In a first-in-human trial, early efficacy is observed. Three out of ten patients respond, but the limited TBNK panel offers no clues as to why. The team faces a critical decision point: move forward without understanding the full picture of the biology or find a way to uncover what differentiates responders from non-responders.
With TokuFocus, the full 41-marker panel had already been run, so the answer was already in hand. With a simple unlock, the team uncovers key immune differences and gains the clarity needed to confidently design their next phase.
First-in-human dosing begins. Fresh blood collected and run on 10-marker TBNK panel.
Trial begins with TokuKit. Blood stabilized and full 41-marker mass cytometry panel is run. Only TBNKM subset is unlocked ($1,000/sample).
Clinical team sees response in 3 of 10 patients. No insights yet from basic immune data.
Same responders emerge. TBNK panel doesn't differentiate, but full panel data is already archived.
Internal team asks: Why are these 3 responding? TBNK shows no clear difference.
Internal team asks the same. Plans to unlock deeper immune data post-analysis.
Your team wants to explore mechanism. Best case, there are some additional samples banked for for deeper profiling. Otherwise, it's time to start from square one and recollect.
Either way, you're left:
Your team wants to explore mechanism. They reach out to Teiko to unlock the data from the full 41-marker panel.
With the unlock, you'll:
A sponsor wraps up a promising Phase 2 trial. The FDA asks for deeper immune data to support the mechanism, but only a basic panel was collected. The team scrambles to recollect samples, but patients are off treatment, key timepoints are lost, and IRB approvals slow everything down.
As the team prepares for a Phase 2 milestone meeting or Phase 3 expansion, the missing data puts the program at risk. With TokuFocus, the full 41-marker panel is already processed on every sample. When more is needed, the data is ready without recollection or delay.
Phase 2/3 starts with a 10-marker TBNK panel. No additional markers are captured.
Phase 2/3 starts with TokuFocus. Full 41-marker panel is processed up front, but only TBNKM data is unlocked.
Initial efficacy is observed in a subset of patients. Team prepares for FDA engagement.
Same result — early data looks promising, and TBNKM readouts are available for review.
FDA requests deeper immune profiling to support mechanism of action and biomarker strategy.
FDA makes same request. Team already has full panel data banked for all samples.
The FDA asks for deeper immune data. Your team only ran a TBNK panel, and the clock is ticking.
In the meantime, your team is stuck:
Your team already has the full dataset banked on a 25- or 41- marker panel. They reach out to unlock the panel for $900/sample.
With the unlock, your team will:
Something we're thinking about, but not with this release. Here are the markers included in our basic TBNK panels:
Unsupervised analysis isn't included in the focused 10-marker panel, but it's available whenever you're ready to dive deeper. Once you upgrade to the full panel, unsupervised analysis is included to help you explore the full complexity of your data.
Upgrades are generally done in full batches, but we’re open to discussing alternative approaches if your study requires more flexibility. Contact our team to explore what might work best for you.
Yes. The dashboard will display the full gating tree, but any locked populations will appear greyed out until you upgrade.
Absolutely. We can support multiple cohorts, but keep in mind:
This is handled on a case-by-case basis. TokuFocus was built for our off-the-shelf panels, but we’re open to discussing custom panel options depending on your study needs. Reach out to our team to explore what’s possible.