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Yes, first patient due to be treated any time now.
HTTP://www.fiercebiotech.com/biotech/adaptimmune-t-cell-therapy-snags-prime-status-putting-it-ema-s-nascent-fast-track
EMA’s Priority Medicines (PRIME) regulatory initiative. The scheme, which to date has accepted 8 drugs while rejecting almost 30, is designed to ensure developers of products with the potential to address major unmet needs receive support with regulatory applications and potentially accelerated reviews.EMA accepted requests for Novartis’ ($NVS) leukemia drug CTL019, Merck’s ($MRK) Ebola vaccine
Novartis will pay an upfront fee of $150 million to Xencor along with potential milestone payments totalling up to $2.41 billion (as and when milestones are achieved)
HTTP://finance.yahoo.com/news/xencor-stock-cancer-drugs-partnership-222010958.html
XmAb antibodies. Not sure how they compare with the 5T4 antibody? It would be nice if they fancied CarT 5T4
HTTP://www.dnavaccine.com/2016/06/cancer-vaccines-conference-in-london/
Tim Watts, Chief Financial Officer, will be presenting at the Jefferies 2016 Healthcare Conference in New York on 9 June 2016 at 8:00am ET.
A replay of the presentation and Q&A session will be available approximately one hour following the completion of the session at HTTP://wsw.com/webcast/jeff97/oxb.l.
The way I see it we now have a platform of off-the-shelf CAR-NK in a similar way Cellectis have off the shelf Car-t. Has to be good news if it all works out. The NK also can treat auto-immune diseases like AIDS if I understand it correctly.
The attached videos have helped me understand NK cells. Green Cross have completed phase II on their lead product MG4101. It is a cell therapy product, which separates NK cells from peripheral blood of healthy donors and grows them in order to treat tumors. Unlike conventional anti-cancer immune cell treatments, which treat cancer with NK cells from patients or living-related donors, such as parents and children, the product contains healthy NK cells from other people. - See more at:HTTP://www.businesskorea.co.kr/english/news/industry/13563-cancer-treatment-green-cross-accelerates-nk-cell-based-therapy-commercialization#sthash.kQfjoWkA.dpuf
Oxford BioMedica and Green Cross LabCell form a Partnership to Develop Gene-modified NK Cell Therapeutics in cancer
http://uk.advfn.com/stock-market/london/oxford-biomedica-OXB/share-news/Oxford-Biomedica-PLC-R-D-Partnership-with-Green-Cr/71635255
HTTPS://clinicaltrials.gov/ct2/show/NCT02008929
HTTP://cancerimmunolres.aacrjournals.org/content/early/2016/01/19/2326-6066.CIR-15-0118
HTTP://www.businesskorea.co.kr/english/news/industry/13563-cancer-treatment-green-cross-accelerates-nk-cell-based-therapy-commercialization
CTL019 Novartis therapy could generate $1.1 billion in annual revenues
HTTP://global.onclive.com/publications/oncology-business-news/2016/june-2016/new-blockbusters-will-offset-generic-price-erosion-in-hematology?p=1
HTTP://www.epicsciences.com/files/3514/6170/9866/2015_AACR_Epic_-Pfizer_Breast_Ovarian_5T4.pdf
SCIENTIFIC BUSINESS
FRIDAY 8April 2016
SHERWELL LOWER LECTURETHEATRE
SHERWELL BUILDING, PLYMOUTH UNIVERSITY
9:30 a.m.
12) Trovax® And Cyclophosphamide InduceAnti-Tumour Immune ResponsesThat CorrelateWith Prolonged
Survival Of End-Stage Colorectal Cancer Patients
Godkin, A; Pembroke, T; Gallimore, A; Scurr, M
The cytotoxic response to cancer is counteracted by tumour-induced immunosuppression. 54 colorectal cancer patients with
inoperable metastatic disease were randomized to a virus vaccine expressing an oncofetal antigen +/-
cyclophophosphamide to counteract immune regulation. The results of this phase I/II trial demonstrate improved outcome
corresponding to tumour-directed T cell responses.
