Re: CTL109 / Kymriah update.. Novartis have issued an update on CTL109 or Kymriah and it is very positive BE Happy Dave Novartis presents data at ASH for patients with serious blood disorders like lymphoma, leukemia and sickle cell disease Primary results of pivotal KymriahTM Phase II JULIET study in relapsed/refractory DLBCL Post-hoc sub-analysis of crizanlizumab (SEG101, formerly SelG1) SUSTAIN trial evaluating time to first sickle cell pain crisis Outcomes from matched analysis of Molecular Recurrence-free Survival from EURO-SKI and ENESTfreedom trials following Tasigna® vs. imatinib in patients with CML-CP eligible for Treatment-free Remission (TFR) Additional data on Rydapt®, Revolade®/Promacta®, Exjade®/Jadenu® and Jakavi® underscore breadth of Novartis Oncology hematology portfolio Basel, November 1, 2017 - Novartis will present new data from across its hematology portfolio at the upcoming 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Atlanta, December 9-12. More than 75 abstracts will be presented, highlighting the robust Novartis development program for serious blood diseases. "This is an exceptionally productive time in hematology, and the breadth of our Novartis Oncology data and presence at ASH underscore our commitment to this space," said Vas Narasimhan, Global Head Drug Development and Chief Medical Officer, Novartis. "Following the launch of Kymriah, the first FDA-approved CAR-T therapy, we are particularly excited about presenting additional data on this new approach to cancer treatment, as well as a new analysis for crizanlizumab, an investigational treatment for patients with sickle cell disease." KymriahTM* (tisagenlecleucel) suspension for intravenous infusion is a CD19-directed genetically modified autologous T cell immunotherapy, indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Additional results evaluating Kymriah in pediatric ALL and in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) will be presented. Data for Kymriah include results from the primary analysis of the JULIET study in adult patients with relapsed or refractory DLBCL, demonstrating sustained complete response rates based on extended follow up, and efficacy and safety findings from additional treated patients compared to a previously presented interim analysis. Additionally, results of a cost-effectiveness analysis of Kymriah for the treatment of relapsed or refractory ALL in the United States will be presented in an oral presentation. Primary Analysis of JULIET: A Global, Pivotal, Phase 2 Trial of CTL019 in Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma [Abstract #577; Monday, December 11, 70 AM EST] Cost-Effectiveness Analysis of CTL019 for the Treatment of Pediatric and Young Adult Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia in the United States [Abstract #609; Monday, December 11, 7:30 AM EST] Patient-Reported Quality of Life (QoL) Following CTL019 Infusion in Adult Patients with Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) [Abstract #5215; publication only] Expert Elicitation of Long-Term Survival for Pediatric Acute Lymphoblastic Leukemia Patients Receiving CTL019 in ELIANA Phase II Study [Abstract #3377; Sunday, December 10, 60 PM EST] Outcomes for chimeric antigen receptor T cell (CAR-T) pipeline therapies in other malignant blood cancers will also be shared at ASH: Updated Safety and Efficacy of B-cell Maturation Antigen (BCMA)-specific Chimeric Antigen Receptor T Cells (CART-BCMA) for Refractory Multiple Myeloma (MM) [Abstract #505; Sunday, December 10, 4:30 PM EST] Durable Remissions with Humanized CD19-Targeted Chimeric Antigen Receptor (CAR)-Modified T Cells in Children and Young Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia, Inclu
Re: CTL109 / Kymriah Marketing application This could be just what OXB needs if the details are correct regarding the news regarding Sanofi not exercising its option on Voyager's VY-AADC gene therapy product for Parkinsons,Be Happy Dave Boost for Oxford Biomedica as Novartis files for further blood cancer indication Tue 31 Oct 2017(ShareCast News) - Oxford Biomedica received a boost as Novartis announced that it has filed for approval of its Kymriah drug for a second blood cancer indication.Kymriah is the main potential driver of revenues and profits for Oxford Biomedica through its deal as the sole manufacturer of the lentiviral vectors used to generate Kymriah.Novartis said on Tuesday it had applied to the US Food & Drug Administration for Kymriah in adult patients suffering from a relapsed or refractory diffuse large B-cell lymphoma who are ineligible for an autologous stem cell transplant.Kymriah was approved by the FDA in August in the smaller indication of paediatric acute lymphoblastic leukemia, which was the first-ever chimeric antigen receptor T cell (CAR-T) therapy approved by the US regulator. Novartis also plans to apply to European authorities to market DLBCL this year. Novartis noted that DLBCL is a significantly larger patient pool with US & EU relapsed/refractory DLBCL incidence of around 50,000 per year versus 2,200 for ALL.Elsewhere, Oxford Biomedica got a second piece of good news as Sanofi chose not to exercise its option on Voyager's VY-AADC gene therapy product for Parkinsons, which is a potential competitor to OXB-102, Oxford BioMedica's own gene therapy pipeline candidate for Parkinsons.According to reports, Sanofi's decision was due to the fact that its existing deal with Voyager did not include US rights.Sanofi has a number of other existing gene therapy projects with Oxford BioMedica, noted analysts at Peel Hunt, also suggesting that further deals, whether for lentiviral vector supply and/or gene therapy partnerships, "are important potential catalysts for Oxford BioMedica and we await further updates with interest".
