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Navidea Biopharmaceuticals Enrolls First Patient in Pediatric Trial of Lymphoseek®

On January 6, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), reported that the first pediatric patient was enrolled in a clinical study comparing Lymphoseek (technetium Tc 99m tilmanocept) injection and vital blue dye (VBD) in a pediatric population of patients with melanoma, rhabdomyosarcoma, or other solid tumors (Press release, Navidea Biopharmaceuticals, JAN 6, 2016, View Source;p=RssLanding&cat=news&id=2126657 [SID:1234508674]). The study is designed to investigate how Lymphoseek compares with VBD in identifying lymph nodes as well as evaluate safety and tolerability in the pediatric population. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer and is approved for adult use only. Enrollment is currently planned at approximately six sites throughout the U.S. The first patient has been enrolled by the Nationwide Children’s Hospital in Columbus, OH.

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"We are pleased to participate in this important clinical study of Lymphoseek in the pediatric patient population where no lymph node mapping agents have yet been approved," said Jennifer Aldrink, M.D., Assistant Professor of Clinical Surgery, The Ohio State University College of Medicine and Director of Surgical Oncology, Division of Pediatric Surgery at Nationwide Children’s Hospital in Columbus, OH. "Intraoperative Lymphatic Mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB) are standards of care in adult and pediatric patients in several forms of cancer, and Lymphoseek is a new agent being used in many adult centers as an alternative to sulfur colloid formulation. Lymphoseek may have the potential to aid physicians in evaluating lymph nodes in children that are necessary for accurate disease staging and optimal post-surgical treatment."

"This study will provide further data on the overall clinical value of Lymphoseek, which has already shown to be a highly effective immunodiagnostic tool in adult patients. Medical literature supports the importance of lymph node evaluations in pediatric patients with rhabdomyosarcoma and melanomas noting that lymph node metastases are highly associated with poorer survival," said Michael Tomblyn, M.D., Chief Medical Officer of Navidea. "Until now, there have been few studies of ILM and SLNB in children. We look forward to the opportunity to evaluate Lymphoseek’s use in pediatric populations."

This study (NAV3-18) is a prospective, open-label, multicenter study comparing Lymphoseek and VBD as lymphoid tissue targeting agents in pediatric patients with melanoma, rhabdomyosarcoma, or other solid tumors who are undergoing lymph node mapping. Primary goals of this study are to evaluate safety and tolerability of Lymphoseek in this subject population and determine the concordance of in vivo detection rates of Lymphoseek and of VBD in tissue excised and histologically confirmed as lymph nodes. In addition, the study will measure other efficacy signals including assessment of the identified lymph node(s) to confirm: the presence/absence of tumor metastases; agent localization per tumor type; degree of localization (nodes per subject both intraoperatively and with preoperative SPECT/CT); reverse concordance parameters; change of subject stage based on histopathology and descriptive assessment on change in treatment plan; number of lymph nodes detected with Lymphoseek intraoperatively compared with preoperative SPECT/CT imaging.

NextCure, Inc., New Immuno-Oncology Firm, Announces $67 Million Series A Financing

On January 6, 2016 NextCure, Inc., a newly formed biopharmaceutical company focused on the discovery and development of new immuno-oncology products, reported that it has raised a $67 million Series A financing (Press release, NextCure, JAN 6, 2016, View Source [SID1234523240]). Major investors in the financing Canaan Partners, Lilly Asia Ventures, OrbiMed Advisors, Pfizer Inc. and Sofinnova Ventures, were joined by Alexandria Venture Investments.

NextCure was founded in 2015 by Michael Richman, who will serve as its President and Chief Executive Officer, and Lieping Chen, M.D., Ph.D., United Technologies Endowed Professor of Cancer Research, Professor of Immunobiology, Dermatology, and Medicine at the Yale School of Medicine. The Company plans to develop product candidates licensed from Dr. Chen’s laboratory and has entered into a multi-year agreement with Yale University under which it will sponsor research and hire new scientists in Dr. Chen’s laboratory. In 2014, Dr. Chen received the William B. Coley Award for outstanding achievements in Basic and Tumor Immunology for his discovery of the PD-1/PD-L1 pathway as target for cancer immunotherapy. This pathway is targeted by two cancer immunotherapy drugs in current clinical use (Opdivo, Keytruda) and by many other products in clinical development.

"Immuno-oncology drugs are making a big impact on the survival of many cancer patients. Our research is targeted to finding new cures for those patients and tumor types which do not adequately respond to available therapy," said Dr. Chen.

"The NextCure management team is honored to once again collaborate with Dr. Chen and we are gratified by the support of our Series A investors in funding our ambitious target discovery and product development plans," said Mr. Richman. "The Company has begun recruiting scientists and will commence operations in the coming months."

Mr. Richman was previously President and Chief Executive Officer of Amplimmune, Inc., a biologics company focused on cancer and autoimmune diseases that was acquired by AstraZeneca plc. Three other former members of the Amplimmune management team will join Mr. Richman on the NextCure management team: Solomon Langermann, Ph.D., who will serve as senior vice president of research; James Bingham, Ph.D., senior vice president of development and manufacturing and Linda Liu, Ph.D., vice president of translational research. David Kabakoff, Ph.D., executive partner of Sofinnova Ventures, who was a co-founder of and Chairman of Amplimmune, will serve as Chairman of NextCure. Dr. Chen was also a scientific co-founder of Amplimmune and inventor of key programs developed by the company.

