BioInvent har beviljats särläkemedelsstatus av det amerikanska läkemedelsverket, FDA, för anti-FcyRllB-antikroppen BI-1206, för behandling av den vanligaste formen av långsamväxande non-Hodgkins lymfom, follikulärt lymfom. För BioStock berättar BioInvents Chief Medical Officer Andres McAllister mer om betydelsen av FDA:s beslut.

BioInvent utvecklar immunmodulerande antikroppar för cancerbehandling. BI-1206 är bolagets primära läkemedelskandidat som för närvarande utvärderas i två fas I/II-studier. Kandidaten utvärderas dels i kombination med rituximab för behandling av non-Hodgkins lymfom (NHL), dels i kombination med Keytruda (pembrolizumab) i solida tumörer. I bolagets pipeline finns även kandidaterna BI-1808 och BT-001 för behandling av solida tumörer, vilka båda befinner sig i fas I-utveckling.

Särläkemedelsstatus för BI-1206

BI-1206 har sedan januari 2019 särläkemedelsstatus (Orphan Drug Designation, ODD) från FDA för behandling av mantelcellslymfom (MCL) och i onsdags, den 19 januari, erhöll BioInvent ytterligare en ODD från FDA, nu för behandling av follikulärt lymfom.

Idag är en av de vanligaste behandlingarna mot bägge dessa maligna tumörsjukdomar rituximab. Under hösten 2021 publicerade BioInvent interimsdata gällande kombinationsbehandlingen BI-1206 och just rituximab, för patienter med NHL som återfallit i sin sjukdom eller blivit resistenta mot nuvarande behandling. Resultaten visade på ökade svarsnivåer och varaktiga fullständiga responser.

Enligt bolaget var i synnerhet svarsfrekvensen för undergruppen med follikulärt lymfom särskilt imponerande. Tidigare behandlingar med rituximab utan BI-1206 fungerade inte i dessa patienter och samtliga hade återfallit i sjukdom. De tre fullständiga responserna var bestående och den längsta varade i mer än 36 månader. Hos två av patienterna hade de fullständiga responserna varat i mer än 12 respektive 24 månader efter avslutad behandling.

BioInvents CMO kommenterar

Särläkemedelsstatus ger vissa fördelar såsom marknadsexklusivitet vid regulatoriskt godkännande, undantag från ansökningsavgift till FDA för marknadsföringstillstånd och skattelättnader för kliniska prövningar.

BioStock sökte BioInvents Chief Medical Officer Andres McAllister som berättar mer.

Andres, can you talk about the FDA decision and how they view the data you’ve presented?

– We view this as a strong signal that the responses we have observed are meaningful and could have significant impact in the lives of patients suffering from Follicular lymphoma. In particular those patients who have received previous lines that included chemotherapy and who continue having relapses of their disease after treatment. These patients are often elderly, and chemotherapy can have an important toll in their quality of life. A treatment regimen based on two antibodies (without chemotherapy or other agents) will certainly be very positive for patients and clinicians.

Rituximab is an important standard treatment but many patients become resistant after a period of treatment. How strong do you think your previous data is?

– The question of patients developing resistance to rituximab has been a matter of intense research for a number of years, and FcgRIIB has been identified as a potential important culprit in different types of B-cell malignancies. BI-1206 is allowing to test this hypothesis for the first time, and this thanks to the fact that it is an antibody highly selective for FcgRIIB and does not cross-react with the activating receptors FcgRIIA and Fcg We are seeing patients who had relapsed after treatment with rituximab, now develop a long-lasting complete response only because this time they received BI-1206 in combination with rituximab. Imagine the feeling of those patients, especially if they have been through previous lines of chemotherapy!

– We looked recently at cells derived from MCL patients who had become resistant to several different drugs, including Car-T cells. They were all susceptible to the combination of BI-1206 and rituximab. This is very impressive! This indicates, once again, that high expression of FcgRIIB is an important mechanism of resistance. In addition, there are several studies looking at patient cohorts of follicular lymphoma, mantle cell lymphoma and large B-cell lymphoma, where it has been observed that high expression of FcgRIIB correlates with poor prognosis, once again pointing in the direction that this receptor plays an important role in the pathogenesis of these diseases.

Going forward, what is your view on BI-1206 which is now being developed for multiple indications?

– The larger body of evidence we are accumulating is in follicular lymphoma. This for the simple reason that FL patients are easier to recruit given that it is more frequent than the other subtypes. In that regard, it was important for us to obtain ODD in this specific indication. It means we can now move forward directly and accrue patients in the one indication where it will be easier to complete the studies. In parallel we will also be recruiting MCL and MZL patients, and of course, we will be diligent in enrolling those patients as well. At the end of the day, we will pursue approval in the three subtypes as quickly as possible, but now each indication can be pursued independently, and approval can be pursued as soon as the studies have completed enrolment. It is important to note that in these three diseases, fast track designation and conditional approval are possible given the orphan nature of the diseases. For a small company like ours, this constitutes an important opportunity.

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