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AXO-Lenti-PD
http://investors.axovant.com/static-files/b6b0cded-8d58-46d4-99a2-f0bdfb5e566e
Good luck and GOD bless,
Novartis's $90 million Swiss factory to help solve cell therapy bottleneck
https://www.reuters.com/article/us-novartis-swiss-factory/novartiss-90-million-swiss-factory-to-help-solve-cell-therapy-bottleneck-idUSKBN1Y214Y
Good luck and GOD bless,
Novartis Q3 Results:
Kymriah (USD 79 million) strong demand continued and sales increased primarily driven by ongoing uptake in the US and Europe. There are over 160 qualified treatment centers and more than 20 countries worldwide that have coverage for at least one indication. Reimbursement for DLBCL was received in Scotland and for both pediatric ALL and DLBCL in Italy.
HTTPS://www.novartis.com/sites/www.novartis.com/files/2019-10-interim-financial-report-en.pdf
Excellent $79 m ( $58 Q2 ). I make that a 36% increase in just 3 months.
Then in 2021 it will be available for 1st relapse and in FL.
Hopefully China approval soon.
We could possibly see full year sales of $400m + by the end of 2020.
Nice royalties and manufacturing profits for OXB.
Oxford Biomedica (OXB) - Burgeoning bioprocessing revenues
07:24 EDT 5 Sep 2019 | Edison Investment Research
Edison Investment Research - Pharmaceuticals & healthcare - Oxford Biomedica : Oxford BioMedica’s (OXB’s) interim results were broadly in line with our expectations for 2019. The decrease in H119 revenues to £32.1m (-9%) largely reflects the exceptional performance in the previous period, which was bolstered by strong licence income (H119: £13.3m vs H118: £19.9m) primarily from upfront payments with the Axovant and Bioverativ deals signed (£18.5m combined). Importantly, in H119 bioprocessing revenues grew 23% to £18.8m, which we expect was driven by the continued uptake of Novartis’s CAR-T Kymriah. Typically, bioprocessing revenues are back-end loaded so a stronger performance can be expected in the second half of the year. With OXB transitioning one of its GMP suites across to bioreactor processing in H119 and its new OxBox bioprocessing facility expected to be fully operational in Q220, we expect this growth to continue in the near term. We retain our valuation of £649m.
Oxford Biomedica is about to clinch new partnerships. In separate talks over licensing or spin-outs.in partnership talks with a “big company at the moment”.
thetimes.co.uk/article/new-deals-to-lift-oxford-biomedica-ftwfxsfpn……
Gene Therapy for Parkinson’s Disease: Preclinical Evaluation of Optimally Configured TH:CH1 Fusion for Maximal Dopamine Synthesis
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6685641/
Good luck and GOD bless,
Robert has a proven track record of helping to grow life sciences companies in the US. he was focused on mergers and acquisitions
https://uk.advfn.com/stock-market/london/oxford-biomedica-OXB/share-news/Oxford-Biomedica-PLC-Board-Change/80198460
In a cell and gene therapy sweet spot Oxford BioMedica 4 June 2019 Outlook
https://www.edisongroup.com/publication/in-a-cell-and-gene-therapy-sweet-spot/24313
Good luck and GOD bless,
GREAT NEWS!!!
Oxford Biomedica announces strategic investment by Novo Holdings A/S
Oxford, UK - 28 May 2019: Oxford Biomedica plc (LSE:OXB) ("OXB" or "the Group"), a leading gene and cell therapy group, today announces that Novo Holdings A/S ("Novo Holdings"), has agreed to invest up to £53.5 million in the Group in return for new ordinary shares representing up to 10.1% of the outstanding shares after the capital increase (the "Transaction").
The proceeds from the Transaction will be used to repay the existing debt facility with Oaktree Capital Management in full and to further develop the LentiVector® platform and the proprietary product portfolio. The price per new ordinary share to be paid by Novo Holdings is equal to the closing market price on Friday, 24 May 2019. For more information, see section "About the Transaction" below.
OXB is at the centre of the rapidly emerging gene and cell therapy sector by which life-changing and curative treatment has become a therapeutic reality. Leveraging its world-leading LentiVector® platform, OXB benefits from a dual strategy to support its partners in the development and commercialisation of their gene and cell therapy programmes while also pursuing the development of a proprietary product portfolio for later out-licensing. This strategy has resulted in a number of partnerships, including with Novartis and Sanofi, as well as the out-licensing of OXB-102 (AXO-Lenti-PD) to Axovant Gene Therapies.
