From page 46, CM 17, impressive from OXB

HTTPS://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/oncologicdrugsadvisorycommittee/ucm567385.pdf

Oxford Biomedica has the ability to deliver the next blockbuster, how to deliver virus to T-cells in the patient directly without the need for isolating, transforming and amplifying the cells ex-vivo.

the interests of Vulpes investors and indeed all shareholders, will be protected against the threat of either unwise dilution or indeed, the threat of a takeover approach at an unreasonably low valuation. Given OXB’s unmatched gene therapy and lentivector expertise and it’s very strong patent protected IP for gene therapy manufacturing, we see OXB has a very attractive target for acquisition in a world with a growing shortage of biologics manufacturing.



HTTP://www.vulpesinvest.com/wp-content/uploads/2017/07/VLSF%20Special%20Report_Oxford%20BioMedica%20_July_2017.pdf

BCMA CAR T being done by Bluebird, Penn Novartis, China.

They are very excited about it for Multiple Myeloma

OXB own 4% plus supply the Lenti

ADA-SCID at phase II/III

MPS IIIA (Sanfilippo A) about to start trials HTTP://mpssociety.org/mps/mps-iii/

HTTP://orchard-tx.com/programmes/

To be granted Rare Paediatric Disease Designation, a drug must be designed for the treatment of a serious or life-threatening disease which affects less than 200,000 patients in the United States and which primarily includes patients aged between 0 and 18 years.

This designation acknowledges that the company may qualify for a paediatric priority review voucher at the time the drug gets approved for this indication. That voucher could then be redeemed to receive a priority review of a subsequent marketing application for a different product or be transferable to other company.

https://www.nytimes.com/2017/07/23/health/gene-therapy-cancer.html

Re acquisitions, listen to 4mins.

CTL019 at 2mins

CTL019 JULIET trial interim analysis showed durable complete responses in adults with r/r DLBCL. The three-month overall response rate was 45%, with 37% complete response (CR); all patients in CR at three months remained in CR at data cutoff. Primary analysis at six months confirmed the interim analysis.

CTL019 ELIANA 6-month follow-up data show durable remission rates in children and young adults with r/r B-cell ALL.

CTL119 in combination with ibrutinib showed that eight of nine patients tested had no signs of chronic lymphocytic leukemia in their bone marrow three months after treatment.

Plus BCMA CART in a few months

Here is our Boss !

HTTP://www.cnbc.com/2017/07/18/novartis-earnings-q2-2017.html

Too early to say whether $1 billion/ yr is the top as we are developing it in other cancers like ovarian !

Buying opportunity atm

3,088.33m £238.11m

These will hopefully be coming to OXB and they will not be last resort treatments. Big indications and this is when the numbers/royalties will really excite ;


CTL119 represents one of our latest advances in CAR-T cell therapy research and our broader commitment to pioneering breakthrough immuno-oncology treatments.
Said James Bradner, president of the Novartis Institutes for BioMedical Research

The underlying message: Novartis is planning to stay a leader long after CTL019 makes drug history.
(CLL), is the most common type of leukemia, generally considered incurable

CART-BCMA
Globally, multiple myeloma affected 488,000 people and resulted in 101,100 deaths in 2015
With high-dose therapy followed by autologous stem cell transplantation, the median survival has been estimated in 2003 to be approximately 4.5 years, compared to a median of approximately 3.5 years with "standard" therapy.[49] Overall the 5-year survival rate is around 35%

HTTPS://endpts.com/novartis-isnt-messing-around-with-car-t-and-it-has-a-next-gen-therapy-to-help-prove-it/

TTPS://www.youtube.com/watch?v=Oyv5QogoJhw

Novartis CAR-T programmes
Candidate Target antigen *Indication Development
CTL019 CD19 B-ALL Pivotal phase II (ELIANA trial)
CTL019 CD19 DLBCL Pivotal phase II (JULIET trial)
BCMA MM Phase I/II
CTL119 CD19 CLL Human pilot
“CART22� CD22 B-ALL Terminated in phase I (June 2017)
Multiple Pre-clinical/phase I

HTTPS://clinicaltrials.gov/ct2/show/NCT02546167

Reni Benjamin, a biotechnology analyst for the financial services company Raymond James who tracks the gene therapy market, estimates the price will be set at around $450,000 for the one-time treatment.

