BioInvents CMO kommenterar presentationen vid ESMO
BioInvent och Transgene presenterade lovande fas I/IIa-data för BT-001 på ESMO i Barcelona under helgen. BioStock kontaktade BioInvents CMO Andres McAllister som deltar på konferensen, för att diskutera dessa resultat och andra framsteg på senare tid.
Med hjälp av sitt antikroppsbibliotek n-CoDeR och screeningplattform F.I.R.S.T., har BioInvent utvecklat fem antikroppskandidater som för närvarande utvärderas i sex olika kliniska program. Kandidaterna testas både som monoterapi och i kombination med nuvarande standardbehandlingar för olika typer av cancer.
De två ledande läkemedelskandidaterna, BI-1808, en anti-TNFR2-antikropp, och BI-1206, utvärderas i fas I/IIa-studier. BI-1206 undersöks i non-Hodgkins lymfom (NHL) och solida tumörer.
Portföljen inkluderar även tre tidiga kliniska program; BI-1607, BI-1910 och BT-001, som potentiella behandlingar för flera cancertyper.
Lovande data med BT-001
BT-001 utvecklas som monoterapi och i kombination med MSD:s (Merck & Co) anti-PD-1-behandling KEYTRUDA (pembrolizumab). Förra veckan meddelade BioInvent att nya lovande initiala fas I/IIa-data med BT-001 skulle presenteras vid ESMO:s årsmöte i Barcelona, 13–17 september, tillsammans med samarbetspartnern Transgene. Läs mer här.
CMO kommenterar
Initiala fas I/II-data för BT-001 som monoterapi visade stabil sjukdom och en minskning av injicerade lesioner i patienter med långt fortskridna solida tumörer. Kombinationsdelen av studien visade lovande effektdata med partiell respons hos patienter med relapserande och refraktärt avancerat melanom och leiomyosarkom.
BioStock tog kontakt med BioInvents CMO Andres McAllister, på plats i Barcelona, för att diskutera datapresentationen vid ESMO.
Andres, BioInvent and Transgene presented promising phase I/IIa data on BT-001 at ESMO this weekend. Could you summarise the key findings you have made so far?
– BT-001 induced tumor regression in patients unresponsive to previous treatments with anti PD(L)-1, both as a monotherapy and in combination with MSD’s KEYTRUDA (pembrolizumab).
– Preliminary data suggest that BT-001 replicates in the tumor, the payloads are expressed, and, importantly, with undetectable systemic exposure, which is, of course, the purpose as it will get rid of the toxicity observed when anti-CTLA4 is administered IV. The treatment was well tolerated and showed first signs of efficacy with clinical responses in 2 of 6 patients when given in combination with pembrolizumab. BT-001 treatment turned “cold” tumors to “hot” inducing T cell infiltration, a higher M1/M2 macrophage ratio, and a shift to PD(L)-1 positivity in the tumor microenvironment.
The European Society for Medical Oncology published an abstract for a BI-1910 trial-in-progress poster. What are the next steps for this program?
– Unfortunately, we could not disclose data given the restrictions imposed by the type of poster session. The study has progressed incredibly quick given the adequate behavior of the drug, and we plan to present data from the phase I part before year-end and hope to be in phase II soon.
The phase IIa study of BI-1808 as a monotherapy has yielded preliminary positive efficacy data. How might this impact the future development?
– The results we are observing are important since single agent activity is seldom observed in this area of cancer immunotherapy. If this trajectory is confirmed, we have in our hands a very safe drug capable of treating a difficult to treat disease where few options exist, and those treatments approved come with a great deal of toxicity. Being a rare disease, it opens the way for facilitated regulatory pathways, that should accelerate the development and will significantly decrease the time to market.
The first patient has been enrolled in the triple combination study of BI-1206, rituximab, and Calquence for NHL. What are your expectations for this therapy?
– This approach will be very competitive given the ease of subcutaneous administration, the safe profile of the treatment and the potential to observe high response rates, similar to those observed with more complex agents where toxicity remains an issue for the treatment of indolent forms of disease.
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