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Vulpes buy
Today : Wednesday 11 April 2018
TIDMOXB
RNS Number : 6083K
Oxford Biomedica PLC
11 April 2018
Director Dealings / Market Share Purchase
Oxford, UK - 11 April 2018: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE: OXB), a leading gene and cell therapy group, today announces that Vulpes Testudo Fund, a person closely associated with Martin Diggle, Non-Executive Director, has purchased 1,000,000 ordinary shares of 1p each ("Ordinary Shares") in the Company on 10 April 2018 on the London Stock Exchange at a price of 11.0p per share. Following this purchase Vulpes Testudo/Vulpes Life Sciences Fund holds 582,008,434 ordinary shares representing 17.7% of the Company.
Great stuff thanks George. A deal for it would be nice.
Kymriah DLBCL approval any day now
more than 2 companies very interested in Prosavin and a lot of interest in Car T 5T4, great!
expecting further Car Ts from Novartis
lots of pre -clinical candidates.
Couple of years ahead of competitors with tech. Expansion will take manuf to similar size as Bluebird.
very positive
JD says they have so many options that they are picking through them to choose the best ones for OXB.
Biov deal, royalties will increase IF.... inaudible !
when Kymriah reaches peak sales, the royalties become as interesting as manufacturing revenue
http://www.hardmanandco.com/docs/default-source/company-docs/oxford-biomedica-documents/20.03.18-supply-to-meet-demand.pdf
with the first phase of expansion expected to become operational from 3Q’19.
Additional approvals can be expected within a month given the regulatory timelines experienced for Kymriah in B-ALL.
Furthermore, the footprint of the proposed new facility is sufficiently large to allow the addition of a further three GMP vector manufacturing suites in the future (7 new in total)
The first phase is expected to be completed at the end of 2019, with 50% of the new capacity to be live in 2020. At this point in time, the manufacturing capacity at OXB will be broadly equivalent to one of Lonza’s smaller manufacturing sites. OXB is adopting a modular design approach that will allow further capacity expansion to meet the expected increase in demand in the future. For example, another GMP vector manufacturing suite could be added relatively easily in an unutilised part of the new facility, without causing disruption, for ca.£4m.
(So we can build on further suites on site)
The space available allows flexibility to buy in larger volume bioreactors (up to 2,000l), as suspension culture technology advances.
. Combined, higher-volume suspension cultures and TRiP technology support ‘next generation bioprocessing’, reducing cost of goods and further attracting customers.
Product
However, OXB has been in active communication with US-based venture capital partners, and discussions are ongoing.
Staff up to .500 in 2019
Gross income 86.9 million 2020
14:05 Advances in CAR-T Therapy for Chronic Lymphocytic Leukemia (CLL)
J. Joseph Melenhorst, PhD, Director, Product Development & Correlative Sciences, Center for Cellular Immunotherapies, University of Pennsylvania
We have shown that CD19-specific chimeric antigen receptor (CAR) T cell therapy can induce durable remission in most patients with acute but not chronic lymphocytic leukemia (ALL and CLL). We have now identified markers predictive of response and identified key mechanisms of response in CLL. Our preclinical studies have informed next-generation CAR-T based therapies for CLL. Our current trial in CLL has trumped our highest expectations in terms of response rate.
Table 2: Potential of CAR-T Therapy for Solid Tumours
Moderator: Boris Engels, PhD, Senior Investigator, Exploratory Immuno-Oncology, Novartis, Inc.
HTTPS://www.ncbi.nlm.nih.gov/pmc/articles/PMC5358667/
In Brief
Posey and colleagues developed a CAR T cell therapy to break immune tolerance to solid tumors by targeting an aberrantly glycosylated, cancer-specific glycoprotein in multiple cancer histotypes and demonstrated efficacy and safety in tumors as diverse as leukemia and pancreatic cancer.
Highlights
Cancer cells of many tissues express an abnormal glycoform of MUC1, Tn-MUC1
Normal human tissue does not express detectable Tn-MUC1 on the cellular surface
CAR T cells are engineered to target Tn-MUC1 lyse tumor cells in vitro and in vivo
Abnormal glycoform epitopes are valid clinical targets for CAR T cells
09:35 Design of a Highly Efficacious CAR Targeting Mesothelin in Solid Tumors
Boris Engels, PhD, Senior Investigator, Exploratory Immuno-Oncology, Novartis, Inc.
