The Prudential Assurance Company Limited (a wholly owned subsidiary of Prudential plc) has increased above a 4% notifiable interest
8. Notified details:
A: Voting rights attached to shares
Class/type of shares if possible using Situation previous to the Triggering transaction
the ISIN CODE... Number of shares..43,402,426... Number of voting Rights..43,402,426 (viii)... GB0006648157
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Oxford BioMedica (OXB.L)(OXBDF.PK) clinches $690m licensing deal for cancer vaccine
Thursday, March 29, 2007 By Karen Attwood
Oxford BioMedica has struck a licensing agreement with Sanofi-Aventis for its groundbreaking cancer vaccine in one of the biggest deals seen in British biotechnology.
The French pharmaceutical giant will pay the Oxford-based company up to $690m (£351m) if all development milestones are met for TroVax and there could be additional payments if it wins approval for treating different types of cancer. Analysts believe potential payments could total more than $1bn plus royalties. ----- Sanofi is the world's second-largest oncology company and the leader in Europe.
Dr Jonathan Senior, an analyst at Evolution, said this made it the " ideal partner for TroVax in terms of marketing muscle on a global basis" . In addition, Sanofi had "clearly signalled its openness to new approaches and has been discussing new, more biotech-like ways of treating the disease including vaccines", he added.
TroVax is a therapeutic vaccine designed to be given once a disease has developed rather than to prevent an infection. It uses a pox virus to introduce genes to boost the body's immune system and has the potential to be used in a wide range of tumours, including renal, colorectal, lung, breast and prostrate cancer. It is currently in late stage trials as a treatment for kidney cancer and this is expected to go to market by 2009. Sanofi is to develop the vaccine to treat colorectal cancer but Oxford BioMedica retains the option to develop TroVax for other types of cancer.
Alan Kingsman, the chief executive, said he was pleased to have Sanofi on board "given their broad expertise, experience and resources".
The company will receive an upfront payment of $39m and Mr Kingsman said this would enable it to take other key products further along the path to market. The company has eight core products in the pipeline including a treatment for Parkinson's disease, which is set to move to clinical trials after showing "stunning" pre-clinical results,he said.
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Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on the areas of oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange.
Oxford BioMedica's products use genes as the mediators of a therapeutic effect and/or immune response. The Company’s gene therapy products deliver therapeutic molecules in vivo whilst its gene-based immunotherapy products deliver genes that recruit the patient’s immune system to mediate a therapeutic effect. The genes are delivered by the Company’s highly engineered viral systems.
Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes TroVax®, a cancer immunotherapy, which was recently licensed to Sanofi-Aventis for global development and commercialisation. TroVax is in Phase III development for renal cancer (see www.trovax.co.uk) and Sanofi-Aventis is implementing a development plan for metastatic colorectal cancer. The recent acquisition of Oxxon Therapeutics adds a Phase II cancer immunotherapy for melanoma, HI-8® MEL, to the Company's pipeline. Other oncology product candidates include a gene therapy, MetXia®, which is in Phase II development for pancreatic cancer, and a preclinical targeted antibody therapy, which is being developed in collaboration with Wyeth. In neurotherapy, the Company's lead product, ProSavin, is expected to enter clinical trials in Parkinso's disease in 2007. The preclinical pipeline includes gene-based products for vision loss, motor neuron disease and nerve repair. The acquisition of Oxxon also provides a platform for the development of therapeutic vaccines for infectious diseases.
The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 75 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. In addition to the TroVax collaboration with Sanofi-Aventis and the targeted antibody therapy collaboration with Wyeth, Oxford BioMedica has corporate collaborations with Arius Research, Intervet, MolMed, Sigma-Aldrich, Viragen, Virxsys and Wyeth. In addition, the Company has technology licence agreements with Biogen Idec, GlaxoSmithKline, Merck & Co, Pfizer.
Oxford BioMedica is a member of the BioIndustry Association and the Biotechnology Industry Organization.
check out pipeline of drugs at bottom of page and look at their partners: Wyeth, Merck, Glaxo, Pfizer, and now SNY for the cancer vaccine
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Note: Oxford Biomedica is a foreign firm, based in England,OXB on the London Exchange / can buy the ADR in the US as OXBDF.PK
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I am bought Oxford Biomedica (US ADR OXBDF.PK, London OXB.L) and holding for as a longer term horizon, as in 2009-2010
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This thing is too exciting for me!
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Kevin Goldstein-Jackson: Healthy option is a promising buy By Kevin Goldstein-Jackson
Published: April 20 2007 17:21 | Last updated: April 20 2007 17:21
On March 29 I took a major gamble with my self-invested personal pension (Sipp) scheme by increasing its shareholding in Oxford BioMedica, paying 49.5p per share.
Before this purchase my Sipp was already overweight in the pharmaceuticals and biotechnology sector, so why did I expose it to increased sector risk?
My Sipp first invested in Oxford BioMedica in November 2001, paying 26p per share. Over the years I increased my stake via market and rights issue purchases at prices ranging from 14.5p to 17p until, in 2005, I took some profits at 39p by selling slightly less than half my holding.
This meant that I had recouped much of the cost of my Sipp’s entire Oxford shareholding. It also meant that the “cost” of my remaining stake was less than 5p per share and it seemed unlikely the shares would fall below that price. Whatever happened, I had banked some useful profits while continuing to benefit if the share price rose.
In December 2005 my Sipp acquired more Oxford shares as a result of a placing and open offer at 25p per share. I believed the company had good long-term prospects.
What prompted my most recent purchase was Oxford’s announcement on March 6 of its financial results for 2006 and, on March 28, the news of its global licensing agreement with pharmaceuticals giant Sanofi-Aventis to develop and commercialise Oxford’s TroVax for the treatment and prevention of cancer.
More than 180 patients have been treated with TroVax in clinical trials in renal, colorectal and prostate cancer. According to Oxford, clinical data show that “over 95 per cent of patients treated with TroVax mount an anti-tumour immune response to the 5T4 tumour antigen and, in a number of clinical studies, there is a strong correlation between the level of the immune response elicited by TroVax and the clinical benefit to patients”.