These were the results from 2007;
August 13, 2007
Oxford BioMedica reported positive results from a phase II trial of TroVax for the treatment of metastatic colorectal cancer. This trial was designed to evaluate the safety and immunogenicity of TroVax when administered with chemotherapy. The trial enrolled 17 subjects who received the vaccine before, during and after the standard chemotherapy regimen FOLFOX. A course of treatment consisted of six vaccinations. Throughout the study, subjects were monitored for an immune response to 5T4. Eleven of the 17 subjects who had completed a course of treatment mounted a strong immune response to 5T4. Of these 11 subjects, six showed significant tumor shrinkage and one no longer had any detectable tumors. The overall median survival was 68 weeks in all 17 vaccinated subjects and 118 weeks in the 11 subjects who received all six vaccinations. Additional phase II and III trials are ongoing at this time.
(without the blood test for those likely to respond)
HTTPS://www.firstwordpharma.com/node/109750?tsid=17
It`s evolving quickly George. At least we are in with the first mover, Novartis. Their oncology looks impressive;
https://www.novartis.com/sites/www.novartis.com/files/2016-06-meet-the-management-2-pharma-oncology.pdf
http://www.totaljobs.com/jobs-at/oxford-biomedica/jobs
Tim said "And we now have sufficient cash to take us well into the third quarter but that doesn't include any potential proceeds from further partnering transactions and as John will be telling you later there are a number of potential deals in the pipeline at the moment. Parkinson's disease follow-up program, as John has said, that we're likely to see the first patient dosed and during the third quarter of 2016 and we will file for the OXB-202 which is the Corneal graft program in the second half of the year. And by the end of the year we will have the preclinical study results from OXB-302 which is the CAR-T 5T4 program.
In terms of partnered products, Novartis have indicated that they will have their study results from CTL-019 in the second half of the year, and they've also indicated that they will file that BLA submission either in very end of 2016 or early 2017. And we believe those items of news flow will help us and if all goes all, it holds out the prospect of -- for us a commercial supply agreement with Novartis to supply the commercial launch of CTL-019. We're making great progress at the moment in coming up with a bioreactor process. We are hoping shortly to move into 200 liter bioreactors with a serum-free suspension process. This offers the prospect of improved yield but also improved volumes .we have every confidence that we will gain third contracts with new partners which will not only give us a short-term benefit of bioprocessing and process development fees but also a long-term economic interest in the product candidates that they bring to us. CAR-T-5T4 is not the only preclinical thing that we're looking at. Is CAR-T-5T4that something we should do by ourselves or is it something we should try and partner with a company who is in a better place in the oncology area for example to work with us? debt facility is repayable in 2022, we are under no obligation to repay it earlier but we can repay earlier if we see the opportunity.
Yes I have long thought that a possibility especially if they think Car-T 5T4 is promising and they also need to improve their ocular division. OXB directors have granted themselves more options today, maybe making sure that they get a slice if a bid does arrive! Jefferies Hoare Govett have Novartis as a client already!
Novartis
Enterprise Value: $205 Billion
3rd largest pharmaceutical company in the world
RECENT TRANSACTIONS
05/12 Sole financial advisor on $1.5 billion acquisition of Fougera Pharmaceuticals
What do you think George? A US listing, merger or acquisition, take-over or simply the dreaded cash call and further dilution ?
HTTP://theassociationofphysicians.org.uk/files/APAM_2016_Programme.pdf
9:30 a.m.
12) Trovax® And Cyclophosphamide InduceAnti-Tumour Immune ResponsesThat CorrelateWith Prolonged
Survival Of End-Stage Colorectal Cancer Patients
Godkin, A; Pembroke, T; Gallimore, A; Scurr, M
The cytotoxic response to cancer is counteracted by tumour-induced immunosuppression. 54 colorectal cancer patients with
inoperable metastatic disease were randomized to a virus vaccine expressing an oncofetal antigen +/-
cyclophophosphamide to counteract immune regulation. The results of this phase I/II trial demonstrate improved outcome
corresponding to tumour-directed T cell responses.
Superb presentation by Jason Slingsby. I am now maxed out and very optimistic.
Bargain price for topping up!
I understand it a little better now George!
Way over my head George! I was thinking the delay was due to either 1-evaluating an offer, 2-keeping the next stage of development in house or perhaps just no good enough offer yet. Then I was thinking that Novartis who need to improve their optical division may be wanting the whole company at some stage? Do you think there is any possibility of someone taking Trovax forward combined with a PD-1 ?
Yes it is looking good for more orders. Hopefully some decent Retinostat or Trovax news soon!
