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Discontinued development of obatoclax in lung cancer (Presentation, Teva Investor Day, Teva, DEC 11, 2012, View Source [SID:1234500811]).

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Amgen to Acquire deCODE Genetics, a Global Leader in Human Genetics

On December 10, 2012 Amgen (NASDAQ:AMGN) and deCODE Genetics reported that the companies have entered into a definitive agreement under which Amgen will acquire deCODE Genetics, a global leader in human genetics, headquartered in Reykjavik, Iceland (Press release, Amgen, DEC 10, 2012, View Source;p=irol-newsArticle&ID=1765710 [SID:SID1234515199]). The all-cash transaction values deCODE Genetics at $415 million, subject to customary closing adjustments, and was unanimously approved by the Amgen Board of Directors.

"deCODE Genetics has built a world-class capability in the study of the genetics of human disease," said Robert A. Bradway, president and CEO at Amgen. "This capability will enhance our efforts to identify and validate human disease targets. This fits perfectly with our objective to pursue rapid development of relevant molecules that reach the right disease targets while avoiding investments in programs based on less well-validated targets."

Founded in 1996, deCODE Genetics is a global leader in analyzing and understanding the link between the genome and disease susceptibility. Using its unique expertise and access to a well-defined population in Iceland, deCODE Genetics has discovered genetic risk factors for dozens of diseases ranging from cardiovascular disease to cancer.

"One of the ways to truly realize the full value of human genetics, is to make our research synergistic with drug development efforts where target discovery, validation and prioritization efforts can be accelerated," said Kari Stefansson, M.D., Dr. Med., founder and CEO at deCODE Genetics. "We believe Amgen’s focus and ability to incorporate our genetic research into their research and development efforts will translate our discoveries into meaningful therapies for patients."

This transaction does not require regulatory approval, and is expected to close before the end of 2012.

UT MD Anderson, GlaxoSmithKline to collaborate on new approach to cancer immune therapy; success could earn cancer center $335 million plus royalties

On December 7, 2012 The University of Texas MD Anderson Cancer Center and GlaxoSmithKline (GSK) have signed a research collaboration and license agreement to develop new therapeutic antibodies that promote an immune system attack against cancer (Press release MD Anderson, DEC 7, 2012, View Source [SID:1234500845]).

Under terms of the agreement, MD Anderson grants GSK exclusive worldwide rights to develop and commercialize the antibodies, which activate OX40 on the surface of T cells. They were discovered by Yong-Jun Liu, M.D., Ph.D., and colleagues when he was professor and chair of MD Anderson’s Department of Immunology.

MD Anderson, through its new Institute for Applied Cancer Science (IACS), will collaborate with GSK to conduct preclinical research on the antibodies.

"This agreement is not only a tribute to the ability of MD Anderson scientists to discover new targets and potential therapies against those targets for cancer patients, it’s also a testament to the vision shared by GSK and MD Anderson that successful clinical development of oncology drugs requires seamless integration of drug development expertise and deep biological knowledge," said Giulio Draetta, M.D., Ph.D., IACS director. "The IACS was formed to enable precisely such integration to expedite the accurate translation of great science into drugs."

The overall potential value of the agreement to MD Anderson over the life of the agreement is estimated at more than $335 million. Under the terms of the agreement, MD Anderson will receive an upfront license payment and funding for IACS research collaboration activities, as well as payments for reaching development, regulatory and commercial milestones. In addition, MD Anderson will also be entitled to royalties deriving from the commercial sales of products developed under the collaboration.

"We’re excited about this opportunity with GSK to improve cancer treatment," Draetta said. "The IACS is a drug development engine with industry-seasoned scientists embedded in a comprehensive cancer center, and as such is ideally suited for this type of collaboration."

The institute is a vital platform resource for MD Anderson’s recently announced and unprecedented Moon Shots Program, which focuses resources and diverse expertise to significantly reduce mortality in the short term and promote cures long term, beginning with eight inaugural cancers.

Unleashing the immune system

Malignant cells are an abnormality that usually attracts a response from the body’s immune system, yet cancer often survives by evading or thwarting anti-tumor immunity. Consistently unleashing the power of the immune system against cancer would be a major step forward for cancer patients.

T cells are lymphocytes, a type of white blood cell produced by the thymus, equipped with receptors that recognize and bind to antigens, which may include abnormal cells.

"T cell recognition of a tumor antigen is not enough to activate the T cells against cancer cells, they need a secondary signal to tell them ‘that antigen you have is a bad thing, you have to attack,’" said Liu, who is now chief scientific officer and vice president of the Baylor Research Institute of the Baylor Health Care System in Dallas.

OX40 is one of these secondary or co-stimulatory receptor proteins. Liu and colleagues found that when it’s activated, it enhances immune attack and blocks suppressors of immune response.

Liu and his MD Anderson colleagues generated and screened hundreds of antibodies that could potentially act as on switches for OX40 by mimicking its natural activator, OX40L, a molecule that binds to OX40. Years of research narrowed the candidates to a handful of activators, or agonists, which were tested in mice and then altered for human use.

"It’s gratifying to see MD Anderson and GSK take this important step towards translating a basic science discovery into a potential new therapy that can proceed to clinical trial," Liu said.

Initial clinical trials will occur only after necessary preclinical drug development conducted under the agreement succeeds.