TroVax has attracted support from the US National Cancer Institute, Cancer Research UK and the UK clinical trials network Quasar.
Under the agreement with Sanofi-Aventis, Sanofi will pay Oxford BioMedica “up to €518m if all development and registration targets are met for certain defined indications. Additional payments will be made if regulatory milestones are achieved in other cancer types.”
Oxford will receive an initial payment of €29m and further “near-term payments” of €19m as “milestones linked to an ongoing phase 3 study in renal cancer”. Oxford is also entitled to “escalating royalties on global sales of TroVax”.
To me, these – and other terms relating to funding certain research – looked like very good news for Oxford’s growth and profitability.
Unfortunately, some City and other investors seem to view the deal as making Oxford less likely to be the target of a takeover and so the share price may remain subdued.
While a takeover might have provided a quick profit I would be happy for Oxford to grow and eventually become a major UK firm.
Oxford may already seem highly valued with a market capitalisation of around £270m as its results for the year to December 31, 2006 showed a loss of £17.6m. However, the company had cash balances at the year-end of £28.5m and the deal with Sanofi-Aventis shows promise.
Oxford BioMedica is also working on a variety of products, including ProSavin for the treatment of Parkinson’s disease, and RetinoStat – a gene-based treatment for neovascular age-related macular degeneration (AMD) and diabetic retinopathy.
The company also has three “early stage” neurological programmes aimed at motor neurone disease, spinal muscular atrophy and nerve repair for spinal cord injury. Oxford has a variety of licensing agreements with major pharmaceutical companies, including Merck, Pfizer and GlaxoSmithKline.
While an investment in Oxford BioMedica may be risky, at least its products are aimed at helping people. I have never, for example, invested in a tobacco company – even though many investors have made large profits from doing so. Also, with time rushing by who knows what ailments I and many other people might get and which, with good fortune, one day Oxford BioMedica and other companies like it (such as Protherics) may be able to treat or cure.
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Oxford Biomedica - one of a few using ground-breaking gene therapy
"The present invention relates to a novel cytokine, referred to as osteopontin (Eta-1), to nucleic acids that encode Eta-1 and to antibodies that specifically recognize and bind to Eta-1. More particularly, the invention relates to feline and canine Eta-1 and its use in compositions for the prevention or treatment of infectious diseases or cancer."
"Various companies produce viral vectors commercially, including Avigen, Inc. (Alameda, Calif.; AAV vectors), Cell Genesys (Foster City, Calif.; retroviral, adenoviral, AAV vectors, and lentiviral vectors), Clontech (retroviral and baculoviral vectors), Genovo, Inc. (Sharon Hill, Pa.; adenoviral and AAV vectors), Genvec (adenoviral vectors), IntroGene (Leiden, Netherlands; adenoviral vectors), Molecular Medicine (retroviral, adenoviral, AAV, and herpes viral vectors), Norgen (adenoviral vectors), Oxford BioMedica (Oxford, United Kingdom; lentiviral vectors), Transgene (Strasbourg, France; adenoviral, vaccinia, retroviral, and lentiviral vectors) and Invitrogen (Carlsbad, Calif.)."
"...In another embodiment, the vector can be introduced in vivo by lipofection, as naked DNA, or with other transfection facilitating agents (peptides, polymers, etc.)..."
"...It is also possible to introduce the vector in vivo as a naked DNA plasmid. Naked DNA vectors for gene therapy can be introduced into the desired host cells by methods known in the art, e.g., electroporation, microinjection, cell fusion, DEAE dextran, calcium phosphate precipitation, use of a gene gun, or use of a DNA vector transporter..."
"...Preferably, for in vivo administration, an appropriate immunosuppressive treatment is employed in conjunction with the viral vector, e.g., adenovirus vector, to avoid immuno-deactivation of the viral vector and transfected cells..."
Sentiment : Strong Buy
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OXFORD BIOMEDICA ANNOUNCES THAT PHASE II RESULTS WITH HI-8R MEL IN MELANOMA WILL BE PRESENTED AT AMERICAN ASSOCIATION OF IMMUNOLOGISTS MEETING
Oxford, UK: 17 May 2007: Oxford BioMedica LSE: OXB, the leading gene therapy company, today announces that scientists from its wholly owned subsidiary, Oxxon Therapeutics, and its clinical collaborators will present results from a Phase II trial of Hi-8 MEL in melanoma at the American Association of Immunologists AAI Annual Meeting, to be held on 18-22 May in Miami, Florida. The abstract has been selected for both an oral and a poster presentation.
The presentation will include updated data from the completed Phase II trial of Hi-8 MEL in 41 patients with Stage III/IV melanoma, which was conducted at multiple sites in the UK and Germany. The trial was designed to evaluate the immune and clinical responses elicited by the prime-boost immunotherapeutic vaccine, Hi-8 MEL. The product consists of a recombinant DNA vaccine and modified vaccinia virus Ankara MVA, both of which have been engineered to contain DNA that encodes a string of seven cytotoxic T-cell epitopes from five melanoma antigens.
The presentation will include further follow-up of a patient that exhibited both a sustained partial clinical response tumour shrinkage and also a strong antigen-specific immune response following treatment. In addition, the presentation will highlight previously reported data on immunogenicity and clinical benefit. The product was highly immunogenic with 91% of patients that received the optimal dose showing an antigen-specific immune response. In terms of clinical benefit, eight patients 20% showed disease control, including the patient with a partial response and an additional seven patients with periods of stable disease. The median survival for immune responders was 100 weeks versus 37 weeks for non-responders p<0.001. Details of the presentations are as follows:
Title: Induction of antigen-specific CD8+ T cells in melanoma patients using a prime-boost therapeutic vaccine Abstract #48.18.
For further information, please contact: Oxford BioMedica plc: Tel: +44 0 1865 783 000 Professor Alan Kingsman, Chief Executive City/Financial Tel: +44 0 20 7466 5000 Notes to editors
1. Oxford BioMedica
Oxford BioMedica LSE: OXB is a biopharmaceutical company specialising in the development and commercialisation of novel therapeutic vaccines and gene-based therapies with a focus on oncology and neurotherapy. The Company was established in 1995 as a spin-out from Oxford University, and is listed on the London Stock Exchange.