The investment from Novo Holdings will enable OXB to take advantage of its leading position and further exploit the growth opportunities in the sector.
John Dawson, Chief Executive Officer of Oxford Biomedica, commented:
"We are delighted that Novo Holdings has become a shareholder in Oxford Biomedica. Novo Holdings is a well-known and highly regarded long-term investor with significant expertise in working with innovative, life sciences businesses to unlock their growth potential. This experience will be a great asset far beyond the financial commitment they have made to the Group and their collaboration and support will be highly valuable as we seek to scale up our operations both on the platform and on the proprietary product portfolio."
Robert Ghenchev, Director at Novo Holdings, added:
"Oxford Biomedica is a global scientific and manufacturing leader within lentiviral vectors, one of the most established and well-validated technologies for delivering gene and cell therapies. This investment underscores Novo Holdings' commitment to supporting companies developing cutting-edge science that makes a real difference to patients and society. We are genuinely excited about this investment and look forward to working with Oxford Biomedica and supporting the Group going forward."
About the Transaction
Under the Subscription Agreement entered into by Novo Holdings and OXB in relation to the Transaction, Novo Holdings has agreed to subscribe for 6,568,024 new ordinary shares in OXB (the "Subscription Shares") at a price of £6.90 per share (the "Subscription Price"). The Subscription Agreement also provides an option for Novo Holdings to subscribe for up to a further 1,181,976 new ordinary shares in OXB (the "Further Shares") at the Subscription Price by the 30 June 2019 (the "Subscription Option"). Exercise of the Subscription Option in full would increase Novo Holdings' ownership to 10.1% of the Company following the issuance of the Subscription Shares and the Further Shares. Under the Subscription Agreement, Novo Holdings is granted the right to appoint a non-executive director to the Board of OXB following the issuance of the Subscription Shares.
Q1 Kymriah (USD 45 million) strong demand continued and sales increased driven by new treatment sites in the EU, additional progress with reimbursement, coverage for at least one indication in 14 countries, increased manuf capacity and widened commercial spec in the EU.
Marcus,
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148396631
Update on Friday April 26, 2019.
http://4965zs3ha2l125fk78zkozo3.wpengine.netdna-cdn.com/wp-content/uploads/RENE-RP-clinical-update-FINAL.pdf
Good luck and GOD bless,
Yes well done.
ReNeuron will also receive tiered royalties at rates between 12% and 14% on sales of the licensed products in the Chinese market.
I can see OXB at least doubling in value within a year.
Marcus,
Again just FYI
RENE has just about tripled within the past 2 weeks so far
https://finance.yahoo.com/news/reneuron-partners-fosun-pharma-china-110000716.html
Good luck and GOD bless,
Marcus, thank you
This market is prime for acquisition and partnerships
Good luck and GOD bless
They are doing well.
Look at the recent price history and trading volume, especially today Thursday April 4, 2019.
https://finance.yahoo.com/quote/RENE.L?p=RENE.L&.tsrc=fin-srch
http://4965zs3ha2l125fk78zkozo3.wpengine.netdna-cdn.com/wp-content/uploads/RENE-RP-clinical-update-FINAL.pdf
https://www.proactiveinvestors.co.uk/companies/news/217933/reneuron-provides-further-encouraging-update-for-potential-sight-saving-treatment-217933.html
Good luck and GOD bless,
Marcus,
Just FYI.
Look at the recent price history and trading volume, especially today Thursday March 4, 2019.
https://finance.yahoo.com/quote/RENE.L?p=RENE.L&.tsrc=fin-srch
http://4965zs3ha2l125fk78zkozo3.wpengine.netdna-cdn.com/wp-content/uploads/RENE-RP-clinical-update-FINAL.pdf
https://www.proactiveinvestors.co.uk/companies/news/217933/reneuron-provides-further-encouraging-update-for-potential-sight-saving-treatment-217933.html
Good luck and GOD bless,
Marcus,
Unrelated to OXB.
Look into RENE ReNeuron
https://finance.yahoo.com/quote/RENE.L?p=RENE.L
Good luck and GOD bless,
See page 4 through 20 and 34, 35, 36 regarding AXO-Lenti-PD
http://investors.axovant.com/static-files/02c997e8-92d8-443f-9f7e-91e60e364470
Good luck and GOD bless,
Oxford Biomedica
@OxfordBiomedica
5h
5 hours ago
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Kymriah has now been approved in Japan as the first CAR-T cell therapy authorised in Japan. Read our announcement here #celltherapy
Yes George, JD says that more deals are in the pipeline and they need the manufacturing expansion to cope with demand. I think the valuation will be much higher later in the year.
