ADAP: Adaptimmune - Transforming T-Cell therapy
es werden wohl laut Adaptimmune Pressemitteilung die Daten Stand 16 August, 2017 vorgestellt werden. Aber selbst wenn die weiteren Monate bis jetzt dazu kommen, wird dies das Gesamtbild wohl nur geringfügig ändern.
Interessant wäre natürlich, ob bei den Rückfall-Patienten eine Gabe von Keytruda die TCR-modifizierten T-Zellen nochmal gegen den dann wieder sichtbaren Krebs aktivieren würde. Aber zu diesem Zweck wurde ja eine neue ASCT-unabhängige Studie mit und ohne Keytruda aufgesetzt ( NCT03168438 ).
neuen GSK Strategie im Bereich der Onkologie, bei der Adaptimmune eine von 3 Schwerpunkten bilden soll.
Adaptimmune.
Von nun an wird wohl nur noch GSK über den Stand bei diesen TCR Studien mit NY-ESO-1 berichten, da dann die noch laufenden und alle zukünftigen Studien unter deren Regie weitergeführt werden.
Der Kurs reagiert nach US-Börsenschluss positiv.
1) funktioniert (Proof of concept) und
2) sicher sei, um dann aber
3) die Wirtschaftlichkeit aufgrund der komplexen Herstellung und Durchführung der T-Zelltherapie wieder in Frage zu stellen.
Als Beleg werden die Durchlaufzeiten bei der vorgestellten Pilotstudie von bis zu 6 Wochen genannt.
Das diese Bedingungen auch für die gerade in der Zulassung bejubelten CAR T-Zelltherapien von Novartis und Gilead (KITE) gilt und es sich bei der ASH-Präsentation um eine uni-Studie handelt die 2015 abgeschlossen wurde, ignoriert BAML wohlweislich. Strafe muss sein, denn man verdient ja bei BAML an den ADAP Aktien nichts mehr, nachdem Adaptimmune diese von der Citi Bank und Cowen verwalten lässt. Den Kurs hat es jedenfalls gestern erstmal gedrückt.
Meine Meinung - KEINE Handelsempfehlung
verbunden mit dem Hinweis, daß solide Tumorerkrankungen die nächste Herausforderung für die T-Zell Immuntherapien sind und Adaptimmune mit NY-ESO dort bereits Erfolge vorweisen kann.
Langfrist-Daten in Multiple Myeloma.
Könnte von einem Übersetzungsprogramm stammen - aber wenn es zum Verständnis beiträgt und scheinbar keine groben Falschaussagen enthält, kann ich damit leben.
von über 1.8 Millionen Aktien gehandelt - ohne einen müden Kurszucker.
Das ist wohl der Aufnahme in den NASDAQ BioTech Index zu verdanken.
PHILADELPHIA and OXFORD, United Kingdom, Jan. 08, 2018 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced initial safety data from its two ongoing pilot studies of SPEAR T-cells targeting MAGE-A10, one in non-small cell lung cancer (NSCLC) and a triple tumor study in bladder, melanoma, and head & neck cancers.
To date, 8 patients have each received 100 million transduced MAGE‑A10 SPEAR T-cells in the first dose cohorts of both studies. No evidence of toxicity related to off-target binding or alloreactivity has been observed. There have been no reports of neurotoxicity safety events similar to CAR‑T cell-related encephalopathy syndrome (CRES)1. In the NSCLC study, there has been one serious adverse event of cytokine release syndrome (CRS), a Grade 4 event that resolved with treatment. This event led to cohort 1 expansion from 3 to 6 patients. No dose limiting toxicities were observed in cohort 1 of the triple tumor study.
Following review by the independent safety review committee (SRC), the decision has been made to escalate to the next dose of 1 billion transduced MAGE-A10 SPEAR T-cells in the triple tumor study. This was the therapeutic threshold dose observed with SPEAR T‑cells targeting NY-ESO in the synovial sarcoma pilot study. The decision to escalate in the NSCLC cohort will be reviewed by the SRC following dosing of the 6th patient.
“These safety results, with one of our wholly-owned SPEAR T-cell treatments, and the upcoming escalation to the next dose in the triple tumor study are significant as they allow us to progress treating patients in these studies at a potentially active cell dose,” said Rafael Amado, Adaptimmune’s Chief Medical Officer. “As data accumulate throughout 2018, we will continue to share meaningful safety and efficacy data from the MAGE-A10 and MAGE-A4 programs at relevant scientific venues.”