Following clinical experience with a murine scFv based CAR (SS1) targeting mesothelin (MSLN), we pursued the generation of a fully human MSLN-targeting CAR with increased potency against solid tumors. The strong anti-tumor activity of the lead CAR was confirmed in a unique primary pancreatic cancer xenograft mouse “clinical trial”. The lead candidate is now being evaluated in a Phase I clinical study in patients with malignant mesothelioma, ovarian, and lung cancer.
Carl June "Cancer therapy poised for rapid advances, noted researcher says"
Cutting edge;
CART-PSMA-TGFßRDN Cells for Castrate-Resistant Prostate Cancer
University of Pennsylvania
HTTPS://clinicaltrials.gov/ct2/show/NCT03089203
NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)
Multiple Myeloma
Melanoma
Synovial Sarcoma
Myxoid/Round Cell Liposarcoma
University of Pennsylvania
HTTPS://clinicaltrials.gov/ct2/show/NCT03399448
HTTP://www.sandiegouniontribune.com/business/biotech/sd-me-cancer-ucsd-20180223-story.html
M&G is an investment manager in the UK and overseas. Current chief investment officer of M&G Investments is Anne Richards. It is an autonomous business within the Prudential Group
If they are happy to buy 21 million at 11.75 it bodes well for us.
The Placing has been supported by a range of new and existing institutional shareholders from both the U.S. and the UK.
M&G Investment Management Ltd ("M&G") has agreed to subscribe for 21,891,383
That was a surprise at 3pm!
Well everyone has covered my thoughts. I said before, investing in more Pizza ovens to satisfy demand is fine by me.
A briefing for analysts will be held at 9.30 a.m. GMT on 15 March 2018 at 85 Gresham Street, London, EC2V 7NQ. There will be a simultaneous live conference call with Q&A and the presentation will be available on the Group's website at www.oxfordbiomedica.co.uk. An audio replay file will be made available shortly afterwards.
Oxford BioMedica is the first and only commercial supplier of lentiviral vectors to the gene and cell therapy market. The Company estimates that the lentiviral vector bioprocessing market was worth approximately $200 million in 2017 and is expected to grow at a 15.4 per cent. compound annual growth rate from $158 million in 2015 to $800 million by 2026. These estimates exclude milestones and royalties from partnerships which may be earned by companies operating in this space.
The Company expects OXB-102 (Parkinson's disease) to advance into clinical development in H1 2018. The Board expects to spin out / out-license at least one of the Group's in-house product candidates before the end of 2018.
Oxford BioMedica believes it can grow its market share of the bioprocessing market to between 25 per cent. and 30 per cent. with new facilities to be funded from the proceeds of the Placing.
The Company has a short list of potential sites identified as potential suitable premises for its bioprocessing expansion plans. The lead facility is in Oxford and close to the Company's existing headquarters and the Company has been negotiating a potential long lease for the premises which is around 84,000 sq. ft (7,800 sq. mts) and is currently vacant. The Company has been working with a third party consultant to advise on facility layout and anticipated costs of fit out with phase I and II of the plans contemplating that 45,000 sq.ft (4,200 sq. mts) are converted into four GMP suites, a fill and finish facility and warehouse and office space with additional space available for further future expansion as required. The Company believes that this expansion plan will be sufficient for its biomanufacturing requirements for the foreseeable future. The Company estimates that the costs of conversion, fit out and finishing of phase I and II will be GBP19.0 million split as to GBP14.0 million on 4 GMP vector suites, GBP3.0 million on fill and finish suites and GBP2.0 million on the warehouse and administrative offices. The Company expects to incur these development costs between Q2 2018 and H1 2021, with the first phase of expansion expected to come on stream in Q3 2019.
Gross income (revenue and other operating income) was GBP39.4 million
Cash balances as at 31 December 2017 were GBP14.3 million compared to GBP15.3 million at 31 December 2016.
discussions with several large pharmaceutical companies about potential collaboration and licence agreements are ongoing. The Company is also in discussions with additional companies around feasibility studies, which provides the Company with a large pipeline of opportunities.