Good find George, I will share that.It`s looking good.
Oxford, UK – 29 January 2016: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE: OXB), a leading gene and cell therapy group, announces today that the Group has initiated work on a second Chimeric Antigen Receptor T cell (CART) programme for an undisclosed indication. Under an agreement signed with Novartis in October 2014, Oxford BioMedica will undertake process development and manufacturing for the lentiviral vector associated with the new programme.
Oxford BioMedica is currently manufacturing lentiviral vector expressing CTL019 for Novartis and carrying out process development work to establish the next-generation manufacturing process. The Group also granted Novartis a non-exclusive licence in oncology under the Group’s LentiVector® platform and an exclusive licence for the worldwide development and commercialisation of all CART cell products arising from the process development collaboration. In return, Oxford BioMedica will receive undisclosed royalties on potential future sales of CART products covered by the agreement.
Commenting on the announcement, John Dawson, Chief Executive Officer of Oxford BioMedica, said: “We are excited to be providing Novartis with the licence, process development and manufacturing that they require for CTL019 and now for a second CART programme. Oxford BioMedica is recognised as a world leader in the field of lentiviral vectors and we are delighted to be supporting clinical programmes where the need for this type of medical intervention is vital.”
Thanks George. There seems to be promise with 5T4/ Trovax in comination with a check point inhibitor.
Pembrolizumab (formerly MK-3475 and lambrolizumab, trade name Keytruda[1]) is a humanized antibody used in cancer immunotherapy. It targets the programmed cell death 1 (PD-1) receptor.[2] The drug was initially used in treating metastatic melanoma.
HTTPS://www.clinicaltrials.gov/ct2/show/NCT02650999
HTTP://in.reuters.com/article/us-novartis-pricing-idINKBN0U30EV20151220?type=companyNews
Board change
Oxford, UK – 5 January 2016: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE: OXB), a leading gene and cell therapy group, announces that Dan Soland has been required to step down as a Non-Executive Director, due to his appointment as CEO of uniQure with immediate effect.
Commenting on the announcement, Dan Soland, said: "It is with regret that I have to step down as a Board member of Oxford BioMedica as a result of my appointment as CEO of uniQure. Oxford BioMedica has an outstanding position as a world-leader in gene and cell-therapy. The Company has an excellent business model well balanced by an exciting pipeline of wholly owned products, sought-after IP and third party manufacturing and process development. With its strong management team, I have no doubt that Oxford BioMedica is en route to long-term success and I have greatly enjoyed working with the team. I step down from my role feeling I leave the Company in an extremely strong position."
Oxford BioMedica’s Chairman*, Nick Rodgers, said: “Dan has made a valuable contribution to Oxford BioMedica. We thank him for his input and wish him well for the future.”
*Oxford BioMedica announced on 15 December 2015 that Lorenzo Tallarigo (experience includes: Intercept Pharmaceuticals, Genextra and Eli Lilly) has been appointed as Non-Executive Chairman of the Group and will join on 1 February 2016.
-Ends-
HTTP://www.uniqure.com/pipeline/clinical-pipeline/
But the biggest Intercept beneficiary overall is Italian biopharma investment company Genextra, which owns a 30% stake in the company now worth about $2.6 billion — a $2.2 billion increase in the past week. Genextra, which is closely held, hasn’t disclosed its ownership structure, but it’s likely that Francesco Micheli, co-founder and chairman of Genextra and a former billionaire, and Dr. Lorenzo Tallarigo, Genextra’s CEO, have made a fortune off Intercept Pharmaceutical’s remarkable stock movement.
Uveitis
We are currently evaluating product candidates for four new ocular indications including uveitis and three undisclosed genetic retinal diseases.
By cross-referring data generated across the LentiVector® platform portfolio, we are in an increasingly strong position to develop a new wave of high value products and improve our leading intellectual property position.
We are currently evaluating product candidates for four new ocular indications, including three undisclosed genetic retinal diseases, where there is a clear unmet medical need.
For further information, please contact our Business Development team at licensing@oxfordbiomedica.co.uk.
HTTP://healthcare.globaldata.com/media-center/press-releases/pharmaceuticals/uveitis-treatment-market-to-undergo-steady-growth-by-2017-with-launch-of-humira-and-xoma-052-but-unmet-needs-still-to-be-fulfilled-says-globaldata
take your pick!
too kind.