Oxford BioMedica Live Discussion

d_gaser 30 Jan 2019

Novartis release good figures relating to Kymriah sale's •Please to see Novartis are doing well with this product, as it impacts OXB future, the only problem I see for OXB is the fact Novartis are building further manufacturing facilities around the world , but can OXB continue to grow at the same pace ?or are Novartis looking at other ways of delivering their product .the RNS read .Kymriah sales were USD 28 million with the US as the main driver. Progress was made on access in Europe with commercial orders in five countries, and Australia approved both indications in December. EMA approved wider commercial specifications in Q4 and a corresponding FDA submission was completed. Additionally, we are expanding global manufacturing including multiple collaborations and doubling the capacity at Morris Plains. BE HAPPY Dave

riverside_red 31 Dec 2018

Share price rise What does someone know?

d_gaser 23 Nov 2018

OXB get £2m grant for new digital framework initiative Oxford BioMedica announces new digital framework initiative to streamline the production of next-generation medicines with cash injection from Innovate UK Oxford, UK – 23 November 2018: Oxford BioMedica plc (“OXB” or “the Group”), a leading gene and cell therapy group, today announces the formation of a new digital framework initiative to streamline the production of next-generation medicines. OXB will invest a total of £4 million, supported by a £2 million grant from Innovate UK, the UK’s innovation agency, in building digital and robotics capabilities that are designed to drive improvements in analytical methodology, supply times and cost of goods. The goal is to increase capacity, reduce the cost of manufacturing and reduce waste. The aims of the project are aligned with the UK Government’s Life Sciences Sector Deal to help ensure that the next wave of breakthrough treatments, innovative medical research and technologies, and high skill jobs are created in Britain. OXB is committed to investing in the UK and has recently announced the expansion of its manufacturing capacity to create an additional 82,398 sqft facility near its headquarters in Oxford. This new facility secures Oxford as a bioprocessing centre for OXB and will create up to 100 new, highly skilled positions at the Group over the next two years. John Dawson, Chief Executive Officer of Oxford BioMedica, commented: “With demand for advanced therapy medicinal products expected to grow at unprecedented levels, underlined by the interest received from our current and future potential partners at OXB, it is imperative that we continue to invest in our technology, capacity and innovation. BE HAPPY DAVE

d_gaser 07 Nov 2018

Price Up daily ,yet price has fallen. WHY I just don’t get this market ,every day the market shows OXB has moved up by a small % yet the next day the opening bid is lower .I was all ways afraid that the 100-1 consolidation was to much, and it now appears that with only 66m shares out there ,the M/M are unable to make the market work for OXB . It’s a Sad state of affairs, when big share holders are able to sell out when price bounced (yes I know, I could have sold as well, and did sell some ),but now most of the shares are held pension funds ,and that has limited OXB liquidity, and offers shorters a way in to make money on the backs of those who have stuck by this company . The management must have been aware of this possibility, when they made their decission, why then did they do it ? . . BE HAPPY DAVE .

d_gaser 17 Oct 2018

Who said the less shares issued means a stabile price Like you Chris, I to would love to have the old board back , as the new one has very little going for it. I’m still invested here, and have topped up several times over the past year ,but now it feels like I’m trying to catch a falling knife .I have no idea why this share has fallen so fast ,but the last time it did this, we were only a few weeks away from collapse ,I’m sure we are not in that position now, but it is worrying . Hope your OK and that other investments are holding up for you … BE HAPPY DAVE

cafestock 16 Oct 2018

Who said the less shares issued means a stabile price Dave - for me, its time to hold and maybe even top up. Fundamenals have not changed, its still going to fly on some good news. IMHO. Ps - I sure miss the old style board wher convestaions were much uch esier. Chris

d_gaser 15 Oct 2018

Who said the less shares issued means a stabile price Well I don’t know about the rest of you, but to me, this shares has become more unstable since the consolidation, and resent good news.to me it’s up and down like a yo-yo ,and has even managed to loss 25% of it’s value since it hit it’s high of £10.70p. is it now time to dump or hold this yo-yo ? Be Happy Dave