Positive imo and at a small discount. I reckon this will be a very busy year.
University of Pennsylvania, told HemOnc Today. “I would really like to see eventual approval for adult ALL next. The large multicenter trials haven’t been done, but there are so much preliminary data that it’s hard to envision these therapies won’t be tested and approved.”
Following adult ALL, focus should be on CLL and myeloma, Porter said.
“To me, there is no difference between CLL and non-Hodgkin lymphoma,” he said. “It’s solely a matter of resources to do larger clinical trials and show efficacy. Those are the low-hanging fruit. This provides therapy for an incredible unmet need when there is nothing else.”
Novartis is continuing studies of tisagenlecleucel in DLBCL, ALL and relapsed or refractory follicular lymphoma. Other CAR T-cell therapies in Novartis’s pipeline include targeting CD19 in CLL, anti-B-cell maturation antigen (BCMA) CAR T for multiple myeloma, anti-EGFRvIII CAR T for recurrent glioblastoma, and CAR-T-Meso for advanced ovarian cancer and mesothelioma, according to Touchon.
HTTPS://www.healio.com/hematology-oncology/leukemia/news/print/hemonc-today/%7Bbce73f3b-0172-4e05-a109-ba531502b2c6%7D/reimbursement-remains-difficult-issue-in-car-t-cell-therapy-rollout
Gene therapy was a boy’s last chance to stop leukemia. And it worked.
Science Mar 4, 2018 1:52 PM EST
“If this had been a year or two ago we wouldn’t have had this treatment to offer him.” — Dr. Jennifer Willert, UCSF
Six years ago, he was diagnosed with a form of leukemia called Acute Lymphoblastic Leukemia (ALL), which is the most common cancer in children.
HTTPS://www.pbs.org/newshour/science/gene-therapy-was-a-boys-last-chance-to-stop-leukemia-and-it-worked
Shaun is one of at least 50 children who are in remission because of a breakthrough treatment that engineers the body’s own immune system to fight cancer. Last August, the U.S. Food and Drug Administration (FDA) approved the treatment
So I would guess that our 2nd undisclosed Car T may be;
CAR-T-Meso
Metastatic Pancreatic (Ductal) Adenocarcinoma
Epithelial Ovarian Cancer
Malignant Epithelial Pleural Mesothelioma
HTTPS://clinicaltrials.gov/ct2/show/NCT02159716
Even more to come
The latest exciting developments with CAR-T are still ringing in the ears of the industry and the good news is expected to keep coming. Novartis is far from done, with a slew of plans ready to unfold in the space, as Althoff outlined: “We are excited about the possibility of CAR-Ts to transform cancer care. Kymriah is just the first of Novartis' CAR-T cell therapies. The company also plans to file Kymriah with the FDA in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), as well as file applications with the European Medicines Agency for both B-cell ALL and DLBCL by the end of this year.
“As part of the company’ ongoing research and development collaboration with Penn, together we’ve generated CTL119 – a humanised anti-CD19 CAR – which is in initial clinical development for multiple B-cell malignancies,” he continued. “We’re also studying CART-BCMA, a novel, fully human CAR targeting BCMA, in multiple myeloma and CD123 CAR-T in myeloid leukaemia. Additionally we are studying a number of other CAR therapies in solid tumours, including a humanised anti-EGFRvIII CAR for Glioblastoma Multiforme, a lethal and common brain cancer, and a fully human anti-Mesothelin CAR (huCART-Meso) which recently began clinical testing.”
