days.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

About KTE-C19

Kite Pharma’s lead product candidate, KTE-C19, is an investigational therapy in which a patient’s T cells are engineered to express a CAR to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. KTE-C19 has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.