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Novartis is clearly looking like it will be the big winner. No one else has followed CAR-treated leukemic patients and their persistently circulating, transgenic T lymphocytes for as long as Professor Carl June's team which has published results on patients followed beyond 5 years. As of May 2016 Professor June claimed to have treated 224 patients. DNA fingerprinting methods revealed that the CAR T cells were still on patrol in small but sufficient numbers to watch for re-emergence of cancer cells. No one has that kind of followup data and published it. No company other than Novartis has the in-house manufacturing expertise and has scaled it for global distribution.
HTTPS://seekingalpha.com/article/4061124-juno-can-car-ts-big-loser-still-worth-2_5b
They assume 4% royalties on ctl019
http://hardmanandco.com/docs/default-source/company-docs/oxford-biomedica-documents/31.03.17-delivering-commercial-gene-therapy-vector.pdf
We estimate that Novartis will achieve sales of $2.05bn per annum from CTL-019 by 2025. OXB could, therefore, receive a total of $82.0m in royalties per annum, in addition to manufacturing revenue.
Novartis announces first CAR-T cell therapy BLA for pediatric and young adult patients with r/r B-cell ALL granted FDA Priority Review
http://finance.yahoo.com/news/novartis-announces-first-car-t-200202645.html
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.”
Oxford Biomedica PLC Publication in the Journal Nature Communications
Commenting on the publication, John Dawson, Chief Executive Officer of Oxford BioMedica, said: "The data published demonstrates Oxford BioMedica's innovative capabilities and our commitment to invest in our technology to maintain our leading position in vector manufacture for gene therapy products. As demand for vectors grows with the introduction of gene and cell therapy products, we are confident there will be significant demand from third parties to licence the rights to utilise our TRiP technology."
-Ends-
http://uk.advfn.com/stock-market/london/oxford-biomedica-OXB/share-news/Oxford-Biomedica-PLC-Publication-in-the-Journal-Na/74187902
OXB-302 (CAR-T 5T4)
• Pre-clinical studies completed, demonstrating proof-of-concept
• Highlights include:
• CAR-T 5T4 cells can kill tumour cells derived from colorectal cancer and mesothelioma in
a “test tube” (in vitro)
• T cells taken from patients with ovarian cancer can be re-programmed with the 5T4 CAR
construct and respond (in vitro) to their own tumour cells, resulting in tumour cell death
• In industry standard animal model (in vivo) 5T4 CAR-T cells can treat established ovarian cancer
2 great ‘hidden’ shares for growth investors
Jam tomorrow?
Motley Fool
Oxford Biomedica (LSE: OXB) shares have lost 59% over two years to 5.3p, so you might wonder what growth I see there. I could point out that we’ve seen a bit of a recovery of late, and that the price is actually up 68% from its recent low in October 2016, but that’s only part of the picture.
The bigger picture is one of ‘growth tomorrow’, hopefully, as Oxford Biomedica is a small biotech firm specialising in gene and cell therapy. It is not making any profits yet — and isn’t expected to this year nor next either, though the forecast loss per share should drop considerably in 2018.
The key to the firm’s 2016 results announcement was not in its finances, though it appears to have enough cash for now, especially after fundraising £17.5m during the year. But the key is in the collaboration agreements it has with other firms making use of its “world-leading lentiviral vector delivery platform for gene and cell therapy” (to use the words of chief executive John Dawson).
The firm’s collaboration with Novartis for what it calls a “blockbuster potential product” is said to be progressing well and is “close to market“, and collaborations with Orchard Therapeutics, Immune Design and others have been expanded with a new research and development collaboration with Green Cross LabCell.
The company’s own proprietary developments, which target conditions including Parkinson’s, cancer tumours and corneal graft rejection, also appear to be progressing well, though they’re mostly at relatively early stages of development.
Oxford Biomedica is a classic blue sky investment right now, but I think we’re looking at a future growth star.
Plenty of buying. Maybe news is close?
Conclusions: Both CPM and TroVax induced highly beneficial anti-tumor immune responses resulting in significantly prolonged survival of end-stage CRC patients without toxicity. This is the first study to show a clear benefit of immunotherapy in advanced CRC, and suggests this approach may be superior (and less toxic) to continuous palliative chemotherapy in these patients.
HTTP://abstracts.asco.org/194/AbstView_194_178575.html
MVA-5T4 immunotherapy and low-dose cyclophosphamide for advanced colorectal cancer (TaCTiCC): An open-label, randomized phase I/II trial.