The initial data from Sunrise - pd is excellent at the lowest dose. higher dose to be given in May.
If efficacy improves it could be a game changer in Parkinson`s.
Oxford Biomedica announces R&D collaboration with Microsoft to improve gene and cell therapy manufacturing using the intelligent cloud and machine learning
Oxford, UK – 12 March 2019: Oxford Biomedica plc (LSE:OXB), a leading gene and cell therapy group, today announces that it has entered into a research and development collaboration with Microsoft Research to improve the yield and quality of next generation gene therapy vectors using the cloud and machine learning.
Cell and gene therapy has the potential to transform medicine, providing long-term and potentially curative treatment options for a wide range of diseases. The first products are already approved and available for patients however, with the increase in demand for these innovative therapies comes manufacturing challenges for the delivery systems that enable them.
The collaboration will combine the expertise of Oxford Biomedica researchers in cutting edge vector development and large scale manufacture and the team within the Station B initiative at Microsoft to explore new ways to increase the yield and improve the purity of Oxford Biomedica’s lentiviral vectors, while further reducing the cost. Oxford Biomedica will contribute large data sets for analysis via the Microsoft Azure intelligent cloud platform. Microsoft, in collaboration with Oxford Biomedica scientists, will utilise its cloud computing and machine learning capabilities to develop in silico models and novel algorithms to help advance the next generation of cell and gene delivery technology. The collaboration will run for an initial two-year period and may be extended by either party.
Jason Slingsby, Chief Business Officer of Oxford Biomedica, said: “Our LentiVector® gene delivery platform is recognised as a leading solution by major industry players but developing next-generation manufacturing technologies is complex and often involves uncertain outcomes.
“The collaboration with Microsoft Research will harness our rich data resources to offer greater insights into the biological processes required to enhance quality and optimise yields of lentiviral vectors. It builds on our digital framework initiative, established in 2018, and the work underway in our collaboration with Synthace to rapidly and flexibly design, simulate and execute complex experimental designs to develop next generation manufacturing processes, including with stable producer cell lines for lentiviral vectors. Our goal is to enable faster, cheaper and more reliable manufacture of high quality next-generation cell and gene therapies to allow more patients to benefit.”
Andrew Phillips, Head of Biological Computation at Microsoft, said: “Programming biology has the potential to solve some of the world’s toughest problems in medicine, and to lay the foundations for a future bioeconomy based on sustainable technology. Oxford Biomedica is at the cutting edge of cell and gene therapy delivery and their highly sophisticated manufacturing processes generate a vast wealth of valuable data. We anticipate that by combining computational modelling, lab automation, machine learning and the power of the cloud, we can help them in their quest to make existing treatments more cost effective and in future to develop groundbreaking new treatments.
https://www.oxfordbiomedica.co.uk/news-media/press-release/oxford-biomedica-announces-rd-collaboration-microsoft-improve-gene-and-cell
Good luck and GOD bless,
A MUST READ REGARDING TODAY'S NEWS!!!
Could this possibly be a $15 billion deal like P was?
Doubling Down on Gene Therapies, Novartis Buys CellforCure to Manufacture CAR-T Products
https://www.biospace.com/article/novartis-to-buy-kymriah-manufacturer-cellforcure/
Good luck and GOD bless,
George
Novartis, still struggling with Kymriah manufacturing, is providing some out-of-spec doses to patients who ask
https://www.fiercepharma.com/manufacturing/novartis-still-struggling-kymriah-manufacturing-providing-some-out-spec-doses-to
Good luck and GOD bless,
George
Safety and Efficacy of OXB-202, a Genetically Engineered Tissue Therapy for the Prevention of Rejection in High-Risk Corneal Transplant Patients.
Fouladi N1, Parker M2, Kennedy V1, Binley K1, McCloskey L1, Loader J1, Kelleher M1, Mitrophanous KA1, Stout JT3, Ellis S1.