"The drug companies are talking to the payers, and at this point it seems that the payers are onboard with covering it."

HTTP://www.consumerreports.org/cancer/what-families-need-to-know-about-first-gene-therapy-for-deadly-childhood-cancer/

HTTP://www.fdanews.com/articles/182643-fda-advisory-committee-sees-benefits-of-car-t-leukemia-therapy

An experienced biotech investor, Loncar created the Loncar Immunotherapy Index, a collection of 30 life science companies with five large-cap and 25 growth stocks. He said the advisory committee will need to make a very human calculation. "It must be noted that the patients being treated in these studies are very sick and likely facing certain death so there is a risk/reward trade-off the FDA will have to consider."

In an investor note Loncar said, "I predict that both Novartis and Kite will earn approval in the coming months, and this will be an inflection point for cellular therapies. This unique method of treating cancer is very special and has the potential to revolutionize the treatment of many cancers in the future

Analyst John Newman of Canaccord Genuity;

"We view the Novartis briefing documents as suggestive of FDA support for approval, and beneficial to all CART players. Importantly, we will listen carefully to any details on manufacturing, which may benefit KITE. We believe safety for the CART class, specifically CRS, will be carefully managed, and will not prevent a positive panel vote and FDA approval."

Canaccord analyst John Newman reiterated his "Buy" rating and $115 price target on Kite Pharma Tuesday, saying that the briefing documents from Novartis thus far are positive.

If approved, the drug would be first gene therapy to be approved in the United States

Reuters

The keenly anticipated preliminary review of the leukemia treatment, posted on the FDA's website on Monday, comes two days ahead of the advisory panel meeting, which will discuss the drug and vote on whether the benefits exceed the risks.

If approved, the drug would be first gene therapy to be approved in the United States. The FDA is not obliged to follow the recommendations of its advisors but typically does so.

(OXB has been mentioned in the New York Times, FT I think things are looking up.)

HTTP://www.reuters.com/article/us-novartis-leukemia-fda-idUSKBN19V1GF

s. From Novartis’
point of view, it was important to have a commercial deal in place prior to the ODAC
meeting otherwise a positive outcome would have strengthened even further OXB’s
already strong negotiating position.

. Forecasts suggest OXB will turn EBITDA
positive in 2017, and become profitable overall at the EBIT level in 2018.Bioprocessing
royalties are likely to result in significant upside potential in the near future.

Should CTL019 be approved,
OXB’s facilities would need another inspection by Novartis, adding to OXB’s
attractiveness as a clinical-grade vector manufacturer.

Our conservative estimate is that OXB will receive $82m in royalties by 2025
for CTL019 in B-ALL and DLBCL (including a lead-in period to include Health
Technology Assessments and other market access requirements). This does not take
into account bioprocessing revenues, or royalties from other CAR-T programmes.

Novartis CAR-T programmes
Candidate Target antigen *Indication Development
CTL019 CD19 B-ALL Pivotal phase II (ELIANA trial)
CTL019 CD19 DLBCL Pivotal phase II (JULIET trial)
BCMA MM Phase I/II
CTL119 CD19 CLL Human pilot
“CART22” CD22 B-ALL Terminated in phase I (June 2017)
Multiple Pre-clinical/phase I

HTTP://hardmanandco.com/docs/default-source/company-docs/oxford-biomedica-documents/07.07.17-major-deal-to-supply-novartis-car-t-programmes.pdf

and other undisclosed Chimeric Antigen Receptor T cell (CART) products.




http://www.oxfordbiomedica.co.uk/press-releases/oxford-biomedica-announces-a-major-supply-agreement/

The Sunday Times

Full article:


After chemotherapy failed to cure Emily Whitehead’s severe form of leukaemia, Oxford BioMedica’s new treatment has given her five cancer-free years

At just six years old, cancer patient Emily Whitehead had run out of options. Three rounds of chemotherapy had failed to cure a severe form of leukaemia. Her doctors could do no more; she was sent into hospice care.

Her desperate parents were left with only one option. They put Emily into an experimental programme, making her the first patient in the world to receive a new kind of gene therapy. The revolutionary treatment uses a stripped-down version of the HIV virus that reprograms cells to hunt down and kill cancer.

Within weeks of a single injection, Emily was at home, playing football again and spending time with her dog Lucy, who was born around the time she was diagnosed.

