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.

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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 12, 2016 Transgenomic, Inc. (NASDAQ: TBIO), and privately-held Precipio Diagnostics, LLC reported entry into a merger agreement, pursuant to which Precipio will become a wholly owned subsidiary of Transgenomic, and Transgenomic will be renamed Precipio, Inc (Press release, Transgenomic, OCT 12, 2016, View Source [SID:SID1234515801]). In connection with the merger, it is anticipated that the original Precipio security holders will receive between 62% and 80% of the outstanding shares of the combined company, depending on the relative amount of outstanding liabilities of the parties at closing and prior to the investment of new capital. The merger is expected to close in 2016, pending approval by Transgenomic shareholders and other closing conditions set forth in the merger agreement. Simultaneous to the merger, the combined company will receive an investment of up to $7 million from a syndicate led by BV Advisory Partners in a private placement of preferred convertible securities, and $3.0 million of outstanding debt of each company is expected to convert into this same class of preferred convertible securities. This comprehensive transaction will provide the Company with a clean balance sheet and sufficient capital to achieve its planned expansion.

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Transgenomic has filed to complete a reverse stock split of between one-for-ten and one-for-thirty before the merger closes, and the company’s outstanding debt is expected to convert into common and preferred shares. The companies expect that shares of the combined company will be listed on the NASDAQ exchange and trade under the "PRPO" ticker (subject to filing and approval by NASDAQ). The merger agreement provides that, Ilan Danieli, Precipio founder and Chief Executive Officer, will serve as the Chief Executive Officer of the combined company. BV Advisory Partners is acting as advisor to the transaction.

Paul Kinnon, Transgenomic President and Chief Executive Officer, said "In recent years we have transitioned from a provider of conventional life science tools and diagnostic services into an innovative biotechnology enterprise focused on advancing precision medicine. We have done this through our revolutionary ICE COLD-PCR (ICP) technology, which enables accurate, non-invasive tumor profiling using circulating DNA in patient plasma. We have established a solid platform for commercialization of ICP, with leading global distributors and a solid pipeline of potential agreements with partners and customers. This is a good time to join forces with Precipio, which shares our commitment to accurate and timely advanced cancer diagnostics and has established an impressive infrastructure of academic experts and a growing customer base, validated by successful case studies. I look forward to working with my new colleagues to ensure a successful transition."

Ilan Danieli, Precipio founder and Chief Executive Officer, said "We are proud of Precipio’s progress in building a growing platform that provides unique services to cancer patients and their physicians by providing a demonstrated superior level of diagnostic accuracy, ensuring that patients receive the best possible treatment. Cancer misdiagnosis is an all too common and underappreciated problem, which frequently has a negative impact on patient treatment, and may cause needless loss of life. We provide both primary and second opinion screening, and our network of leading academic cancer researchers and advanced diagnostic technologies have proven to be an invaluable resource for patients and physicians. Our entire team is committed to ensuring that our services are made widely available. To that end we will continue building out our sales team to accelerate adoption and revenue growth. We believe Transgenomic’s ICP technology and commercial infrastructure fit well with our values and our business model, and look forward to this next stage of growth, as we work together to integrate our teams, technologies and services."

Keith Barksdale, Founder of BV Advisory Partners, commented, "Transgenomic and Precipio have complementary strengths with the potential to be a dynamic and strong competitor in the rapidly growing market for advanced cancer diagnostics. ICP is a revolutionary mutation detection technology that is now available through global distributors, and adoption by drug researchers and developers is ramping up. The technology is also available to help guide cancer diagnosis and treatment through Transgenomic’s CLIA laboratory. Precipio’s platform of leading academic cancer experts provides superior diagnostic accuracy level to oncologists and their patients; it represents a unique resource that can benefit from and leverage the power of ICE COLD-PCR. We look forward to working with the combined company going forward to help assure its growth and success."

Transgenomic’s ICE COLD-PCR offers major advantages over current sequencing technologies. It delivers at least a 100-fold improvement in sensitivity compared to standard methodologies, allowing detection of both known and previously unknown genetic alterations in any exon of any gene using a single assay. It is robust, easy to use and easily implemented, requiring minimal disruption to established sequencing workflows. It is available as ICEme Kits that deliver up to a 500-fold increase in mutation detection compared to most current methods, with levels of detection routinely achievable down to 0.01%. This ultra-high sensitivity enables detection of low level mutations and allows accurate patient monitoring as well as stratification of cancer sub-populations. ICEme Kits are compatible with most patient samples, including tissue, blood, plasma, urine and other biofluids. The kits are simple to use and work with most of the genomic analysis platforms available in laboratories today. They are easily customizable for use with single mutations or multiple mutations in combination. The current menu includes approximately 20 clinically relevant, actionable mutations that are associated with important cancers. The ICP range of mutation targets is being expanded on an ongoing basis.

ICE COLD-PCR was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology exclusively to Transgenomic.

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.