Den publicerade fas I-studien utvärderade en ny trippelkombinationsbehandling: avutometinib tillsammans med abemaciklib och fulvestrant. Behandlingen gavs till patienter med HR-positiv, HER2-negativ metastaserande bröstcancer vars sjukdom hade fortskridit efter tidigare behandling med CDK4/6-hämmare. Avutometinib riktar in sig på en signalväg som är kopplad till resistens mot just dessa standardbehandlingar.
Tidiga biomarkörsignaler
Studiens explorativa biomarköranalys visade en tydlig korrelation mellan TKa-nivåer och behandlingssvar. Samtliga patienter som upplevde klinisk nytta av kombinationsbehandlingen uppvisade låga TKa-nivåer tidigt under behandlingen. De som inte svarade på behandlingen uppvisade däremot högre nivåer. Resultaten pekar på DiviTum TKas potential som en tidig indikator på behandlingsnytta.
Kommersiell faktor
Vetenskapen är inte ett självändamål för Biovica, utan den driver den kommersiella sidan av verksamheten. Genom affärsområdet Pharma Services hjälper bolaget läkemedelsutvecklare att följa tumörtillväxt i deras egna kliniska studier. Divisionen växte med 72 procent under det senaste räkenskapsåret och är fortsatt bolagets högsta strategiska prioritet.
En publikation av det här slaget ger erbjudandet ny klinisk tyngd, och den landar mot en bakgrund av en intensiv kommersiell aktivitet. Biovica har på senare tid säkrat flera arbetsordrar samt ett utökat Master Services Agreement inom nästa generations cellcykelterapier.
Nästa steg i den kliniska valideringen
Fas I-studien var visserligen liten med sina 16 patienter, och TKa-resultaten var explorativa. Trots det lägger de en solid grund för vad som komma skall. En pågående fas II-studie utvärderar nu TKa parallellt med andra biomarkörer. Denna större studie blir det verkliga elddopet – en möjlighet att validera den tidiga signalen och stödja en framtida användning av DiviTum TKa inom både läkemedelsutveckling och rutinmässiga behandlingsbeslut.
Frågor till vd
Theis, how does this new publication strengthen your ongoing dialogues with pharmaceutical companies?
– It gives us a concrete, peer-reviewed example to put in front of drug developers rather than just a scientific hypothesis. When we talk to a company developing a next-generation cell-cycle or resistance-pathway therapy, the conversation used to be ”here’s why we think TKa should track response.” Now it’s ”here’s a published dataset where it did.” That distinction matters in pharma business development. Teams need evidence they can take to their own clinical and regulatory colleagues before committing to a work order. We’re already seeing interest from companies developing non-CDK4/6 inhibitor therapies who want to use TKa as a biomarker in their own trials, and this publication is exactly the kind of proof point that moves those conversations from exploratory to contractual.
Why is an early read on treatment benefit particularly important in this patient population?
– These are patients who have already progressed on a CDK4/6 inhibitor and are being tried on a new combination to overcome that resistance. Today, the only way to know if it’s working is to wait for imaging, typically months into treatment. If a patient isn’t benefiting, that’s months of toxicity, cost, and delay before switching to something that might work. An early, low-cost blood test that flags non-response within weeks as we saw in this study, means both patients and physicians can make that call much sooner. That’s valuable in the clinic, and it’s equally valuable to a drug developer running a trial, because it can inform go/no-go decisions and trial design far earlier than imaging-based endpoints allow.
You have secured several work orders and expanded agreements within Pharma Services. How do these new clinical findings support your strategy to scale that business area?
– Pharma Services grew 72 percent last year and it’s our top strategic priority, so everything we do scientifically needs to translate into commercial traction there. Publications like this one are the foundation that traction is built on, they give prospective pharma partners independent, peer-reviewed validation that TKa behaves the way we say it does, in exactly the treatment classes they’re developing drugs for. It’s not a coincidence that we’re seeing this kind of scientific output alongside expanded master agreements and new work orders in cell-cycle therapies. The two reinforce each other: strong data lowers the barrier to a partner’s first work order, and each successful engagement builds the case for the next one.
What specifically are you hoping to validate in the larger phase II study?
– Three things. First, whether the correlation we saw between early TKa levels and clinical benefit holds up in a larger, more diverse patient population – 16 patients gives us a strong signal, not proof. Second, how TKa performs alongside the other biomarkers being evaluated in that study, since we see TKa’s real value in combination rather than in isolation. And third, timing, how early the signal reliably appears, because the earlier we can validate a benefit or non-benefit call, the more actionable it becomes for both physicians and drug developers designing adaptive trials.
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