Cancer Research Technology, Cell Therapy Catapult and University of Birmingham launch new collaboration for CAR-T cell immuno-oncology therapy development

On January 6, 2016 The Cell Therapy Catapult, the UK organisation dedicated to the growth of the UK cell and gene therapy industry by bridging the gap between scientific research and commercialisation, the University of Birmingham and Cancer Research Technology, the commercialisation arm of Cancer Research UK, reported the launch of a collaboration to develop a new immuno-oncology cellular therapy based on gene modifying T cells to target solid tumours (Press release, Cancer Research Technology, JUN 6, 2016, View Source [SID1234523190]).

The project is aimed at translating an academic discovery programme funded by Cancer Research UK and developed by Dr Steven Lee and Prof Roy Bicknell at the University of Birmingham into a commercially viable cell therapy.

The collaborating partners have launched a new company, Chimeric Therapeutics Ltd. This new company will hold all future IP rights to the resultant discoveries.

The project is based on a new generation chimeric antigen receptor T-Cell (CAR-T) immuno-oncology therapy for solid tumours. This involves directing the CAR-T cell towards a new, highly specific marker of tumour angiogenesis, CLEC14a. This therapy will act as a vasculature disruptive agent compromising oxygen supply to the tumours and inhibiting tumour growth. The technology is currently undergoing the final stages of preclinical development, and is planned to enter into clinical trials soon after.

Cancer Research Technology and the University of Birmingham have partnered with The Cell Therapy Catapult to bring their extensive regulatory, clinical, analytical and manufacturing process development expertise into the program, utilising their experience in developing immunotherapies for cancer. The Cell Therapy Catapult will specifically be involved in the project to accelerate the translation of the academic discoveries made in Birmingham with Cancer Research Technology around CAR-T immunotherapies for solid tumours and the CLEC14a target towards a commercially available cell therapy.

"The Cell Therapy Catapult has extensive experience in working with early stage cell and gene therapies to develop them for clinical trial and commercialisation. We are delighted to assist Cancer Research Technology and Birmingham University to form this new company, Chimeric Technologies and apply this new CAR-T target to address solid tumours for the benefit of patients," said Keith Thompson, CEO, the Cell Therapy Catapult. "The Cell Therapy Catapult look forward to developing partnerships with other Cancer Research UK supported academic groups."

"Scientists at University of Birmingham have demonstrated that these new engineered CAR-T cells exhibit anti-tumour effects and therefore have considerable potential as a therapy," said David Coleman, Head of Spinout Portfolio, University of Birmingham. "We’re delighted to be working with Cancer Research Technology and the Cell Therapy Catapult, through this new spinout company, Chimeric Therapeutics Limited, in order to develop the technology further and into clinical trials."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re very pleased to partner with the Cell Therapy Catapult and bring their extensive experience to bear on this project. This new partnership builds on a very successful relationship with the University of Birmingham. Immunotherapy is an exciting area in cancer treatment and this technology could provide a powerful route to harness the power of the immune system to block the development of blood vessels, and stop tumours growing."

Immunocore and GlaxoSmithKline Select First ImmTAC Clinical Candidate in Discovery Collaboration

On January 6, 2016 Immunocore Limited, a world-leading biotechnology company developing novel T cell receptor (TCR) based biological drugs to treat cancer, viral infections and autoimmune disease, reported that GlaxoSmithKline (GSK) has selected the first clinical candidate as part of a discovery collaboration, resulting in an undisclosed milestone payment to Immunocore (Press release, Immunocore, JAN 6, 2016, View Source [SID1234518906]).

The candidate selected ImmTAC addresses a target relevant in a number of different cancer indications including synovial sarcoma, bladder and non-small cell lung (NSCL) cancers.

Immunocore will now undertake further preclinical testing and cGMP manufacture before progressing the ImmTAC to Phase I clinical development.

Eliot Forster, Chief Executive Officer of Immunocore, said: "We are delighted by the progress being made in our collaboration with GSK, one of our key alliance partners, and look forward to the first ImmTAC under this agreement entering the clinic in due course."

Bent Jakobsen, Chief Scientific Officer of Immunocore, said: "Our proprietary ImmTACs are soluble TCRs that naturally recognise diseased cells with ultra-high affinity and enable circulating T cells to be re-directed to kill the diseased cells. We believe that this technology has significant potential in the treatment of a range of cancers, and we are delighted to be working with GSK as it moves towards clinical development."

Axel Hoos, Vice President Oncology R&D at GSK, said: "Selection of this ImmTAC clinical candidate is an important milestone in our successful collaboration with Immunocore and speaks to the strong science underlying the ImmTAC platform. As GSK continues to explore potential next generation immuno-oncology therapies, we look forward to learning more about this asset as development progresses. "

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On January 6, 2016 Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and other molecular diagnostics, reported the signing of an agreement with Mirna Therapeutics (NASDAQ: MIRN), for a worldwide sublicense to Rosetta’s patents related to therapeutic uses of certain microRNA technologies (Filing, 6-K, Rosetta Genomics, JAN 6, 2016, View Source [SID:1234508680]).

The agreement includes an exclusive sublicense related to Mirna’s MRX34 product candidate, a mimic of naturally occurring microRNA-34 being evaluated in clinical studies for a variety of cancers.

Under the terms of the agreement, Rosetta Genomics will receive an upfront payment of $1.6 million from Mirna, and is eligible for low single-digit royalties on product sales and potential milestone payments and sublicense fees. The sublicensed patents are jointly owned by YEDA Research and Development Company Ltd., the commercial arm of the Weizmann Institute of Science, and Rosetta Genomics. As such, YEDA is entitled to a portion of these and other proceeds Rosetta may receive under the agreement with Mirna.

"We are pleased to execute this agreement with Mirna as it underscores the value of our leading intellectual property position in microRNA technology and represents a new avenue through which we can create value by leveraging our extensive patent portfolio," noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "We look forward to Mirna pursuing the potential of microRNAs as new and effective cancer therapeutics and believe microRNAs can play an important role in developing treatments for different cancers."