Details about Ongoing Trials with SPEAR T-cells Targeting MAGE-A10
There are two ongoing clinical trials with SPEAR T-cells targeting MAGE-A10; one in non-small cell lung cancer (NSCLC), and a triple tumor study in bladder, melanoma, and head & neck cancers. Both studies are dose escalation trials that evaluate three doses of transduced SPEAR T-cells, administered after a lymphodepleting chemotherapy regimen. The three doses being evaluated are 100 million, 1 billion and 1 to 5 billion transduced SPEAR T-cells.
NSCLC study: In this study, five patients have received SPEAR T-cells in the first group of Cohort 1 (1a without fludarabine) 2, and there was one report of Grade 4 CRS that resolved with treatment.
Triple Tumor Study: Three patients have been dosed in the first cohort. There were no reports of CRS greater or equal to Grade 3, and all cases resolved with supportive treatment.
Adaptimmune Announces Two Manufacturing Achievements on Its way to Become the First Fully Integrated TCR T-cell Therapy Company
Successful Manufacturing of SPEAR T-cells for a Patient at its Navy Yard Site and Agreement with Cell and Gene Therapy Catapult to Increase Vector Manufacturing Capacity
PHILADELPHIA and OXFORD, United Kingdom, Jan. 08, 2018 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced that it has successfully manufactured the first SPEAR T-cells for a patient at its Navy Yard facility in Philadelphia. In addition, Adaptimmune announced an agreement with Cell and Gene Therapy Catapult for vector production in the UK, which will ensure vector supply for its ongoing and future clinical studies.
“We are making great strides to becoming a fully integrated cell therapy company. Our Navy Yard facility is now fully operational producing SPEAR T-cells for patients. In addition, we have vector supply into 2019, and the initiation of our own vector manufacturing capability at the Catapult facility will extend vector supply further,” said James Noble, Adaptimmune’s Chief Executive Officer. “We will continue to work with our cell manufacturing partner PCT, now part of Hitachi, where we have dedicated space and personnel for production of our SPEAR T-cells, as well as our other vector suppliers. Having these dedicated resources both in-house and through external partnerships is essential to ensure our future success as a fully integrated cell therapy company.”
First SPEAR T-cells manufactured at the Navy Yard
The first SPEAR T-cells have been successfully manufactured by the Adaptimmune team at our own Navy Yard headquarters for a patient in the first dose cohort of the ongoing MAGE-A4 multiple tumor study in bladder, melanoma, head & neck, ovarian, non-small cell lung, esophageal, and gastric cancers.
The manufacturing facility at the Navy Yard can deliver cells for up to 300 patients per year, with the possibility of expansion that would enable manufacture for up to 1000 patients per year. In addition to production at its wholly-owned manufacturing facility at the Navy Yard, Adaptimmune will continue working with the PCT team to manufacture SPEAR T-cells.
Vector supply extended to beyond 2020
The agreement, which was executed on January 5, 2018 with Cell and Gene Therapy (CGT) Catapult, will enable Adaptimmune to have its own dedicated vector manufacturing space in the UK. It will ensure vector supply production beyond 2020 for ongoing studies with all three SPEAR T-cell therapies, MAGE-A4, MAGE-A10 and AFP.
The module, in which Adaptimmune will use its own novel vector manufacturing process and be responsible for operation of the manufacturing process, is located in the UK-based CGT Manufacturing Centre. The CGT manufacturing Centre is a Good Manufacturing Practice (GMP) facility designed to enable the development of commercial scale manufacturing systems in cell and gene therapy by offering a full suite of GMP facilities, support and expertise.
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Wertpapier: Adaptimmune Therapeutic |
welches im wesentlichen ein Abklatsch von Inhalten des Internetauftritts in Form eines PDF-Dokuments ist (vorausgesetzt der verfügbare PDF-reader gibt es her).
Vielleicht ganz nett für neue Investoren oder um einen gewissen Stand der Selbstdarstellung festzuhalten. In den Details wichtiger sind m.E. die Informationen in der Firmenpräsentation #545
Zelltherapie Deals via John Carrolls Endpoints News "GSK’s long-quiet cancer R&D group is ready to make some noise as it mounts a breakout late-stage effort"
Mal abwarten, was da kommen könnte ... derjenige wird wohl mit Adaptimmune zusammenspielen dürfen.