On October 26, 2010 4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and development company focused on autoimmune and cancer indications, reported the presentation of Phase II data from Hodgkin Lymphoma patients treated in the 1st Simon Stage cohort of the ongoing SAPHIRE study with resminostat (4SC-201), an oral pan-histone deacetylase (HDAC) inhibitor, at the 8th International Symposium on Hodgkin Lymphoma in Cologne, Germany (Press release, 4SC, OCT 26, 2010, View Source [SID1234533469]).

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The oral presentation will be given by the lead investigator of the SAPHIRE study, Prof Dr Jan Walewski of the Marie-Skłodowska-Curie Memorial Institute in Warsaw, Poland. It highlights initial safety and tolerability as well as efficacy data from the first 18 patients with relapsed or refractory Hodgkin Lymphoma in this study.

Daily oral application of 600 mg resminostat for 5 consecutive days per 2-week treatment cycle was well tolerated with the majority being mild to moderate gastrointestinal and haematological side effects. In addition, a number of anaemia cases were observed, however these were judged as being primarily related to the underlying disease. Pharmacokinetic data indicate good bioavailability of this HDAC inhibitor and plasma exposure levels yielded significant pharmacodynamic activity as exemplified by time dependent HDAC enzyme inhibition after dosing.

In this first patient cohort, the average treatment duration with resminostat reached approximately nine weeks. Anti-tumour activity of the drug was assessed every six weeks by combination of computer tomography (CT) and positron-emission tomography (PET), a technique which allows the simultaneous evaluation of changes in the metabolic activity and the size of a tumour lesion. Based on established PET/CT evaluation criteria, 10 patients out of 18 benefited from treatment with resminostat with two patients being assessed as partial responders (PR) (i.e. more than 50% reduction in size of tumour lesions) and a further eight patients with stabilization of disease (SD). Based on PET analysis almost all of these patients showed a diminished metabolic activity of their lesions with the majority being evaluated as partial metabolic responders (more than 25% decrease in PET activity). These results are based on intermediate analysis of the data and are therefore subject to final review.

According to the statistical design of the SAPHIRE study (Simon two-stage design), a minimum number of five responders were required in this reported 1st Simon stage in order to extend the study to a second enrolment phase of an additional 15 patients (the 2nd Simon stage). After reaching this threshold the study has recently proceeded into the 2nd Simon stage recruitment phase. Due to the good tolerability and side effect profile observed in this relatively young HL patient population an optional increase of the daily dose of resminostat from 600 mg to 800 mg has been implemented.

Prof Walewski of the Marie-Skłodowska-Curie Memorial Institute in Warsaw, Poland, the lead investigator of the SAPHIRE study, commented: ‘Despite the fact that patients with Hodgkin Lymphoma often respond well to first-line treatment with chemotherapy, there is an urgent medical need for new therapeutic approaches for patients relapsing or becoming refractory to standard therapy. For patients not responding to second line high-dose chemotherapy the 5-year progression-free survival rate is as low as 17%. Hodgkin Lymphoma patients are often very young and the repeated use of chemotherapy can lead to secondary tumour developments in addition to the primary lymphatic cancer. Based on the initial data presented on the 1st Simon stage of the trial, we are hopeful that resminostat may provide a new therapy option to relapsed or refractory HL patients.’

Dr Bernd Hentsch, Chief Development Officer at 4SC, commented: ‘We were very pleased with these initial results and are hopeful of the potential of our oral, pan-HDAC Inhibitor resminostat as a monotherapy treatment for advanced Hodgkin Lymphoma patients. We feel that this indication could provide a clinical proof-of-concept for resminostat, which is currently also being evaluated as a combination treatment in solid tumour indications.’

On October 25, 2010  The Servier Research Group and Vernalis reported they have achieved a research milestone in their three year oncology drug discovery collaboration initiated in May 2009 (Press release, Servier, OCT 25, 2010, View Source [SID:1234508828]). This is the second collaboration between Servier and Vernalis, the first collaboration is focused on developing two promising oncology targets involved in protein-protein interactions.

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Emmanuel Canet, MD, PhD, President Servier Research and Development, added: "We are very satisfied with this collaboration reaching an important milestone on a truly innovative oncology target. This is a step further in our aim to finalise the discovery of innovative compounds with potential use in therapeutic indications with high unmet medical need. Cancer represents a major cause of mortality worldwide and Servier is committed to providing patients with novel therapeutic approaches for treating this devastating disease.
Vernalis is an English biotech company which has a high-level technical background and recognised expertise in research and development.

On October 19, 2010 Cancer Research UK and Cancer Research Technology – the charity’s development and commercialisation arm – together with immatics biotechnologies, reported that they have launched the first clinical trial of a promising cancer vaccine to treat glioblastoma, one of the most common forms of brain cancer* (Press release, Cancer Research Technology, OCT 19, 2010, View Source [SID1234523330]).

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The treatment IMA950, is a vaccine developed specifically for glioblastoma which is an aggressive form of glioma. The vaccine will direct and boost the body’s immune system to enable it to fight cancer. The vaccine will be used together with the standard treatments of surgery, radiotherapy and chemotherapy.

IMA950 contains 11 peptides – strings of amino acids – that are found on the surface of glioblastoma tumours but not on the surface of healthy cells. These peptides when incorporated into the vaccine ‘train’ T cells in the immune system to recognise cancer cells as unhealthy cells – and then to target and destroy them.

Using a large number of peptides compared with a small number increases the chance of a beneficial immune response.

The launch of the trial is the result of Cancer Research UK’s innovative Clinical Development Partnerships (CDP) scheme.

