BioInvent kommenterar nästa kapitel för BI-1206

Med utgångspunkt i lovande tidiga data ska BioInvent nu utvärdera BI-1206 i första linjens behandling, det vill säga i patienter som ännu inte har fått någon läkemedelsbehandling för sin cancer.

Vid ASCO-konferensen 2024 presenterade BioInvent data från en fas I-studie med 36 patienter med avancerad cancer som redan genomgått flera behandlingsförsök, inklusive immunterapier som Keytruda. Resultaten visade att behandlingen med BI-1206 i kombination med Keytruda var säker och väl tolererad samt uppvisade klinisk aktivitet. En patient uppnådde komplett respons, en annan hade en långvarig partiell respons och elva patienter bibehöll stabil sjukdom – däribland en melanompatient som förblev stabil i hela två år trots tidigare misslyckade behandlingar.

BioInvent har sedan dess utvecklat en subkutan (under huden) version av BI-1206, som frisätter läkemedlet långsammare och därmed kan förlänga exponeringen och förbättra både säkerhet och användarvänlighet.

I grunden verkar BI-1206 genom att blockera en receptor kallad FcγRIIB på immunceller. Denna receptor fungerar som en ”broms” på immunsystemet vilket kan innebära att immunterapier som Keytruda tappar effekt. Genom att häva denna broms kan BI-1206 hjälpa fler patienter att svara på immunterapi redan från början och samtidigt förlänga behandlingseffekten.

Från plan till genombrott – studiedesignen

Fas IIa-studien inleds nu med en signalsökande fas där upp till 30 patienter med icke-småcellig lungcancer (NSCLC) och 12 patienter med uvealt melanom inkluderas. Samtliga deltagare får kombinationsbehandlingen med BI-1206 och Keytruda i upp till två år. När de första säkerhets- och effektdata finns tillgängliga går studien vidare till en dosoptimeringsfas. Här delas patienterna in i grupper som får högre eller lägre doser av BI-1206, medan en kontrollgrupp får enbart Keytruda.

Denna design gör det möjligt att hitta den optimala balansen mellan effekt och säkerhet.

Studien kommer att genomföras på kliniker i Europa (bland annat Georgien, Tyskland, Polen, Rumänien, Spanien och Sverige) samt i USA. De första resultaten väntas under andra halvåret 2026.

BioInvents vd Martin Welschof beskriver studiestarten som ”en viktig milstolpe i vårt uppdrag att ge patienter tillgång till BI-1206”, och tillägger att ”eftersom BI-1206 adresserar en mekanism för resistens mot anti-PD1, sträcker sig potentialen för användning av BI-1206 över alla indikationer där pembrolizumab är godkänt.” Detta antyder att BI-1206 kan förstärka effekten av checkpoint-hämmare som Keytruda hos patienter med begränsade behandlingsalternativ, såsom vid NSCLC och uvealt melanom.

CMO kommenterar – intervju med Dr. Andres McAllister

För att få veta mer om studiens syfte och BioInvents förväntningar kontaktade vi bolagets CMO Dr. Andres McAllister.

What does the start of this phase IIa study mean for BioInvent and BI-1206?

– The launch of this study marks a pivotal moment for BioInvent. It’s the first time we’re evaluating BI-1206 in treatment-naive patients, which allows us to better understand its full therapeutic potential earlier in the disease course. It also reflects our confidence in the molecule’s ability to enhance checkpoint inhibitor efficacy.

Why is it important to study treatment-naive patients this time?

– In phase I, we saw promising responses in heavily pre-treated patients, that included several lines of treatment with immunotherapeutic agents. However, treatment-naive patients offer a better clinical situation to characterize the therapeutic potential. Their immune system hasn’t been altered by prior therapies, which gives us a clearer view of how BI-1206 interacts with pembrolizumab and the tumor microenvironment.

What lessons from phase I helped shape this new trial?

– Phase I taught us that BI-1206 is well tolerated and showed signs of robust and durable responses, even in patients who had failed previous immunotherapies. These insights helped us refine the dosing strategy and the transition to subcutaneous administration, which may improve target engagement and convenience for patients and clinicians.

How does BI-1206 actually help overcome resistance to drugs like Keytruda?

– BI-1206 targets FcγRIIB, a receptor that dampens immune activation and contributes to resistance against anti-PD-1 therapies like Keytruda. FcγRIIB is the only inhibitory Fc receptor (all other Fc receptors activate the immune system), and it is also the most highly expressed in the tumor microenvironment. By blocking FcγRIIB, BI-1206 reactivates immune cells and enhances the anti-tumor response, potentially converting non-responders into responders, and prolonging and deepening the quality of the responses.

Why were NSCLC and uveal melanoma selected as the focus for this trial?

– NSCLC represents a major unmet need, with variable responses to PD-1 inhibitors depending on PD-L1 expression. It also represents an ideal opportunity to test the activity of BI-1206 and Keytruda, without chemotherapy or any other agents, and yet in the frontline treatment. This makes it a very clean experimental situation because patients will receive the standard of care for their disease, with the addition of BI-1206. Uveal melanoma has very limited treatment options and poor response rates to current immunotherapies. Both indications offer a strong rationale for testing BI-1206’s ability to boost checkpoint blockade. If the responses are as we expect, this will drive major inflexion points for the value of BI-1206”

How does the two-part study design strengthen your chances of success?

– The study begins with a signal-seeking phase to identify early signs of efficacy in up to 30 NSCLC and 12 uveal melanoma patients. This is followed by a dose optimization phase. It’s a flexible design that allows us to adapt based on initial findings and maximize the likelihood of meaningful clinical benefit. During the second part (dose optimization) two cohorts will receive BI-1206 and pembrolizumab, and one cohort will receive pembrolizumab alone. This will help us establish the magnitude of BI-1206 contribution to the response.

What will you be looking for as early indicators of success?

– We’ll be monitoring objective response rates, duration of response, and biomarker changes—particularly in PD-L1 expression and immune cell activation. Stable disease and partial responses in early cohorts would be encouraging signs.

How has the collaboration with MSD contributed to the program’s progress?

– MSD’s support has been instrumental. Providing Keytruda for our studies and their shared commitment to exploring combination strategies has enabled our development strategy and has added credibility to the program. They are an ideal partner!

When do you expect the first results?

– We anticipate initial readouts from the signal-seeking phase in the second half of 2026. These will guide the dose optimization and help us determine the next steps for broader clinical development.

Looking ahead, what role could BI-1206 play in cancer immunotherapy?

– If successful, BI-1206 could become a key component in overcoming resistance and enhancing the activity of immune checkpoint inhibitors. We now know that the activity of these agents is strongly influenced by Fc receptors, and among them, a key determinant is the inhibitory FcγRIIB. In that context, our initial data in lung cancer will very likely reflect the situation in other tumor types. Thus, we believe BI-1206 has the potential to expand the reach of immunotherapy to patients who currently don’t benefit, and to deepen responses in those who do in many different indications.

– The fact that it is administered through a simple and quick subcutaneous administration adds to the value, in particular considering that the subcutaneous formulation of Keytruda has recently been approved. We are envisaging the moment when lung and other cancer types will be treated with convenient and efficacious treatments, and this will be one important milestone toward that end.