Abstract:
Background: Current immunotherapies including checkpoint inhibitors and vaccines for advanced colorectal cancer (CRC) have been largely ineffective. We hypothesized that combining an MVA-based vaccine targeting the tumor-associated antigen 5T4 (TroVax) with low-dose cyclophosphamide to deplete Foxp3+regulatory T-cells (Tregs), could improve immunological responses and patient outcomes. Methods: In this open-label phase I/II clinical trial, TaCTiCC (TroVax and Cyclophosphamide Treatment in Colorectal Cancer) 53 patients with inoperable metastatic CRC were randomized to receive either no treatment (group 1, n=8), metronomic low-dose CPM (50mg B.D. during treatment weeks 1&3; group 2, n=9), TroVax only (6 i.m. injections weeks 4 to 16, group 3, n=18), or low-dose CPM followed by TroVax (group 4, n=18). The primary endpoint was boosted anti-5T4 responses at week 7, as measured by increased T-cell and antibody responses; secondary endpoints included progression-free (PFS)/overall survival (OS), and anti-5T4 responses over the trial period. Results: CPM depleted Tregs in 21/27 patients during treatment week 3 (p=0.0045), resulting in significantly prolonged PFS amongst groups 2&4 over group 1 (5.0 vs. 2.5 months, HR=0.17 95% CI 0.048-0.62, p=0.0072). TroVax induced a >2-fold increase in anti-5T4 immune responses in 15/36 group 3&4 patients; these patients experienced significantly prolonged median PFS (6.5 vs. 2.4 months, HR 0.31 95% CI 0.14-0.65, p=0.0022) and OS (20 vs. 12 months, HR=0.37 95% CI 0.17-0.82, p=0.014). Combination of CPM & TroVax was not significantly superior. The primary endpoint at a single timepoint was not met since CPM-induced responses declined by week 7, and TroVax-induced responses were greatest at weeks 10-16. No serious adverse events were reported. Conclusions: Both CPM and TroVax induced highly beneficial anti-tumor immune responses resulting in significantly prolonged survival of end-stage CRC patients without toxicity. This is the first study to show a clear benefit of immunotherapy in advanced CRC, and suggests this approach may be superior (and less toxic) to continuous palliative chemotherapy in these patients. Clinical trial information: 54669986.
Such high ambitions draw an obvious comparison between Oxford’s humble $158m valuation and the $3.2bn market cap of its lentivirus rival bluebird Bio (NASDAQ:BLUE). Mr Dawson puts this down largely to the fund-raising power of a US biotech; in terms of lentivirus science there is nothing bluebird has done that Oxford has been unable to do, he insists.
HTTP://seekingalpha.com/article/4045447-oxford-biomedica-set-flirt-venture-financing?auth_param=1d8lsm:1ca42qb:f1cd40677110479dbf339020e89a73f0&uprof=82&dr=1
3 weeks
FEBRUARY 21, 2017 TaCTiCC Trovax
Abstracts Released on Meeting Library
HTTP://immunosym.org/program/poster-sessions
How do you understand that patent George as compared to what OXB have?
we forecast at least $1bn WW peak sales for £65-75m income to OXB (Oxford BioMedica) p.a. providing an important sustainable revenue stream for c.5p/share NPV at 80% probability, more than underpinning the current share price.”
https://endpts.com/fighting-a-generic-onslaught-novartis-adds-car-t-to-its-growing-list-of-late-stage-blockbusters/
CTL019 on its pipeline of possible blockbusters, underscoring its confidence in the product’s commercial potential. Despite logistical challenges, we forecast at least $1bn WW peak sales for £65-75m income to OXB (Oxford BioMedica) p.a. providing an important sustainable revenue stream for c.5p/share NPV at 80% probability, more than underpinning the current share price.”
