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CELYAD NOV DEC 2016

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Zo gaat dat
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Celyad’s NKR-2 Phase I safety trial delivers encouraging results to be presented at ASH 2016
Corporate press releases November 07, 2016
Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, today announces that first data analysis of the NKR-2 Phase I trial shows encouraging results which will be presented during a poster session at the 58th American Society of Hematology (ASH) Annual Meeting, taking place on December 3-6, 2016, in San Diego, CA.

The NKR-2 Phase I trial is a single infusion, dose escalation study evaluating the safety and feasibility of NKR-2 T-cells in Acute Myeloid Leukemia and Multiple Myeloma patients. This study was completed in September 2016 with a successful safety follow-up for all dose level cohorts. There were no cases of cytokine release syndrome, cell-related neurotoxicity, auto-immunity, or CAR-T related death.

Based on recent analysis, encouraging clinical update and correlative analysis, including post-infusion immunophenotyping, will be presented at the poster session of the ASH Annual Meeting:

Title: Safety Data from a First-in-Human Phase 1 Trial of NKG2D Chimeric Antigen Receptor-T Cells in AML/MDS and Multiple Myeloma (Poster Presentation)
Abstract: 4052
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III
Presentation: Monday, December 5, 2016, 6:00pm – 8:00pm PST
Location: San Diego Convention Center, Hall GH
Dr. Christian Homsy, CEO of Celyad commented: “NKR-2 Phase I trial was a safety study with the primary objective of ensuring that there was no on-target, off-tumor toxicity. We are positively surprised at reports of unexpected clinical benefit, while testing just one single infusion dosed between 50 and 1,000 times lower than our expected efficacious dose extrapolated from animal experiments. Our exceptionally strong animal data was obtained with three injections of human equivalent doses of 1 to 2 billion cells per injection, while the highest dose tested in the NKR-2 study was 30 million cells in a single infusion. These results are therefore encouraging and we look forward to triggering the next phase of our NKR-T program once European agencies and the FDA have approved our THINK trial protocol”.

Dr. Frédéric Lehmann, VP Immuno-Oncology at Celyad: “We are excited to present these data at ASH and to explore the full potential of our NKR-2 autologous therapy in our next development phase. The THINK trial will evaluate the clinical activity and safety in seven indications, in both hematologic malignancies and solid tumors. It is our hope that this study will be the foundation of a robust approach to treating patients with advanced tumors.”

Dr. David Gilham, VP Research and Development at Celyad: “NKR-2 CAR T cell therapy was designed to act like a drug with short term persistence and multiple injections in order to provide a better controlled and more predictable safety profile than that of other traditional CAR-T products. The primary objective is to avoid uncontrolled in-vivo cell expansion and long term persistence thereby replacing this paradigm with well controlled pharmacokinetics. We are re-assured to note that the safety outcome of this Phase I study confirms the pre-clinical animal data generated to date.”
Zo gaat dat
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www.celyad.com/news/celyad-announces-...

First clinical trial of NKR-2 T-cells therapy completed with good safety outcome and unexpected signals of clinical activity at the low doses tested

Strong cash management leading to a cash runway until mid-2019

Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, today provides an update on key clinical and operational developments over the three-month period ended 30 September 2016.

HIGHLIGHTS OF THE THIRD QUARTER

Strategic License agreement with ONO PHARMACEUTICAL CO., LTD, Japan, to develop allogeneic NKR-2 T-cell immunotherapy.
Completion of the autologous NKR-2 Phase I trial conducted at the Dana Farber Cancer Institute in Boston, USA, with successful safety follow-up.
NKR-2 safety data demonstrating encouraging results to be presented early December at the American Society of Hematology (ASH) Annual Meeting
Reinforcement of the corporate management team with the appointment of Philippe Dechamps as Chief Legal Officer.
Dr. Christian Homsy, CEO of Celyad commented: “The third quarter of 2016 saw us increase our focus on the development of our NKR-T platform in line with our strategy. We continued to deliver on our development objectives for NKR-2 and reached important safety outcomes with the successful completion of our Phase I trial. We also saw reports of unexpected clinical benefits which were encouraging. We now look forward to reporting the outcome of this trial at ASH in December, and starting THINK, our multiple dosing umbrella trials testing NKR-2 in five solid and two blood malignancies.”