Five years later, Emily is a fit, healthy 12-year-old who aspires to be an artist and enjoys making YouTube videos of her craft projects. And the British university spinout behind the technology that saved her life is on the cusp of finding out whether the treatment is likely to get full regulatory approval.

In two weeks, America’s Food and Drug Administration will put the treatment devised by Oxford BioMedica, in league with Swiss pharmaceutical giant Novartis, before a panel of independent experts. If they like the findings from the human trials, it could pave the way for a full approval in October. A European Medicines Agency filing could follow later this year.

Last week, the market started to get excited; shares in Oxford BioMedica surged 40% amid expectations that it will be given the green light. Analysts predict the treatment could become worth in excess of $1bn (£770m).

Oxford BioMedica developed the technique of modifying the HIV virus to carry the treatment; Novartis is behind the treatment itself, after working with the University of Pennsylvania.

John Dawson, chief executive of Oxford BioMedica, is investing in his laboratories in Oxford to ensure they are ready for an upcoming — and vital — FDA inspection. “Parents are scrambling to get to this drug in the US,” he said. “We are the best in the world at doing this. It is hugely significant for us as a company.”

Analysts at Jefferies say the collaboration with Novartis is a significant endorsement of Oxford BioMedica’s technology, cementing its position as a leader in what is known as the lentiviral vectors field.

Jefferies estimates the treatment could cost up to $400,000 (£308,000) per patient in the US, with Oxford BioMedica receiving a royalty on each treatment. New York investment bank Rodman & Renshaw reckons that this royalty would be about 3% of overall treatment cost. On that assumption, it predicts Oxford’s share price could double to 14p.

By 2022, it forecasts $127.3m in annual revenue to Oxford BioMedica from sales of CTL019, the scientific name for the treatment. The company’s overall revenues were £30.8m last year.

For 20 years, Oxford BioMedica has sought to develop medicines for serious diseases such as Parkinson’s, blindness and cancer. It was founded in 1995 by professors Alan and Susan Kingsman, a couple who worked in Oxford University’s biochemistry department. They left to set up Oxford BioMedica, initially in search of a cancer vaccine.

The company floated on AIM in December 1996 with a market capitalisation of £50m — it now stands at £229.7m. Its partners include Glaxo Smith Kline, Sanofi and Orchard Therapeutics. However, it is the leukaemia treatment that excites investors and offers hope to millions of families. For Emily’s parents, from Philipsburg, Pennsylvania, it simply saved their only child’s life. “We were fighting every day so she could survive to the next,” said her father, Tom, 46.

Emily was the first of only 10 children to receive the treatment. In 2010, she was diagnosed with acute lymphoblastic leukaemia, a blood cancer that originates in young white blood cells in the bone marrow. It accounts for about 25% of cancers diagnosed in children under 15, and affected 760 children in the UK in 2014, the most recent figures show.

Initially, doctors were hopeful that Emily would recover. The first signs were good. However, 16 months after she went into remission, Emily suffered a relapse.

Her parents sought the help of the children’s hospital in Philadelphia, where Emily had been treated. Here, the couple learnt of the trial using the Oxford BioMedica and Novartis gene therapy. It works by removing the patient’s T-cells, a type of white blood cell, and reprogramming them in a lab. The genetically modified cells are injected back into the patient, where they multiply into an army of cancer-killing cells.

Kyriacos Mitrophanous, Oxford BioMedica’s chief scientific officer, said: “We take the HIV virus and strip out all the bits that cause disease, but retain the capabilities of getting genes and DNA into cells.” The body’s own attack cells are trained to recognise leukaemia. A key feature of the treatment is that it requires just one injection.

OXFORD BIOMEDICA IN NUMBERS
40% Increase in the share price last week
10 The number of days until a key US meeting to assess the treatment for approval
£229m The company’s current market capitalisation
In the first global trial of 63 relapsed children and young people, 83% of patients reached complete remission within three months of treatment, according to Novartis.

Emily received the treatment in April 2012 when she received the genetically modified cells in the clinical trials. She spent several weeks in intensive care before her parents were told the treatment had worked. Only two months after returning home on June 1, 2012, Emily was back on the sports field.

Her remarkable story is not unique; other children have enjoyed similar recoveries. Among them is Austin Schuetz, from Wisconsin, who was just three when diagnosed with the same kind of leukaemia. After multiple relapses, he was enrolled in a trial. Five years on, he is celebrating 3½ years cancer-free.