HTTPS://endpts.com/fighting-a-generic-onslaught-novartis-adds-car-t-to-its-growing-list-of-late-stage-blockbusters/
From pages 20,21 I make that 45,800 potential patients for CTL019
HTTPS://www.novartis.com/sites/www.novartis.com/files/q4-2016-ir-presentation-development.pdf
Twitter in June ;
HTTPS://twitter.com/hashtag/CARDIFFSIURI?src=hash
CancerResearchWales ?@cancer_wales 25 Jun 2016
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TroVax and Cyclophosphamide have proven highly effective in the TaCTiCC trials - Dr Martin Scurr #CARDIFFSIURI
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CancerResearchWales ?@cancer_wales 25 Jun 2016
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The CRW-funded TaCTiCC trial strives to induce bigger immune responses from the body #CARDIFFSIURI
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Jefferies & Co Indicates Potential 92.77% Increase In Shares Of Oxford BioMedica PLC
http://newsden.net/analysts-price-targets/jefferies-co-indicates-potential-92-77-increase-in-shares-of-oxford-biomedica-plc/284889
Trovax
HTTP://immunosym.org/program/poster-sessions
Poster Session A: Humoral Immunity for Diagnosis and Therapy, Immune Checkpoints and Stimulatory Receptors, and Therapies Targeting T cells
Thursday, February 23 2017: 11:30 AM-1:00 PM and 5:30 PM-6:30 PM
BOARD H3
MVA-5T4 immunotherapy and low-dose cyclophosphamide for advanced colorectal cancer (TaCTiCC): An open-label, randomized phase I/II trial. (Abstract 154)
First Author: Martin Scurr
HTTP://medicine.caerdydd.ac.uk/media/filer_public/85/a0/85a0407a-e02a-4086-bfb3-6fc902eb7ecc/science_in_practice_infection__immunity_2014.pdf
Excellent results,
CTL019 Highly Effective in Global Phase II ALL Study, FDA Submission Anticipated
Silas Inman @silasinman
Published Online: Sunday, Dec 04, 2016
HTTP://www.onclive.com/conference-coverage/ash-2016/ctl019-highly-effective-in-global-phase-ii-all-study-fda-submission-anticipated
The CAR T-cell therapy CTL019 demonstrated an 82% complete remission (CR) or CR with incomplete blood count recovery (CRi) rate for pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), according to findings from the global, phase II ELIANA study presented at the 2016 ASH Annual Meeting.
The phase II study enrolled patients at 25 centers in the United States, Europe, Asia, and Australia. In the first 50 patients enrolled, the CR rate was 68% and the CRi rate was 14%. All patients with a CR/CRi also tested negative for minimal residual disease (95% CI, 69-91; P <.0001). The 6-month overall survival rate was 89% (95% CI, 76-95) and the disease-free survival rate was 60%.
"There was high efficacy, with the primary endpoint met. All complete remissions were MRD-negative and durable," said lead investigator Stephan Grupp, MD, PhD, the Yetta Deitch Novotny Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania. "These global multicenter trial data build on earlier encouraging research conducted at a single trial site, and advance the case for CTL019 as a potential treatment for children and young adults with relapsed or refractory B-cell ALL.” - See more at: hxxp://www.onclive.com/conference-coverage/ash-2016/ctl019-highly-effective-in-global-phase-ii-all-study-fda-submission-anticipated#sthash.jCz3aKat.dpuf
Oxford BioMedica Announces a Strategic Alliance with Orchard Therapeutics
http://uk.advfn.com/stock-market/london/oxford-biomedica-OXB/share-news/Oxford-Biomedica-PLC-Strategic-Alliance-with-Orcha/73014848
Latest results demonstrate that those patients whose immune systems have been stimulated to produce an anti-tumour response have significantly prolonged survival.
https://www.cancerresearchwales.co.uk/blog/cancer-research-wales-study-scoops-award-at-international-symposium-on-immunotherapy/
This will rocket if news on Trovax, CTL019 or CAR T 5T4 is good. A vital few months ahead.
HTTP://www.essentialkids.com.au/health/allergies-illness/girl6-battling-cancer-for-the-third-time-is-one-step-closer-to-receiving-lifesaving-treatment-in-us-20161031-gsedet
Dr Wan used two of the new so-called gene editing technologies (TALEN and CRISPR) to completely remove the 5T4 gene from cultured ovarian cancer cells.....
HTTP://www.humaneresearch.org.uk/our-spring-2016-newsletter-is-now-available-to-download/
Recruitment to the SKOPOS mesothelioma study has now been completed and of treatment benefit for the the.utic cancer vaccine MVA-5T4 TroVax .. Learn about how mesothelioma is being researched and the progress being made towards a cure.. In patients with mesothelioma it is hoped that the vaccine will stimulate the immune system to mesothelioma cells carrying the 5T4 .