CAR-T Type Cancer indication Phase 1 Phase 2/ pivotal Phase 3 Submitted Approved
CD19 CAR-T Pediatric & young adult r/r ALL1 EU US
CD19 CAR-T r/r DLBCL2 US/EU
CD19 CAR-T DLBCL in 1st relapse2 Starting 2018
CD19 CAR-T r/r FL3 Starting 2018
CD19 CAR-T r/r DLBCL2
in combination
with pembrolizumab Starting 2018
CD19 CAR-T CLL4 Starting 2018
CAR-T-BCMA r/r Multiple Myeloma Starting 2018
CAR-T-EGFRvIII Recurrent GBM5 Started
CAR-T-Meso Advanced ovarian cancer,
Mesothelioma Started
Novartis has one of the most comprehensive CAR-T
development programs across multiple large indications
1. ALL – acute lymphoblastic leukemia 2. DLBCL – diffuse large B-cell lymphoma
So in Haemophilia Lenti should be better than AAV as Lenti maintains it`s expression while the Liver is growing. AAV expresses to a small degree and over time drops off.
All extremely promising. If we can produce the best in class Haemophilia gene therapy, big market.
DLBCL and 2nd Car T, Prosavin etc. Happy days indeed.
HTTP://www.oxfordbiomedica.co.uk/system/files/corporate-presentations/BIVV%20Annoucement%20AnalystPresentation.pdf
There's also a webcast to go with it:
HTTP://www.oxfordbiomedica.co.uk/system/files/webcasts-and-audios/Conf%20call%20150218.mp3
Helen Maunder, PhD
Principal Scientist, Oxford BioMedica plc
The Use of Automation in the Development of
Lentiviral Vector Packaging and Producer Cell Lines
Abstract
Large-scale production of lentiviral vectors (LV) for therapeutic applications in gene therapy is challenging with current transient transfection processes. The development of packaging (PaCL) and producer cell lines (PCL) enabling the generation of large quantities of vectors will not only reduce the cost of raw materials but provide consistency between manufacturing runs and downstream processing. To generate PaCLs and PCLs, isolation of stably transfected clones by cloning by limiting dilution (LDC) in antibiotic selective media is required. Oxford BioMedica (OXB) has developed a bespoke Automated Cell Screening System (ACSS) which uses state of the art automation. The ACSS enables the isolation of up to 3000 clones by automated LDC in either 96- or 384-well format. Furthermore, the ACSS can perform routine passage and high-throughput (HTP) clonal LV production and evaluation of clonal LV productivity using various screening methods.
HIV-1 PaCLs were generated at OXB by stably transfecting an HEK293T.TetR cell line which constitutively expresses the Tet Repressor (TetR) protein, with inducible plasmids encoding HIV-1 GagPol, HIV-1 Rev, VSV-G envelope, and selectable antibiotic resistance makers. Following antibiotic selection, more than 1000 HIV-1 PaCL clones were isolated and screened for their ability to produce LV using the ACSS. The best LV producing candidate PaCL clones were selected and expanded, then were screened further to select the best five clones. The best candidate PaCL clones underwent a second round of LDC to ensure monoclonality and were further screened using the ACSS before scale-up and selection of the best sub-clones. The best sub-clones produced higher titre LV than obtained using the manual clone selection process, and also demonstrated higher titres than those achieved using the current HEK293T transient transfection process. In conclusion, the isolation and screening of larger numbers of clones (>1000) using the ACSS leads to the selection of higher titre LV producing clones than previously achieved when screening smaller numbers of clones (100–200) manually.
From LSE. Nice to hear
Today 09:59
JonTaylor
Oxb
11.96
Strong Buy
My son is a recipient of the CAR-T cell therapy for acute lymphoblastic leukaemia - and I'm also a modest shareholder in this company. So you could say on both counts I have a vested interest in the share price and technology behind it!
If it helps anyone out there deciding whether to stay in or out - I can tell you that for my son the treatment is working. Good luck to all !
https://endpts.com/bioverativ-inks-100m-gene-therapy-deal-with-oxford-biomedica/
Peter Conradi(Sunday Times): Convinced you can spot the next big thing? Me neither.
"It is not easy, however, for the majority of us who are not skilled in analysing balance sheets to spot potential threats to a business — let alone to judge whether it will be able to turn a profit once it has burnt through its initial funding.
Picking which stocks in the FTSE 250 are likely to outperform their peers is tricky enough. Spotting the next Asos, ARM Holdings or Oxford BioMedica seems well-nigh impossible."
http://www.oxfordbiomedica.co.uk/sites/default/files/OXB_MFG_18_v7_website.pdf
He reckons Novartis` Cart BCMA has cured him of Multiple Myeloma !
