Member Info for JohnnyB1

Scancell are due to give their presentation at the AACR Annual Meeting between 1.30 and 5.00 pm U.S ET on Tuesday 18 April’23.

It has been established that Modi-1 patients receive their first, second and third scans at weeks 8, 16 and 24 respectively.

On Tuesday 21 February’23 Scancell gave an RNS update on the ModiFY trial advising that 23 patients had been vaccinated to date and went on to say “So far, initial clinical responses have been assessed in 14 patients reaching the first imaging evaluation timepoint at week 8. Of these patients, one has had a confirmed partial response and seven patients have stable disease, despite having progressive disease prior to enrolment in the study.”

Note this RNS was issued exactly 8 weeks TO THE DAY before Lindy gives her presentation. This was AIMHO no coincidence and was planned in order to compare maximum data at the presentation.

The 14 previously assessed patients will all have had their second (16 week scan) by 18 April’23. The other 9 (of the 23) patients will all have had their first (8 week scan) by this same date.

Lindy should have a lot of data to present on these 23 patients:-
2 with head and neck squamous cell carcinoma (SCCHN).
One with renal cell carcinoma (RCC).
2 with triple negative breast cancer (TNBC).
18 with high grade serous ovarian carcinoma (HGSOC).

I hope that Scancell do not need to raise funds.

The interim results issued 25 January’23 (under “Outlook” at the bottom of page 5 thereof) state:-

“In addition, the Board continues to evaluate further potential deals to develop the business, generate revenue and provide further third-party validation of our platforms.”

If Scancell are to “evaluate further potential deals” there must be potential deals on the table (i.e. they can only evaluate something that actually exists and cannot evaluate thin air).

This would explain the lack of a Proactive interview and the radio silence. Maybe Lindy is also understandably scared of accidentally giving something away in an interview. I have only held shares 2 years but I know for example that modi-1 was kept secret for a year.

Sorry Ratcliffewriter, I think we are saying the same thing. I did not see your post until after I posted mine.

I believe I understand what Chester18 is saying and it does make sense.

Scancell’s abstract is embargoed at present. The earliest embargoed abstracts can be posted to the AACR Online Itinerary Planner and the Meeting App is 12:00 p.m. U.S. ET on Friday, April 14, 2023.

Scancell are due to give their presentation between 1.30 and 5.00 pm U.S ET on Tuesday 18 April’23. If we have not heard details of the abstract by that time it would follow that Scancell have been selected to feature in the official AACR press program. AIMHO

I understand we are 4 hours ahead of U.S. ET so the presentation will be between 5.30 and 9.00 pm Greenwich mean time on Tuesday 18 April’23.

It would certainly be great publicity if Scancell were selected to feature in the official AACR press program:-

https://www.aacr.org/meeting/aacr-annual-meeting-2023/spotlight-on-clinical-trials/

“EMBARGO POLICY AND ONLINE PUBLICATION OF ABSTRACTS”

“The full text of the Clinical Trial and Late-Breaking Abstracts will be posted to the AACR Online Itinerary Planner and the Meeting App no earlier than 12:00 p.m. U.S. ET on Friday, April 14, 2023, except those abstracts that are selected for inclusion in the official AACR press program. Abstracts that are featured in the official AACR press program will be made publicly available at the date and time of presentation, either at the meeting or an official AACR press conference.”

Lindy, forget the limo, this time it may be a job for Parker and the pink Rolls-Royce :-)

Getting COVID-19 could weaken your immune system:-

https://time.com/6265510/covid-19-weaken-immune-system/

“We hope that with this study, people will look at some of the more recent vaccine formulations, not just mRNA,” he says, to gain more knowledge about which formulation might produce the strongest T cell response. As more and more people get infected, “the best impact of this would be to stimulate further investigations to see if we can boost those CD8 T cells.”

Hi Givemesunshine,

Thank you for coming back on that. I was working on basis of:-

Third scan Day 173 = 24 weeks 5 days
Second scan Day 111 = 15 weeks 6 days

I agree the date of the first scan is unclear. I was working on the assumption that the RNS on Day 76 was more about the first patient in the expansion phase of the monotherapy arms being dosed. Yes, it also says the first patient to be assessed has shown a partial tumour response at first radiological reassessment but it does not say when that scan took place.

This coupled with the fact that the RNS 21 February’23 refers to week 8, it states “So far, initial clinical responses have been assessed in 14 patients reaching the first imaging evaluation timepoint at week 8.”

I guess things will be clearer as the trial progresses and we get more information.