The Company has a platform of gene delivery technologies, which are based on highly engineered viral systems. Oxford BioMedica also has in-house clinical, regulatory and manufacturing know-how. In oncology, the lead product candidate is TroVaxR, an immunotherapy for multiple solid cancers, which is licensed to Sanofi-Aventis for global development and commercialisation. A Phase III trial of TroVax in renal cancer is ongoing and Sanofi-Aventis is implementing a development plan for colorectal cancer. Oxford BioMedica's oncology pipeline includes a specific immunotherapy candidate, Hi-8 R MEL, for melanoma, which has completed two clinical trials. In neurotherapy, the Company's lead product, ProSavinR, is expected to enter clinical development for Parkinson's disease in 2007. The neurotherapy pipeline also includes preclinical gene-based therapeutics for vision loss, motor neuron disease and nerve repair. In addition, the Company has a platform technology for therapeutic vaccines for infectious diseases.
The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 75 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Corporate partners include Sanofi-Aventis for TroVax and Wyeth for a targeted antibody therapy. The Company also has collaborations with Intervet, Sigma-Aldrich, Viragen, MolMed and Virxsys. Technology licensees include Merck & Co, Biogen Idec, GlaxoSmithKline and Pfizer.
Hi-8 MEL is Oxford BioMedica's therapeutic vaccine for metastatic melanoma. The product consists of two recombinant vectors, a plasmid DNA and a non-replicating Modified Vaccinia Ankara MVA virus. Both vectors encode the Mel3 polyepitope string derived from five different melanoma-associated antigens. Administration of the two recombinant vectors in a heterologous prime-boost format is designed to induce broad melanoma-specific CD8+ T-cell responses. All clinical endpoints have been achieved in two completed clinical trials, which included a Phase II dose-selection study in 41 patients with non-resectable, Stage III/IV melanoma. Melanoma comprises just 5% of all skin cancers but it is the most deadly. It is the seventh most common cancer in the USA. Median survival is less than one year for Stage IV disease and less than five years for Stage III disease. The total treatment market for melanoma is forecast to be in excess of US$775 million by 2010 Datamonitor.
This information is provided by RNS. The company news service from the London Stock Exchange END
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Oxford Biomedica to present at Windhover Euro-Biotech Forum
Windhover Information's Euro-Biotech Forum to Focus on Specialist Dealmaking, Featuring Top Biopharma Decision-Makers Monday May 21, 9:30 am ET June 26-28, 2007 Westin Paris Hotel, Paris, France
NORWALK, Conn.--(BUSINESS WIRE)--Windhover Information's 14th Annual Euro-Biotech Forum, the industry's most targeted one-on-one partnering meeting for American and European life science companies, is scheduled for June 26-28 in Paris.
Euro-Biotech sold out last year, and all the leading life sciences and investment companies have already registered to attend, including Amgen, AstraZeneca, Atlas Venture, Bayer, Bristol-Myers Squibb, Johnson & Johnson, Lehman Brothers, Merck, Novartis and Pfizer. Most of these companies are seeking partnership opportunities for maximizing their research and development pipelines.
This upscale and efficient partnering event gives health care industry executives access to industry leaders, plus the opportunity to hear about exciting new trends in European life sciences and dealmaking strategies. More than 400 top executives attended last year.
Top biopharma minds to dissect specialist deals
Euro-Biotech features an intriguing plenary panel discussion, "Specialist Dealmaking: Is the Price Sustainable?" The session will consider rising prices for specialist assets, along with the unpredictability of the commercial value of those assets.
Three of the most prominent biopharmaceutical dealmakers - Scott Myers, VP, Global Strategic Marketing, UCB; Nigel Sheail, Vice President, Global Head of Licensing, Roche Pharma Partnering; and a senior executive from AstraZeneca -will discuss whether or not deal prices can remain high, and for how long, as well as how, if at all, it's affecting their business development strategies. There will be case studies from oncology, which is one of the most popular specialist TAs, but also one where pricing pressure may be heaviest.
Also, Windhover Information Managing Partner Roger Longman, a biopharma industry expert analyst, will give a presentation titled "Key Trends in Dealmaking Rationale and Structures."
A premier partnering event
Euro-Biotech, which hosted more than 1,200 one-on-one partnering meetings last year, features Windhover's exclusive online partnering software, which now allows attendees to screen the partnering database for opportunities by multiple criteria:
More than 22 therapeutic categories including cardiovascular, oncology, CNS and more Products or technologies Phase of project Market type (specialty or general) Geographic marketing rights desired Molecule type (small molecule, protein, antibody, peptide, or other macromolecule) Mode of administration More than 50 companies will present their technologies, with new companies being added daily. Presenters to date are Ablynx, Actelion Pharmaceuticals Ltd., Aerovance Inc., Affymax Inc., Alk-Abello A/S, Antisoma PLC , Artisan Pharma, Altea Therapeutics, BioWa, bioXel, Borean Pharma A/S, CardioVascular BioTherapeutics, CombinatoRx, CV Therapeutics, Cyclacel Pharmaceuticals, Endo Pharmaceuticals, ESBATech AG, FibroGen Inc, Genmab, Indevus Pharmaceuticals Inc., KAI Pharmaceuticals Inc., MAP Pharma, MediGene Development, Mutabilis, Nautilus Biotech, Nektar Therapeutics, NeuroSearch A/S, NicOx SA, Novosom AG, Novexel SA, NOXXON Pharma Inc., OctoPlus, Osprey Pharmaceuticals Limited, Osteologix, Oxford BioMedica, PanGenetics B.V., Palau Pharma, Pieris AG, Progenics Pharmaceuticals Inc., Regeneron, Santaris Pharma A/S, Scynexis Inc., Sepracor Inc., Tranzyme Pharma, Vectura Group PLC, XDx and Ziopharm Oncology Inc.
