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This will get wider media coverage, as the day progresses, bringing in new buyers.

Fabulous news and still a hold for me, for much bigger gains!

Proactive Investors coverage first thing..

Scancell Holdings' 'impressive' melanoma data surpasses expectations

Published: 02:26 19 Sep 2023

Scancell Holdings PLC -

Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF) said the results from the initial stage of its phase II SCOPE trial in advanced melanoma surpassed expectations.

The study investigated the efficacy of Scancell's SCIB1 in combination with checkpoint inhibitors (CPIs).

Preliminary data from 11 patients indicate an 82% objective response rate (ORR), surpassing the trial's target of a 70% ORR.

"These results, if confirmed in a larger cohort, will be a significant improvement on what patients can expect from available treatment today. We look forward to continuing the second stage of the study and reporting further data in due course," said professor Poulam Patel, chief investigator.

Researchers aimed to enhance the ORR in patients suffering from unresectable metastatic melanoma through the combined use of SCIB1 and CPIs.

The vaccine is believed to either initiate new immune responses or amplify existing ones, which are then safeguarded within the tumour environment by the CPIs.

In this evaluation, patients were administered SCIB1 through a needle-free device, along with the currently most effective CPIs, nivolumab and ipilimumab.

The first milestone of the trial was to achieve positive responses in over eight out of 15 patients, thereby suggesting that SCIB1, when combined with doublet CPI therapy, could significantly improve patient outcomes.

Out of 16 stage IV metastatic patients who have received this combination, 11 have been evaluated at 13 weeks through radiological imaging. Nine of these have shown an objective response, equating to an 82% ORR without any increase in toxicity levels. The reduction in tumour volume ranged from 31% to 94%.

These results are particularly noteworthy when compared to a 50% ORR in patients receiving only the doublet CPI therapy, with a progression-free survival time of 11.5 months.

"We are excited by these highly impressive results for SCIB1 combined with the doublet CPI therapy," said Scancell's chief executive, professor Lindy Durrant.

"We thought results from the phase I/II trial evaluating SCIB1 as a monotherapy were positive but results from this combination are even more meaningful.

"Previous studies indicated that a response rate of 50% was the best that could be achieved in the real-world setting for patients with unresectable metastatic melanoma, as no other combination had improved on the response rates for doublet CPI alone.

"Confirmation of this data in a larger cohort could make a significant impact on melanoma patient survival, especially as melanoma is now one of the most common cancers in young women."

Last couple of paragraphs...

Four patients are still ongoing in this cohort. The number of patients who have experienced long periods of stable disease following monotherapy with Modi-1 is encouraging in this difficult to treat cancer and the Company believes that combination therapy with checkpoint inhibitors, which are not currently approved for the treatment of ovarian cancer, could further improve outcomes for this patient group.

Evaluation of Modi-1 plus checkpoint inhibitors in other tumour types in the ongoing Phase 1/2 study, will provide supporting data for this proposed combination use.

MarketScreener posted this on 14th Sept..

Update on Its Two Ongoing Phase 1/2 Clinical Trials with Lead Cancer Vaccine Assets SCIB1/iSCIB-1+ and Modi-1

September 14, 2023 at 02:00 am EDT

Scancell Holdings plc provided an update on its two ongoing Phase 1/2 clinical trials with lead cancer vaccine assets SCIB1/iSCIB-1+ and Modi-1. Encouraging data from these open label studies provides validation for the Company's decision to concentrate its strategic focus and resources on these two assets. SCIB1/iSCIB1+: The open-label, Phase 2 single arm SCOPE trial is investigating the safety and tolerability of using SCIB1/iSCIB1+, the company's lead ImmunoBody® cancer vaccine, in combination with checkpoint inhibitors in patients with advanced melanoma. The current trial is designed to determine whether any clinical effect is unlikely to be due to checkpoints alone based on the rate of clinical responses in each cohort, that is, with either a single or double checkpoint combination.

The trial is progressing well, with 73% of the required number of patients receiving SCIB1 in combination with two checkpoint inhibitors (ipilimumab and nivolumab) recruited to date. The company expects the initial topline data readout from this double checkpoint arm of the study in fourth quarter 2023. Following the data readout, Scancell intends to initiate a similar double checkpoint cohort with iSCIB1+ before the end of the year.

iSCIB1+ has a number of competitive advantages, with potentially increased potency due to modifications to the product using Scancell's propriety AvidiMab ® platform, and an extended patent life to 2039. iSCIB1+ is able to be used by a broader patient population because it incorporates more melanoma-specific epitopes. If positive, data generated by iSCIB1+ could lead to the initiation of a potential, rapid clinical development programme in second half 2024.