ATB

Hi Givemesunshine,

I totally agree with you that the first Scan is at 8 weeks and third scan is at 24 weeks. However, having looked at what we know about the Modi 1 timeline (From RNS and Macmillan) I still interpret that the second scan is at week 16 not week 12:-

DAY 1: 16 August’22 RNS First patient dosed in cohort 2

DAY 76: 31 October’22 RNS first patient in the expansion phase of the monotherapy arms in the multicentre Phase 1 Modi-1 clinical trial (ModiFY) has been enrolled and dosed. All 3 patients in cohort 2 have successfully received 2 doses. The first patient to be assessed has shown a partial tumour response at first radiological reassessment.
(We know that this first scan was week 8)

DAY 78: 2 November’22 Patient X (First patient cohort 2) had received 3 doses to date. Reported a 30-40% reduction in Tumour size.

DAY 92: 16 November’22 Patient X had their 4th dose. Reported hearing completely restored.

DAY 111: 5 December’22 Patient X had their 2nd scan. Reported a further 15% reduction in her tumour, now 55% smaller than it was before the treatment started.
(This is their week 16)

DAY 173: 5 February’23 Patient X had their 3rd Scan. Tumour is stable perhaps slightly better.
(This is their week 24)

DAY 175: 7 February’23 Patient X had their 5th dose.

BioNTech have done an antibody deal with OncoC4 with $200 million up front payment. The antibody ONC-392 appears to already be in a Phase 1A/1B trial

https://www.biospace.com/article/biontech-returns-to-oncology-origins-with-oncoc4-partnership/

Let’s hope Scancell are next in the queue.

The percentage reduction is unclear and ambiguous. Clearly there are different ways to measure tumour size.

If you look at the axis on the waterfall chart on page 11 of the 2022 AGM Presentation you will see that Scancell measured the mouse tumours three dimensionally by their volume in mm cubed:-

https://www.scancell.co.uk/Data/Sites/1/media/docspres/agm-presentationnovember-2022_final.pdf

Whereas Patient X appears to have been measured on a one dimensional basis. On 5 December 2022 Patient X was advised that their tumour had reduced by 55%. As Bermuda pointed out a reduction from 4cm to 1.8cm is a 55% reduction (on a one dimensional basis).

Hi Givemesunshine,
I stand to be corrected but my understanding is that the second scan is at week 16. By my calculations the 14 patients will all have their second (16 week scan) by 18 April’23. The other 9 (of the 23) patients will all have their first (8 week scan) by this same date. If Scancell give us an update at this time it should be a lot more informative.

I was looking at the presenters/Authors for the Modi-1 presentation:-

https://www.abstractsonline.com/pp8/#!/10828/presentation/10452

Apart from Lindy, Scancell employees, Robert Miller and Christian Ottensmeier we also have significant others:-

Rebecca Herbertson:-

https://sussex-cancer-centre.org.uk/index.php/dr-rebecca-herbertson/

“My strong interest in clinical trials has led to my role as a researcher on the Clinical and Investigation Unit (CIRU) at the Royal Sussex County. I currently attend the National Cancer Research Network Ovarian Cancer Sub-Group meetings, and have published in a number of medical journals. I am local Principal investigator for many national trials.”

Dr David Pinato, Principal Investigator at Imperial College:-

In the RNS 21 February’23 he commented: “Advanced ovarian cancer is an aggressive cancer which is hard to treat. The early efficacy data showing that the Modi-1 vaccine is stabilising this advanced disease is very encouraging”.

Anne Armstrong:-

https://www.christie.nhs.uk/internal-lists/consultant-list/armstrong-anne

“Principal Investigator for a broad portfolio of phase I-III studies within the breast disease group (lead for investigational agents for triple-negative trials) Qualitative studies into fertility concerns after a diagnosis of breast cancer.”

Stefan Symeonides:-

https://www.ed.ac.uk/profile/stefan-symeonides

“In the clinic, he leads the Phase I Trials Unit and also has a specialty focus on renal cancers within the Uro-oncology team. He leads a growing portfolio of early phase trials and also continues in drug development, working with CRUK’s Centre for Drug Development and in an advisory role for a number of UK Biotechs.”

I have looked again at wording of the RNS dated 21 February’23. This states:-

“Modi-1 cancer vaccine showed partial response and stable disease in patients with hard-to-treat head and neck, high grade serous ovarian or triple negative breast cancers.”

Note that there is no mention of patients with renal cell carcinoma in this sentence.

The RNS goes on to state:-

“So far, initial clinical responses have been assessed in 14 patients reaching the first imaging evaluation timepoint at week 8. Of these patients, one has had a confirmed partial response and seven patients have stable disease, despite having progressive disease prior to enrolment in the study.”

To date, 23 patients have been vaccinated:-

2 with head and neck squamous cell carcinoma (SCCHN). We know one has had a partial response.

One with renal cell carcinoma (RCC). The sentence I highlighted above makes no reference to RCC. So either this patient is not one of the 14 who have had their first 8 week scan OR this patient did not have stable disease at their scan.

2 with triple negative breast cancer (TNBC). The above sentence tells us that at least one of these patients has stable disease.