The complete list of presenters, along with information on Windhover's partnering software, is available at www.eurobiotechforum.com.
Sponsors for Euro-Biotech include Edwards, Angell, Palmer & Dodge, DefinedHealth and BioWa. Event Partner Sponsors are Fold Rx and Scynexis. PTC Therapeutics is a Coffee Break Sponsor, and Media Sponsors are BusinessWire, The PharmYard and Scandinavian Life Sciences.
To register, contact Alexandria Riley at (203) 838-4401 ext. 113 or ariley*windhover.com; or register on the Euro-Biotech website at www.eurobiotechforum.com.
About Windhover Information
Windhover Information Inc. has led the field in providing analysis of the healthcare industry to decision-makers at all levels since the founding of its flagship publication, IN VIVO, The Business & Medicine Report,(TM) in 1983. Windhover provides its information and analysis in many formats, including print, electronic databases, international conferences and audio conferences. For more on the company's products and services, please see www.windhover.com.
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SNY presenting Trovax cancer vaccine at ASCO
Trovax was licensed from British firm Oxford Biomedica, UK:OXB, OXB.L, US ADR = OXBDF.PK
Data to be Presented at ASCO 2007 Highlights sanofi-aventis Commitment to Cancer Care and Research Tuesday May 29, 11:27 am ET New data on Eloxatin(R), Taxotere(R) and on three investigational agents (VEGF Trap, S-1 and TroVax(R)) will be presented at the 43rd annual ASCO meeting
BRIDGEWATER, N.J., May 29 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that a total of 375 abstracts indicative of its oncology commitment have been accepted for the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois (June 1-5, 2007). The results from key studies involving the company's leading anticancer agents, Eloxatin® (oxaliplatin injection) and Taxotere® (docetaxel injection concentrate), will be presented alongside clinical trial data examining investigational agents, aflibercept (VEGF Trap), S-1 (oral fluoropyrimidine) and TroVax® (Therapeutic Cancer Vaccine). ADVERTISEMENT
Of the abstracts which have been accepted, 129 focus on Eloxatin®, 214 on Taxotere®, 29 on S-1, two on VEGF Trap and one on TroVax®. One hundred and ninety three Eloxatin® and Taxotere® abstracts were also accepted for presentation at the scientific sessions, with five Eloxatin® and 15 Taxotere® abstracts to be oral communications, including one Eloxatin® presentation at the ASCO plenary session.
The key results presented with Eloxatin®-based treatment (in combination with 5FU/LV) cover clinical trials in the adjuvant (post-surgery) colon cancer (MOSAIC study) and the metastatic (advanced) colorectal cancer (NCCTG/N9741study, EORTC40983/EPOC study) settings.
Data looking at Taxotere®-based regimens in adjuvant and in metastatic breast cancer will be presented during the meeting.
Two phase II studies examined aflibercept (VEGF Trap) as a single agent in recurrent ovarian and lung cancers. VEGF Trap is an anti-angiogenic agent that blocks the Vascular Endothelial Growth Factor (VEGF), and is currently being investigated to assess its use in stopping tumor growth. Aflibercept is in phase III development as part of a collaboration between sanofi-aventis and Regeneron.
S-1 is a novel oral fluoropyrimidine that combines three investigational agents: tegafur, a pro-drug of 5 fluoro-uracil; gimeracil (5-chloro-2,4 dihydropyridine) which inhibits dihydropyrimidine dehydrogenase enzyme; and oteracil (potassium oxonate), a gastrointestinal side effect corrector. The Phase III data to be presented evaluate the addition of cisplatin to S-1 in advanced gastric cancer. S-1 is marketed in Japan by Taiho for a variety of indications including gastric cancer. Sanofi-aventis is leading the development of the compound outside of Japan and in some Asian countries.
TroVax® is a therapeutic cancer vaccine developed in collaboration with Oxford BioMedica. It targets the tumor antigen 5T4, broadly distributed in a wide range of solid tumors. The presentation will include new data from two Phase II trials of TroVax® in renal cancer.
Finally, the first outcomes of the innovative program "My Child Matters," a unique humanitarian pediatric cancer initiative in developing countries co- sponsored by sanofi-aventis and the International Union Against Cancer (UICC), will be presented.
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Oxford Biomedica and Sanofi-Aventis Report new TroVax(R) Phase II Trial Results in Renal Cancer Sunday June 3, 9:00 am ET - Presentation at the American Society of Clinical Oncology Annual Meeting -
CHICAGO, June 3 /PRNewswire-FirstCall/ -- Oxford BioMedica (LSE: OXB - News) and sanofi-aventis (EURONEXT: SAN) (NYSE: SNY - News) today announce new data from two Phase II trials of TroVax® in renal cancer. TroVax® is Oxford BioMedica's lead cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis. The Phase II data were presented by Oxford BioMedica and its clinical collaborators from the Methodist Hospital in Houston, Texas, at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) on 3 June in Chicago, Illinois (Abstract #3069).
Fifty-three patients with progressive metastatic renal cell cancer (RCC) have been enrolled and 48 patients are currently evaluable in the Methodist Hospital's two non-randomised Phase II trials of TroVax®. The trials are designed to evaluate TroVax® either as a single agent, or in combination with either interleukin-2 or interferon-alpha. The treatment regimen in the two trials comprises seven intramuscular injections of TroVax® over 41 weeks. The patients had previously failed various anti-cancer treatments before entering the trials.
TroVax® was well tolerated with no serious adverse events attributable to the treatment. TroVax® induced anti-5T4 antibody responses in 91% of patients. In patients with clear cell RCC, which is the most common subtype of renal cancer and is the patient group for the Phase III TRIST study, 24 of 35 (68%) evaluable patients showed disease control. Two patients had complete responses, three had partial responses and 19 had stable disease for periods exceeding three months, including three patients that have been stable for more than 17 months. Preliminary analysis of clinical benefit shows a statistically significant relationship between reduction in tumour burden (biologic response) in patients with clear cell RCC and patients' anti-5T4 antibody responses (p = 0.028). This is particularly encouraging since it supports the rationale that the 5T4-specific immune response induced by TroVax® has therapeutic benefit.
