1stOncology™: Cancer Intelligence Service – Page 17112 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BeiGene and Merck KGaA enter into global co-develop and commercialization agreement for cancer therapy

On May 31, 2013 BeiGene and Merck KGaA reported that they have entered into a global licensing, co-development, and commercialization agreement for BeiGene-283 (Press release BeiGene, MAY 31, 2013, View Source [SID:1234500415]).
The compound is a second-generation BRAF inhibitor for the treatment of cancer. BeiGene-283, which is currently in preclinical development, was discovered and developed in the People’s Republic of China by BeiGene. It is expected to enter clinical development next year. BRAF inhibitors target a protein (BRAF) that is a downstream component of the MAPK pathway, which is thought to promote cancer cell growth and is dysregulated in a number of human cancers.
Under the terms of the collaboration, BeiGene will be responsible for the development and commercialization of BeiGene-283 in the People’s Republic of China and Merck KGaA will be responsible for the development and commercialization of BGB-283 for the rest of the world. BeiGene will receive an undisclosed upfront payment and is eligible to receive further payments of up to US$ 233 million for the achievement of clinical development and potential commercial milestones in both the People’s Republic of China and rest of the world, as well as up to double digit royalties on net sales.

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!

Cancer Research UK launches trial for potential new drug to block cancer cells’ energy supply

On May 31, 2013 Cancer Research UK’s Drug Development Office (DDO) has reported a new clinical trial of a brand new type of experimental drug to treat a range of cancers (Press release, Cancer Research Technology, 31 31, 2013, View Source [SID1234523256]).

The trial of the drug called AZD3965, developed by AstraZeneca, will be undertaken by Cancer Research UK’s National Institute of Health Research (NIHR) Experimental Cancer Medicine Centre, based at the Northern Institute of Cancer Research at Newcastle University, as well as at least one other clinical centre.

Approximately 63 cancer patients will take part in the first clinical trial of the compound to see if it is safe and can benefit cancer patients.*

Cancer Research UK’s DDO have collaborated closely with the trial clinical centres to plan, design and gain regulatory and ethical approval for this exciting first in class, first in man study. The DDO is sponsoring, funding and managing the trial whilst AstraZeneca is providing the drug.

Trial lead, Professor Ruth Plummer, Cancer Research UK clinician at the Northern Institute of Cancer Research at Newcastle University, said: "I’m excited to open this trial of a completely new type of cancer treatment, which continues our drive for the most effective new treatments to give patients the best chance of surviving this dreadful disease.

"It’s heartbreaking for cancer patients when the drugs have stopped working and they have run out of options. But we hope new drugs will be able to save their lives in the future."

AZD3965 targets monocarboxylate transporter 1 (MCT1) which is essential in cell metabolism. Blocking this transporter limits cancer cells’ ability to generate energy, and decreases their capacity to survive.

Susan Galbraith, head of the oncology innovative medicines unit at AstraZeneca, said: "Targeting tumour cell metabolism represents a novel and exciting approach to potentially treat cancer. AstraZeneca is delighted to be working with Cancer Research UK to investigate the utility of AZD3965 which is aimed to address the needs of cancer sufferers."

The drug has been developed through Cancer Research UK’s Clinical Development Partnerships (CDP) scheme.**

CDP is a joint initiative between Cancer Research UK’s DDO and Cancer Research Technology, to progress promising anti-cancer agents which pharmaceutical companies do not have the resources to progress, through early phase clinical trials. This is the fifth drug from the scheme to enter clinical trials.

Dr Nigel Blackburn, director of drug development at the DDO, said: "We’re delighted to open this clinical trial of such a promising new drug which cuts off the energy supply to tumour cells and kills them.

"This is the fifth drug from our CDP programme to reach clinical trials – without the scheme it simply might not have been possible to provide this drug to patients. We’ll continue to build on these successes to accelerate the development of further treatments though new trials of drugs which otherwise may not have reached patients for many years."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Burzynski Research Institute has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

Alethia Biotherapeutics and IBC Generium sign agreements

On May 29, 2013 Alethia Biotherapeutics Inc., a privately held biotechnology company focused on developing therapeutic monoclonal antibodies (mAb) reported that it has entered into a global strategic alliance with the International Biotechnology Center (IBC) Generium to jointly develop AB-16B5, a mAB inhibitor of epithelial-to-mesenchymal transition (EMT) (Company Pipeline, Alethia Biotherapeutics, MAY 29, 2013, View Source [SID1234518222]).

Under the terms of the alliance, Alethia and IBC Generium will collaborate for the ongoing development of AB-16B5 and, upon completion of the initial clinical study, share equally in the downstream economics in territories outside Russia and the CIS states. Alethia will receive an upfront cash payment and R&D funding to conduct the initial clinical study in Canada. In addition, to an exclusive license granted to IBC Generium for other territories, IBC Generium has also been granted the right to an exclusive license for Russia and the CIS states for which development milestones and royalties would be payable to Alethia. Further financial terms were not disclosed.