Another is Tori Lee of New Jersey, diagnosed with the disease in 2008, aged five. Years of chemotherapy had failed and she was offered the gene therapy. After five days in hospital, Tori went home and was back at school a month later.

The Whiteheads established a foundation in their daughter’s name to spread awareness of the therapy. Tom will speak at the FDA advisory hearing on July 12, backing approval for the treatment. The FDA’s decision is due in October.

“They need to know how much this has changed our lives, changed the world and given families hope,” said the power plant worker.

“The doctors never tell you what’s going to happen long term. But when she gets up in the morning everything is normal. That’s what a cure looks like as a parent.”

A GREAT read, and a 14p recommendation:-

It is a One stop lentiviral shopping places OXB in gene therapy
leadership role. We are initiating coverage of Oxford BioMedica with
a Buy rating and £0.14 price target. Through its LentiVector platform,
the company has been able to generate multiple product candidates
(internally and for partners) using lentiviral gene delivery using either
in vivo or ex vivo techniques. Additionally, the platform has led to
a bioprocessing business model with current partnerships in hand
(led by Novartis) with more anticipated in the future. In 2016, the
company completed a major manufacturing expansion establishing a
firm readiness for imminent and future needs.
CTL019 in the leading role right now. OXB is responsible for the
generation of the lentiviral vector expressing the chimeric antigen
receptor (CAR) for Novartis' CTL019 CAR-T asset and we project a 3%
royalty to OXB. As described below, we believe that CTL019 is on the
brink of approval and Novartis indicated on June 16 (JULIET conference
call) that availability of vector does not play any role as a bottleneck for
CTL019 manufacturing. We believe OXB's role in CTL019's anticipated
success is not currently reflected in the shares since most of the focus
is on Novartis.
Visibility to increase rapidly for shares; facilities are prepped and
ready for action. From a visibility standpoint for OXB shares, we
project two important upcoming catalysts for the shares: 1) July 12
FDA Advisory Committee for CTL019 (we project positive vote); and
2) September 29 PDUFA date for CTL019. Overall, we project FDA
approval for CTL019, which should be the first CAR-T approved in the
U.S., and have the added benefit of OXB locking in a revenue stream
to the company. In 2022, we project $127.3 million in revenue to OXB
from sales of CTL019.
Multiple assets with important proof-of-concept ready for right
partners. As part of the company's manufacturing expansion and
overall readiness for the anticipated CTL019 launch, the company
made difficult, yet correct financial decisions, in our belief. In order to
effectively manage cash burn, it paused the development of several of
its internal pipeline candidates in order to focus on its manufacturing
partners. Most of these assets already have clinical proof-of-concept
in hand, which we believe positions them well for potential spin-out
or outlicensing. As an example, OXB-101 (formerly ProSavin) was in
development for Parkinson's. A single injection into the brain showed
significant impact on motor responses at six and 12 months as well as
showing evidence of transgene expression of at least four years of follow
up. A next generation vector with 5-10x more potency is in development
and Phase 2 ready.
Valuation and risks to price target achievement. Our £0.14 price
target is based on our clinical net present value (NPV) model,
which derives value primarily (85%) from Novartis' CTL019 (lentiviral
production and royalty). This model allows us to flex multiple
assumptions affecting a drug's potential commercial profile. Factors
which could impede reaching our price target include failed or
inconclusive clinical trials or inability of the company to secure adequate
funding to progress its drugs through the development pathway.

FT article

FT Health: war and the spread of disease



5 HOURS AGO by: Sarah Neville, Global Pharmaceuticals Editor
From gene-editing, to remedies for potentially fatal allergies, a cohort of biotechs are making scientific leaps that could radically change the outlook for people suffering from an array of diseases and conditions — and simultaneously propel their revenues to new heights.

Some of these groups are teaming up with big pharmaceuticals companies, which hope to get a slice of the profits without spending cash on acquiring them outright. For the biotechs, relationships with big pharma offer the infrastructure and reach that they do not possess — but may need if they are fully to commercialise their discoveries.

For three, in particular, the next 12 months could prove pivotal.