At ASCO, the conclusions presented from this updated analysis of safety, immunogenicity and clinical benefit parameters were as follows:
* TroVax® was well tolerated and immunogenic in the context of these cytokines and has promising anti-tumor activity
* A significant number of objective responses have been seen in this heterogeneous group of heavily pre-treated renal cancer patients. These responses appear to be durable and are notable in the clear cell population.
* A preliminary analysis indicates a trend between 5T4-specific immune responses induced by TroVax® and clinical benefit in clear cell patients.
* These studies provide further support for the ongoing randomised Phase III TRIST study in renal cancer.
Dr. Bob Amato of the Genitourinary Oncology Centre, the Methodist Hospital in Houston, USA, who is the Principal Investigator for these two Phase II trials of TroVax® in renal cancer, said: "TroVax® continues to give encouraging indications of benefit in this heavily pre-treated renal cancer population. Although these are small, non-randomized studies, there have been a significant number of responders in this patient population. The ongoing analysis supports the notion that TroVax® may have activity in this indication and further justifies the ongoing Phase III study, TRIST."
Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the new data: "Oxford BioMedica continue to be encouraged by the clinical data from ongoing trials of TroVax®. This updated analysis from the renal cancer trials at the Methodist Hospital supports our development strategy with sanofi-aventis, which includes the Phase III TRIST trial in renal cancer and a randomized registration trial in metastatic colorectal cancer. Over 300 patients have been enrolled in trials of TroVax® in various cancer types and stages of disease. The data suggest that the product was well tolerated, immunogenic and potentially clinically active in all settings evaluated."
Dr Mark Cluzel, Senior Vice President, Science and Medical Affairs of sanofi-aventis commented: "TroVax® is a very exciting compound that complements sanofi-aventis' oncology and sanofi pasteur's vaccine activities. We are very encouraged by these further positive data on TroVax® and looking forward to developing it in collaboration with Oxford Biomedica." The abstract may be accessed online at http://www.asco.org at the conclusion of the meeting.
About renal cancer
Renal cancer includes renal cell carcinoma (cancer that forms in the lining of very small tubes in the kidney that filter the blood and remove waste products) and renal pelvis carcinoma (cancer that forms in the center of the kidney where urine collects). It also includes Wilms' tumor, which is a type of kidney cancer that usually develops in children under the age of 5. More than 36,600 new cases in the US and 38,400 in Europe were diagnosed in 2004 and almost 12,500 patients in the US and 18,100 patients in Europe died. There were more males than females.
About Oxford BioMedica
Oxford BioMedica (LSE: OXB - News) is a biopharmaceutical company specialising in the development and commercialisation of novel therapeutic vaccines and gene- based therapies with a focus on oncology and neurotherapy. The Company was established in 1995 as a spin-out from Oxford University, and is listed on the London Stock Exchange.
The Company has a platform of gene delivery technologies, which are based on highly engineered viral systems. Oxford BioMedica also has in-house clinical, regulatory and manufacturing know-how. In oncology, the lead product candidate is TroVax®, an immunotherapy for multiple solid cancers, which is licensed to Sanofi-Aventis for global development and commercialisation. A Phase III trial of TroVax in renal cancer is ongoing and Sanofi-Aventis is implementing a development plan for colorectal cancer. Oxford BioMedica's oncology pipeline includes a specific immunotherapy candidate, Hi-8® MEL, for melanoma, which has completed two clinical trials. In neurotherapy, the Company's lead product, ProSavin®, is expected to enter clinical development for Parkinson's disease in 2007. The neurotherapy pipeline also includes preclinical gene-based therapeutics for vision loss, motor neuron disease and nerve repair. In addition, the Company has a platform technology for therapeutic vaccines for infectious diseases.
The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 75 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Corporate partners include Sanofi-Aventis for TroVax® and Wyeth for a targeted antibody therapy. The Company also has collaborations with Intervet, Sigma-Aldrich, Viragen, MolMed and Virxsys. Technology licensees include Merck & Co, Biogen Idec, GlaxoSmithKline and Pfizer.
TroVax®is Oxford BioMedica's leading cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis. It is designed specifically to stimulate an anti-cancer immune response and has potential application in most solid tumour types. TroVax® targets the tumor antigen 5T4, which is broadly distributed throughout a wide range of solid tumors. The presence of 5T4 is correlated with poor prognosis. The product consists of a poxvirus (MVA) gene transfer system, which delivers the gene for 5T4 and stimulates a patient's body to produce an anti-5T4 immune response. This immune response destroys tumor cells carrying the 5T4.
In 2006, Oxford BioMedica started a Phase III trial of TroVax® in renal cancer and sanofi-aventis is implementing a development plan for colorectal cancer. The product has attracted support from Cancer Research UK, the US National Cancer Institute, and the UK clinical trials network, QUASAR. These organizations are conducting or plan to conduct clinical trials with TroVax®.
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Look at all these Phase II and Phase III results for cancer - renal, kidney (III), and colorectal
Oxford Biomedica and Sanofi-Aventis Report new TroVax(R) Phase II Trial Results in Renal Cancer FinanzNachrichten - Jun 3, 9:19am ET CHICAGO, June 3 /PRNewswire-FirstCall/ -- Oxford BioMedica ( Nachrichten ) and sanofi-aventis ( Nachrichten / Aktienkurs ) (EURONEXT: SAN) today announce new data from two Phase II trials of TroVax(R) in renal cancer.
Oxford Biomedica and Sanofi-Aventis Report new TroVax(R) Phase II Trial Results in Renal Cancer PR Newswire via Yahoo! Finance - Jun 3, 9:00am ET Oxford BioMedica and sanofi-aventis today announce new data from two Phase II trials of TroVax® in renal cancer. TroVax® is Oxford BioMedica's lead cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis.
TroVax trials 'encouraging', says Oxford Bio ShareCast - Jun 4, 5:08am ET LONDON (SHARECAST) - Gene therapy firm Oxford BioMedica and Sanofi-Aventis of France today announced “encouraging” new data from two Phase II trials of TroVax in renal cancer.