d_gaser 05 Oct 2018

OXB up dates deal with Orchard Therapeutics Seems we have quite a financial holding in Orchard . BE HAPPY Dave Oxford BioMedica announces additional details of its strategic alliance with Orchard Therapeutics London, UK – 5 October 2018: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today announces additional details of its strategic alliance with Orchard Therapeutics, as disclosed in the public filing by Orchard Therapeutics on a Form F-1 Registration Statement ahead of a planned NASDAQ Initial Public Offering (IPO). In November 2016, Oxford BioMedica entered into a strategic alliance with Orchard Therapeutics for the development of gene therapies for ADA-SCID, MPS-IIIA and certain other diseases (Subsequent Indications). In the agreement, Oxford BioMedica granted to Orchard Therapeutics an exclusive, worldwide license for the research, development and commercialisation of ex vivo gene therapy products for the treatment of ADA-SCID, MPS-IIIA and Subsequent Indications. Oxford BioMedica also granted Orchard Therapeutics a non-exclusive, worldwide license for the treatment of certain diseases other than ADA-SCID, MPS-IIIA and Subsequent Indications. As consideration for the licenses granted under the agreement, Oxford BioMedica was issued 735,000 ordinary shares in Orchard Therapeutics. Additional shares were awarded to the Group on the achievement of certain milestones, including 188,462 ordinary shares in November 2017 and a further 188,462 ordinary shares in August 2018. Additional ordinary shares will be issued to Oxford BioMedica upon achievement of the remaining milestones. 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. Ends -

techno-foxx 14 Sep 2018

This car-t target works in solid pancreatic cancers in mice Immuno-Oncology News – 12 Sep 18 'Switchable' CAR T-cell Therapy Kills Advanced Pancreatic Cancer Cells in Mice,... Read aboout a new immunotherapy approach that completely eliminated tumors in mice transplated with patient-derived aggressive pancreatic cancer cells.

d_gaser 13 Sep 2018

OXB show 118% growth ,plus need new plant to meet demand Great set of accounts for a change ,and even better things to come in the future , we all new this company would come good one day . Well done OXB, here’s hoping OXB can keep this up in the future. BE HAPPY DAVE Oxford, UK – 13 September 2018: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE: OXB), a leading gene and cell therapy group, today announces interim results for the six months ended 30 June 2018. FINANCIAL HIGHLIGHTS Gross income growth of 118% to £36.0 million (H1 2017: £15.7 million) Operating EBITDA of £11.9 million compared to a loss of £2.1 million in H1 2017 Licence income of £18.3 million recognised (due to Axovant and Bioverativ deals), segmented by Product (£10.2 million) and Platform (£8.1 million) Cash inflow, before financing activities, of £12.2 million compared to an outflow of £2.2 million in H1 2017 Cash at 30 June 2018 was £44.0 million (31 December 2017: £14.3 million), reflecting significantly improved trading performance and placing to raise £20.5 million (gross) £3.0 million capital expenditure grant received from Innovate UK to support the UK’s efforts to produce viral vectors and ensure adequate supply to service expected demand Gross proceeds of £20.5 million raised from new and existing investors through a placing to fund the proposed expansion and fit-out of the additional bioprocessing facilities at a new facility in Oxford Share consolidation completed to reduce the number of issued ordinary shares in the Oxford BioMedica by a factor of 50 whilst increasing the trading price of each Existing Ordinary Share proportionally OPERATIONAL HIGHLIGHTS (including post period-end events) Novartis’ commercialised product Kymriah™ The collaboration with Novartis continues to progress well with Kymriah’s