Dr. Wright was placed on the list for the clinical trial of CAR-T therapy for multiple myeloma at the University of Pennsylvania. His condition was becoming critical by this time. There were two individuals ahead of Dr. Wright to be treated in the clinical trial, but both dropped out and Dr. Wright ended up being their first multiple myeloma patient to be treated with CAR-T.
Dr. Wright said he didn’t have a moment’s hesitation about participating. “I was all in. There were risks but I had basically run out of options. I know enough immunology to understand what they were trying to do and I thought it had a good chance of success,” said Dr. Wright, also Professor of Internal Medicine who holds an M.D. and Ph.D. from Stanford.
The risk turned out to be real. The clinical trial he was in called for participants to get their CAR-T cells in three doses. The first dose went well. But when he received the second dose there was a reaction. You might say the CAR-T therapy worked too well: His body had so many cancer cells and they were being attacked so effectively by the CAR T-cells, that his body was overwhelmed by the immune response. It’s what happens when you get the flu – the fever, the chills, the body aches are caused by the body’s immune system fighting the viral invader. But in Dr. Wright’s case, the immune response was so great that he was hospitalized for two weeks, receiving supportive therapy.
But all the while, the cancerous B cells were being beaten back. By the time the crisis was over, Dr. Wright’s “light-chain numbers” – the indicator of cancer – had dropped from 6,725 to an astonishing 5.
He remains cancer-free more than two years after the treatment.
“I considered myself cured,” said Dr. Wright, who has been with UT Southwestern, which is recognizing its 75th anniversary this year, for 40 years.
While his physicians are more cautious – they prefer to call it a “sustained complete remission” – his success is inspiring for oncologists like Dr. Larry Anderson, Associate Professor of Internal Medicine, who recently began enrolling patients for a CAR-T multiple myeloma trial at UT Southwestern. “Dr. Wright’s story is an example of why it’s so thrilling to be part of this pioneering effort,” Dr. Anderson said.
HTTP://www.utsouthwestern.edu/newsroom/articles/year-2018/wright-car-t.html
Oxford BioMedica
LentiVector platform expanding into haemophilia
16 February 2018
Oxford BioMedica (OXB) has announced a collaboration and licence agreement with Bioverativ to develop gene therapy products for the treatment of haemophilia. Under the terms of the agreement OXB will receive a $5m upfront payment, plus milestone payments (potentially worth in excess of $100m) and royalties on net sales of any commercialised products. This agreement further validates the value partners see in OXB’s LentiVector expertise and manufacturing capabilities. OXB now has multiple partnered products in various stages of development. Clinical progression and potential commercialisation of these could lead to substantial milestone and royalty revenues over the coming years. We place our numbers under review.
Exact timelines of the development were not disclosed. However, we anticipate that Bioverativ (and soon-to-be parent company, Sanofi) will put significant resources into this partnership to accelerate its gene therapy candidates into the clinic and narrow the gap between its competitors, Spark Therapeutics’ and BioMarin’s haemophilia gene therapies (which have impressive albeit early clinical data packages). As such, OXB could be a rapid beneficiary of the aforementioned milestones and any manufacturing revenues if a clinical supply agreement is later completed.
FDA approval of partner Novartis’s CAR-T Kymriah at the end of 2017 has given clinical and regulatory validation of OXB’s LentiVector platform. We anticipate further partnership deals as OXB leverages its FDA- and MHRA-approved lentiviral manufacturing capabilities, predominately its next-generation 200 litre bioreactors, which enable it to deliver a higher quantity of lentiviral vector at a reduced cost. This is needed for larger indications like haemophilia. We believe partners will be attracted by these capacity upgrades, as few companies worldwide are able to deliver on such scale.
-
HTTP://www.edisoninvestmentresearch.com/research/report/oxford-biomedica568783/full
HTTPS://www.thetimes.co.uk/article/oxford-biomedica-clinches-second-gene-therapy-deal-wst3z8p5s
Alan Oscroft
Fool.co.uk15 February 2018
Important deal
Thursday’s news boosted Oxford Biomedica’s prospects, with the firm announcing “a major new collaboration & licence agreement with Bioverativ Inc. for the development and manufacturing of lentiviral vectors to treat haemophilia.“
Bioverativ will gain access to Oxford’s LentiVector and manufacturing technologies, in a deal which is worth a $5m upfront payment coupled with “various milestone payments, potentially worth in excess of $100m” and royalties. I wonder if those Oxford Biomedica forecasts will be upgraded now?
