Scancell Share Discussion Threads

[ruckrover] 06/4/2024 13:46

Inan,

Yes, I am aware that HPV is a virus. The HVP vaccine produced by GSK and Merke has resulted in an 87% reduction in cervical cancer.

So you statement:

“and we are the only company that has a vaccine that has achieved 85% !!”

is factually incorrect. It remains incorrect even with you edit adding the word cancer.

Unfortunately, your failure to correct your statements reduces the credibility of subsequent posts.

[inanaco] 06/4/2024 13:46

That's Ok Ivy ........ 1.5m shares under the cosh

and no subprime debt .........

[ivyspivey] 06/4/2024 13:29

Yep Nigel much better to wait until we get official news and a real experts view of it’s significance rather than place any value on a wannabe expert who insists on posting a lot of waffle just so he can announce on Monday that he was right whatever the outcome of any info put out in an RNS.
Suggest you are better off just waiting for the news rather than speculating based on the self professed utterings of someone really under the cosh

[inanaco] 06/4/2024 12:58

moonparty

Posts: 804

Price: 10.25

Strong Buy

RE: Abstract TextToday 12:12
"The goal is 43 patients enrolled by end of the 1st half 2024, that would mean 19 more in approx 12 weeks. Which seems to be a high number."

When you can show such high response rates, it makes it easier to recruit. I think it was mentioned in one of the presentations that they are not struggling to recruit.

I imagine it's a snowball effect - the more that show response, the more that will be prepared to try the treatment. So, hopefully (for investors and patients) recruitment will be faster as the trial progresses.

--------------------------------------------------------------------------------


its not 43 its 27 Partial Response out of how many it took to a max of 43

scancell can dismiss the Null ...

"""The null hypothesis will be rejected if 27 or more responses are observed in 43 patients."""

example

. For example, the null could be that new drug B is not more effective than old drug A, while the alternative would be that drug B is more effective than drug A.

Google

[nigelpm] 06/4/2024 12:41

I'd definitely expect an RNS monday but not sure I completely follow your logic Inanaco.

[inanaco] 06/4/2024 12:13

whats also interesting ....

From first scan to second scan

""" Patients showed a 40-95% reduction in tumor volume between 13 and 25 weeks."""

[inanaco] 06/4/2024 12:01

think its best to explain what scancell has done .... because the first stage completed was in 15 patients and this is what they are reporting on because it was halted because it achieved over 8 PR thus scancell could declare a positive end point
on the second stage that needs to be 27 so this is why scancell is not getting a head of itself as the success point has not been achieved yet its only when you look at the abstract in full does that become evident ... i should have looked myself before


Session CTMS01 - Cancer Vaccines: Ready for Prime Time?
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
Add to My Itinerary
April 7, 2024, 3:50 PM - 4:00 PM Ballroom 20 AB - Upper Level - Convention Center
Presenter/Authors
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
Disclosures
H. Shaw, None..
P. Patel, None..
M. Payne, None..
S. Kumar, None..
M. Highley, None..
K. Prasad, None..
R. Board, None..
C. Barlow, None..
S. Danson, None..
R. Miller, None..
G. Goodhew, None..
F. Master, None..
L. Durrant, None.
Abstract
Background Targeting melanoma by T cells drives anti-tumor responses. We previously showed that a DNA vaccine, SCIB1, incorporating T cell epitopes from TRP-2/gp100 into an antibody framework to allow Fc targeting of activated dendritic cells, was successfully evaluated as a monotherapy in a phase 1/2 in stage 3/4 melanoma patients. Unresectable melanoma patients showed a 60% ORR and 88% of patients treated with SCIB1 post tumor resection, remained disease free for 5 years [1]. The current SCOPE trial tests the hypothesis that unresectable patients may have an improved response when SCIB1 is combined with checkpoint inhibitors (CPI).
Methods Patients were treated with nivolumab with ipilimumab and SCIB1 (8mg) i.m. using needle-free injection at a fixed dosing schedule for a total of 10 doses over 24 months. The CPI therapy was administered i.v. in accordance with their respective SmPC. ORR as measured by RECIST 1.1 in the overall intention-to-treat population was the primary endpoint. The study is designed using Simon's two stage methodology with 80% power when the true response rate is 70% with an overall type I error of 5%. In the first stage, 15 patients will be enrolled and if there are eight or fewer clinical responses (RECIST 1.1 objective response [CR or PR] within 25 weeks of the first dose of SCIB1), further recruitment will be stopped. The null hypothesis will be rejected if 27 or more responses are observed in 43 patients.
Results 19 patients received the combination of SCIB1 with nivolumab and ipilimumab. At study entry, all patients were stage IV. 13 patients had reached the first imaging timepoint at 13 weeks, and the objective response rate is 85%. 9/9 responses were confirmed in a subsequent scan. Patients showed a 40-95% reduction in tumor volume between 13 and 25 weeks. Most of the SCIB1-related adverse events were Grade 1/2. Only 1 patient reported a Grade 3 rash. No enhancement of immune-mediated adverse events was observed when SCIB1 was added to nivolumab with ipilimumab.
Conclusions SCIB1 in combination with nivolumab and ipilimumab as first line treatment for unresectable melanoma improved the ORR to 85% without an increase in clinically meaningful adverse events. These results if confirmed in a larger patient cohort provide confidence in initiating a randomized registration program in unresectable melanoma patients with the novel DNA plasmid technology