Oxford BioMedica

Founded 20 years ago, Oxford BioMedica has grown rapidly in recent years, increasing staffing levels from 80 at the start of 2014 to 275 now, and investing £26m in the past two years in manufacturing facilities and laboratories. Its most important asset is the LentiVector platform — a gene delivery system using a virus that is introduced into the body, where it is used to transport cells that have been engineered to recognise and attack cancerous cells.

This treatment, known as CAR-T, is one of the most promising new approaches to tackling cancer. This opens up the prospect of lucrative partnerships with big drugmakers, which will need its delivery system as they develop their own CAR-T products.

In particular, the LentiVector has spawned a tie-up with Novartis, the Swiss pharma group, which has helped to increase the company’s revenues by 64 per cent in a year, from £18.8m in 2015 to £30.8m in 2016.

John Dawson, Oxford BioMedica’s chief executive, says a key “trigger” for the share price will be the expected approval, and launch, this year of the first CAR-T therapy for the treatment of leukaemia.

Peter Welford, an analyst at Jefferies, recently noted that Novartis had, for the first time, included Oxford BioMedica’s CTL019 on its pipeline of possible blockbusters, “underscoring its confidence in the product’s commercial potential”.

Jefferies is forecasting at least $1bn worldwide peak sales, which will provide “an important sustainable revenue stream” of about £65m to £75m in annual income for Oxford BioMedica, Mr Welford adds. The biotech’s share price has risen more than 30 per cent since the start of the year, at 5.37p.

https://seekingalpha.com/news/3275240-novartis-car-t-candidate-ctl019-shows-sustained-remission-rates-mid-stage-leukemia-study?uprof=82

Prof. Gill | The results of using the combination of CD19 CAR-T cells and ibrutinib in CLL patients


CTL 119 has to be a winner.

I am in total awe of these guys, amazing!

Tom Whitehead, father of emily (patient #1) to speak at ctl-19 approval hearing on July 12.

Love this bit: "With FDA approval, the CTL019 CAR-T cell therapy would no longer be constrained to clinical trials—effectively making this life-saving cancer immunotherapy treatment accessible to many more children around the world! "


http://emilywhiteheadfoundation.org/tom-whitehead-to-speak-at-fda-approval-hearing-car-t-cell-therapy-ctl019/

British company Oxford BioMedica is the sole manufacturer of the lentiviral vector expressing CTL019 for Novartis. The commercial launch of CTL019 is anticipated by Novartis later this year and Oxford BioMedica will receive undisclosed royalties on potential future sales of Novartis CAR-T products.

Oxford Biomedica are developing further immunotherapies with Novartis for many other cancers.
http://www.oxfordbiomedica.co.uk/investor-contacts/

Oxford Biomedica PLC Findings from Phase II JULIET Study

14/06/2017 3:00pm
RNS Non-Regulatory

TIDMOXB

Oxford Biomedica PLC

14 June 2017

Oxford BioMedica Notes Findings on CTL019 from Phase II JULIET Study Presented at the 14(th) Meeting of International Conference on Malignant Lymphoma (ICML)

Oxford, UK - 14 June 2017: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, today notes the findings reported by Novartis on its global multi-centre Phase II JULIET study evaluating the efficacy and safety of CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The study met its primary objective at interim analysis.

Oxford BioMedica is the sole manufacturer of the lentiviral vector expressing CTL019 for Novartis. The commercial launch of CTL019 is anticipated by Novartis later this year and Oxford BioMedica will receive undisclosed royalties on potential future sales of Novartis CAR-T products.

The findings were presented during an oral session at 15:40 CET on Wednesday 14(th) June 2017 at the 14(th) International Conference on Malignant Lymphoma (ICML) meeting (Abstract #007).

Novartis reported the interim analysis of the global multi-centre Phase II JULIET study which showed a 3-month Overall Response Rate (ORR) of 45% (23 of the 51 patients evaluated), with 37% achieving a Complete Response (CR) and 8% achieving a Partial Response (PR), respectively. CR remained stable from three months through data cut off among the patient group. Among 51 patients with >3 month follow-up or earlier discontinuation, best ORR was 59% (95% CI, 44%-72%; P<0.0001) with 43% achieving CR and achieving 16% PR. CR and PR rates at 3 months were 37% and 8% respectively. Cytokine Release Syndrome (CRS) occurred in 57% of infused patients (17% grade 3, 9% grade 4); no CRS associated deaths occurred. No cerebral oedema was reported. Three patients died from disease progression, within 30 days of infusion. No deaths were attributed to CTL019. The abstract is available online here: http://onlinelibrary.wiley.com/doi/10.1002/hon.2437_6/full.