Sanofi, Oxford Bio's TroVax Controls Kidney Cancer, Study Shows Bloomberg.com - Jun 3, 1:11pm ET June 3 (Bloomberg) -- Sanofi-Aventis SA and Oxford BioMedica Plc's TroVax experimental cancer drug controlled the spread of kidney cancer, according to the results of a study presented at a medical meeting today.
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OXFORD BIOMEDICA SECURES RIGHTS TO ENDOSTATIN AND ANGIOSTATIN GENES FOR CANCER FROM CHILDREN'S HOSPITAL BOSTON
Oxford, UK: 6 July 2007: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that it has signed a license agreement with Children's Hospital Boston to extend the Company's existing rights for the anti-angiogenic genes, endostatin and angiostatin, for the treatment of cancer using gene therapy. Angiogenesis, which is the formation of new blood vessels, is a critical mechanism for tumour progression. It has been clinically proven that tumour growth can be suppressed by using anti-angiogenic approaches to inhibit tumour angiogenesis. Endostatin and angiostatin are endogenous anti-angiogenic proteins discovered in the laboratory of Dr. Judah Folkman, director of the Vascular Biology Program at Children's Hospital Boston.
Oxford BioMedica previously licensed the endostatin and angiostatin genes for its RetinoStat(R) product candidate for the treatment of wet age-related macular degeneration (wet AMD) and other ocular diseases associated with aberrant blood vessel growth. The RetinoStat programme is expected to enter clinical development in 2008 for wet AMD. Under the terms of the new license agreement with Children's Hospital Boston, Oxford BioMedica will pay an upfront payment, milestone payments and royalties on sales. Further details were not disclosed.
In a separate agreement, also announced today, Children's Hospital, Boston has agreed to subscribe for a total of 243,306 ordinary shares of 1p each at £0.4075 per share. Application will be made to the United Kingdom Listing Authority ('UKLA') for the newly issued ordinary shares in Oxford BioMedica to be admitted to the Official List of the UKLA and to the London Stock Exchange plc for admission to trading on its market for listed securities. The shares are expected to commence trading on 12 July 2007.
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OXFORD BIOMEDICA AND SIGMA-ALDRICH ISSUE JOINT LICENCE FOR LENTIVECTOR(R) TECHNOLOGY TO MAJOR BIOTECHNOLOGY COMPANY
Oxford, UK: 2 July 2007: Oxford BioMedica (LSE: OXB), a leading gene therapy company, and Sigma-Aldrich, a leading life science and high technology company, today announced that they have signed a joint licence agreement for the LentiVector technology with a major US-based biotechnology company, which provides the company with access to the technology for global research activities. Sigma-Aldrich is Oxford BioMedica's strategic partner and exclusive licensee in the commercialisation of the LentiVector technology for research use. Financial details were not disclosed.
Oxford BioMedica's lentivirus-based gene delivery technology, known as LentiVector, is one of the most powerful technologies for the delivery of genes to a wide range of cell and tissue types. The LentiVector technology has applications both in therapeutic products and as a drug discovery tool for target validation and the creation of targeted disease models. Oxford BioMedica has a comprehensive portfolio of US and European patents and applications that cover the technology. Sigma-Aldrich and Oxford BioMedica have an active licensing programme providing access to the LentiVector technology on a non-exclusive basis for research activities. Licensees include Biogen Idec, GlaxoSmithKline, Merck & Co and Pfizer.
Commenting on the news, Oxford BioMedica's Senior Vice President Commercial Development, Peter Nolan, said: "We are delighted to have secured another licensee for the LentiVector gene delivery technology, which has become the industry gold standard for various applications in research and drug discovery. With our strategic partner, Sigma-Aldrich, we believe that the technology has significant commercial potential as a research tool, which is in addition to its application in gene-based therapies."
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OXFORD BIOMEDICA ANNOUNCES DATA SAFETY MONITORING BOARD RECOMMENDATION TO CONTINUE TROVAX(R) PHASE III TRIAL IN RENAL CANCER AS PLANNED
Oxford, UK: 25 July 2007: Oxford BioMedica (LSE: OXB)(US ADR OXBDF.PK), a leading gene therapy company, announced today that the independent Data Safety Monitoring Board (DSMB) for the Phase III TRIST study of TroVax in renal cancer has completed its first scheduled interim analysis. The DSMB concluded that the trial should continue as planned without modifcation. The DSMB reviewed safety and anticancer immune responses from the first 50 patients enrolled. TroVax is Oxford BioMedica's novel cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis.
The role of the DSMB is to evaluate data from the ongoing trial to determine whether there are safety issues or efficacy issues that would warrant modification of the protocol or early termination of the study. The DSMB is independent of Oxford BioMedica and sanofi-aventis and is comprised of leading clinicians and biostatisticians with relevant expertise in the treatment of renal cancer and the conduct of clinical trials.
TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial of TroVax in patients with locally advanced or metastatic clear cell renal carcinoma. The trial is a randomised, placebo-controlled, two-arm study comparing TroVax in combination with standard of care to placebo with standard of care. The standard of care therapies are interleukin-2, interferon-alpha or Sutent(R) (sunitinib). The protocol stratifies treatment between the standard of care options to ensure that the allocation of TroVax and placebo is rigorously balanced.
The trial started in November 2006. To date, over 250 patients have been randomised of a target enrolment of approximately 700 patients. Approximately 100 sites of 150 identified centres in the USA, European Union and Eastern Europe are open for recruitment. The primary endpoint for the trial is survival improvement and secondary endpoints include progression-free survival, tumour response rates and quality of life scores. The trial is being conducted under a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA). The SPA agreement ensures that the design, conduct, analysis and endpoints of the trial are all acceptable to the FDA. The trial is expected to complete in early 2009.
Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the DSMB recommendation: "We are pleased that the immunology data from this first analysis of the Phase III TRIST study meet the pre-set criteria for continuation. The safety profile remains encouraging. Recruitment into TRIST has been rapid and we are on track to complete patient enrolment during Q1 2008."