I see Oxford Biomedica as a ‘picks and shovels’ operator in the gene and cell therapy business, offering technology that can be used for a variety of genetic therapies. Whichever treatments are eventually successful, companies which offer the development platforms should do well.
The market response has been a 7.5% share price rise (at the time of writing), but the full potential of this latest development might not have been fully understood. Oxford Biomedica looks a strong long-term buy to me.
HTTPS://uk.finance.yahoo.com/news/one-growth-stock-d-buy-132534311.html
Under the terms of the agreement, Oxford BioMedica will receive a $5 million upfront payment from Bioverativ. Oxford BioMedica is also eligible to receive various milestone payments, potentially worth in excess of $100 million, and undisclosed royalties on net sales of Bioverativ’s lentiviral vector haemophilia products. Bioverativ will also fund process development and scale-up activities for its lentiviral vector haemophilia products at Oxford BioMedica. The agreement also allows for the parties to put in place a clinical supply agreement for GMP manufacturing of haemophilia products at Oxford BioMedica.
Mantle Cell Lymphoma
Oxford BioMedica : US investors swooping in on British biotechs
"They've done as much as they can in the US... but they're seeing more mature companies in Europe not getting the same valuation that, if you picked [the company] up and put on Nasdaq, they would get," he said.
Paynter, who moved to Oxford BioMedica about six months ago after a decade-long stint at leading biotech firm Shire, said capital is easier to access in North America than Europe, largely because there is more money to work with.
"If you have a product they think could be huge they'll invest early and try to get you up and running," he said.
The world's top two biotech hubs are located in San Francisco and Boston, but the UK is fighting to hold on to the number three spot.
HTTP://www.4-traders.com/OXFORD-BIOMEDICA-PLC-4001068/news/Oxford-BioMedica-US-investors-swooping-in-on-British-biotechs-25886245/
REVENUE FORECAST: Novartis is expected to report sales of about $12.79 billion, according to analysts surveyed by FactSet. This compares with $12.32 billion in the fourth quarter last year.
WHAT TO WATCH
CAR-T: In August, Novartis received approval for its CAR-T treatment, Kymriah, from the U.S. Food and Drug Administration, and fourth-quarter results should give an idea of how its commercialization is progressing. Kymriah, a gene therapy that re-engineers the patient's immune cells to fight cancer, was first approved to treat acute lymphoblastic leukemia and Novartis is seeking approval to expand its usage to include large B-cell lymphoma, or DLBCL. Broadening its use would grow Kymriah's opportunity, analysts at Berenberg say. However, they say Novartis would probably need to adopt a different pricing approach for DLBCL, where response rates are lower, so the analysts will be looking for insights into Novartis's pricing strategy for future indications.
Phase III DLBCL in 1st relapse starts this year
Page 5 excites me for 2018 ;
HTTPS://www.novartis.com/sites/www.novartis.com/files/2017-12-investor-presentation-ash-sabcs.pdf
Further deals and progress with the in-house drugs will be the icing on the cake.
New Deals
In -house drugs progressing
DLBCL approval
DLBCL, ALL profits
2nd and further CAR Ts
Orchard approval for ADA-SCID
New In-house programs including Green Cross
TRiP sales
Possible USA listing
Possible buy out, etc.
Even a few of those may have a dramatic affect on the share price.
The next 1-2 yrs should be interesting.
Novartis plans additional regulatory submissions for Kymriah in pediatric and young adult patients with r/r B-cell ALL and adult patients with r/r DLBCL beyond the US and EU in 2018
Building on the company's experience, having manufactured CAR-T cells for over 300 patients from 11 countries across various indications in clinical trials,
Active research programs are underway targeting other hematologic malignancies and solid tumors, and include efforts focused on next generation CAR-Ts that involve simplified manufacturing schemes and gene edited cells.
