Scancell Share Discussion Threads

[marcusl2] 09/3/2024 22:21

ADCs

11 FDA-approved ADCs, expected to sell $28B in 2030

95 ADC programs active in clinical development today
Crowding is happening: HER2 has 14 active programs in the clinic, FRa and CLDN18.2 have 7 each

Scancell has unique targets with its Glymabs

[sci102] 08/3/2024 15:10

Btw, "sub group analysis", "data deep dives" etc usually accompany bad results to calm down investors (and to inform future trials, but mostly the first reason).

[sci102] 08/3/2024 15:00

It was obvious from the data the company already had that it wasn't going far.

Some comments when that guy from UV came to the board. I did warn..

"Sci102 - 08 Feb 2024 - 10:30:26 - 186 of 257
Msrcus

Since the PFS/OS data is terrible, the ORR doesn't even matter anymore. It just doesn't work well enough.

Sci102 - 08 Feb 2024 - 10:24:17 - 185 of 257
3n. Looked at the latest co presentation. As suspected, that 27% risk reduction is complete nonsense, sorry. Look at the OS kaplan graph there is basically no difference and it is not statistically significant. Far from actually. I hope that is not the data you were counting on. Also there is no difference in PFS by Blinded Independent Central Review while there is some difference when assesed by the investigator. This is exactly the kind of company I would never ever touch.
.

Sci102 - 08 Feb 2024 - 07:24:31 - 180 of 257
27% risk reduction is not a lot. What is the p value/CI? Do you have a link to the presentation?"

[marcusl2] 08/3/2024 09:59

I would love a first deal with Avidimab

Attractive to big pharma to enhance efficacy and extend patent life of highly profitable mAbs

[marcusl2] 08/3/2024 09:57

► Scancell is one of only a few companies worldwide with the know how to make high affinity anti-glycan
monoclonal antibodies (mAbs)
► Portfolio of anti-glycan antibodies with excellent specificity provide multiple licensing opportunities
► Validation of the GlyMab® platform by leading antibody biotech, Genmab
► Upfront payment plus milestones totalling up to $624m, plus single digit royalties on sales
► Opportunities to co-develop and develop own products in-house
► Each antibody can be developed into multiple products, expanding utility and potential market value
► Global cancer monoclonal antibody market size $42 billion in 2021; market anticipated to reach $57 billion by 2028*

[marcusl2] 08/3/2024 09:56

AvidiMab® technology has potential to improve the therapeutic index of any mAb
► Attractive to big pharma to enhance efficacy and extend patent life of highly profitable mAbs
► CPI pembrolizumab (Keytruda) is one of the best-selling drugs worldwide, generating nearly $21 billion in revenue
during 2022ǂ
► Global drug sales of trastuzumab (Herceptin) were $4 billion in 2020; declining due to the rise in biosimilars§

[marcusl2] 08/3/2024 09:55

Modi-1

► Potent T cell responses and strong anti-tumour activity observed in preclinical models
► Early data from patients receiving Modi-1 as a monotherapy showed good T cell responses, safety and tolerability. Similar to SCIB1 monotherapy in metastatic disease, one patient achieved a partial response and 60% of patients showed stable disease in response to Modi-1 monotherapy.
► Combination therapy with checkpoint inhibitors, should further improve outcomes with Modi-1. With this intention we will investigate Modi-1 in renal cancer in combination with ipilimumab (Yervoy® ) plus nivolumab (Opdivo® ) checkpoint inhibitors. This is partly due to a change of standard of care and partly because our results from SCOPE suggest that the double checkpoints are ideal in synergising with vaccines.

[marcusl2] 08/3/2024 09:54

SCIB1 is being developed in cutaneous melanoma –compelling efficacy data
► Post resection patients: 95% disease-free survival (DFS) at 12 months and 88% at 5 years
► Unresected patients: 60% stable disease
► Unresected patients in combination with double CPIs: 85% ORR
► iSCIB1+ second generation technology offers improved product
► No HLA screening, can access 100% of the addressable market
► AvidiMab® modification increases potency and gives 15 years extended patent protection
► Very little risk of iSCIB1+ not working as it the same as SCIB1 but with more epitopes expressed by melanoma
► A study amendment has been approved by the MRHA to add a new cohort of iSCIB1+ patients to the SCOPE trial
► SCIB1 currently in Phase 2 in combination with ipilimumab and nivolumab, delivered with needle free device, and
iSCIB1+ will start in Q1 2024
► Phase 2/3 adapted registration trial being planned with attractive licensing potential

[supernumerary] 07/3/2024 23:24

Bermuda

yes - you just can't get good placebos these days :¬(

When you say 'sadly' I'm not so sure - from a patient's point of view it's good to have the losers winnowed, and in a way, nothing much has changed - all small biotechs spend their lives clambering up the north face of the Eiger - ulti just has to adapt to a steeper slope. I'd guess they're still funded further ahead than sclp?