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Man Financial just invested 21 million in Oxford Biomedica
RNS Number:4433B Oxford Biomedica PLC 02 August 2007
TR-1(i): NOTIFICATION OF MAJOR INTERESTS IN SHARES
1. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached (ii):
Oxford BioMedica PLC
2. Reason for the notification (please state Yes/No): ( )
An acquisition or disposal of voting rights: (Yes)
An acquisition or disposal of financial instruments which may result in the acquisition of shares already issued to which voting rights are attached: ( )
Man Financial Limited
August 2007
Threshold(s) that is/are crossed or reached:
3% to 2%
Number of shares Number of voting Rights (viii)
GB0006648157 21,070,855 21,070,855
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Link to Man Financial transaction notification
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OXFORD BIOMEDICA AND SIGMA-ALDRICH ISSUE JOINT LICENCE FOR LENTIVECTOR® TECHNOLOGY TO MAJOR BIOTECHNOLOGY COMPANY Oxford, UK: 2 July 2007: Oxford BioMedica (LSE: OXB), a leading gene therapy company, and Sigma-Aldrich, a leading life science and high technology company, today announced that they have signed a joint licence agreement for the LentiVector technology with a major US-based biotechnology company, which provides the company with access to the technology for global research activities. Sigma-Aldrich is Oxford BioMedica's strategic partner and exclusive licensee in the commercialisation of the LentiVector technology for research use. Financial details were not disclosed.
Oxford BioMedica's lentivirus-based gene delivery technology, known as LentiVector, is one of the most powerful technologies for the delivery of genes to a wide range of cell and tissue types. The LentiVector technology has applications both in therapeutic products and as a drug discovery tool for target validation and the creation of targeted disease models. Oxford BioMedica has a comprehensive portfolio of US and European patents and applications that cover the technology. Sigma-Aldrich and Oxford BioMedica have an active licensing programme providing access to the LentiVector technology on a non-exclusive basis for research activities. Licensees include Biogen Idec, GlaxoSmithKline, Merck & Co and Pfizer.
Commenting on the news, Oxford BioMedica's Senior Vice President Commercial Development, Peter Nolan, said: "We are delighted to have secured another licensee for the LentiVector gene delivery technology, which has become the industry gold standard for various applications in research and drug discovery. With our strategic partner, Sigma-Aldrich, we believe that the technology has significant commercial potential as a research tool, which is in addition to its application in gene-based therapies."
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OXFORD BIOMEDICA REACHES FIRST MILESTONE IN TROVAX(R) COLLABORATION WITH SANOFI-AVENTIS
Oxford, UK - 11 September 2007: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced that it has reached the first development milestone in its collaboration with sanofi-aventis for TroVax, the cancer immunotherapy, which triggers a payment of €9 million. The milestone relates to the successful enrolment of 350 patients in the Phase III TRIST study of TroVax in renal cancer. This represents half of the anticipated 700 patients to be enrolled into the trial.
Oxford BioMedica and sanofi-aventis entered a global development and commercialisation agreement for TroVax in March 2007. Under the terms of this agreement, Oxford BioMedica received an initial payment of €29 million. This first development milestone of €9 million is part of a potential €19 million in near-term milestone payments linked to the Phase III TRIST study. The Company could receive a total of €518 million in initial and milestone payments if development and registration targets are met for certain defined indications. The agreement includes additional undisclosed regulatory milestone payments for other cancer types; undisclosed commercial milestones when sales reach certain levels; and escalating royalties on global sales. Sanofi-aventis and Oxford BioMedica are co-funding the ongoing TRIST study and sanofi-aventis is committed to fund all other research, development, regulatory and commercialisation activities. Furthermore, Oxford BioMedica retains an option to participate in the promotion of TroVax in the USA and the European Union.
Professor Alan Kingsman, Chief Executive of Oxford BioMedica, commented: "The clinical team at Oxford BioMedica is doing an excellent job in its management of the TRIST study. The trial remains on track to complete recruitment in the first quarter of 2008. It is encouraging that we have reached this milestone of recruiting half of the anticipated patients within a few months of our collaboration with sanofi-aventis."
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OXFORD BIOMEDICA PLC
INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2007
Oxford, UK - 11 September 2007: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today its interim financial results for the six months ended 30 June 2007. Year to date highlights:
Operational highlights:
TroVax(R) (multiple cancers)
• Global development and commercialisation deal with sanofi-aventis • Successful first DSMB review of Phase III TRIST study in renal cancer • First milestone under sanofi-aventis agreement achieved • Encouraging further Phase II results in renal cancer • Sanofi-aventis to start Phase III trial in metastatic colorectal cancer • QUASAR to start Phase III trial in early-stage colorectal cancer
ProSavin(R) (Parkinson's disease)
• Regulatory submission for start of Phase I/II trial in Parkinson's disease
Other
• Acquisition of Oxxon Therapeutics for £16 million in shares • Initiated new anti-cancer development programme • Licensing agreement for LentiVector(R) technology with major US biotechnology company
Financial highlights:
• Received initial payment of £19.7 million from sanofi-aventis • Revenue recognised of £2.0 million (H1 2006: £0.2 million) • Research and development costs of £10.8 million (H1 2006: £9.5 million) • Loss after tax of £9.3 million (H1 2006: £8.7 million) • Net cash generated1 of £10.4 million (H1 2006: cash burn1 £5.4 million) • Gross cash and cash equivalents acquired with Oxxon Therapeutics of £3.8 million • Net cash2 at 30 June of £42.5 million (30 June 2006: £38.7 million)
1. Net cash generated/used in operating activities plus sales and purchases of non-current assets
2. Cash, cash equivalents and current financial assets
Commenting on the interim results, Oxford BioMedica's Chief Executive, Professor Alan Kingsman, said: "We have made excellent progress in the first half of the year. Our collaboration with sanofi-aventis on TroVax is a significant event for the Company. It validates our development strategy for TroVax and the product's potential commercial value. The payments from the collaboration have also put the Company in a strong financial position. Patient recruitment into the Phase III TRIST trial of TroVax in renal cancer continues to be rapid, and sanofi-aventis is now planning to start a Phase III trial in colorectal cancer. Following the completion of our landmark deal with sanofi-aventis, we conducted a strategic review of our pipeline to prioritise programmes for accelerated development in order to maximise shareholder value. Arising from this review is the key development priority of starting the first clinical trial of ProSavin in Parkinson's disease, and we are on track with the regulatory process for this study. We look forward to pursuing our development and commercial goals with confidence. The Company has never been stronger than it is today."