Author information
1
1 Oxford BioMedica (UK) Ltd. , Oxford, United Kingdom .
2
2 Casey Eye Institute, Oregon Health and Sciences University , Portland, Oregon.
3
3 Cullen Eye Institute, Baylor College of Medicine , Houston, Texas.
Abstract
Due to both the avascularity of the cornea and the relatively immune-privileged status of the eye, corneal transplantation is one of the most successful clinical transplant procedures. However, in high-risk patients, which account for >20% of the 180,000 transplants carried out worldwide each year, the rejection rate is high due to vascularization of the recipient cornea. The main reason for graft failure is irreversible immunological rejection, and it is therefore unsurprising that neovascularization (NV; both pre and post grafting) is a significant risk factor for subsequent graft failure. NV is thus an attractive target to prevent corneal graft rejection. OXB-202 (previously known as EncorStat®) is a donor cornea modified prior to transplant by ex vivo genetic modification with genes encoding secretable forms of the angiostatic human proteins, endostatin and angiostatin. This is achieved using a lentiviral vector derived from the equine infectious anemia virus called pONYK1EiA, which subsequently prevents rejection by suppressing NV. Previously, it has been shown that rabbit donor corneas treated with pONYK1EiA substantially suppress corneal NV, opacity, and subsequent rejection in an aggressive rabbit model of cornea graft rejection. Here, efficacy data are presented in a second rabbit model, which more closely mirrors the clinical setting for high-risk corneal transplant patients, and safety data from a 3-month good laboratory practice toxicology and biodistribution study of pONYK1EiA-modified rabbit corneas in a rabbit corneal transplant model. It is shown that pONYK1EiA-modified rabbit corneas (OXB-202) significantly reduce corneal NV and the rate of corneal rejection in a dose-dependent fashion, and are tolerated with no adverse toxicological findings or significant biodistribution up to 13 weeks post surgery in these rabbit studies. In conclusion, angiogenesis is a valid target to prevent corneal graft rejection in a high-risk setting, and transplanted genetically modified corneas are safe and well-tolerated in an animal model. These data support the evaluation of OXB-202 in a first-in-human trial.
https://www.ncbi.nlm.nih.gov/pubmed/29361840
Good luck and GOD bless,
George
Oxford BioMedica to capture 25-30% of lentiviral vector market by 2026, predicts CTO
10-Dec-2018 By Flora Southey
According to the lentiviral vector manufacturer, which supplies vectors for Novartis’ Kymriah, the market is growing – and could be worth $800m by 2026.
HTTps://www.biopharma-reporter.com/Article/2018/12/10/Oxford-BioMedica-to-capture-25-30-of-lentiviral-vector-market-by-2026-predicts-CTO
(This is VERY interesting)
We are looking to work with other Car T companies in areas beyond those covered by our existing partnership with Novartis !
AXOVANT ANNOUNCES FEEDBACK FROM FDA MEETING REGARDING AXO-LENTI-PD FOR PARKINSON’S DISEASE AND PROGRESS IN ONGOING SUNRISE-PD PHASE 2 CLINICAL TRIAL
12.06.2018
Download PDF
Meeting with FDA confirmed that studies previously conducted using first generation ProSavin® may be considered part of a single development program with AXO-Lenti-PD
Confirmed with FDA that the proposed current manufacturing process and quality control testing is adequate for the clinical program
Dosed second patient in the SUNRISE-PD phase 2 clinical trial of AXO-Lenti-PD in November 2018, with data expected in March 2019
BASEL, Switzerland, Dec. 06, 2018 (GLOBE NEWSWIRE) -- Axovant Sciences (NASDAQ: AXON), a clinical-stage company developing innovative gene therapies for neurological conditions, today announced feedback from a face-to-face pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding AXO-Lenti-PD for patients with Parkinson’s disease. Based on the discussion at the meeting, the totality of data collected on the initial vector construct, ProSavin, including over six years of phase 1/2 clinical data and IND-enabling preclinical data, may be supportive of the planned development program for AXO-Lenti-PD.
The phase 2 clinical trial of AXO-Lenti-PD (NCT03720418), now called SUNRISE-PD, was initiated in the U.K. in the fourth quarter of 2018. The SUNRISE-PD study is advancing as planned with dosing of the second patient in November 2018. To date, both patients tolerated the surgical procedure well and were discharged home with no serious adverse events observed. Axovant expects to announce data from the first two patients in March 2019.
During the meeting discussion and subsequent written meeting minutes, Axovant received feedback from the FDA on several key features of the AXO-Lenti-PD development program:
The target patient population will be adult patients with Parkinson’s disease who are refractory to additional medical management due to motor complications
The ongoing SUNRISE-PD clinical study of AXO-Lenti-PD constitutes an early-phase, exploratory trial that may support a future marketing application if safety and efficacy data are meaningful
The primary efficacy measure of the randomized, sham-controlled portion of the phase 2 study will be assessed at 12 months using data from Hauser patient diaries
Additional secondary efficacy data will be collected on the UPDRS Part III “OFF” score, a motor function assessment completed by clinicians after oral levodopa has been washed out
The proposed current manufacturing process and quality control testing is adequate for the clinical program
FDA agreed in principle with the proposed approach to demonstrate compatibility between the current manufacturing process and the planned serum-free, suspension manufacturing process that will be used to support scale-up and commercialization.
