On October 5, 2009 AstraZeneca reported that it has to double its investment in Cancer Research UK’s biomarker research in an effort to better understand how drugs behave in early stage clinical trials (Press release, Cancer Research Technology, OCT 5, 2009, View Source [SID1234523346]).

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This announcement coincides with a presentation at the NCRI Cancer Conference in Birmingham by Professor Caroline Dive from Cancer Research UK’s Paterson Institute for Cancer Research at the University of Manchester*, who will lead this biomarker** research programme.

The programme will enable the charity to step-up its capacity to undertake both biomarker discovery research and evaluate biomarkers in a range of AstraZeneca clinical trials through a commitment to process up to 30,000 biomarker assays a year over the next 3 years. This will rise from the 14,000 a year currently undertaken.

The biomarkers studied in this programme help to determine whether new AstraZeneca drugs kill tumour cells and/or prevent angiogenesis – the growth of new blood vessels to supply tumour cells with nutrients and oxygen.

This partnership between Cancer Research UK, the Paterson Institute and AstraZeneca is based on the development of ‘proof of concept’ biomarkers***. It has been facilitated by Cancer Research Technology (CRT) – Cancer Research UK’s development and commercialisation arm – after AstraZeneca completed a scoping exercise to decide where to base their collaborative biomarker research efforts.

Cancer Research UK and AstraZeneca will also boost their scientific expertise to make use of biomarker technologies by creating additional Clinical Pharmacology Fellowship awards and a new Radiation Fellowship post. These follow the success of the Cancer Research UK/AstraZeneca Clinical Pharmacology Programme to date, under which six Clinical Pharmacology Fellowships have been supported since it began in 2006. These scientists will support the research programme already underway and explore further the use of biomarkers in radiotherapy and/or chemotherapy clinical trials.

It is expected the programme will help doctors conducting clinical trials to establish the right dose to give patients and to predict the effect the drug could have. It will also set the parameters of how to measure a drug’s effectiveness.

Professor Dive will present new biomarker data at the NCRI Cancer Conference revealing that circulating tumour cells (CTCs) can be used to measure the effects of cancer drugs currently used to treat lung cancer. Her team measured the number of CTCs in blood samples taken from patients with lung cancer and showed that their frequency was higher among the patients whose cancer had spread. The number of CTCs dropped following chemotherapy treatment, suggesting that CTCs could be used as a biomarker in clinical trials of new drugs to help doctors treat patients with this type of cancer more effectively.

Professor Caroline Dive, clinical and experimental pharmacology group leader at the Paterson Institute, said: "Most people in the cancer field have bought into the notion that biomarker research is key to the successful development of new treatments, but very few have really followed through with the thorough investigations and investment necessary for biomarkers to pay off. This deal will enable us to advance our understanding of how biomarker research contributes to drug development and patient care whilst building on the know-how we have gained so far. Everyone stands to gain."

Professor Andrew Hughes, AstraZeneca’s early phase clinical development head, said: "We are continually investing in potential new treatments and are delighted to be expanding this collaboration with Cancer Research UK to develop biomarkers. Before starting a clinical trial, it’s crucial that we understand as much as possible about how the drug will behave so we can decide which patients are most likely to gain from it, and how strong to make the dose in order for it to have the most beneficial effect – this research aims deliver just that."

Dr Phil L’Huillier, CRT’s director of business management, said: "This increased investment is a significant step forward in our commitment to develop this research and improve cancer treatments. By working collaboratively with academia and our commercial partners we are continuing to ensure that we progress these important advances and develop new drugs to treat cancer patients in the fastest possible time."

Dr Peter Sneddon, Cancer Research UK’s executive director of clinical and translational research funding, added: "Biomarkers are fundamental to the development of more targeted medicines and Cancer Research UK has strongly supported this area of research, so we are delighted that AstraZeneca have chosen to invest in our programme in Manchester. It has taken a lot of work to get to a point where biomarkers can reliably be used in clinical trials and as today’s presentation illustrates, new evidence is increasingly showing their worth.

"Today’s presentation about a new biomarker for lung cancer is very welcome because it is vitally important that we improve treatment for this disease – a form of cancer that has not seen the same progress as many others in terms of survival rates."

(Press release, Innate Pharma, SEP 14, 2009, View Source [SID:1234505994])

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On August 13, 2009 IMBiotechnologies reported that the company has completed purchase of all assets related to the Occlusin tumor starvation technology from Paladin Labs (Press release, IMBiotechnologies, AUG 13, 2009, View Source [SID:1234502249]). In addition to the cash payment provided to purchase the technology, Paladin will receive a one time milestone payment on first sale of product and a royalty with a capped payment. IMBio will focus its efforts on obtaining regulatory approval for its lead product candidate, Occlusin 500 Artificial Embolization Device ("OCL 500 AED"), which is a medical device.