"We are very excited to conclude this global strategic alliance with IBC Generium," said Yves Cornellier, President and CEO of Alethia. "Like Alethia, IBC Generium is dedicated to improving the treatments available to cancer patients and is committing significant resources to develop innovative biological therapeutics including AB-16B5"

Mr. Daniil Talyanskiy, Chief Business Officer at IBC Generium commented: "We are very pleased to have formed this global strategic alliance with Alethia. EMT is a key contributor to both tumor invasion and the emergence of resistance to many cancer therapies. The excellent EMT inhibitor program developed at Alethia represents a unique opportunity for our company to accelerate the development of a novel therapy with potential applications in multiple cancer indications."

"This transaction with IBC Generium represents an important milestone for Alethia" commented Mrs. Ela Borenstein from BDC Capital. "It serves as recognition of the excellent preclinical development performed at Alethia to date, added Mr. Louis Lacasse of Agechem Venture Fund. Progressing to a clinical stage company through the advancement of AB-16B5 contributes to the potential for material value creation for Alethia’s shareholders."

Ignyta Announces Acquisition of Actagene Oncology and Entry into Oncology Personalized Medicine

On May 20, 2013 Ignyta, Inc. reported that it has acquired Actagene Oncology, Inc., effective May 20, 2013. Actagene was a San Diego based privately held biotechnology company founded in February 2013 that was developing personalized medicines for high unmet need cancer indications, based on cancer genome mining and sequencing (Press release, Ignyta, MAY 20, 2013, View Source [SID1234625377]).

With the acquisition, Ignyta has evolved its business strategy from a sole focus on molecular diagnostics for autoimmune disease to an integrated "Rx/Dx" focus on drug and biomarker discovery and development for cancer and immunology. Patrick O’Connor, Ph.D., CEO of Actagene Oncology, has joined Ignyta as Chief Scientific Officer and SVP, Head of Research. His contributions to the field of oncology include over 100 publications and patents and over 20 compounds brought into development, including the recently approved anticancer drugs Xalkori (Crizotinib) and Inlyta (Axitinib), discovered at Pfizer where Dr. O’Connor served as the Global Research Therapeutic Area Head for Oncology.

Other additions to Ignyta’s management team include Jean-Michel Vernier, Ph.D., who formerly led chemistry groups at Ardea Biosciences, Valeant Pharmaceuticals and Merck Research Laboratories, to serve as VP, Medicinal Chemistry; Paul Pearson, Ph.D., former Global Head and VP, Pharmacokinetics and Drug Metabolism at Amgen, to head PK, Drug Metabolism & Safety; and Dave Matthews, Ph.D., the scientific founder of Agouron Pharmaceuticals, to head Crystallography at Ignyta. James Bristol, Ph.D., former Worldwide Head of Pfizer Discovery and Former Head of Discovery and Chemistry at Warner-Lambert/Parke Davis, at which site Lipitor was discovered by his Chemistry team, joined Ignyta’s Scientific Advisory Board.

"The Actagene acquisition provides Ignyta with a strategic entry into oncology personalized medicine, an area with high unmet medical need and opportunities to give patients customized treatment options that leverage Ignyta’s biomarker discovery capabilities. Ignyta also gains the addition of Patrick O’Connor and the rest of his world class oncology drug hunter team that has collectively discovered and developed 10 approved drugs representing over $5 billion in 2012 sales," said Jonathan Lim, M.D., chairman and CEO of Ignyta. "Actagene’s R&D team complements Ignyta’s existing team, platform and capabilities, such as whole genome methylation analysis, next generation sequencing, Methylome database, and bioinformatics expertise. This transaction reshapes us into a seamless Rx/Dx company pursuing a significant growth area of patient stratification and targeted drug discovery and development for cancer patients."

Actagene Oncology applies its proprietary Oncolome database and technologies such as synthetic lethal screening, x-ray crystallography and structure-based drug design to develop new chemical entities against genetic targets that are enriched in certain cancer populations.

"I am excited for the Actagene team to join forces with the Ignyta team, several of whom I had the pleasure to previously work with when I was at Halozyme," said Dr. O’Connor. "Actagene’s Oncolome platform will combine synergistically with Ignyta’s Methylome platform to provide both genetic and epigenetic insights from patient tumor samples to identify and pursue personalized medicines against activated genes in cancer. The driving scientific focus for our new company will be the discovery and development of revolutionary new drugs targeting activated genes driving cancer growth and evasion of the immune system."

In addition to its new focus on targeted therapeutic discovery for cancer, Ignyta will continue to advance its companion diagnostic initiatives to generate epigenetic signatures that are predictive of treatment response for specific drug mechanisms within both autoimmune disease and cancer.