Stephen J. Schuster, MD
Oxford Biomedica PLC Kymriah receives Priority Review for adult DLBCL
17/01/2018 7:00am
UK Regulatory (RNS & others)
Oxford Biomedica (LSE:OXB)
Intraday Stock Chart
Today : Wednesday 17 January 2018
Click Here for more Oxford Biomedica Charts.
TIDMOXB
RNS Number : 0627C
Oxford Biomedica PLC
17 January 2018
Oxford BioMedica notes the US FDA Priority Review for Kymriah(TM) for adults with r/r DLBCL and EMA accelerated assessment for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL
Oxford, UK - 17 January 2018: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis that the supplemental Biologics License Application (sBLA) for Kymriah(TM) (tisagenlecleucel, formerly CTL019) suspension for intravenous infusion for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who are ineligible for or relapse after autologous stem cell transplant (ASCT), has been accepted by the US Food and Drug Administration (FDA) for Priority Review. In addition, the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Authorisation Application (MAA) for Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukaemia (ALL) and for adult patients with r/r DLBCL who are ineligible for ASCT. CTL019 is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer.
Priority Review and accelerated assessment are granted to therapies which may provide a significant improvement in the safety and effectiveness of the treatment of a serious disease, and the designations are intended to expedite the standard review time. If approved by the FDA and EMA, Kymriah would represent the first chimeric antigen receptor T cell (CAR-T) therapy available for two distinct indications in non-Hodgkin lymphoma and B-cell ALL.
Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes CTL019. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate CTL019 and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products.
- Ends -
For further information, please
contact:
Oxford BioMedica plc: Tel: +44 (0)1865
John Dawson, Chief Executive Officer 783 000
Stuart Paynter, Chief Financial
Officer
Consilium Strategic Communications Tel: +44 (0)20
Mary-Jane Elliott/Matthew Neal/Philippa 3709 5700
Gardner/Laura Thornton/Rosie Phillips
Notes for editors
About Oxford BioMedica
Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsidiaries (the "Group") have built a sector leading lentiviral vector delivery platform (LentiVector(R) ), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Sanofi, GSK, Orchard Therapeutics and Immune Design, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more than 300 people. Further information is available at www.oxfordbiomedica.co.uk.
This information is provided by RNS
This should be a good year George
Chaka, broker targets 13p atm. Further contracts/ deals to come plus DLBCL approval soon. It will go up but really needs a US listing.
https://www.thetimes.co.uk/edition/business/our-top-share-tips-for-2018-5skb87lxq
The Sunday Times Our top share tips for 2018 Oxford Biomedica
Iain Dey
Oxford BioMedica
Backing British biotech has served me well this year, so I am going to attempt to repeat the trick. Medicine is making quicker advances than the general public seems to acknowledge. One biotech that seems to offer upside, with limited downside, is Oxford BioMedica.
Having more than doubled this year to 8.85p on the back of test results that showed one of its treatments could help cure a form of childhood leukaemia, it is not necessarily an obvious choice for 2018. Nonetheless, Peel Hunt and Jefferies both have a price target of 13p per share, implying more than 40% upside.
Formal approval of the aforementioned leukaemia treatment could lead to a reappraisal of what some analysts reckon could be a $1bn blockbuster.
But that still misses the point. Oxford BioMedica, through its tie-up with Novartis, is now at the forefront of the revolution in immunotherapy — a process whereby your own cells are modified to beat cancer, then reinserted in your body. Oxford is providing the vehicle to transport the Swiss giant’s drugs in this new process. And it earns hard cash for doing so — $127m in 2022, according to estimates from Rodman & Renshaw.
Don’t be fooled by the penny share price. This is a £280m company with relatively freely traded shares and a long history on the stock market.
The sales, profits and royalties will eventually do the job for us.
HTTPS://vimeo.com/246820473
So the way I read this is humanised CAR, combined with PD-1 given earlier or to patients who would have been healthy enough to survive a few months and we will see 60% plus Complete remissions past 3 months. Great news.
A superstar !!!!!!!!!!
So the CR should increase from 30% to 60+% using pd-1, humanised CAR. *