An adapted registration trial could yield Phase 2 data within 2 years and would provide the company with a pathway to a potential deal. The Phase 3 data could be complete within the following 3 years. Modi-1: Modi-1 is the first vaccine based on Scancell's Moditope® platform.

Recruitment is progressing well in the ModiFY open-label Phase 2a dose expansion study investigating the safety, tolerability and preliminary efficacy of Modi-1 as a monotherapy and in combination with checkpoint inhibitors in patients with ovarian, triple negative breast, renal and head and neck cancers. The cohort of 16 ovarian cancer patients receiving Modi-1 has now been fully recruited. All patients had failed on previous treatments and their disease was actively progressing when they entered the study.

Following treatment with Modi-1 44% of patients achieved stable disease for at least 8 weeks, with some patients experiencing a longer duration of disease stability for 4 months or more. Four patients are still ongoing in this cohort. The number of patients who have experienced long periods of s

Hopefully its Moulding who has bought the 2m shares at 72.1p

this is the funds punishing moulding for being too ****y. results just slightly worse than forecast eg debt. however not worthy of 20% plus fall. plain daft. no wonder no company wants to ipo in london.

Opened just 3.5% down, then went into auction within minutes. Then around 1300, with 2m buys at 72.1p went into auction again. Suspect it will also go before close as market makers sort out their stocks.

RNS tone sounds promising. Revised price of 67p on the table. Buyer has till 5pm Friday to firm up offer, walk away or extend time for more negotiations.

237,851 shares just bought at 8.4p. Someone still believes in Scancell despite the sillyness of the last 24 hours

Well there's 6 different market makers wanting to buy your shares at 7.5p. Obviously they believe that Scancell shares are cheap or have larger buyers orders to fill.

I'm holding

Times on line report that Viking Global have taken out a large short on LLOY = 0.61%.

I've already got plenty of LLOY shares, but this has tempted me to buy more!

Strange price action at RFX the last couple of days. Normally market makers move RFX price up and down on virtually no volume, but recently it has flatlined at 225ask/220bid (although real share prices are actually 222p/220p)

Clearly there is an overhang to be cleared, but normally market maker would push the bid down harder after just a few more sales, especially when the UK FTSE 100/250 index has been down every session for the 6 days..

Weird. But a good buying opportunity for those who believe RFX as a pawnbroker is a likely beneficiary from economy slowing down further or going into recession..

Good news! Cannacord announce they have reduced holding from 9.6% to 4.9%. A strange move as this share looks solid, even if UK goes into recession later this year; but at least big chunky seller is out and hopefully RNWH can climb back towards 800p+

At 35.5p/share business is worth £8m. Even if they have no cash left, surely a business with £20m plus revenue and a brand of sorts, has got to be worth more than this?

Results are due "Mid August", whenever that is?

So Qube's current declared holding of a 0.79% short position = 10.27m shares to buy back.

That's going to be a struggle if daily volumes don't pick up...LOL

Low volume of trades, hence big spread?

Qube (the biggest declared shorter) finally joining the rest of the pack and reducing their short position. Down 0.10% to 0.79% on 2 August

Good update and happy to add more on the opening.

Can't understand why some are selling after this update? Clearly share price is going to rise further, particularly when Simon Thompson at Investors Chronicle covers it.

Tree shake first thing to unsettle weaker hands? Perhaps a few broker upgrades later today to encourage buying over next few days to drive price above 500p

Okay so SCLP price is in the doldrums. I put it down to several reasons:

- Lack of enthusiasm for UK shares generally at the moment. Worries about future BofE base rates. inflation, recession.

- Withdrawal of funds by PIs to either put into high interest bank accounts. high dividend paying larger company shares

- A large seller of big blocks recently. We saw this the last 2 days with relentless selling into any decent buys.

Why are they selling? Who knows, probably just need funds for PIs taking money out of stock market.

- Summer season, when trades in AIM stocks are always low volume and the market makers drop the bid hard and open up the spread prices.

There's loads of AIM stocks in this situation where prices have been dropped 30% recently, despite contract wins and good news updates.

Blaming Lindy or the BOD for the share price failings is not good, Particularly if new investors wanting to buy into SCLP read this bb. We all know the huge personal effort she has put in to getting SCLP science to where it is today.

So please all chill and accept the share price is a snap shot in time of the value of the business. We all know it worth considerably more than today's price.

Relax, go for a walk, have a pint or two. Life's too short to get into arguments about short term share price movements.

Rich

Closing price 10.5p, up 0.125p (1.2%) on just shy of 2.5m shares traded.

I note that yesterday's big seller reappeared at the close - 3 large sells at 10.5p (200K, 200k and 266k) presumably into todays' stronger buy action and hence liquidity.

I'd be interested to know who is dumping the big blocks, hopefully get an RNS confirming soon..