The overall response rate seen in this early analysis is impressive for these heavily pre-treated patients with relapsed/refractory DLBCL, who have limited treatment options. The full JULIET primary analysis is expected to be available later this year and will serve as the basis for US and EU regulatory submissions.

John Dawson, Chief Executive Officer of Oxford BioMedica, commented: "We are pleased that Novartis has reported these additional strong data with CTL019 in another indication, r/r DLBCL, which is a much larger target patient population than for r/r ALL. We continue to work closely with Novartis in delivering the lentiviral vector across their CTL019 pipeline/franchise, a product group described earlier this year, by Novartis, as having "blockbuster" potential."

-Ends-

For further information, please contact:

Oxford BioMedica plc: Tel: +44 (0)1865 783 000

John Dawson, Chief Executive Officer

Tim Watts, Chief Financial Officer

Financial PR Enquiries: Tel: +44 (0)20 3709 5700

Mary-Jane Elliott / Matthew Neal / Chris Welsh / Laura Thornton

Consilium Strategic Communications

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 250 people. Further information is available at www.oxfordbiomedica.co.uk.

This information is provided by RNS

The company news service from the London Stock Exchange

END

NRAXZLFFDQFLBBX

(END) Dow Jones Newswires

June 14, 2017 10:00 ET (14:00 GMT)

1 Year Oxford Biomedica Chart
1 Year Oxford Biomedica Chart
1 Month Oxford Biomedica Chart
1 Month Oxford Biomedica Chart

"We are pleased the interim results from JULIET highlight the potential for CTL019 to elicit durable responses in patients with relapsed/refractory DLBCL, an area of high unmet need," said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. "Novartis is committed to progressing our portfolio of CAR-T therapies in hematological and solid tumors to advance the care of cancer patients."

https://www.novartis.com/news/media-releases/novartis-interim-results-global-pivotal-ctl019-trial-show-durable-complete

London, UK - 7 June 2017: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, notes that the US Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee meeting on 12 July 2017 to review the CTL019 (tisagenlecleucel-T) Biologics License Application (BLA) filing in relapsed and refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL).

Novartis announced in March 2017 that the FDA accepted CTL019 for review and granted priority review status.

Oxford BioMedica is the sole manufacturer of the lentiviral vector expressing CTL019 for Novartis. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products

HTTP://meetinglibrary.asco.org/record/147114/abstract
HTTP://meetinglibrary.asco.org/record/144601/abstract

HTTP://meetinglibrary.asco.org/record/125777/abstract
HTTP://meetinglibrary.asco.org/record/153344/abstract

HTTP://meetinglibrary.asco.org/record/144894/abstract

Carl H. June, MD, receives ASCO’s highest scientific honor

June 3, 2017

HTTP://www.healio.com/hematology-oncology/practice-management/news/online/%7Bce3bbb3a-8a8b-4326-a1a9-9caf0258658e%7D/carl-h-june-md-receives-ascos-highest-scientific-honor

Great news if we keep on getting this work from Novartis!

CLL is one of the most common types of adult leukemia

Novartis next generation CAR-T cell therapy CTL119 combined with ibrutinib shows high rate of responses in CLL patients
MAY 31, 2017
Eight of nine evaluable patients tested had no signs of CLL in their bone marrow at three months.
CTL119 is a humanized CD19-directed CAR-T cell therapy being developed in collaboration with the University of Pennsylvania
Novartis is committed to advancing a portfolio of next-generation CAR-T cell therapies

HTTPS://www.novartis.com/news/media-releases/novartis-next-generation-car-t-cell-therapy-ctl119-combined-ibrutinib-shows-high

In addition our CAR-T cell program continues to advance in a range of hematological and solid tumors including emerging programs in Chronic Lymphocytic Leukemia (CLL) and Follicular Lymphoma (FL).

The Innovative Medicines Oncology business unit is advancing the Novartis Immuno-oncology (IO) strategy to win with CAR-T and accelerating development of second generation combinations with PD-1.