[inanaco] 06/4/2024 11:33

this is an important bit .............. and it applies to Moditope as well

To prevent recurrence of melanoma it would be ideal to
stimulate memory responses. In animal models, SCIB1 stimulated memory T cell responses that continued to increase in avidity as the T cells were selectively recruited into memory.19
Similarly, in this current study, patients have shown stronger
and broader responses following extended treatment with
SCIB1. All patients on continuation responded to all four epitopes after five continuation doses at 21 months or after 10
immunizations; this suggests that vaccination for the
prevention of recurrence should continue for at least 2 years
post-surgery and that maintenance vaccination should be considered as it appears to improve the strength and breadth of the
T cell response to vaccine-encoded epitopes. The former maybe
related to memory but this is difficult to assess as we did not
phenotype these responses. The latter may indicate de novo
stimulation of new populations of T cells.


"""SCIB1 stimulated memory T cell responses that continued to increase in avidity as the T cells were selectively recruited into memory.19""

[inanaco] 06/4/2024 11:21

SCIB1
Time to build a response


Thirty-three patients were evaluated by proliferation and the
results are summarized in Fig. 3, Tables 2 and 3. Seven of 13
tumor-bearing patients and all 20 tumor-free patients made a
detectable proliferation response. A typical proliferation response
from a patient to all four epitopes is shown in Fig. 3, A-D. Only 1/3
tumor-bearing patients receiving 0.4 mg generated a proliferation
response, and that was only to a single peptide; 3/3 patients receiving 2 mg/4 mg doses, 12/17 patients receiving 4 mg doses and 6/10
patients receiving 8 mg doses responded to at least two peptides.
Proliferation responses to any peptide were observed after three or
more doses, but they continued to increase with continued administration of SCIB1. Two of the six fully-resected patients receiving
the 4 mg dose, who continued therapy and eventually received at
least 10 doses of SCIB1, responded with proliferative responses to
three epitopes following the initial five doses; however, five of six
had proliferation responses to three or more epitopes following 10
SCIB1 administrations (Fig. 3, E). Overall, six patients did not
respond, six patients responded to a single epitope, six patients
responded to two, five patients responded to three and 10 patients
responded to all four epitopes.
Patients showed similar responses in both assays used for
immune monitoring with 27/33 (82%) evaluable patients responding in the proliferation assay, 23/26 (89%) in the Elispot assay, 21/
26 (81%) in both assays and 29/33 (88%) in either assay. 67% (22/
33) of patients responded to all four epitopes, 85% to TRP2, 76% to
gp100A2, 76% to gp100DR4 and 67% to gp100DR7/DR53/DQ6
long peptide (shown in graphs as gp100DR7; Tables 2, 3). 100% of
patients without detectable tumor responded in either assay with
80% responding to all four epitopes. In contrast, only 69% of
patients with tumor present responded in either assay, with 46%
responding to all four epitopes.