On December 4, 2014 Parabon NanoLabs reported that it has received a joint grant award from the National Science Foundation (NSF) for a project with Janssen Research & Development, LLC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Press release , DEC 4, 2012, View Source [SID:1234501617]). The funds will support development and testing of a novel therapeutic for prostate cancer – the most common cause of death from cancer in men over age 75. The compound under investigation, PJ-01, will be produced using Parabon’s Essemblix Drug Development Platform, a powerful combination of computer-aided design (CAD) software for designing macromolecules and nanoscale fabrication technology for their production.

With input from Janssen scientists, the Parabon research team has designed PJ-01 to deliver an FDA approved chemotherapy drug, docetaxel, specifically to prostate tumor cells. Targeting cancerous tissue and avoiding healthy tissue can enable lower doses of the chemotherapy drug to be used, which in turn is expected to reduce unwanted side effects. In addition, the compound is outfitted with molecules to make prostate cancer cells more responsive to the treatment, with the goals of improving efficacy and reducing side effects. The effort will add to Parabon’s oncology drug pipeline, which includes compounds for treating glioblastoma, a deadly form of brain cancer.

The NSF grant program that funds the work, called Technology Enhancement for Commercial Partnerships (TECP), is a supplemental funding opportunity available only to companies, such as Parabon, that have received a Phase II Small Business Innovation Research (SBIR) award from NSF. It is intended to foster co-development relationships between SBIR awardees and strategic corporate partners.

"The NSF TECP program not only funds groundbreaking research," said Dr. Steven Armentrout, President and CEO of Parabon NanoLabs, "it also enables small business innovators to establish valuable industry relationships. With intellectual partnership from Janssen’s creative scientists, we are confident this project will further validate our Essemblix platform."

The project allows Janssen scientists to test Essemblix compounds in a rigorous and cost controlled manner. Dr. Edward Lawson, a principal scientist at Janssen and lead advisor on the project, said, "We are excited about our collaboration with Parabon and the potential of this new technology to enable us to bring innovative treatments to patients faster."

Eporgen’s Portfolio Company Genovax Sells GX301, its Clinical-Stage Therapeutic Vaccine for the Treatment of Various Types of Cancer, to Mediolanum Farmaceutici

On December 3, 2012 Mediolanum Farmaceutici SpA, a privately owned company that leads the Mediolanum Farmaceutici Group of companies, and Genovax srl, a private company which belongs to the portfolio of Eporgen Venture and was originated from the University of Genoa, reported the acquisition by Mediolanum of the global rights to GX301, Genovax’s therapeutic vaccine to treat various types of cancer (Press release, Mediolanum Farmaceutici, DEC 3, 2012, View Source [SID:1234514894]). The first clinical study with GX301 was successfully completed earlier this year in prostate and renal cancer patients. Further clinical studies are scheduled to be initiated in the next few months, and all future development and commercialization activities will be the responsibility of Mediolanum with the support of Genovax. Under the agreement, Genovax will receive upfront and milestone payments as well as royalties.

The acquisition of Genovax’s innovative therapeutic vaccine for the treatment of various type of cancer is part of a strategy that we initiated since the late ’90s and is a testament to our commitment to Research and Development", said Dr Rinaldo Del Bono, founder and President of Mediolanum Farmaceutici. "The acquisition of GX301 expands the interests of Mediolanum to a new therapeutic area (oncology). We look forward to advancing the development of the product through to its worldwide registration and make it available to cancer patients as soon as possible" added Dr Del Bono.

Dr Domenico Criscuolo, President of Genovax commented: "The agreement with Mediolanum is a remarkable achievement, which confirms the vision of all researchers who trusted in the therapeutic potential of GX301. In only four years Genovax’s team was able to consolidate with clinical results the original idea and to attract the interest of Mediolanum, which will lead the further development work. My personal thanks to all Genovax team members, for their dedication and support to GX301 project, and a special acknowledgement to the memory of Silvano Fumero, who shared my enthusiasm for this project, and was instrumental for the foundation of Genovax."

Genovax was founded in March 2008 in Ivrea by Prof. Francesco Indiveri, Prof. Gilberto Filaci, Dr Daniela Fenoglio, Dr Giuseppe Balbi and Dr Domenico Criscuolo, with the financial support of Eporgen Venture. The science behind Genovax’s technology was originated at the Centre of Excellence for Biomedical Research (CEBR), which is based at the University of Genoa. Konstantinos Efthymiopoulos, President of Eporgen Venture said: "We are delighted by this event which is the first major transaction of a company in our portfolio. It validates the vision of Eporgen’s founder, the late Dr Silvano Fumero, and vindicates the 70 private shareholders of Eporgen who also believed in it and are nurturing innovation, Italian science and scientists and hope that new therapies will eventually emerge through their financial support. We would like to congratulate the Genovax team for bringing GX301 thus far and to wish every success in the further development of the product, hoping that it will become a life saving therapy for cancer patients."

Further notes for Editors:

About GX301

GX301 is a telomerase-based vaccine against cancer, which completed in February 2012 the first phase I study in prostate and renal cancer patients with very promising results. The study was conducted in Italy and showed that GX301 was very well tolerated and that induced vaccine-specific immune response in all patients. Disease stabilisation was observed in about one third of the patients and overall survival was longer than expected. GX301 is composed by multiple peptides and adjuvants and is designed to induce potent immune responses that are specific for cancer cells through the activation of both CD4+ and CD8+ T lymphocytes. It is envisaged that GX301 may be useful also in other types of cancer and this will be explored in future clinical studies.