But what happens now is an interesting question. They talk about sub-group analysis, but that would take probably 6 months or so to produce reliable results; then say 12 months to design and obtain approval for a more focused trial; then another 18 months minimum to run the trial and process results. A minimum total of 3 years which is well beyond their cash horizon, long after they've had other significant results, and meanwhile competitors will have raised the bar even further. So unless something really dramatic emerges, I think it's the end of the road for them with melanoma.

Of the remaining trials, I'm not a fan of head and neck - too heterogeneous, too distorted by other side-effects of the cancer (but I accept that's a personal view) - and nsclc and ovarian are not only hard, but face that ever-rising bar, which leaves mesothelioma.

A very difficult cancer, but it's a decent size market and there's not a lot of competition, so maybe that's the best option? They do have some results from NIPU, which was another ipi+nivo trial, but again they missed the primary (also pfs), however the secondaries didn't look too bad and I think were regarded as encouraging so they do have a chance.

Glad to be watching not holding - another bullet missed....

3n - I'm sure you're right and BMS is happy to see these results (putting aside minor questions of morality of course!), although it won't (I don't think) change their commercial position at all.

I also agree that comparisons with historical data mean little - one of the reasons sclp has been untouchable for me for many years now. As ever the problem is that the signals are so small, which is why the trials need to be so large and go on so long. We've reached a stage where progress is almost invariably made in tiny steps - the great leaps forward have gone until such time as a completely new model of cancer is achieved.

Your comments on pfs are interesting, thank you. It's really just a poignant illustration of the previous point - ipo and nivo have achieved a certain plateau, and climbing over that is necessarily a long and arduous process. It's also a reminder that sclp is far from out of the woods yet.

Anyway, assuming you're still holding, I wish you luck.

[3nobody] 07/3/2024 22:33

Regarding Ultimovacs and protocol amendment for the Initium trial.
There has been NONE PFS events since march 2023.

Also, at readout median follow-up time is 28mo and mPFS has still not been reached in either control OR experimental arm and will not be reached by a minimum of many additional months. CM067 had mPFS 11.7mo with ipi+nivo.

I guess BMS is guite happy with their drug combo suddenly sees a threefold increase in mPFS for advanced Melanoma,

This also means it is meaningless to compare any Melanoma studies including CPI's with historical data. Only a RCT can give any sort of validation.

Does Scancell runs randomized studies with control arm's for their vaccines combining with CPI?

[bermudashorts] 07/3/2024 19:07

Super,

Thanks for that. It's interesting that the protocol amendment was needed in the first place:-

'Based on published historical references, progression was estimated to occur in 70 patients by the first half of 2023.'

In other words patients on their trial had improved results from the ipi/nivo combination over those making up the historical data. I guess in only 156 patients they could have just had a group of patients who happened to respond particularly well which is obviously great for the patients but resulted in failure for Ultimovacs. As you say, perhaps if they'd had a longer follow up differences may have emerged. On the other hand, the fact that it failed on all secondary endpoints too, including ORR doesn't bode well.

Sadly they have a bit of a mountain to climb - not least due to their cash position.

[supernumerary] 07/3/2024 18:17

Ref Ulti again, it's interesting that they shortened the data analysis period because it was taking too long for results to emerge. Summary below. I wonder if they're regretting that now - it's still possible I guess that if they'd waited long enough, a difference would have emerged.



Oslo, October 31, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announced that the analysis of the INITIUM data will be initiated in mid-January 2024, following an amendment of the clinical trial protocol. The INITIUM protocol has been amended to allow data readout based on a minimum of 18-month follow-up of all evaluable patients, at which time the patients have a mean follow-up time of 24 months. The amendment will maintain the integrity of the study statistics.

The protocol amendment was submitted to the regulatory authorities in the countries where the INITIUM trial is conducted: The U.S. Food and Drug Administration (FDA) and regulatory bodies in Belgium, Norway, and the U.K. The FDA has not issued any objections to the amendment and the Regulatory Authorities in two European countries have approved the amendment with one pending.

The INITIUM study (NCT04382664) evaluates Ultimovacs’ universal cancer vaccine, UV1, as first-line treatment in unresectable or metastatic malignant melanoma in combination with PD-1 checkpoint inhibitor nivolumab and CTLA-4 checkpoint inhibitor ipilimumab. The first patient was enrolled in June 2020, and the trial completed enrollment of 156 patients in July 2022. Per the original trial protocol, data analysis would be conducted after cancer progression or death has been verified in 70 patients.

Based on published historical references, progression was estimated to occur in 70 patients by the first half of 2023. With the current development in patient progression, reaching these 70 events could take many months or even years, justifying the decision to implement the protocol amendment. Based on the recent acceptance from the regulators, the data can now be analyzed in early 2024, enabling Ultimovacs to maintain its guidance on reporting the outcome of the study two to three months later in the first half of 2024.

“We are pleased for the patients in the INITIUM study that it takes longer than anticipated to experience progression of the disease. With positive survival results from the first randomized Phase II study in malignant mesothelioma, a very hard-to-treat cancer, we are increasingly optimistic about UV1’s potential to benefit cancer patients. As we seek to bring UV1 to the patients as quickly as possible, it is important to advance the INITIUM trial towards a data readout,” said Carlos de Sousa, CEO of Ultimovacs. “We appreciate the support from regulatory authorities, and we now look forward to sharing the results in the first half of 2024.”