""immune monitoring with 27/33 (82%) evaluable patients responding in the proliferation assay, 23/26 (89%) in the Elispot assay,""

[inanaco] 06/4/2024 11:03

Thanks GF123

Desouza

and I have just done exactly that based on a week 25 cut off

a PR response requires a min reduction of 30% based on the evidence i have just presented the best point using the same checkpoints as scancell trial achieved 44% against scancells 85 %

this might increase over time to 55% using the checkpoints alone ... but scancell has not been in trial long enough to compare over 1 or 2 years from SCIB1 earlier trial data the max point of T cell potency was achieved at 10 doses this is when nearly every patient responded to the vaccine so it may still be possible to arrest those progressing and increase the 85% further but the most important thing is no new lesions as that means we are clearing circulating cancer cells

Desouza

Posts: 7

Price: 10.25

Strong Buy

RE: Abstract TextToday 10:51
Here in the forum it was once mentioned that the ORR without SCIB1 is about 50% (I don't remember who wrote this but it is assumed to be correct here).

Please correct me if this is wrong.

My question now is whether anyone knows what the reduction in tumour volume looks like without SCIB1.

Just to be able to make a comparison from this side. If this is possible at all.

[inanaco] 06/4/2024 10:08

I hope that puts scancells "CONFIRMED" data into prospective

[inanaco] 06/4/2024 10:06

Week 25 Entire study period
Nivolumab followed by ipilimumab (n=68) Ipilimumab followed by nivolumab (n=70) Nivolumab followed by ipilimumab (n=68) Ipilimumab followed by nivolumab (n=70)
Best overall response
Complete response ·· ·· 8/68 (12%) 4/70 (6%)
Partial response ·· ·· 30/68 (44%) 18/70 (26%)
Stable disease ·· ·· 2/68 (3%) 6/70 (9%)
Progressive disease ·· ·· 15/68 (22%) 20/70 (29%)
Unable to determine ·· ·· 13/68 (19%) 22/70 (31%)
Overall response, n/N (%; 95% CI) 28/68 14/70 (41%; 29·4-53·8)* (20%; 11·4-31·3)* 38/68 (56%; 43·3-67·0) 22/70 (31%; 20·9-43·6)
Median duration of overall response, months (IQR) ·· ·· NR (8·4-19·3) NR (7·5-17·

PR best they got was 44% at week 25

[inanaco] 06/4/2024 10:04

this is highly valuable .... data at 25 weeks

they are experimenting on how to give the checkpoint in both cases Progression was observed

as yet we have NONE and we blow the socks of the data they have achieved on efficacy at week 25

To assess the proportion of patients who achieved a response, RECIST v1.1 response criteria were modified in this study to disregard the week 13 assessment, which only reflects the activity of the first agent in the treatment sequence, at all post-week 13 assessment timepoints. Therefore, confirmed response at week 25 was defined as the number of patients with a complete or partial response at week 25, irrespective of the tumour assessment at week 13, with confirmatory imaging at week 33. The proportion of patients who achieved a response and best overall response during the overall study were assessed with additional follow-up during the continuation period, also disregarding the week 13 assessment. Progressive disease was defined at week 13 with RECIST v1.1 criteria, and at week 25 with modified RECIST v1.1 criteria (data at week 25 were compared with baseline data, discounting data from the week 13 scan).