HTTP://serbaserbi22.com/5t4-mesothelioma.html
Name removed (Still posting on facebook today)
29 April 2014 ·
Just returned from my oncologist with results from my latest cat scan and still cancer free. Thank God for Trovax, the best way to beat stage 4 kidney cancer!
Broker Forecast - Jefferies International issues a broker note on Oxford BioMedica PLC
21st October 2016 11:40 | Oxford BioMedica PLC
Jefferies International today initiates coverage of Oxford BioMedica PLC (LON:OXB) with a buy investment rating and price target of 8p.
Story provided by StockMarketWire.com
George, this is interesting; 5T4 oncofoetal antigen: an attractive target for immune intervention in ...
link.springer.com/article/10.1007/s00262-016-1917-3
Peter L. Stern; Richard HarropEmail author. Review. First Online: 18 ..... Unpublished data are provided by Oxford BioMedica (OXB). The table summarises the .
In addition, a chimeric antigen receptor T cell approach targeting 5T4 expressing tumour cells is in pre-clinical development. A key challenge will include how best to combine each 5T4 targeted immunotherapy with the most appropriate standard of care treatment (or adjunct therapy) to maximise the recovery of immune control and ultimately eliminate the tumour.
HTTP://link.springer.com/article/10.1007/s00262-016-1917-3
Carl June/Novartis, early next year they are using Crisp R to knock out the PD-1 before using CAR T.
The patents are baffling to me!
Phase II/III trials look likely with survival end-points which, if positive, would potentially change clinical practice.
Case Studies
TACTICC
Despite advances in potentially-curative therapies, bowel cancer remains one of the leading causes of death from cancer. Researchers at Cardiff ECMC are looking for ways to improve standard treatment.
TACTICC is a randomised trial looking at how the TroVax vaccine and cyclophosphamide affect the immune system in people with advanced bowel cancer. The trial was designed in Cardiff, based on local lab data and recruitment was successfully completed with patients from Cardiff.
Eligible patients had stable or responding disease, following completion of an initial 12 weeks of palliative chemotherapy, and were randomised to one of four groups:
Group 1: Watch and wait, i.e. no additional treatment unless clinically indicated.
Group 2: Metronomic cyclophosphamide only.
Group 3: Vaccination with TroVax® (intra-muscular administration) only
Group 4: Metronomic cyclophosphamide, followed by TroVax® vaccination.
A total of 54 patients were randomised: 9 to each of groups 1 and 2 and 18 to each of groups 3 and 4.
The study was not powered to compare survival, but investigated immune response, following administration of the therapies, and clinical outcome.
The trial has successfully completed in March 2016, and follow-up data will be collected until February 2017. Preliminary results are not yet ready for release, but are suggestive of a positive correlation between specific anti-cancer immune responses and both increased Progression Free and Overall Survival. Potential future randomised Phase II/III trials look likely with survival end-points which, if positive, would potentially change clinical practice.
HTTP://www.ecmcnetwork.org.uk/network-centres/cardiff/contacts/Cardiff%20ECMC
Oxford BioMedica Announces Publication of Pioneering RetinoStat® (OXB-201) Phase I Study Data in the Journal, Human Gene Therapy
-- RetinoStat® met its primary endpoint, demonstrating favourable safety and tolerability profiles
Oxford, UK – 10 October 2016: Oxford BioMedica plc (LSE:OXB) (“Oxford BioMedica” or “the Group”), a leading gene and cell therapy group, today announces the publication in the journal Human Gene Therapy of the previously announced ground-breaking results from the RetinoStat® (OXB-201) Phase I study in patients with advanced wet age-related macular degeneration (AMD) on 6 May 2016. According to key published findings in the associated peer-reviewed paper, RetinoStat® demonstrated a favourable safety profile and led to robust, reproducible sustained expression of endostatin and angiostatin in the eye.
The Phase I study was primarily designed to evaluate the safety and tolerability of RetinoStat® for the treatment of severe wet AMD following a single subretinal injection and represented the first time a lentiviral based vector had been administered to the human eye. Twenty-one subjects with highly fibrotic retinas who were refractory to anti-VEGF therapy following a prior responsive history were treated. As previously announced the results of the Phase I study indicated that RetinoStat® met the primary endpoint of safety and tolerability. Importantly, therapeutic gene expression, measured in these patients as a secondary study endpoint, was found to be dose-dependent and maintained at the last measurement (2.5 years in 8 subjects and >4 years in two subjects).
