--Cytovant--
|
dass es sich bei dem ersten der drei an Cytovant verkauften TCR um NY-ESO-1 als Ziel geht und dieses bestehende Medigene Forschungsprogramm sowie die beiden zusätzlichen TCR Discovery-Projekte auf die asiatische Zielgruppe (HLA-Klasse und Indikationen) angepasst werden sollen. Ausserdem sind die Lizenzen auf den ostasiatischen Raum begrenzt.
Insofern dürfte es sich um lediglich einen TCR aus der Vorklinik Pipeline handeln und dieser müsste für den Rest der Welt eigentlich dort auch weiter auftauchen.
Ansonsten hast Du natürlich Recht, dass man aus den Pipelines in so frühen Phasen oder im Entwicklungsstadium praktisch nicht auf den tatsächlichen Fortschritt schliessen kann, sondern allenfalls das grobe Potential der Technologie abschätzen kann.
Edison-->
"bluebird has recently announced the target (MAGE-A4) of the first TCR product candidate
developed in the partnership and it plans to take the MAGE-A4 TCR product candidate into the
clinic in 2020. MAGE-A4 is a member of the melanoma antigen gene (MAGE) protein family and is
highly expressed in a number of cancer types (melanoma, breast, colon and ovarian) while
retaining low expression in healthy tissues.
One of the most advanced assets in the sector is in development by Adaptimmune, which is
developing a TCR targeting MAGE-A4 (ADP-A2M4). ADP-A2M4 is being tested in a Phase I, openlabel trial in a range of cancer patients who are HLA-A*02 positive. The trial is expected to enrol 42
patients and has to date completed three dose expansion groups (100 million, 1 billion and 5 billion
cells) and is in an ongoing expansion group (up to 10 billion cells). The first two cohorts (100 million
and 1 billion) were in six ovarian patients and demonstrated limited efficacy (one patient initially had
27% reduction but progressed at week 12). In cohort 3 (5 billion cells) and the expansion phase (up
to 10 billion cells) a total of 10 synovial patients were treated (five of whom received the maximum
dose of 10 billion cells), of which 4 of 5 at the highest dose (10 billion cells) demonstrated a partial
response. Responses in other tumour types to date have been minimal. Adverse events for all
tumour types have been typical of patients treated with other cell therapies.
As shown by Adaptimmune’s data, selecting the correct indications and dose will be critical to the
success of any MAGE-A4 TCR product. However, arguably the correct T-cell/TCR design is more
important. Using Medigene’s technology, a TCR has been selected that Medigene and bluebird
believe has the highest possible avidity needed to drive tumour response. In tumour xenograft
models, the MAGE-A4 TCR demonstrated durable tumour elimination beyond that of a NY-ESO-1
TCR. Additionally, the TCR has been shown to be co-receptor independent and able to generate
cytotoxicity in both CD8 and CD4 T-cell populations.
Both bluebird and Medigene carried out
significant work to ensure limited cross-reactivity of the TCR with other antigens.
In addition to selecting the correct TCR, bluebird is designing extra features into the T-cells to
promote the best response in solid tumours....
...The Mage-A4 TCR is expected to enter the clinic in 2020 in a range of cancers."
-
Vom begrenzten ADAP-Erfolg lernen..
Es sind offenbare mehrere MAGE-A4-Studien von BLUE geplant... Erhöht dann wohl auch die Chance auf MSt.für Medigene (Für diesen TCR dann aber sicherlich trotzdem begrenzt auf 250Mio.+ Umsatzbet.)
Edison ->
"..If early signs of strong efficacy are observed, data from the Phase II component of the trial could form part of an accelerated regulatory filing.."
Klingt super. Aber mit nur 1 Patienten wird das nix.. (Die weiteren 4 Kliniken sollen aber in den nächsten Monaten rekrutieren)
"..Due to slower than expected patient enrolment, we now expect first MDG1011 data in 2020
(previously 2019) and have pushed back our forecast out-license and launch of MDG1011 to 2020
and 2022 respectively.."
Auslizensieren nach 1.Daten !? OK, Schont den Geldbeutel und vermindert das KE-Gejammer ;)
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