Findings
Between April 30, 2013, and July 21, 2014, 140 patients were enrolled and randomly assigned to nivolumab followed by ipilimumab (n=70) or to the reverse sequence of ipilimumab followed by nivolumab (n=70), of whom 68 and 70 patients, respectively, received at least one dose of study drug and were included in the analyses. The frequencies of treatment-related grade 3–5 adverse events up to week 25 were similar in the nivolumab followed by ipilimumab group (34 [50%; 95% CI 37·6–62·4] of 68 patients) and in the ipilimumab followed by nivolumab group (30 [43%; 31·1–55·3] of 70 patients). The most common treatment-related grade 3–4 adverse events during the whole study period were colitis (ten [15%]) in the nivolumab followed by ipilimumab group vs 14 [20%] in the reverse sequence group), increased lipase (ten [15%] vs 12 [17%]), and diarrhoea (eight [12%] vs five [7%]). No treatment-related deaths occurred. The proportion of patients with a response at week 25 was higher with nivolumab followed by ipilimumab than with the reverse sequence (28 [41%; 95% CI 29·4–53·8] vs 14 [20%; 11·4–31·3]). Progression was reported in 26 (38%; 95% CI 26·7–50·8) patients in the nivolumab followed by ipilimumab group and 43 (61%; 49·0–72·8) patients in the reverse sequence group at week 13 and in 26 (38%; 26·7–50·8) and 42 (60%; 47·6–71·5) patients at week 25, respectively. After a median follow-up of 19·8 months (IQR 12·8–25·7), median overall survival was not reached in the nivolumab followed by ipilimumab group (95% CI 23·7–not reached), whereas over a median follow-up of 14·7 months (IQR 5·6–23·9) in the ipilimumab followed by nivolumab group, median overall survival was 16·9 months (95% CI 9·2–26·5; HR 0·48 [95% CI 0·29–0·80]). A higher proportion of patients in the nivolumab followed by ipilimumab group achieved 12-month overall survival than in the ipilimumab followed by nivolumab group (76%; 95% CI 64–85 vs 54%; 42–65).

[inanaco] 06/4/2024 09:36

again its very important that NO new confirmed lesions present

because this opens us to expand the trial into adjuvant melanoma taking away Moderna rose coloured spectacles

and probably doubling the market potential

[inanaco] 06/4/2024 09:32

I think i have found the difference


so in January ....... 9 confirmed partial responses at 19+ weeks

v

13 patients had reached the first imaging timepoint at 13 weeks, and the objective response rate is 85%. 9/9 responses were confirmed in a subsequent scan.

so this second scan is at 25 weeks

so scancell has followed those 9 patients to get confirmation of efficacy at 25 weeks

[inanaco] 06/4/2024 09:00

Ruck

HPV is a virus ........... only later in the infection does it induce cancer

again your not doing the research

Human papillomavirus (HPV) is the name of a very common group of viruses.

[inanaco] 06/4/2024 08:58

I did ... that's because i never expected somebody that's been in the share as long as you to not follow what the subject matter was and indeed by adding in a prophylactic virus vaccine as a comparison, why would anyone do that apart from to disrupt the discussion or make them selves appear intellectual by talking dressed up nonsense

which is it ?

[ruckrover] 06/4/2024 08:34

I notice you edited your original post and added "cancer" before vaccine.

[ruckrover] 06/4/2024 08:32

Inan,So are you going to qualify this statement to make it correct?"and we are the only company that has a cancer vaccine that has achieved 85% !!"Another example is the HPV vaccine that is 87% effective. (Produced by Merke and GSK) In what context is Scancell the "only company"

[inanaco] 06/4/2024 08:27

they did work but what your measuring is not direct efficacy but a difference between two groups to extrapolate efficacy

scancell is comparing two groups by trying to exceed 55% efficacy with a target at 70% against the checkpoints without a vaccine

buts its doing it with direct measurement which you cannot do for a prophylactic vaccine unless you run challenge studies

[rogerbridge] 06/4/2024 08:10

Basically, they did not work as stated.

[inanaco] 06/4/2024 07:18

was it ? do you want to correct that ? how many caught covid after the vaccine and boosters and did it work in infected patients ?

[ruckrover] 05/4/2024 23:28

Inan,"and we are the only company that has a vaccine that has achieved 85% !!"Do you need to qualify that statement. Moderna's Covid vaccine was 94%

[inanaco] 05/4/2024 22:25

i don't get excited, if anything, happy for a low SP, after all i am constantly buying in ...get more shares in ISA next week if the share price stays low ...

however on the off chance that some sort of realistic value was achieved shortly ... i am well stocked

moditope is still a GO .... with a phase2/3 in the pipeline for 2025

and we are the only company that has a cancer vaccine that has achieved 85% !!

[nigelpm] 05/4/2024 22:18

Bizarrely though with all the great news that has come before somehow we are languishing at 10p - risk:reward really does favour the brave here.