CDP is a joint initiative between Cancer Research UK’s Drug Development Office and Cancer Research Technology, to put drugs that otherwise cannot be developed by pharmaceutical companies through early phase clinical trials. Trials of experimental drugs such as this may have not been possible without this initiative, which strives to deliver the latest potential treatments to cancer patients – and increase survival.

Up to 45 patients newly diagnosed with this form of glioma will take part in this first trial of IMA950 and receive a number of doses of the vaccine.

The trial, is taking place at the Beatson West of Scotland Cancer Centre in Glasgow and up to four other hospitals yet to be confirmed across the UK. The trial has been set up through Cancer Research UK’s Experimental Cancer Medicine Centre network and it will be managed by the charity’s Drug Development Office (DDO).

Under the terms of the partnership, Cancer Research UK is funding the trial and after the trial, immatics biotechnologies will have an option to further develop and commercialise the drug in exchange for future payments to the charity.

Nigel Blackburn, director of drug development at Cancer Research UK’s Drug Development Office, said: "It’s really great news that we have launched this trial for a vaccine which could boost the current treatment for brain cancer.

"Our scientists are working at the cutting edge of the field to find new and powerful ways to treat cancer. Using the immune system to fight cancer is an exciting area of research and something we are heavily investing in as a promising way to treat a broad range of cancers."

Dr Ian Walker, Cancer Research Technology’s licensing manager, said: "This is a truly collaborative deal between our world-class scientists and immatics biotechnologies to ensure promising therapeutic programmes reach patients."

Harpreet Singh, CSO of immatics said: "We are delighted to have joined forces with Cancer Research UK and the University of Glasgow to fight brain cancer. It is pleasing to see that the very first patients have now begun treatment with IMA950 – this is a major step on a path to create a highly innovative new treatment for this deadly disease."

Professor Roy Rampling, from the University of Glasgow who will lead the study nationally said: "One of the hardest parts of my job is telling someone they have brain cancer.

"Glioblastoma can be challenging to treat because there are limited options for therapy – there’s a real need for new treatments for this disease."

On October 11, 2010 (BUSINESS WIRE) — ImmunoGen, Inc. (Nasdaq: IMGN) reported that it has entered into a collaboration agreement with Novartis to discover and develop targeted anticancer therapeutics using antibodies to several antigen targets to be named by Novartis (Press release, ImmunoGen, OCT 11, 2010, View Source [SID:1234515014]).

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Under this agreement, Novartis will pay a $45 million upfront fee to ImmunoGen for exclusive rights to use the Company’s Targeted Antibody Payload (TAP) technology with antibodies to the specified number of antigen targets. For each target that results in an anticancer therapeutic, ImmunoGen is entitled to receive milestone payments potentially totaling $200.5 million plus royalties on product sales, if any. The Company also is entitled to receive financial compensation for research and for any manufacturing done on behalf of Novartis. Novartis is responsible for the development, manufacturing, and marketing of any products resulting from this agreement.

"ImmunoGen has a valuable technology, and we’re committed to developing our own pipeline of anticancer therapeutics," commented Daniel Junius, President and CEO of ImmunoGen. "Our partnerships provide funding support for our internal product programs and further development of our technology. We plan to continue to establish new collaborations on a selective basis."

About ImmunoGen’s Targeted Antibody Payload (TAP) Technology

ImmunoGen developed its TAP technology to achieve more effective, better tolerated anticancer drugs. A TAP compound consists of a tumor-targeting manufactured antibody with one of ImmunoGen’s proprietary, highly potent cancer-killing agents attached as a payload. The antibody serves to deliver the payload specifically to tumor cells, and the payload serves to kill these cells.

ImmunoGen’s technology portfolio uniquely provides:

A selection of highly potent cancer-killing payload agents;
A selection of stable linkers for attachment of these agents to antibodies; and
Means of attaching the payload to the antibody that retain the desired structural and functional properties of the antibody.

Seven TAP compounds are now in clinical testing through ImmunoGen’s own product programs and those of its partners.

On October 1, 2010 Jubilant Organosys Limited, headquartered in India, reported that the company name has been changed to Jubilant Life Sciences Limited with immediate effect (Press release, Jubilant Life Sciences, OCT 1, 2010, View Source;pgid=74&pressid=41 [SID:1234510525]).

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Jubilant Life Sciences is an integrated pharma and life sciences company offering Life Sciences products and services to the global life sciences industry. It is the largest Custom Research and Manufacturing Services Company and a leading integrated drug discovery and development solutions Company out of India.

Commenting on the development, Shyam S Bhartia, Chairman & Managing Director and Hari S Bhartia, Co-Chairman & Managing Director of Jubilant Life Sciences Ltd said:
"In order to create a focused Life Sciences Entity, the Company’s name is being changed to Jubilant Life Sciences Ltd. It is a moment of great pride as we cross another milestone on the path of our evolution into an integrated pharma and life sciences company. Almost a decade ago we had stepped onto this path of transformation and today we have successfully positioned ourselves as a life sciences company with a presence across the value chain."

The Company’s success so far is an outcome of its strategic focus on the pharma and life sciences industry, moving up the value chain for products and services across geographies, constantly investing in various growth platforms and promoting a culture of innovation. With 11 world-class manufacturing facilities and a team of ~ 6000 multicultural people across the globe, the Company is committed to deliver value for its customers spread across 65 countries.

With this change Jubilant Life Sciences becomes the flagship Company of pharma and life sciences business of the Jubilant Bhartia Group which also has interests in Food and Retail, Oil and Gas and Aerospace.