HTTPS://www.sandoz.com/news/media-releases/meet-novartis-management-investor-event-novartis-highlights-focus-innovation-and

Job Description
The role will report to the DLBCL Indication Lead (Lymphoma Marketing Director) and will be responsible for CAR-T Marketing (CTL019) deliverables with the Brand/Disease teams.
HTTP://newjersey.jobing.com/novartis-pharmaceuticals-corporation/product-specialist-cart-marketing


Novartis are obviously very confident about the FDA decision.

I was also heartened by Pram noting at the AGM, “we are into serious discussions with a number of people about spinning off those products”

CTL-019 BLAs awarded for: paediatric r/r B-ALL and paediatric/adult DLBCL by
2Q’18
? CTL-019 treatment mainly in relapsed/refractory patients with poor prognosis:
10% B-ALL patients and 30% DLBCL patients
? Max 20% penetration of the ALL market in Europe and 30% in US; max 15%
penetration of the DLBCL market in Europe and 25% in US by 2025
? Price for single treatment: $600,000
? OXB receives 4% royalties
We estimate that Novartis will achieve sales of $2.05bn per annum from CTL-019 by
2025. OXB could, therefore, receive a total of $82.0m in royalties per annum, in
addition to manufacturing revenue.

HTTP://www.hardmanandco.com/docs/default-source/company-docs/oxford-biomedica-documents/31.03.17-delivering-commercial-gene-therapy-vector.pdf

Another Win for CAR-T Therapy
Study shows benefit in children with CNS-relapsed ALL

In a secondary analysis of the phase I/IIa CHP 959 study, looking only at children with CNS involvement, 71% remain in complete remission a median of 11 months after the therapy, reported Mala Talekar, MD, from Children's Hospital of Philadelphia.
Presenting the findings at the annual meeting of the American Society of Pediatric Hematology/Oncology here, Talekar said the "remarkable milestone" underscores the potential for CTL019


HTTPS://www.medpagetoday.com/meetingcoverage/additionalmeetings/64895

Highlights from
the studies include: the ability of 5T4 CAR-T cells to kill
a wide range of 5T4-expressing tumour cell lines in vitro;
the ability of T cells taken from patients with ovarian
cancer to be re-programmed with the 5T4 CAR construct
and respond functionally to their own tumour cells
in vitro through the secretion of cytokines; and the ability
of 5T4 CAR-T cells to control tumour cell growth in
in vivo models. Further data will be presented in due
course either at a conference or in a publication.

http://www.oxfordbiomedica.co.uk/uploads/corporate-presentation/interims2016-analystpresentation-clean.pdf

Novartis said it will continue to aggressively strengthen its internal pipeline with early stage acquisitions and in-licensing deals.

HTTPS://www.briefing.com/investor/analysis/story-stocks/biotech-stocks-surge-after-novartis-signals-more-dealmaking-for-early-stage-assets-%28xbi%29.htm

Finally! Novartis AG (NVS) to Release Long-Awaited Juliet CAR-T Data in June
http://www.fiercebiotech.com/biotech/jefferies-analyst-novartis-juliet-car-t-data-out-june

Bingo, great news

Novartis gets second CAR-T candidate FDA ‘breakthrough’ tag

This latest label, which can speed things along for Novartis’ CTL019 (tisagenlecleucel), is for relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). This is the most common form of lymphoma and accounts for around 30% of all non-Hodgkin lymphoma cases.

Novartis says its latest breakthrough designation is based on highly-anticipated data from its phase 2 JULIET study, which is looking at the efficacy and safety of CTL019 in adult patients with r/r DLBCL.

Investors have been chomping at the bit for the JULIET data, but Novartis only said they “are expected to be presented at an upcoming medical congress.” Kite Pharma and its investors will also be keen to see how well, or not, the JULIET data turns out to be.

“At Novartis, we are eager to unlock the full potential of CTL019, including the potential to help patients with r/r DLBCL,” said Vas Narasimhan, global head of drug development and CMO at Novartis.

“We look forward to working closely with the FDA to help bring this potential new treatment option to patients as soon as possible.”

If Novartis does turn victor in the race to market, this will come as a major turnaround given that last year, it announced plans to cut back on its gene and cell therapy unit (which developed this drug) and saw the exodus of many of those who had helped create and nurture it.

HTTP://www.fiercebiotech.com/biotech/novartis-gets-second-car-t-candidate-fda-breakthrough-tag