CTL109 / Kymriah Marketing application Novertis has now submitted CTL109 for marketing approval in the US and Europe ,they have also given CTL109 a new name, its now called KymriahTM . This is very good news for the stockholders, and OXB , as marketing clearance for this product should give our S/P a well earned bounce .BE HAPPYDAVE Novartis submits application to FDA for KymriahTM (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy Submission based on updated analyses from global, multi-center Phase II JULIET study, which met primary endpoint, including 6-month data to be presented at ASH 2017 Kymriah has demonstrated durable response rates in r/r DLBCL, a highly aggressive and difficult-to-treat non-Hodgkin lymphoma that is fatal in nearly 40% of patients due to relapsed or refractory disease Novartis plans to submit an application for marketing authorization with the European Medicines Agency (EMA) in both DLBCL and pediatric ALL later this year Basel, October 31, 2017 - Novartis today announced that the company has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). In April 2017, Novartis received Breakthrough Therapy designation for r/r DLBCL which, if approved, would be the second indication for Kymriah. In August 2017, Kymriah became the first available chimeric antigen receptor T cell (CAR-T) therapy when it received FDA approval five weeks prior to its PDUFA date and was launched for patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed at least twice. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer. "Kymriah represents a historic breakthrough in the evolution of individualized immunotherapy and we are committed to bringing this innovation to as many patients who may benefit as possible," said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. "The response rates we've seen in the JULIET trial show that Kymriah has the potential to transform treatment for these patients and we look forward to collaborating with the FDA to make it available to patients for this second indication." DLBCL is the most common form of non-Hodgkin lymphoma (NHL), a cancer of the lymphatic system, accounting for up to 40% of all NHL cases globally. Roughly 50-60% of patients with DLBCL achieve and maintain complete remission after first-line therapy; however, roughly one-third of patients relapse after receiving first-line treatment,. Only about 25% of patients with r/r DLBCL are eligible for ASCT, the mainstay of secondary treatment. If left untreated, r/r DLBCL has a life expectancy of three to four months. "The approval of tisagenlecleucel in the treatment of children and young adults with second relapse or refractory B-cell ALL was a watershed moment in the journey for researchers to develop immunocellular therapies," said Stephen Schuster, MD, director of the Lymphoma Program and Lymphoma Translational Research, University of Pennsylvania Perelman School of Medicine. "The data show this therapy could change the treatment paradigm for patients with r/r DLBCL as we've seen durable complete responses in patients who previously relapsed or were refractory to prior therapies, and this second filing is a significant step toward realizing its potential for even more patients who are currently battling fatal blood cancers." Kymriah is an innovative immunocellular therapy that is a one-time treatment. Kymriah uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enh
Director buys @9.05p on open market It appears that yet another director has purchased shares on the open market ,this can only be good news and shows at least the BOD believe they have a good chance of making good money from OXB in the future. This gives me confidence of good things to come , so I to will be joining them, and will be adding more OXB shares to my portfolio BE HAPPYDAVE Director Dealings / Market Share Purchase Oxford, UK - 26 September 2017: Oxford BioMedica plc ("Oxford BioMedica" or "the Company" (LSE: OXB), a leading gene and cell therapy group, was informed that on 26 September 2017 Andrew Heath, Deputy Chairman and Senior Independent Director, acquired ordinary shares of 1p each ("Ordinary Shares" in the Company for his wife as follows: Interest after purchasePrice per share (p)Number of Ordinary Shares acquired 110,511;price paid 9.05p total holding 1,607,086 totalissued share capital 0.05% The issued share capital of the Group is 3,106,253,317 1p ordinary shares.
Director buys 100.000 shares @8.10p Its good to see Martin buying more shares it's just a pity some of the others don't follow his lead ,RNS 15.09.2017Martin Diggle, Non Executive Director, bought 100,000 shares in the company on the 14th September 2017 at a price of 8.10p. The Director now holds 549,932,000 shares.BE HAPPYDav
Re: Sell: Bearish Charts To clarify. If there had been an immediate sell off following the announcements I could have understood that; buy on rumour sell on news. What bamboozles me is that there wasn't an immeidate sell off. There was real, if but too briefly, demand until the MMs stepped in and shut the market down (the MMs tied up the market in auctions until they'd rested back control and were able to move the price down). I can't ever recollect seeing that before.
Re: Sell: Bearish Charts They will eventually; a share offer out of the blue would probably turn your charts upside down.But, back in the real world, you do appear to have called it right this time.I know they say buy on rumour sell on news but I am still perplexed by the share price action on the day of both announcements (the recommendation and the approval). Most bizarre; generally PI enthusiasm is allowed to run its course before the MMs step in but the way they stepped in and killed any momentum was brutal. Was it simply because there was a large seller or something more to it.I'm sticking for the time being. It will probably cost me but I'm irked!
