Faronilla on ainakin kaksi patenttia (vai liekö nuo vielä hakemuksia) immunovärjäysmenetelmiin Bex-hoidosta todennäköisesti hyötyvien potilaiden tunnistamiseksi: anti-CLEVER-1 värjäys ja anti-CLEVER-1 + anti-PD-L1 värjäys. Nämä perustuvat aiempaan MATINS dataan kiinteistä kasvaimista. Noiden analysointi pitäisi olla toteutettu Aiforian create työkalulla. Tuo cut-off taso hoidosta mahdollisesti hyötyvien potilaiden tunnistamiseen on hyvin suoraviivaisesti joko prosenttiosuus tai suhde.
Ensimmäisestä patentista:
According to the present invention, it has been observed that anti-CLEVER-1 antibody bexmarilimab is most valuable for cancer patient having diagnosed with a tumor which comprises at least 1% of intra-tumoral CLEVER-1 expressing cells from the total amount of the viable intra-tumoral cells in a sample obtained from the tumor. In an embodiment of the present invention, a tumor sample which comprises 1-10% or 3-7% of CLEVER-1 expressing intra-tumoral cells from the total amount of viable intra-tumoral cells, is an indication that the cancer patient is responsive to the anti-CLEVER-1 therapy.
Ja toisesta patentista:
CLEVER-1 ratio is an indication that the cancer patient is responsive to the anti-CLEVER-1 treatment. PD-L1/intra-tumoral CLEVER-1 ratio is calculated from the percentages of PD-L1 expressing cells and CLEVER-1 intra-tumoral expressing cells. According to an embodiment of the present invention, the stained tumor sample, which shows 0-2% of PD-L1 expressing cells, calculated from the total amount of viable cells present in the stained sample, together with at least 1% of CLEVER-1 expressing intra-tumoral cells, calculated from the total amount of viable intra-tumoral cells present in the stained sample, is an indication that the cancer patient is responsive to the anti-CLEVER-1 therapy. Hence, according to an embodiment of the present invention a ratio of PD-L1 expression and intra-tumoral CLEVER-1 expressions is ≤2, preferably <2, calculated based on the percentage values, wherein it is an indication that the cancer patient is responsive to the anti-CLEVER-1 treatment.
Noiden immunohistokemiallisten testien lisäksi Faronilta löytyy MATINSIN pohjalta myös tämä tulehdusvälittäjäaineiden tasoihin perustuva menetelmä En sitten tiedä onko MDS:ään kehitetty nyt BEXMAB:in myötä uusia menetelmiä. Siinä ainakin on kerätty yksisolusekvenointinäytteitä potilailta, ja sitä dataa on myös aiemmin esitetty postereissa. Tuon datan perusteella voisi löytää responssia ennustavia markkereita myös MDS:ään.