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Nine Ten Capital Management LLC Buys , Oxford BioMedica PLC
https://www.gurufocus.com/news/1139080/nine-ten-capital-management-llc-buys-par-technology-corp-oxford-biomedica-plc-agilysys-inc-sells-instructure-inc-techtarget-inc
John Dawson, Chief Executive Officer of Oxford Biomedica, said:
"We are delighted that despite COVID-19 the MHRA has been able to complete the inspection and sign off of the two suites and supporting areas within our world class Oxbox manufacturing facility. This not only secures facilities for our current and future cell and gene therapy partner programmes but also potentially provides access to the Oxford COVID-19 Vaccine Consortium for production of vaccine should the clinical trials prove to be successful."
https://uk.advfn.com/stock-market/london/oxford-biomedica-OXB/share-news/Oxford-Biomedica-PLC-OXB-receives-approval-for-fir/82441882
AXO-Lenti-PD delivers a 22-point (44%) improvement from baseline in the second dose cohort at 6 months
$65 million offering is expected to close on February 24, 2020
HTTps://synthace.com/lp-oxb-webinar-feb20
@markusgershater
Biologist who aspires to engineer. CSO & cofounder
@synthace
I've just had a sneak preview of what Tom Evans and André Raposo from
@OxfordBiomedica
are going to present at next week's webinar. Truly blown away by the science they're doing with Antha.
Oxford Biomedica PLC
19 December 2019
The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.
Oxford Biomedica Extends Commercial Supply Agreement by Five Years for Manufacture of Lentiviral Vectors
Oxford, UK - 19 December 2019: Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Group"), a leading gene and cell therapy group, announced today that it has extended its commercial supply agreement with Novartis for the manufacture of lentiviral vectors for the Novartis CAR-T portfolio including five lentiviral vectors for CAR-T products. This builds on the existing three year commercial supply agreement signed by the parties in July 2017.
Under the terms of the Agreement, Oxford Biomedica will receive a minimum $75 million from Novartis over the next five years in manufacturing revenue with additional undisclosed process development fees. A mid single digit GBPm payment will also be paid in the medium term as a facility reservation fee with other terms such as royalties on net sales of resulting CAR-T products as previously agreed in 2014.
Oxford Biomedica will dedicate a manufacturing facility to Novartis within its new 7,800m(2) commercial manufacturing centre OxBox, in Oxford, UK. Oxford Biomedica will also be responsible for ensuring that at least two of its GMP facilities are capable of commercial supply for Novartis' CAR-T progammes.
John Dawson, Chief Executive Officer of Oxford Biomedica, said: "This five year extension to our commercial supply agreement with Novartis for the LentiVector(R) platform is testament to the joint success achieved in this strategically important collaboration since 2013. This closely integrated collaboration with Novartis underlines the long-term committment both companies have made to manufacturing CAR-T therapies.
"This is also the first long-term commitment of a partner to reserve a dedicated GMP facility in our new OxBox GMP facility, which we expect to become operational in early 2020. While stable and long-term supply of lentiviral vectors for commercial CAR-T products is key to both companies, we are also pleased to announce that we are now working on five different lentiviral vectors for CAR-T products in the Novartis portfolio and we look forward to helping Novartis to innovate in this exciting therapeutic space".
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……
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
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.
Sounds excellent George. I wish OXB could get some more of their pipeline licensed and progressed.
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.
They are doing well.
Kymriah
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 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 !
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.
Possible ways forward for Car T 5T4 combinations ?
Dr. Eileen Parkes of Queen's University in Belfast
We and others had previously shown that you need STING to upregulate expression of PD-L1, the ligand for PD-1. And cancers with high PD-L1 expression, we already knew, are those that are most likely to respond to immune checkpoint blockade. Moreover, given STING's role in turning on the immune system, it's a very neat way of making a cold tumor hot
Novartis embarked on this first-in-human trial as an important first step in characterizing the safety profile and mechanism of ADU-S100 and its ability to activate the STING pathway.
HTTps://www.creative-biolabs.com/blog/car-t/car-t-armored-with-pd-1-antibody/
HTTps://jamanetwork.com/journals/jama/fullarticle/2714651?utm_source=twitter&utm_medium=social_jama&utm_term=1882413654&utm_content=followers-article_engagement-illustration_medical&utm_campaign=article_alert&linkId=59319702
HTTps://www.bloomberg.com/news/articles/2018-03-01/merck-turns-to-tumor-killing-viruses-in-immune-cancer-treatment
HTTps://endpts.com/turning-cold-tumors-hot-checkmate-pharma-outlines-its-initial-success-story-at-aacr18/
Combining Therapies
A personalized cancer treatment vaccine that targets patient-specific tumor neoantigens showed it could stimulate a potent anti-tumor response in melanoma patients who were at high risk for recurrence following surgery.
Dana-Farber researchers led by Catherine J. Wu, MD, and Patrick A. Ott, MD, PhD, reported in 2017 on six patients who received the vaccine, called NeoVax. The vaccine was created using neoantigen peptides from the patients’ melanoma tumors. When injected into the patients, the vaccine spurred responses by immune T cells, both helper and killer T cells, that recognized the neoantigens on the tumor cells. Four of the six patients had no recurrence of the cancer at a median of 25 months. Two patients had recurrences, but were then treated with the checkpoint inhibitor pembrolizumab, resulting in complete disappearance of their cancer. The researchers say these outcomes support the idea of a doublepunch against tumors: using vaccines to rev up an immune response combined with checkpoint blockers to release the brakes.
HTTp://blog.dana-farber.org/insight/2018/06/enhancing-immunotherapy-race-make-cold-tumors-hot/
the team used biodegradable liposome-based nanoparticles to carry immune-boosting drugs directly to solid tumors and open a window for CAR T cells to be more effective in preclinical models of breast and brain cancer.