Analyst meeting:
An analyst briefing will be held at 10:00 am today at the offices of Buchanan Communications, 45 Moorfields, London EC2Y 9AE.
Web cast:
Simultaneously to the analyst briefing at 10.00 am, there will be a live audio web cast of the results presentation. To connect to the web cast facility, please go to the Company's website: www.oxfordbiomedica.co.uk/ approximately 10 minutes (09:50 am) before the start of the briefing. This will also be available for replay shortly after the presentation.
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Sanofi says plans to reinforce in biotechnology Mon Sep 17, 2007 2:10am EDT Email | Print | Digg | Reprints | Single Page | Recommend (0) [-] Text [+] Market News Dollar slips to 15-year low Oil climbs near record above $82 Futures pare gains on Morgan Stanley results | Video More Business & Investing News... Featured Broker sponsored link ¥ € $ - Learn. Practice. Trade.PARIS (Reuters) - Sanofi-Aventis (SASY.PA: Quote, Profile, Research) plans to build up its presence in biotechnology, particularly in manufacturing capacity, its head of research said on Monday.
"We will reinforce in biotech -- it's part of our weakness," Marc Cluzel told reporters ahead of a research and development presentation. "In terms of manufacturing, we will try and do it by acquisitions."
Cluzel said the company had already moved to expand in biotech, such as with its recent licensing deal with Oxford Biomedica (OXB.L: Quote, Profile, Research) for cancer treatment TroVax.
Last week it also signed a research collaboration agreement with a Chinese institute in the cancer stem-cell field.
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Sanofi says plans to reinforce in biotechnology Mon Sep 17, 2007 2:10am EDT Email | Print | Digg | Reprints | Single Page | Recommend (0) [-] Text [+] Market News Dollar slips to 15-year low Oil climbs near record above $82 Futures pare gains on Morgan Stanley results | Video More Business & Investing News... Featured Broker sponsored link ¥ € $ - Learn. Practice. Trade.PARIS (Reuters) - Sanofi-Aventis (SASY.PA: Quote, Profile, Research) plans to build up its presence in biotechnology, particularly in manufacturing capacity, its head of research said on Monday.
"We will reinforce in biotech -- it's part of our weakness," Marc Cluzel told reporters ahead of a research and development presentation. "In terms of manufacturing, we will try and do it by acquisitions."
Cluzel said the company had already moved to expand in biotech, such as with its recent licensing deal with Oxford Biomedica (OXB.L: Quote, Profile, Research) for cancer treatment TroVax.
Last week it also signed a research collaboration agreement with a Chinese institute in the cancer stem-cell field.
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Cancer Vaccines Attract Interest of Big Drug Firms By Malin Rising Word Count: 971 | Companies Featured in This Article: Sanofi-Aventis, Roche Holding , GlaxoSmithKline, Merck KGaA, Genitope, Antigenics After more than 20 years of setbacks, research into therapeutic cancer vaccines is starting to show promising results and attract the investments of large pharmaceutical firms. But the field remains risky, and so far no drugs have been approved for use.
About eight million people die from cancer each year, a figure that is expected to rise by 50% to approximately 12 million in 2030, making it the world's largest single killer disease, according to the World Health Organization.
Therapeutic vaccines stimulate the body's immune system to attack cancerous cells and leave healthy cells alive, while more traditional cancer treatments ...
• THE FULL WSJ.com ARTICLE IS ONLY AVAILABLE TO SUBSCRIBERS.
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Prudential just bought more shares boosting its ownership interest to 9.3%
RNS Number:7758E Oxford Biomedica PLC 28 September 2007
TR-1(i): NOTIFICATION OF MAJOR INTERESTS IN SHARES
1. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached (ii):
Oxford BioMedica PLC
2. Reason for the notification (please state Yes/No): ( )
An acquisition or disposal of voting rights: ( ) An acquisition or disposal of financial instruments which may result in the acquisition of shares already issued to which voting rights are attached: ( ) An event changing the breakdown of voting rights: ( ) Other (please specify) : (Yes) A purchase of shares has caused a subsidiary of Prudential plc to cross a % threshold.
3. Full name of person(s) subject to the notification obligation (iii):
Prudential plc group of companies
4. Full name of shareholder(s) (if different from 3.) (iv):
Prudential plc (parent company) M&G Group Limited (wholly owned subsidiary of Prudential plc) M&G Limited (wholly owned subsidiary of M&G Group Limited) M&G Investment Management Limited (wholly owned subsidiary of M&G Limited) M&G Securities Limited (wholly owned subsidiary of M&G Limited) The Prudential Assurance Company Limited (wholly owned subsidiary of Prudential plc)
5. Date of the transaction (and date on which the threshold is crossed or reached if different) (v):
25 September 2007
6. Date on which issuer notified:
27 September 2007
7. Threshold(s) that is/are crossed or reached:
M&G Securities Limited (a wholly owned subsidiary of M&G Limited) has crossed the 5% notifiable interest threshold. Within this change in interest, M&G Investments Funds 3, an Open Ended Investment Company (OEIC) which is not a Prudential group company but is included in the Prudential plc group interest, has also crossed the 5% threshold.
8. Notified details:
A: Voting rights attached to shares
Class/type of shares Situation previous to the Triggering transaction if possible using (vi) the ISIN CODE Number of shares Number of voting Rights (viii)
GB0006648157 49,468,428 49,468,428
Resulting situation after the triggering transaction (vii) Class/type of shares Number of shares Number of voting % of voting if possible using rights (ix) rights the ISIN CODE Direct Direct (x) Indirect Direct Indirect (xi)