Patrick Jeanmart, CFO at Celyad, added: “Thanks to the first payment associated to the ONO partnership and a strong management of our operational cash drain, we ended the third quarter of 2016 with EUR 87 million. This cash position will allow the Group to finance all of its operations and clinical development program until the middle of 2019.”

OPERATIONAL AND FINANCIAL REVIEW

Over the third quarter, Celyad has made significant progress in the preclinical and clinical development of its NKR-T platform with the completion of the autologous NKR-2 Phase I trial. This study was completed in September 2016 with a successful safety follow-up for all dose level cohorts. There were no cases of cytokine release syndrome, cell-related neurotoxicity, auto-immunity, or CAR-T related death. Furthermore, some unexpected clinical activity was observed while testing a single infusion dosed between 50 and 1,000 times lower than our expected efficacious dose extrapolated from animal experiments. The NKR-2 Phase I trial was a single infusion, dose escalation study evaluating the safety and feasibility of NKR-2 T-cells in Acute Myeloid Leukemia and Multiple Myeloma patients. Full data readout is confirmed to take place at the ASH conference early December in San Diego.

In July, Celyad entered into an exclusive license agreement with the Japanese company ONO PHARMCEUTICAL CO., LTD, one of the global leaders in the immuno-oncology field, for the development and commercialization of Celyad’s allogeneic NKR-2 T-cell immunotherapy in Japan, Korea and Taiwan. Under the terms of the agreement, Celyad will continue developing its allogeneic NKR-2 T-cell immunotherapy in the EU and US territories, and ONO will be responsible for future development and commercialization in ONO’s territories (Japan, Korea and Taiwan). In exchange for granting ONO an exclusive license in these territories, ONO will pay Celyad a $12.5 million-dollar upfront payment, up to $299 million in additional milestones and a double-digit royalty based on the net sales of the licensed product in ONO’s territory. Both companies will also explore the opportunity to collaborate to collectively run global registration trials and combination trials. In addition, Celyad has also granted to ONO an exclusive option to license for development and commercialization of its autologous NKR-2 T cell product in the above ONO territories.

In August, Celyad presented the primary clinical data of CHART-1 Phase III trial at the European Society of Cardiology. Though the primary endpoint of the study was not reached, a positive trend was seen across all treatment groups, and the primary endpoint was met (p=0.015) for a subset representing 60% of the population of the CHART-1 study (baseline End Diastolic Volume (EDV) segmentation). In this subgroup, a statistical significant positive difference was seen in all individual elements of the composite primary endpoint (Mortality, Worsening Heart Failure Events, Quality of Life, 6 minutes Walking Test, End Systolic Volume and Ejection Fraction). Based on these results, Celyad has initiated business development activities seeking a partner who would pursue the further development and commercialization of the therapy C-Cure®.

Also in August, Mr. Danny Wong resigned amicably from Celyad’s Board of Directors in order to concentrate on his investments in Asia.

In September, Celyad reinforced its management team with the appointment of Philippe Dechamps as Chief Legal Officer.

The Company ended the quarter with €87 million in cash including the first payment of €10 million from ONO. Use of cash over the quarter amounted to €9 million. The Company believes that existing cash and cash equivalents and short term investments are sufficient to fund operating expenses and capital expenditure requirements, based on the current scope of activities, until the middle of 2019.
Zo gaat dat
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nl.quoteweb.com/nl-nl/fonds-detail/te...

Celyad heeft op donderdag 24 november 2016 11:43 het 1e weerstandniveau met een koersstijging naar 18,59 opwaarts doorbroken. In het algemeen wordt dit opgevat als een positief signaal
Zo gaat dat
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www.abc6.com/story/33813345/edison-is...