...

[marcusl2] 07/3/2024 15:30

3nobody,

I am very sorry to hear about that disappointment. I am not familiar with the rest of Ultimovacs pipeline but hopefully they do well with the rest of it.

I have been here before myself and took a huge hit when Trovax failed. Only after looking at Scib-1 early success in trials and researching Scancell at length did I fully invest.

Lindy explained why early vaccines failed

Just a reminder about Scib-1;

From Prof Durrant

At this point in this space Ultimovacs is our only competitor in Melanoma and they are using doublet like us.

She thinks their vaccine is inferior as it only targets a single antigen.

That is why we have not moved forward with Scib-2 as it only targets a single antigen (NY-ESO-1) and she thinks there would be an immune escape.

She also thinks if scib/iScib+ works we will beat Moderna hands down as we are off the shelf.

Moderna has told her "if you are correct Lindy then we are in trouble"


SCIB1 incorporates specific epitopes from the proteins gp100 and TRP-2, which were identified from the cloning of T cells from patients who achieved spontaneous recovery from melanoma skin cancers. Both proteins play key roles in the production of melanin in the skin.

iScib+ adds Avidimab plus several more epitopes.

I am certainly hoping that Scancell reaches a valuation multiples of today's.

Advanced unresectable melanoma is a $1.5 billion market on its own.

[bigglesbingham] 07/3/2024 14:18

Why is this up on that result

[supernumerary] 07/3/2024 12:02

This is the 13 minute debriefing afterwards:

Not really worth bothering with - they're saying nothing beyond what's in the release. More analysis, more trials to come...

[supernumerary] 07/3/2024 11:57

Yes, very disappointing - they were certainly expecting better. Just goes to show, as if we needed it, that you can never predict biotech trial outcomes.

[bermudashorts] 07/3/2024 11:53

What a shame.

[3nobody] 07/3/2024 11:23

Big failure in cancer peptide vaccine space.
Ultimovacs main study in Melanoma FAILED.

"With the 18-month minimum follow-up of the patients in the trial, the median PFS
was not reached in either arm, and the Hazard Ratio (HR) between the arms for
PFS was 0.95. Evaluation of secondary endpoints did not show a difference in
overall survival and objective response rate between the arms. UV1 maintained a
positive safety and tolerability profile."

hxxps://newsweb.oslobors.no/message/612796

[marcusl2] 07/3/2024 08:37

I am not into chartists but something to look at while we wait.

[rogerbridge] 06/3/2024 08:02

Well, that’s something to look forward to!

[marcusl2] 06/3/2024 07:46

3:45 PM - 3:55 PM CT024 - A DNA plasmid melanoma cancer vaccine, SCIB1, combined with nivolumab + ipilimumab in patients with advanced unresectable melanoma: Efficacy and safety results from the open-label Phase 2 SCOPE Trial
H. Shaw1, P. Patel2, M. Payne3, S. Kumar4, M. Highley5, K. Prasad6, R. Board6, C. Barlow7, S. Danson8, R. Miller9, G. Goodhew9, F. Master9, L. Durrant9;
1Mount Vernon Cancer Centre, Northwood, United Kingdom, 2Nottingham Hospitals University Trust, Nottingham, United Kingdom, 3Churchill Hospital, Oxford, United Kingdom, 4Velindre Cancer Centre, Cardiff, United Kingdom, 5Derriford Hospital, Plymouth, United Kingdom, 6Royal Preston Hospital, Preston, United Kingdom, 7Musgrove Park Hospital, Taunton, United Kingdom, 8Weston Park Cancer Centre, Sheffield, United Kingdom, 9SCANCELL Ltd, Oxford, United Kingdom

[marcusl2] 06/3/2024 07:23

Apr 7 2024 3:00PM
CTMS01. Cancer Vaccines: Ready for Prime Time?

Clinical trial abstracts are under embargo and will be released at 3:00 PM ET on Friday, April 5.


Bermuda


poster at AACR in San Diego in April. Lindy Durrant is down to present in the 'Cancer Vaccines: Ready for Prime Time?' session and seems that we'll be getting the SCIB1 results.

'CT024 - A DNA plasmid melanoma cancer vaccine, SCIB1, combined with nivolumab + ipilimumab in patients with advanced unresectable melanoma: Efficacy and safety results from the open-label Phase 2 SCOPE Trial'

[nigelpm] 05/3/2024 20:41

Still a game of chicken to some degree.

As cash is used every month good data is continually needed just to hold above water.

I did like ee's analogy though - it's like an insurance policy - and one day it may pay out.

[rogerbridge] 05/3/2024 20:35

Hopefully, we will hear some more news on Thursday.

We should have an update before long.

[octopus100] 05/3/2024 14:24

If this company wants to get the big bucks when they do a deal or get bought out they need to list in the USA.