In addition, Axovant was encouraged to return for an End-of-Phase 2 meeting after completion of the ongoing SUNRISE-PD study, during which the available data generated in the study will be discussed in the context of a pivotal program design.
“We are pleased with the feedback received at our meeting with the FDA, which reaffirmed our strategy to view the ongoing SUNRISE-PD clinical study of AXO-Lenti-PD as a continuation of the previous ProSavin program, and part of a single development program,” said Gavin Corcoran, M.D., executive vice president of research and development for Axovant. “We believe we are well-positioned to continue to execute on the clinical trial as designed, manufacture drug product at scale, and activate clinical trial sites in the U.S. during the randomized, sham-controlled portion of our SUNRISE-PD study.”
About AXO-Lenti-PD
AXO-Lenti-PD, also known as OXB-102, is an investigational gene therapy for Parkinson’s disease. The product delivers three genes in vivo via a lentiviral vector to encode the set of enzymes required for dopamine synthesis in the brain and is expected to provide patient benefit for many years following a single administration. A phase 1/2 study for ProSavin, a first-generation version of AXO-Lenti-PD, met its primary endpoint. The results, which were published in The Lancet in 2014, demonstrate favorable safety and tolerability and a statistically significant improvement from baseline of motor function as measured by the UPDRS Part III score at 6 and 12 months (p=0.0001). This improvement has been observed to be sustained in patients for up to six years despite the progressively degenerative nature of Parkinson’s disease. Data from the first two patients enrolled in the ongoing AXO-Lenti-PD phase 2 (SUNRISE-PD) study are expected in March 2019.
About Axovant Sciences
Axovant is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurological diseases such as Parkinson's disease, oculopharyngeal muscular dystrophy (OPMD), amyotrophic lateral sclerosis (ALS), frontotemporal dementia, and other indications. For more information, visit www.axovant.com
http://investors.axovant.com/news-releases/news-release-details/axovant-announces-feedback-fda-meeting-regarding-axo-lenti-pd
Good luck and GOD bless,
George
Oxford Biomedica PLC Axovant FDA meeting feedback
06/12/2018 4:11pm
RNS Non-Regulatory
TIDMOXB
Oxford Biomedica PLC
06 December 2018
Oxford BioMedica notes Axovant announcement of feedback from FDA regarding AXO-LENTI-PD and progress with ongoing Phase 2 clinical trial
Oxford, UK - 06 December 2018: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, notes an announcement today by Axovant Sciences regarding feedback from a face-to-face pre-IND meeting with the U.S. Food and Drug Administration (FDA) concerning AXO-Lenti-PD for patients with Parkinson's disease. Based on the discussion at the FDA meeting, the totality of data collected on the initial vector construct, ProSavin, including over six years of phase 1/2 clinical data and IND-enabling preclinical data, may be supportive of the planned development programme for AXO-Lenti-PD.
In addition, the phase 2 clinical trial of AXO-Lenti-PD (NCT03720418), now called SUNRISE-PD, was initiated in the U.K. in the fourth quarter of 2018. The SUNRISE-PD study is advancing as planned with dosing of the second patient in November 2018. To date, both patients have tolerated the surgical procedure well and were discharged home with no serious adverse events observed. Axovant expects to announce data from the first two patients in March 2019.
Under the terms of the agreement with Axovant, Oxford BioMedica received a $30 million upfront payment (approximately GBP22 million) including $5 million as pre-payment for manufacturing activities related to OXB-102, now renamed AXO-Lenti-PD. Oxford BioMedica is also eligible to receive $55 million upon the achievement of specified development milestones and $757.5 million upon the achievement of specified regulatory and sales milestones, with 7% to 10% tiered royalties on net sales of AXO-Lenti-PD.
Read the Axovant press release here
I agree George, but along with a few others like Axovant, Sanofi, Boerhinger (if Cystic Fibrosis works), GSK etc.
Novartis could buyout Oxford BioMedica
http://fortune.com/video/2018/11/30/novartis-ceo-breakthrough-drug/
Good luck and GOD bless,
George
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