I didn't think much of the announcement this morning other than... things a ticking along, safety and early signs etc.
BUT the Pro Active Video made me realise something potentially huge!
CHECKvacc had 8 planned Dose Excalation Cohorts.
From -
https://clinicaltrials.gov/ct2/show/NCT05081492 and Abstract Published at this year ASCO -
https://meetings.asco.org/abstracts-presentations/209942 "CHECKvacc intratumorally at one of 8 assigned dose levels (1 x 10
5 , PFU, 3 x 10
5 PFU,
1 x 106 PFU , 3 x 10
6 PFU...."
Essentailly each cohort is stepping up by a factor of 3.3x.
Cohort 1 - 1 x 10
5 = 100,000
Cohort 2 - 3 x 10
5 = 300,000
Cohort 3 - 1 x 106 = 1,000,000 Cohort 4 - 3 x 10
6 = 3,000,000
So for Leslie to state at 1min mark that "
we KNOW that our Oncolytic virus works at a very low dose and we are quite encoraged that we're already up to Cohort 3 and seen NO SAFETY ISSUES we have seen NO Toxicity and we have hopefully some things to publish here as I said 'very soon' on the first few cohorts. So I'm Delighted!
Andrew: So how many further cohorts are planned...
LC: As I said our Oncolytic virus therapy tends to work quite efficiently at a low dose, I anticipate that if we clear this dose we could even start seeing some real signs and consider maybe the cohort 4 as a dose, this is what we consider as somewhat of a sweet spot for us.... and still continue to see early signals then we may intrrogate Cohort 4.
SO you really don't need to read between the lines here that LC has just confirmed that she feels like they can cut the trial dosing timeframes in HALF! Either dose level 3 or 4 will likely be the optimum dose for the patient expansion as no need to go higher and risk toxicy given that the vius replicates further itself.
This bodes very very well for what we will see in future updates for Vaxinia and then CF33-CD19 OnCARlytics.
Timeline thus far for CF33.
10 August 2022 -
ASX Announcement - FIRST COHORT 3 PATIENT DOSED IN CLINICAL TRIAL OF CHECKVACC VIDEO 13 April 2022 -
ASX Announcement - First Cohort 2 Patient Dosed in Clinical Trial of CHECKvacc Only Cohort 1 was FDA mandated staggered patience however 3 weeks to find next patient does show that it is not most common form, expecially as to be eligible people need to have already failed 2 lines of therapy.
24 March 2022 -
ASX - Dose Escalation in Phase 1 Clinical Trial of CHECKvacc VIDEO GREAT UPDATE TODAY!
(20min delay)