Edison Issues ADR Update on Celyad (CYAD)

Information contained on this page is provided by an independent third-party content provider. Frankly and this Station make no warranties or representations in connection therewith. If you are affiliated with this page and would like it removed please contact pressreleases@franklyinc.com

SOURCE Edison Investment Research

LONDON, November 29, 2016 /PRNewswire/ --

Celyad has noted that the Phase I safety study on its NKR-2 CAR T-cell autologous therapy produced some "reports of clinical benefit". The THINK Phase Ib trial has been approved in Belgium and awaits FDA clearance. This is a major expansion of CAR therapy with five solid tumors plus AML and MM being explored. As a result, we have raised the probability of success to 20% from 18.5%. There is a challenge to the granted 2009 US patent on allogeneic CAR T-cells. While the claim is being re-examined, the patent remains in force; other patents and patent applications provide protection. Edison's interim indicative value has been rebased and increased to [b]$50 per share[/b], formerly $46 per share.

(Logo: photos.prnewswire.com/prnh/20130417/6... )
Our valuation model for Celyad has been rebased to focus on NKR-2 indications. As Celyad is initiating an NKR-2 trial in solid tumors, these have also been added to the valuation but with caution as this could be a challenging set of indications and there is very little current clinical data on the NKR-2 product. The C-Cure value is unchanged at 35% probability and is now regarded as an indicative deal value on partnering. Celyad has also cut its cash burn to no more than $34m per year to conserve cash to mid-2019. These adjustments give an interim indicative value of $50 per share, formerly $46 per share.

Click here to view the full report.

All reports published by Edison are available to download free of charge from its website www.edisoninvestmentresearch.com.

About Edison: Edison is an international equity research firm with a team of over 70 analysts, investment and roadshow professionals and works with both large and smaller capitalised companies, blue chip institutional investors, wealth managers, private equity and corporate finance houses to support their capital markets activity. Edison provides services to more than 420 retained corporate and investor clients from offices in London, New York, Frankfurt, Sydney and Wellington. Edison is authorised and regulated by the Financial Conduct Authority.

Edison is not an adviser or broker-dealer and does not provide investment advice. Edison's reports are not solicitations to buy or sell any securities.

For more information please contact:
John Savin
Edison Investment Research
+44(0)20-3077-5735

Lala Gregorek
Edison Investment Research
+44(0)20-3681-2527
healthcare@edisongroup.com
Contact details: Learn more at www.edisongroup.co and connect with Edison on:

LinkedIn www.linkedin.com/company/edison-inves...
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Zo gaat dat
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quote:

de speurneus schreef op 2 dec 2016 om 12:59:


Opvallende koersbewegingen.


Inderdaad de ene dag -8% en vandaag weer +8% zonder dat er echt nieuws is (voor de buitenwereld althans).
Zo gaat dat
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www.celyad.com/news/celyad-announces-...

Strong safety signals, including no cases of cytokine release syndrome, cell-related neurotoxicity, auto-immunity, or CAR-T related death.
A new AML patient reported no progression (3+ months) and improvement in all hematological parameters under no additional therapy at the highest dose (3x107).
Cases of prolonged survival with improvements in hematological parameters were noted in both acute myeloid leukemia (AML) and multiple myeloma (MM) patients.
In vitro demonstration of NKR-2 specific functionality against autologous tumors in the two patients evaluated is a strong correlative evidence of the potential of this approach.
Sky-jumper
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Hoy @ Zo gaat dat,

Hallo, hoe is het er mee ?? Hopelijk heb je wat kunnen traden met Celyad ?

Misschien kom ik na nieuwjaar misschien terug in Biotech, dan is de spec.taks afgeschaft. Intussen wens ik je heel veel geluk met je beleggingen. Sky.
Zo gaat dat
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Hee Sky,

Zie nu pas je berichtje. Ik heb Celyad maar voor een heel beperkt volume in mijn portefeuile, maar ik vind toch dat ik het een beetje moet bijhouden. Ik trade niet met Celyad, maar hoop dat in 2017/2018 mijn investering vruchten gaat afwerpen. Tot in het nieuwe jaar.
;-)

Groeten Zo gaat dat
Zo gaat dat
0
Celyad blijft voor mij teveel een black box. Fluctuaties vaak niet te verklaren.
Verlies genomen en gestopt in Tigenix.

Succes voor diegene die er nog in blijven.
Basile82
0
Nog geen nieuw draadje voor 2017?


