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The link doesn't work but they're good results, albeit not as good as our P1 and we're ahead in P1b. Illustrates an accelerated route inevitable for us.

6000 prolongs life as it significantly prolongs PFS. Hope that helps.

Https://x.com/tom_the_bomb__/status/2061689525542240578?s=46

Avacta capturing attention and I suspect a matter of time before an accelerated pathway announced. We were already beating benchmark PFS by nearly 50% some 8 months ago. Looking forward to the update end of the month.

Taken with immunotherapy and whilst the shrinkage is impressive as I mentioned yesterday it’s less amazing if not durable which is why PFS is so important. We’ll have an update end of the month but will no doubt far access the 3.5 months SGC.

Below from the article re the pill in combo -

The pill appeared most effective in lung and bowel cancers, halting disease progression for at least six months in more than half of patients – with very few side-effects reported.

It also helped cervical cancer patients – many of whom are diagnosed at a late stage – delaying progression for at least six months in 18 per cent of cases.

I don't get your point as Dox isn't used in the treatment of SGC and they've told us in this setting as a second line treatment with PFS is a mere 3.5 months and that's the benchmark to beat. The obsession with shrinkage bizarre if PFS is not sustained. What's the point in seeing a large decrease in tumour size for it to grow back with a vengeance a few months later? We are seeing sustained PFS which will of course improve OS.

A few thoughts on the latest #AVCT #ASCO26 data.

Importantly, the headline numbers are broadly consistent with previous data releases:

➡️ 4 partial responses

➡️ 9 minor responses

➡️ 92% disease control rate

➡️ Only 3 patients with progressive disease out of 38 evaluable SGC patients

The consistency really stands out to me. Exactly what you want to see nearly 5 years in.

It’s not unusual to see early efficacy signals weaken when cohorts expand. The 1B data is reinforcing what was seen in 1A rather than contradict it (key).

The waterfall plot is very interesting. Tumour shrinkage and disease control appear broad, with multiple patients still on treatment and others remaining under progression follow up.

The cardiac data is possibly the most important aspect of the poster IMO. 6000’s proposition has always been simple = can you deliver dox to tumours whilst avoiding the cardiac toxicity that limits conventional doxorubicin? Yes we can.

The exposure response analysis suggests no meaningful relationship between cumulative released doxorubicin exposure and LVEF. The regression line is essentially flat(...!).

Even more encouraging is the fact that 111 patients have now been dosed and no cardiomyopathy events have been observed.

Released dox appears in circulation gradually following FAP cleavage within the TME, rather than producing the sharp systemic peak concentrations typically associated with standard dox. In other words, the efficacy, PK and cardiac datasets are all pointing in the same direction.

This increasingly looks less like a company generating the evidence required to support discussions around registrational development, not just prove the concept anymore.

The FDA pathway discussions remain key, but I continue to believe the bigger story here is not just AVA6000. It’s the growing body of evidence supporting preCISION as a platform.

AVA6000 might be Gen 1, but every piece of clinical evidence demonstrating tumour selective payload release increases confidence in what Gen 2 assets such as 6103 could achieve.

Next up? The much larger TNBC indication that has been forecasted to achieve $2.2B peak revenue in just 5-6 years.

https://x.com/tom_the_bomb__/status/2061355283104833959?s=46

Whoever takes 6000 forward for SGC they will generate decent revenues for years and whoever acquires 6103 or avacta will not target SGC as it's a small indication and they will have bigger fish to fry. 6000 perfect for a mid sized pharma.

A reminder, thanks CJ

From Claude:- is the a good rns ?