18 with high grade serous ovarian carcinoma (HGSOC). The maths tells me that at least 9 of these or at most 12 of these have had their 8 week scan. At least 3 or at most 6 of these have stable disease.

So things appear to be going pretty well (AIMHO).

The 14 patients will all have their second (16 week scan) by 18 April’23. The other 9 (of the 23) patients will all have their first (8 week scan) by this same date. If Scancell give us an update at this time it should be a lot more informative.

Thank you Wildforce and BOJO2020.

I have looked at slide 12 (3 patients in cohort 1, 3 in cohort 2 and 64 (4x16) in the mono therapy expansion cohorts = a total of 70 patients having monotherapy) but it does not give a definition of what exactly the Monotherapy Dose Finding Arm is.

I will have a think about emailing Scancell.

I am confused by some of the wording in Monday’s RNS, it states (Capital letters are mine for emphasis):-

“Scancell Holdings plc ……………………….. today announces completion of the MONOTHERAPY DOSE FINDING ARM of the multicentre Phase 1/2 ModiFY clinical trial.”

“So far, initial clinical responses have been assessed in 14 patients reaching the first imaging evaluation timepoint at week 8. Of these patients, one has had a confirmed partial response and seven patients have stable disease, despite having progressive disease prior to enrolment in the study. As no dose limiting toxicities were observed in the monotherapy dose escalation cohorts, patients continue to be enrolled into both the ongoing monotherapy expansion cohorts and the CPI combination dose escalation cohorts during H1 2023. “

The 14 patients evaluated consist of 3 from cohort 1, 3 from cohort 2 and 8 from the monotherapy expansion cohort. The wording “Scancell……………….today announces completion of the MONOTHERAPY DOSE FINDING ARM” implies to me that Scancell were experimenting with dosing levels in the 8 in the monotherapy expansion cohort and that the best level of dosing has now been determinined. AIMO

However, the RNS appears to contradict itself, it also states:-

“Based on the safety data from Cohort 2, the ModiFY trial was expanded AT THIS RECOMMENDED PHASE 2 DOSE for Modi-1 monotherapy in all four tumour types.”

I was in two minds whether to even mention this; I realise that there is only an incredibly slim chance that this article is about Covidity.

There follows a link to an article on Fierce Biotech’s website.

Ignore the main article itself and scroll down to the bottom of this where you will find a heading “Related Articles”. The first item on the left is a link to another article:-

“Addressing the next wave of COVID-19 through a new approach to vaccines”

Interestingly this article is dated tomorrow February 20, 2023 08:00 am. I have never seen this done before, it may be price sensitive as it cannot be accessed until the markets open tomorrow morning:-

https://www.fiercebiotech.com/medtech/bd-issues-cybersecurity-alert-hacking-risk-found-alaris-infusion-pump-software

Thank you emptyend. I must admit, after I made my post late last night and slept on it, I was having similar thoughts. Looking at GSK's website they certainly seem a good fit, it states "Over half of the vaccines and medicines in our pipeline address infectious disease".

As we are all aware, Scancell’s RNS 13 February’23 states “the Company will now seek a partner to progress the COVIDITY vaccine programme”.

That very same day Vir Biotechnology made a Press Release mentioning “other partners”:-

“SAN FRANCISCO, Feb. 13, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the research collaboration agreement established with GSK in 2020 has been amended to reflect that Vir will continue its ongoing efforts to discover, develop and advance next-generation solutions for COVID-19 and other potential coronavirus outbreaks, independently or with other partners.”

https://investors.vir.bio/news-releases/news-release-details/vir-biotechnology-announces-amended-collaboration-agreement-gsk

It may not be anything but interesting all the same. For information purposes Vir Biotechnology has a market cap of $3.426 Billion.

The interim financial results advised that the Head and Neck patient in Cohort 2 has now shown a confirmed partial response with further regression of their tumour at Week 16. (Note: On Macmillan, 5 December’22 this patient said “I have a 12 week gap before the next vaccine and scan now but for today I am floating on air”). This patient’s next vaccine and scan should therefore be due on or around 27 February’23.

It will be interesting to get an update on this patient’s progress and that of the 2 Ovarian patients (one in Cohort 1 and one in Cohort 2) that had stable disease.

On 31 October’22 the first patient in the expansion phase of the Monotherapy Arms was dosed. This first patient’s Week 16 commenced yesterday and finishes 20 February’23. Again it will be interesting to get an update here.

I suspect that we may get an update after a number of patients in the expansion phase of the Monotherapy Arms have had their Week 16 scan.

I see that the SCIB1 (The SCOPE Study) on the clinical trials website has been updated today-

https://clinicaltrials.gov/ct2/show/NCT04079166#contacts

University Hospital Plymouth NHS Trust has been added to the list of “locations” but is “not yet recruiting”.