Faron har mindst to patenter (eller måske er det stadig ansøgninger) vedrørende immunfarvningsmetoder til at identificere patienter, der sandsynligvis vil have gavn af Bex-behandling: anti-CLEVER-1 farvning og anti-CLEVER-1 + anti-PD-L1 farvning. Disse er baseret på tidligere MATINS-data fra solide tumorer. Analysen af disse burde være udført med Aiforias “create”-værktøj. Det cut-off-niveau, der bruges til at identificere patienter, som potentielt kan have gavn af behandlingen, er meget ligetil og baseret på enten en procentdel eller et forhold.
Fra det første patent:
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.
Og fra det andet patent:
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.
Udover disse immunhistokemiske tests har Faron, baseret på MATINS, også denne metode baseret på niveauer af inflammatoriske mediatorer. Jeg ved dog ikke, om der er udviklet nye metoder til MDS (myelodysplastisk syndrom) i forbindelse med BEXMAB. Der er i hvert fald indsamlet enkeltcelle-sekventeringsprøver fra patienter, og disse data er også tidligere blevet præsenteret på postere. Baseret på disse data kunne man måske også finde markører, der forudsiger respons i forbindelse med MDS.