Celyad Announces USPTO Decision to Uphold US Patent for Production of Allogeneic TCR-Deficient CAR-T Cells
Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell-based therapies, announced today that the U.S. Patent and Trade Office (USPTO) has decided to uphold Celyad’s U.S. Patent No. 9,181,527, relating to allogeneic human primary T-cells that are engineered to be TCR-deficient and express a CAR.

“We are pleased with the outcome of this re-examination of our patent related to the production of allogeneic TCR-deficient CAR-T cells. This marks the third decision by the USPTO to uphold this patent, which thus remains valid and enforceable, and provides for continued intellectual property protection for this valuable asset”, said Philippe Dechamps, Chief Legal Officer of Celyad.

“Allogeneic CAR T-cells are a promising avenue to broaden the scope of application of cell based immunotherapy”, said Georges Rawadi, VP Business Development and IP of Celyad. “We look forward to the further development of our own allogeneic programs and also continue to offer other parties access to this important patent to advance the field more broadly.”

Celyad’s U.S. patent (No. 9,181,527), and more precisely claim 1 of the said patent, was challenged by an anonymous third party through an Ex Parte Re-examination procedure. The request for Ex Parte re-examination was filed on February 10th, 2016 and an order granting Ex Parte Re-examination of claim 1 was issued by the USPTO on March 24th, 2016. The final decision of this Ex Parte procedure that was issued on January 6th 2017 is not subject to appeal and upholds the validity of the patent.

Therefore, Celyad’s U.S. patent (No. 9,181,527), confirms continued coverage of CAR-expressing human T-cells, according to Claim 1, modified to reduce or eliminate T-cell receptor expression or function. - See more at: beursig.com/forum/viewtopic.php?f=4&a...

Waarschijnlijk aangevochten door Cellectis/Pfizer. Is wel een belangrijke overwinning.
Westvleteren
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Mooie overwinning inderdaad! Koers gaat er ook lekker op de laatste dagen (zelfs bijna weer in het groen in porto; van Tigenix nog niet te zeggen :(, o.a. GLPG maakt dat dan gelukkig weer meer dan goed), geduld... GLTAL!
Basile82
0
van al mijn biotech aandelen heeft celyad het meeste potentie. Kans is klein maar als alles meezit de komende 2 jaar kan dit aandeel gemakkelijk x10 gaan.
[verwijderd]
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quote:

Basile82 schreef op 16 jan 2017 om 16:26:


van al mijn biotech aandelen heeft celyad het meeste potentie. Kans is klein maar als alles meezit de komende 2 jaar kan dit aandeel gemakkelijk x10 gaan.

Want?
Basile82
0
Celyad is minder dan 200 miljoen waard hiervoor krijg je:

- 86 miljoen cash
- C-Cure, conservatieve schatting is waarde rond 150 miljoen imo, partner wordt binnenkort bekend gemaakt imo
- autologe CAR-T voor 7 indicaties, 5 solid en 2 liquid tumors, totale markt van +20 miljard dollar, tegen 10% kans, geeft dit een waarde van 2 miljard
- allogeniec CAR-T is op komst, binnen 10 jaar spreekt niemand nog van autologe CAR-Ts. Allogeneic is de toekomst, goedkoper en gemakkelijker toe te dienen.
- allogeneic CAR-T patent, moeilijk waarde in te schatten maar kan meerdere 100 miljoenen in Royalties opbrengen.

Dus wat mij betreft is Celyad nu ongeveer een miljard waard, is toch x5 op dit moment.

Zo gaat dat
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Ik blijk een contra indicator voor dit fonds te zijn. Elke keer als ik erin stap zakt de koers als ik eruit stap (eind december) stijgt de koers. ;-) Gefeliciteerd voor de zittenblijvers en wees niet ongerust ik ga niet meer instappen. :-)
Westvleteren
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@Zo gaat dat, zou je DAAROM niet juist nog (even) op deze voortdenderende trein moeten springen, paar euro's up meepakken, gun het je van harte.
Zo gaat dat
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Dank je Westvleteren. Wie weet...
Overigens beleef ik momenteel met MdxH en GALA ook goede tijden. Dus medelijden hoeven jullie niet te hebben. ;-)
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