approval by the Federal and Drug Administration (FDA) to treat adult patients with relapsed and refractory (r/r) B-cell diffuse large B-cell lymphoma (DLBCL), the second indication for this transformative and innovative therapy in the US The European Commission (EC) and Health Canada also approved Novartis’ Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukaemia (ALL) and adult patients with r/r/ DLBCL NHS England announced that Novartis’ Kymriah will be made available to children and young adults in England Leading LentiVector® delivery platform for gene and cell therapy partnerships$105.0 million collaboration and licence agreement completed with Bioverativ (now part of Sanofi) to access Oxford BioMedica’s LentiVector® platform and manufacturing technologies in the field of haemophilia gene therapy. Partnership formed with the UK Cystic Fibrosis Gene Therapy Consortium, Boehringer Ingelheim and Imperial Innovations to develop a novel inhaled gene therapy treatment for cystic fibrosis Progress with proprietary product development $842.5 million exclusive worldwide agreement signed with Axovant Sciences for OXB-102 (now known as AXO-Lenti-PD) for the treatment of Parkinson’s disease Phase I/II clinical study for OXB-102 (now known as AXO-Lenti-PD) will start before the end of 2018 The Group is continuing to allocate appropriate value enhancing investment in its proprietary programmes. Discussions are ongoing for further out-licencing or spin-out of its proprietary products Commenting on the Group’s interim results, John Dawson, Oxford BioMedica’s Chief Executive Officer, said: “Oxford BioMedica has had a transformative year so far. The company’s significant progress is highlighted by the ongoing success of our collaboration with Novartis for Kymriah, as well as a number of new partnership agreements. Specifically, the exclusive worldwide licence agreement signed with Axovant for OXB-102, worth up to $842.5 million, successfully executes on our pre-stated strategy to externalise product development beyond the end of the pre-clinical phase. Following these developments, we are greatly encouraged by the outlook for the full year and with the finances now in place, we are able to accelerate our capacity expansion plans to meet future demand.” New Manufacturing facility in Oxford Oxford BioMedica announces further capacity expansion with new facility Lentiviral vector bioprocessing market expected to grow to $800m by 2026 Oxford BioMedica adds fourth facility in Oxford allowing the Group to target 25% to 30% of global lentiviral vector bioprocessing market (excluding milestones and royalties) Oxford, UK – 13 September 2018: Oxford BioMedica plc (LSE:OXB) (“Oxford BioMedica” or “the Group”), a leading gene and cell therapy group, today announces that it has signed a fifteen year lease on a new facility in Oxford that is close to its Windrush Court headquarters. The new facility is approx. 84,000 sqft (7,800 sqm). The Group’s planned Phase I and Phase 2 expansion will fit out around 45,000 sqft (4,200 sqm) for four GMP clean room suites and two fill and finish suites as well as offices, warehousing and QC laboratories, with space available for future expansion. Once open, the facility will more than double the Group’s bioprocessing capacity. The plan is to open the new offices and warehouse in Q1 2019, with the additional GMP suites being ready in Q1 2020. This new full-service site, fully funded through the successful first half year Placing in March 2018, will allow the Group to exploit the immediate market opportunity, meet the expected long-term demand and futureproof Oxford BioMedica’s market leading position. This new facility secures Oxford as a bioprocessing centre for Oxford BioMedica and will create up to 100 new, highly skilled positions at the Group over the next two years. John Dawson, Chief Executive Officer