The nanoparticles “are not supposed to replace conventional CAR T-cell therapy,” said Dr. Matthias Stephan, who led the study. Instead, he envisions that “you could use these nanoparticles to precondition the patient, and precondition the tumor, so that your T cells work much better.
HTTps://www.fredhutch.org/en/news/center-news/2018/07/liposome-nanoparticles-tumors-vulnerable-immunotherapy.html
“Any new therapy is going to start in refractory patients. [Although] we can get responses in completely refractory patients, it will likely be better if you can do this at an earlier time,” said Maloney, medical director of cellular immunotherapy at Fred Hutchinson Cancer Research Center and a professor of medicine at the University of Washington. “We’re going to see these start moving to a place where we think about them before people have failed several lines of salvage.”
https://www.targetedonc.com/publications/targeted-therapy-news/2018/September-2018/the-impact-of-car-tcell-therapies-in-dlbcl
Scott Gottlieb, M.D.
?
Verified account
@SGottliebFDA
14h
14 hours ago
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This year #FDA will receive 250 IND applications for novel cell and gene therapies; about 100 will be for gene therapies. By 2021 we expect the annual total to reach 1,000. These fields are exploding; and hold tremendous promise for advancing public health https://www.statnews.com/2018/11/16/gottlieb-pushes-for-funding-to-speed-gene-therapy-reviews/ …
Digital tech from Autolus and Oxford BioMedica to speed advanced therapies
UK funds efforts to make country a leader in cell and gene therapy
Also receiving funding is Oxford BioMedica, one of the UK’s leading manufacturers of cell and gene therapies, best know for supplying the lentiviral vector used in Novartis’ CAR-T therapy Kymriah.
The three companies will share a £4.3m Digitalisation of Medicines Manufacturing fund from the government Department for Business, Enterprise and Industrial Strategy, (BEIS) which aims to create more efficient and innovative methods for manufacturing medicines.
Oxford Biomedica will look to dramatically reduce the supply time for manufacturing by using a new digital and robotics framework to increase capacity, reduce waste and cut costs.
HTTp://www.pmlive.com/pharma_news/digital_tech_from_autolous_and_oxford_biomedica_to_speed_advanced_therapies_1262473
Looking good.
W. Buffett
"Charlie and I view the marketable common stocks that Berkshire owns as interests in businesses,not as ticker symbols to be bought or sold based on their 'chart' patterns, the'target' prices of analysts or the opinions of media pundits. Instead, we simply believe that if the businesses of the investees are successful (as we believe most will be) our investments will be successful as well."
,"Be fearful when others are greedy and greedy when others are fearful."
"When major declines occur … they offer extraordinary opportunities to those who are not handicapped by debt."
HTTps://www.ruleoneinvesting.com/blog/how-to-invest/warren-buffett-quotes-on-investing-success/
LISTEN: Tom Whitehead joins @PedCancerCare's Dr. Stephan Grupp & @PennCancer's Dr. Carl June in a podcast discussion on #CARTcell immunotherapy. #StrokeOfGenius @IPOFoundation https://t.co/J8dlfHOvX0
— Emily Whitehead Foundation (@EWhiteheadFdn) November 20, 2018
— marcus (@mwl471) November 16, 2018
Oxford BioMedica
?
We are absolutely thrilled to receive the awards for EU Public Company of the Year and EU Public CEO of the year from @LSXLeaders. Thank you and well done to our fantastic team. It's been quite a ride! #Lifestars2018 #genetherapy #Biotech
Yes I am very optimistic George.
“The millions of patients with Parkinson’s disease globally have limited treatment options available to them today. We are very excited to bring AXO-Lenti-PD into clinical development and believe it will be an important new therapy for patients with Parkinson’s disease who suffer from motor fluctuations on the current standard of care. Building upon the evidence of safety and durable improvements in motor symptoms seen up to six years in the prior clinical study of ProSavin, we feel a sense of urgent responsibility to accelerate the development of AXO-Lenti-PD,” said Pavan Cheruvu, M.D., chief executive officer of Axovant. “This marks the first of our gene therapy programs to enter the clinic, and our focus now is on rapid execution of the clinical study. We look forward to sharing initial data in the first half of 2019.”
hTTp://investors.axovant.com/news-releases/news-release-details/axovant-announces-dosing-first-patient-clinical-study-axo-lenti
Best wishes to this chap;
AXO-Lenti-PD was administered to the first patient on the study at the Clinical Research Facility affiliated with the National Institute for Health Research (NIHR) and University College London Hospitals (UCLH). The patient experienced no complications related to the surgery or to administration of the vector and was discharged home as planned.
The ongoing clinical study of AXO-Lenti-PD will evaluate safety and tolerability, as well as collect efficacy data including standard measures of motor function in patients with Parkinson's disease. Initial data from the first cohort of patients in the clinical trial is expected in the first half of 2019.
The London, United Kingdom-based company plans to raise $200 million by offering 13.3 million ADSs at a price range of $14 to $16. At the midpoint of the proposed range, Orchard Therapeutics would command a fully diluted market value of $1.4 billion.
Oxford BioMedica currently owns 1,111,924 shares in Orchard Therapeutics (pre any share capital reorganisation which may be undertaken as part of the IPO process).
Additionally, Oxford BioMedica will receive a low single-digit royalty on net sales of licensed products until January 31, 2039. In the event the products are used for compassionate use, these royalties are reduced by a mid-double-digit percentage. Orchard Therapeutics is also required to pay a set monthly fee to Oxford BioMedica in the event the Group's system for generating stable cell lines is used.