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"All pre-clinical testing of the OCL 500 AED medical device is complete and we are in the process of assembling the pre-market notification (510(k)) submission to the FDA," commented Michael Stewart, President & CEO of IMBio. "The OCL 500 AED embolic agent cuts off the blood supply to tumors and demonstrates equivalent safety and effectiveness in comparison to currently approved embolic agents. One of the significant advantages of OCL 500 AED is that it is biodegradable and is slowly broken down by the body until it ultimately disappears. Competitor’s products are permanent implants and stay in the body for the life of the patient."

OCL 500 AED is designed for the treatment of malignant and non-malignant vascularised tumors. Examples of vascularised tumors include heptocellular carcinoma (HCC; liver cancer), renal cell carcinoma (RCC; kidney cancer) and uterine fibroids. Over 2 million women in the USA alone suffer from debilitating effects of uterine fibroids.

On July 22, 2009 REGiMMUNE Corporation reported that Astellas Pharma Inc. and REGiMMUNE have entered into a collaboration agreement to jointly research and develop a novel vaccine-platform technology (Press release, REGimmune, JUL 22, 2009, View Source [SID1234642238]). The partnership will combine Astellas’ broad range of capabilities in screening and developing natural source-derived compounds with REGiMMUNE’s immune liposome technology. Terms of the agreement have not been disclosed.

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"Our goal is to develop a potent vaccine-platform technology that enables effective vaccination with novel adjuvant and immune liposome technologies, increasing the efficiency of delivery to immune cells. Our approach will eliminate many of the current limitations for vaccine development," explained Haru Morita, CEO of REGiMMUNE. "This is particularly important for responding to new or changing virus strains. Astellas has a strong presence in immunology and is one of the largest vaccine distributors in Japan," Mr. Morita continued. "We believe this collaboration can produce a technology that will allow a rapid response to various viral outbreaks spreading around the world."

"We are pleased to initiate our first partnership with REGiMMUNE," stated Masafumi Nogimori, President and Chief Executive Officer of Astellas. "Disease prevention through timely and adequate vaccination is a key to maintaining human health. Astellas is committed to developing a new vaccine platform and this collaboration with REGiMMUNE will strengthen our position in this important area of disease prevention."

About Vaccines
Prophylactic vaccines need to elicit sufficient immune responses to protect individuals from the challenge by infectious agents. Most commonly, attenuated live viral particles are used to develop effective vaccines; however, development of live viral particles requires significant lead time and lengthy, costly manufacturing processes. While efforts have been made to develop improved adjuvants to enhance the potency of non-viral vaccines, Alum remains the only adjuvant approved by the U.S. FDA for use in humans. The Astellas-REGiMMUNE collaboration is expected to address these obstacles and provide a number of benefits over currently marketed products.

On July 13, 2009 Cancer Research Technology (CRT), Merck Serono, a division of Merck KGaA, Darmstadt, Germany, Cancer Research UK, Cardiff University and The Institute of Cancer Research (ICR) reported new research collaboration for the first time (Press release, Cancer Research Technology, JUL 13, 2009, View Source [SID1234523348]). This will provide substantial investment in research on the WNT signalling pathway in the hope of finding new drug targets.

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This cross-disciplinary, multicentre effort, spanning up to three years, will focus on the discovery of inhibitors of the WNT pathway. This pathway is involved in the physiological tissue development in embryos, as well as in tissue maintenance in adults.

Mutations in this pathway alter the molecular switches that regulate the WNT pathway and leave it permanently switched on. Such continuous activation can result in the development of cancer. Deregulation of this pathway is a frequent activating event in human cancers and is known to be linked to bowel, skin, breast and other cancers. The aim of this collaboration is to identify and develop small molecule inhibitors of the WNT pathway that could eventually become novel treatments for cancer patients.

This collaboration was established by CRT, Cancer Research UK’s commercialisation and development company, following work funded by the charity’s Discovery Committee which set the translational foundations for the programme.

Merck Serono will contribute substantial funding which will augment existing investment by Cancer Research UK and allow more rapid translation of insights into drugs that may benefit cancer patients. The work will take place at Cardiff University, the ICR and Merck Serono. Financial details were not disclosed.

Professor Trevor Dale, lead scientist on the programme at Cardiff University said: "Normal cells communicate with each other by exchanging WNT protein signals. A WNT signal will instruct a cell to grow, divide and behave like a stem cell. Cancer mutations break the molecular switches that connect WNT proteins to cell growth. This in effect leaves the pathway permanently switched on. This collaboration will allow us to convert these biological insights into therapies which one day may help us treat cancer patients."

Professor Julian Blagg, the lead scientist at The Institute of Cancer Research continued: "This collaboration brings together Cardiff’s expertise in the fundamental biology of the pathway along with the drug discovery and development expertise at the ICR and Merck Serono. This will enable us to make real progress in targeting this exciting area and harness the enormous potential in WNT pathway therapy."

Dr Phil L’Huillier, CRT’s director of business management, said: "Today’s deal represents a significant endorsement for investment in the development of early scientific research. It is testament to the promise of the lab-based research that we are now in a position to take it forward with such a large-scale project and begin to think about new treatments for cancer patients. We hope by pooling expertise we will be able to progress WNT pathway inhibitors in the fastest possible time."