A few errors but reasonable

This is a **very strong RNS** for Avacta. Here's why:

**The headline positives**

- **92% disease control rate** across 38 evaluable salivary gland cancer patients — that's a very compelling number for a cancer with limited treatment options

- **Four partial responses and nine minor responses** — meaningful signs of efficacy

- **No severe cardiac toxicity** in 111 patients dosed — this is huge, as heart damage is the primary limiting factor with conventional doxorubicin

- **Lifetime maximum dosing limit removed** — with Health Authority agreement, this is a significant clinical and regulatory milestone, meaning patients can potentially receive more treatment cycles

**The scientific significance**

The cardiac data is arguably the most important element. Conventional doxorubicin is a highly effective chemotherapy but is severely limited by cumulative heart damage. The PK data showing that AVA6000 avoids the sharp systemic peaks that cause cardiac toxicity, and the subsequent removal of the lifetime cap, directly validates the core premise of the pre|CISION® platform.

**What's still needed**

- 38 evaluable patients is still a relatively small cohort

- Partial responses rather than complete responses

- No randomised controlled data yet comparing against standard of care

**Overall verdict:** For a Phase 1b trial this is about as good as it gets — safety validated, efficacy signal consistent, and a meaningful regulatory milestone achieved. The BIO International Convention presentation later in June will be worth watching

Why arte the outcomes so different? 92% disease control rate is remarkable. Remember these patients had received prior treatment/s and their tumours continued to grow. Halting the growth of this hard to treat tumour is the desired outcome to prolong life. Pretty simple and that's what's happening andf with better quality of life

SGC has no standard of care as is very hard to treat with poor outcomes and being a rare condition there aren't many large pharm targeting it so yes it is about extending lives as OS of less than 12 months aint good.

This morning's RNS.

It’s all about extending lives and with usual PFS less than 4 months and OS less than 12 months the fact we are smashing that and with fewer side effects is something special. Not just extending lives but doing so with a better quality of life.

9 remain on treatment and with the lifetime limit being lifted is certainly gives hope for even better outcomes re PFS and shrinkage. 2 with partial responses continue treatment as well as 4 with minor and 1 without change. I assume we get an update on PFS end of June. Disease control rate of 92% is superb and 111 patients treated in total with outstanding safety profile and let’s not forget over 100-1 drug in tumour to plasma ratio.

Teabag, yes there looks to be a better option but 6.5 months PFS will be surpassed by FAP-Dox. Given Johnson & Johnson was targeting this they and others will have their eyes on our data. We had 9+ months PFS in P1 so nearly 50% longer tan there's which was hailed a breakthrough as it was 50% better than the median. It's positive for AVCT and we have fewer adverse events as some 10% had to be taken off drug due to adverse events.

Https://www.msn.com/en-gb/health/other/cancer-jab-eradicates-entire-tumours-in-breakthrough-trial/ar-AA24ruyh?ocid=msedgdhp&pc=DCTS&cvid=6a1bdfa19abc4554bcb8d041c8e4523a&ei=49

Tumour shrinkage is impressive but the most important metric is PFS and as a result OS. Therefore What stands out is - Patients with amivantamab lived for a median of 12.5 months after starting the treatment, despite having a cancer type with “very poor outcomes” once standard treatments stop working, the ICR said.

Tumours started to respond within about six weeks and patients had a median of a little more than six-and-a-half months before the cancer started to grow again, it found.

Although our data to be published likely won't have OS it will have a better PFS than 6.5 months and who knows it could be near to double than the breakthrough above.

Doggy, why heaps of trouble?

I believe SGC is decided at 310 (209 equivalent) and TNBC TBC.

Good points Chris, I suspect an RNS won't be issued if you're right and we will get an RNS next week when new data is published at ASCO.

If this is 'new' data and all they are presenting next week at ASCO we will know as we will get an RNS this morning.

A good post ICE. I was expecting a longer PFS but given it’s ongoing and the benchmark is 3.5 months the main thing is obtaining an accelerated pathway which coupled with the lifetime limit being lifted is surely inevitable. The sooner we can announce that the better.

Given how 6000 improved from animals to human if 6103 improves rather than 10 fold like this but moving from

11 times more CMAX (in minutes) to 33 or 3 times better TSI to nearky 10 will be unbelievable. In the nearer term

Accelerated pathway needed and SGC wasn’t considered sensitive to dox but TNBC and STS was so getting 117 more in the tumour than conventional we should see some even better results.