Peter A. Campochiaro, the Eccles Professor of Ophthalmology and Neuroscience at the Wilmer Eye Institute was the lead author and principal and coordinating investigator. Andreas K. Lauer (Oregon Health Sciences Center of the University of Oregon) and Elliott H. Sohn (University of Iowa) were the other investigators of the study.
The online publication in Human Gene Therapy is entitled: “Lentiviral Vector Gene Transfer of Endostatin/Angiostatin for Macular Degeneration (GEM) Study”. Please follow this link to read the paper in full: http://online.liebertpub.com/doi/full/10.1089/hum.2016.117
Highlights from the Phase I study:
Safety: RetinoStat®, the first ocular lentiviral gene therapy to be administered in Man, has demonstrated a favourable safety profile with no serious adverse events related to the product observed to date.
Pharmacokinetics: significant expression of both therapeutic transgenes was directly measured in patient aqueous humour samples and showed a dose response that was stable and persistent in all patients (out to 4.5 years so far in the earliest patient enrolled).
Oxford BioMedica is evaluating the optimal way to progress the clinical development for RetinoStat®.
Commenting on the publication, John Dawson, Chief Executive Officer of Oxford BioMedica, said: “Like the ProSavin® trial before it, the RetinoStat® First-in-Man study was a clinical trial of ‘firsts’: the first ever trial to directly administer a lentiviral vector-based product to the eye, the first directly administered lentiviral vector trial in the USA, the first direct measurement of an ocular gene therapy transgene during a study and the first reporting of data showing direct demonstration of long-lasting expression of an ocular gene therapy in human subjects.
“These peer-reviewed published results further validate the ground-breaking utility of our LentiVector® delivery platform for the treatment of chronic disease.”
-Ends-
That would be an added bonus George. Let`s hope we hear something about CAR T 5T4 before the end of 2016.
I didn`t see any mention of 5T4
Acknowledgments
We thank our colleagues at Novartis J Brogdon, P. Gotwals, S. Ettenberg and W. Sellers for insightful discussions and L. Johnson for primary cell lines.
Funding: This work was supported in part by grants from the National Institutes of Health (P01CA066726; 2R01CA120409) and by Novartis.
Thanks George, i`ll re-post that
Novartis is seeking to clarify misinformation in the latest Endpoints report on the re-integration of the Cell & Gene Therapies Unit (CGTU) into the broader Novartis organization.
Contrary to your headline that we are “retreating from CAR-T,” our commitment to CAR-T and CRISPR technologies remains strong. As we have previously stated, CTL019 is on track to be filed with the FDA early next year and with the EMA later in 2017. In fact, we expect CTL019 will be the first chimeric antigen receptor T-cell (CAR T) therapy to be approved for pediatric acute lymphoblastic leukemia.
Dr. Usman Azam along with his leadership team helped to design the entire re-integration plan. Actions like re-integration into other parts of businesses can cause redundancies in roles, e.g. HR, finance, legal, and that is why some people will leave our organization. Dr. Azam decided that as part of the re-integration he would like to use this transition to look at new opportunities outside of the company. The CGTU leadership team, along with approximately 120 other associates who will be impacted, have the opportunity to stay at Novartis if there is a role that is available or suitable for them. It is important to note that most of the CGTU employees will be redeployed to other parts of the company.
At Novartis, we are transforming the company to be more focused with a less-complex, more agile structure. While the CGTU structure was critical to ramp up our capabilities in certain areas like manufacturing, clinical trials and commercialization for a completely new way of treating cancer, now that the company has re-organized under a new operating model, the re-integration of CGTU is the logical next step in our evolution.
The Novartis enterprise has all of the capabilities we need to efficiently re-integrate CGTU into the broader organization: leadership in oncology and hematology specifically, a global commercial and development footprint, a strong enterprise manufacturing organization, as well as support functions to enable a successful transition.
Novartis is proud that we have played a leadership role in advancing the scientific concept of CAR-T to the point where this complex way of treating cancer can become a reality for patients. We look forward to continuing to advance the science and our capabilities in this exciting area of medicine.
The market is waiting for clarity on funding plans but I reckon manufacturing Lenti is paying the way ( maybe £16 millions 1st half earnings ). I also think new deals are being negotiated which may bring in more cash. Market cap only $147 m. Totally undervalued.