techno-foxx 05 Sep 2018

Market growth here we have a huge UK announcement about part of our involvement in Cat-T technology and a UK Company and its technology which makes a vital contribution to making this new living drug technology, and still not a single mention about OXB in these news stories, does OXB have a marketing department?

techno-foxx 05 Sep 2018

Market growth the first NHS deal announced today Novartis means once again OXB technology is being used also in todays announcement. extract from BBC website A deal has been struck to let the NHS offer children an expensive new cancer therapy that has been called the most exciting treatment advance for decades. CAR-T is a cutting-edge treatment for aggressive leukaemia when other drugs have failed but usually costs hundreds of thousands of pounds per patient. NHS England boss Simon Stevens says a fair and affordable price has been reached with manufacturer Novartis. Hospitals could start giving it to a small number of children within weeks. The first three NHS hospitals to apply to use the CAR-T (chimeric antigen receptor T-cell) therapy are in London, Manchester and Newcastle.

techno-foxx 05 Sep 2018

Market growth BBC News NHS deal for exciting new cancer therapy The cutting-edge treatment is expensive but could potentially cure children with advanced leukaemia.

d_gaser 27 Aug 2018

Novartis gets European clearence for Kymriah Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel) • The EC approval is based on the first global CAR-T registration trials, which included patients from eight European countries and demonstrated durable responses and a consistent safety profile in r/r pediatric B-cell ALL and r/r DLBCL • Novartis is the only company with an approved CAR-T cell therapy for pediatric r/r B-cell ALL and the first to receive approval in two distinct indications, both in the EU and the US • Novartis continues its strategy to expand manufacturing facilities with agreements with external collaborators, such as CELLforCURE in France Basel, August 27, 2018 Novartis today announced that the European Commission (EC) has approved Kymriah® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah developed in collaboration with the University of Pennsylvania (Penn) is a ground-breaking one-time treatment that uses a patient’s own T cells to fight cancer, and the only chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies. Kymriah was also the first CAR-T cell therapy ever approved by the US Food and Drug Administration (FDA). “The Kymriah approval is a transformational milestone for patients in Europe in need of new treatment options,” said Liz Barrett, CEO, Novartis Oncology. “Novartis will continue to build a global infrastructure for delivering CAR-T cell therapies where none existed before remaining steadfast in our goal of reimagining cancer.” Kymriah, a cell dispersion for infusion with doses varying between 1.2 x 106 6 x 108 CAR- positive viable T cells, is a living medicinal product, manufactured individually for each patient by reprogramming the patient’s own immune system cells. Kymriah is the only approved CAR-T cell therapy built using the 4-1BB costimulatory domain, which is critical for full activation of the therapy, enhancement of cellular expansion and durable persistence of the cancer-fighting cells. This approval was based on the review of the only two global registration CAR-T clinical trials, JULIET and ELIANA, which included patients from eight European countries. In these trials, Kymriah demonstrated strong and durable response rates and a consistent safety profile in two difficult-to-treat patient populations[1]. In 2012, Novartis and Penn entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers. This collaboration between industry and academia was the first-of-its-kind in CAR-T research and development. “When the University of Pennsylvania and Novartis agreed to work together to develop CAR-T therapy, our main goal was clear and ambitious to address unmet needs for patients and to extend, improve and save lives,” said Carl June, MD, the Richard W. Vague Professor in Immunotherapy in the Department of Pathology and Laboratory Medicine at Penn and Director of the Center for Cellular Immunotherapies in the Abramson Cancer Center. “We are proud that our efforts in CAR-T now offer the European blood cancer community a breakthrough that brings new hope.” Kymriah was designated as an orphan medicinal product and is one of the first PRIME-designated therapies to receive EU approval; PRIME (PRIority MEdicines) is a program launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need and help patients benefit as early as possible from therapies that may significantly improve their quality of life. “Bringing Kymriah to patients in the EU advances the treatment paradigm in an unprecedented way and delivers a lifesaving therapy to young patients with ALL who have not been successfully treated with existing therapies, and who have limited options left[2],” said Prof. Peter Bader, Head of the Division for Stem Cell Transplantation and Immunology and Principal Investigator of the ELIANA study at the University Hospital for Children and Adolescents in Frankfurt/Main. Both B-cell ALL and DLBCL are aggressive malignancies with significant treatment gaps for patients. In Europe, ALL accounts for approximately 80% of leukemia cases among children[3], and for patients who relapse from standard of care therapies, the outlook is poor[2]. This low survival rate is in spite of patients having to undergo multiple treatments, including chemotherapy, radiation, targeted therapy or stem cell transplant, and further highlights the need for new treatment options. DLBCL is the most common form of non-Hodgkin lymphoma, accounting for up to 40% of all cases globally[4]. For patients who relapse or don’t respond to initial therapy, there are limited treatment options that provide durable responses, and survival rates are low for the majority of patients due to ineligibility for autologous stem cell transplant (ASCT) or because salvage chemotherapy or ASCT have failed[5]. Novartis expects to launch initially in the pediatric ALL indication, as we continue to ramp up capacity. Moreover, timing for Kymriah availability in each country will depend on multiple factors, including the onboarding of qualified treatment centers for the appropriate indications, as well as the completion of national reimbursement procedures. Training is already underway at key qualified treatment centers to facilitate safe and seamless delivery to patients; and Novartis continues to collaborate with national health and reimbursement authorities across Europe on a fair, value-based pricing approach that is sustainable for national healthcare systems. As this innovative treatment is made available to more patients globally, Novartis has been actively pursuing options to expand manufacturing capabilities beyond our facility in Morris Plains, New Jersey. This includes our agreement with CELLforCURE, based in France and one of the first and largest contract development and manufacturing organizations (CDMOs) producing cell and gene therapies in Europe, the expanded alliance with Fraunhofer Institute which currently supports the manufacturing of Kymriah for global clinical trials and for post approval manufacturing , as well as technology transfer efforts to a CDMO in Japan

Kestrel205 27 Aug 2018

Market growth [link]