Re: Sell: Bearish Charts The charts have never let me down.13 Sep 2017DAILY8.19 Triple Moving Average Crossover (4-day 9-day 18-day) 11 Sep 2017DAILY8.71 Momentum 08 Sep 2017DAILY8.82 Double Moving Average Crossover (21-day 50-day) 08 Sep 2017WEEKLY8.82 Relative Strength Index (RSI) TTGLAH
Hardman 120917 not in here but noted this today[link]
Gene therapy fantasy deal not realistic ? pharmaspecialist I thought I should just let you know OXB all ready has a US Nasdaq listing, it goes' under Oxford Biomedica (NASDAQ:OXBDF) So any listing by Nightstar Therapeutics wouldn't help OXB , unless of course a deal could be done prior to them listing ,in which case, they would lose out on the £65m they are raising via that I.P.O. As we know from our own experience that cash won't get them to their end stage 4, especially if they don't have FDA approval for their AAV2 vector and manufacturing facilities, and would also need to get same clearance for the recombinant human complementary DNA they use before the FDA would give them a licence .Where as Novartis, Sanofi Aventis , Pfizer , and GSK and our self's all ready have a licence for production of the vector ,and DNA products,so why would OXB want to give a potential rival access to their technology for free?.Remember it will take years before Nightstar get any thing to market, by which time, most of the big Bio 4 companies will have got their own retinal disease products to market, as there is a big race going on right now to see who can capture that this massif market,especially for the wet &Dry Macular disease, and for retinitis pigmentosa market.Personally I don't see any incentives for OXB or Novartis, or any other company come to that, who are all ready involved in this science to buy out nightstar, unless of course they have some excellent intellectual property, or other science that others don't have, and if that is the case, then it's normal practice for such companies' to licence out that technology as it would generate their only means of income ,which in nightstars case, would be crucial to their survival over the next 5-10 years I would of thought, just as it has been for OXB over the last 20 years .Maybe one of the big boys might take them out in order to obtain the cash ,but I don't see how OXB could amalgamate with them, unless they formed a new company with new stock ,or OXB reversed in to Nighthawk ,and then cancel OXB 3billion plus shares they have, and then re rate Night hawk shares prorate .just my personal thoughts on this subject so .P.D.Y.HBE HAPPYDAVE
Despite ... ... the bearish charts, I'm going to put my neck out and say that I do believe that OXB may have turned this morning.Somebody was in first thing to pick up 500,000 at 9.0327 and the bid/offer spread is now edging up.I saw yesterday's RNS that Joy Group have recently disposed of 30m shares, which might explain the "strange" price movements over the last month.
Re: Marketing Authority is next line That's the trouble with this share. Too few buyers understand the science and the long lead time from initial research, to discovery, careful testing, further development with other companies, to production, to selling enough to make a profit. All the talk of charts and MMs is fine, but the fundamental issue is how well all the above can be managed along with the cash burn until substantial and reliable revenues can flow in. Almost 20 years ago I wrote of taking a 10 year view and was told I was too pessimistic. I warned that speculators would make, and lose along the way, but the MMs would always ensure they won. Dead right I've been. I still think we may need to look beyond a year or two, and 5 years is a more reasonable timescale before we'll know which way this is going.In 5 years we could have failed entirely, been taken over, or the SP may be 5, 10 or 50 times higher. I wrote off such hopes many years ago, but wouldn't mind if that did eventually happen - although 50x won't! In all probability we'll be tottering along, hand to mouth, still looking forward to jam tomorow.In the meantime I'm happy that OXB is developing science that may one day lead to treatments to benefit future generations.
Marketing Authority is next line Just because we have FDA approval it doesn't mean we can start production and the market knows this ,it can take another 6 months be fore Novartis will gain marketing approval ,and this includes pre production testing to ensure the product is safe once the manufacturing lines start.It could take another 3 months from that date before the product is offered to the likes of N.I.C.E ,or the U.S.A or European agencies' ,or any other countries agencies, the product will go through scrutiny and price negotiations before they can even think about selling it ,in all, it could be another year to eighteen months before any country agree to use it ,but there again, they could accept the product with in 6 months if the price is right, and they can prove the procedure will help them make savings but even then they would have to train the doctors on how to use it ..This time gap is probably why the price is now falling back again, what happens next lie's with the individual countries health authorities,and how quick this procedure is taken up and marketed .PDYH BE HAPPYDAVE
Re: Sell: Bearish Charts MaxThis news is not helping the Novartis or OXB share prices, it should because it lengthens the time where we have the market, but I guess investors do not know the difference between our CAR-T treatment and an allogeneic CAR-T. Since the "good news" this share has gone from 11p to 8.8p. SP support around 6p. Maybe I should stay away from shares that I don't understand (i.e. HEALTH). If I look at the performance of this share since the "good news", then I am really confused and lost faith (even with 25 years of trading). But as always DYOR and GL.TT
Re: Sell: Bearish Charts That's a buy signal in my books; Trouble-Two has been a 100% wrong thus far! Only joking!Still mulling this one nd trying to make sense of the recent price movements.