Another positive announcement yesterday, but not one that will likely boost the SP.
• Interim results from the MAST trial have demonstrated positive responses in gastrointestinal cancers, particularly incholangiocarcinoma where one patient treated with CF33-hNIS (VAXINIA) achieveda complete response and another patient achieved stable disease
This has been questioned by many, but here it is in black and white, direct from the company ... at the first data cut, there were only two cholangiocinoma patients and BOTH had a response to Vaxinia ... one a complete response (CR) and the other achieved stable disease (SD). For those who struggle with maths... that’s 2 out of 2.
• the Cohort Review Committee cleared the fifth cohort in the IT arm of the monotherapy dose escalation portion of the MAST trial, withno safety signals seen to date.
This is clearly very positive ... as we continue to increase the dose, we are STILL not seeing any safety issues. Note: Our OV is clearly safer than most of the cancer treatments currently enjoying FDA approval. Please don’t underestimate this aspect because it will be the ‘deal breaker in indications that already have an approved treatment.
Reading through these threads I wonder if some folk herereally understand the purpose of the MAST study.
So I note once again, the MAST study is what I like to call a ‘science sandpit’ trial. It wasn’t ever designed to be a traditional Phase 1. How many FDA approved cancer trials have welcomed any cancer? It is bold, uncommon and very clever. And, it is paying off in bucket loads already.
• It has spun-off a Bile Duct cancer trial that has already received Fast Track designation from the FDA. As of yesterday, this expansion trial has opened enrolment ... just before IMU is about to be ‘featured’ at the 2024 Cholangiocarcinoma Annual Conference !! IMU has had a special invite, which it will use to speed enrolment. According to Leslie, if this expansion trial produces positive data, the next step is a Phase 2 confirmation trial.
• Further expansion trials are likely to emerge from the ‘sandpit’ in the very near future. All with the added knowledge that only comes from a trial structured in this way.
• The MAST trial has also confirmed that patients with a higher level of T cell diversity in peripheral blood respond better to VAXINIA therapy. You can bet your last dollar that this will now heavily impact patient selection to the Bile Duct cancer trial, thus greatly increasing the chances of success.
And to ‘wrap up’, as further explanation of the intricacies and purpose of the MAST study, along with how foolish it is to compare MAST to ‘regular’ trials, we have LC’s reply to@Nicwaa yesterday ... “it is futile to compare efficacy at different dose levels and different dosing regimen of 3 patients in each dosing regimen per cohort”. Her statement should clarify, and put an end to the nonsense, that one particular ‘visiting’ poster was trying to stir up over here. I’m all for a good debate across these threads, that is HC’s primary purpose, but keep it honest.
PS @Fibber - loved your fox analogy.
@b1gcr4ig- thanks, I’m thinking perhaps a cold Guinness
All opinion
