We would love to hear your thoughts about our site and services, please take our survey here.
Moonparty,
The AACR abstract submission deadline was around the first week in Jan and so the data in the abstract probably comes from end of Dec at the latest. We have no idea how many patients have now been recruited or indeed whether the SCIB1 study is already fully recruited.
We will have to wait and see whether Lindy includes more recent updated results in her presentation.
TF
The text of late breaking abstracts will be published on the AACR website today at 3pm eastern time which is 8pm UK time. Whilst the text of the abstract will be published, any additional information from a poster or presentation will remain embargoed unti presented.
Violin,
Genmab clearly do like what Scancell has to offer as they have licensed one mAb and are evaluating another. Just to add some context here to explain why Genmab have spent so much on this acquisition:-
1) First and foremost it fits with their strategy. Genmab specialise in antibodies, their entire focus is on developing antibody based products. ProfoundBio also only develop antibodies and have a pipeline stuffed full of clinical and preclinical ADCs so the fit is perfect for Genmab.
2) ProfoundBio's ADCs target proven and/or hot targets. For example, their lead candidate targets FRa which has already been proven and validated as a target by other drugs with FDA approval in ovarian cancer. I can't stress enough what a difference this can make to valuations.
3) They have at least 2 or 3 ADCs in clincal trials. So fully defined products that have successfully been taken all the way through preclinical development, manufacture, trial design, regulatory approval etc. etc. and are now in the clinic. Scancell's mAbs are at a much eariler stage.
4) Their lead product has FDA Fast Track Designation and has produced some stunning early clinical results in ovarian/endometrial cancer patients with advanced metastatic inoperable disease who had failed on several previous lines of other therapies -
'Among 21 response-evaluable patients with ovarian and endometrial cancer, unselected for FRα expression, an initial objective response rate of 38% was observed (1 complete response (CR), 7 partial responses (PR)); an additional 9 patients had stable disease (SD), including 7 with decreasing tumor measurements'
Seems like a sensible acquisition for Genmab and good to see some M&A activity.
Genmab demonstrating that ADCs are still hot through the acquistion of ProfoundBio for $1.8 billion.
https://www.globenewswire.com/news-release/2024/04/03/2856591/0/en/Genmab-to-Broaden-and-Strengthen-Oncology-Portfolio-with-Acquisition-of-ProfoundBio.html
Moniman,
I'd strongly urge you to check with your broker and try to understand exactly how today's news impacts you. My understanding is that shares in almost any company can be held in a SIPP but your provider might have their own restrictions. If you can give them a call tomorrow I'm sure you'd find it helpful.
I think your comments regarding the Company's motives are a bit strong and you might want to reconsider once you've spoken to your broker. The Company has to be able to develop the pipeline and to do that it needs to raise huge amounts of cash - it goes with the territory if you're going to invest in early stage biotech. If it can't raise enough cash on the right terms then there either it won't be able to fund the level of clinical development required and will forever be running underfunded, inadequate clinical trials or shareholders will be subjected to massive dilution.
To add some context here, according to the BIA last year the UK biotech sector raised over £1.8 billion in equity funding but only £551m of that went to listed companies. Moreover,only £114m of the £551m went to AIM listed companies, with the bulk going to main market and NASDAQ listed bios. It was clear from the abandoned reverse takeover of Jounce onto NASDAQ that Redx were looking at options and it may well be that they revisit a NASDAQ IPO when market conditions are more favourable.
By the way, the 84% figure is likely just Redmile and Sofinnova both of whom have a seat on the Board. The fact they have backed the plans to delist means that they obviously have inside information but they wouldn't have been allowed to trade.
Moniman,
They're held in an ISA and that will obviously not be possible once Redx delist. At that time they'll be automatically moved from my ISA account to my share dealing account and I will have to pay full CGT if they come good.
Xviolet,
Sorry have only just seen the question to me in your 9.13 post - yes I will continue to hold. When it comes to AIM stocks I only really invest in the biotech/medtech sector so it's interesting to read your comment regarding other companies delisting. All I can say is that whilst I'm taking a punt on Redx, I certainly wouldn't make the same decision on every stock that I hold/have held.
Yes, no great surprise given the news from C4X last week. IMO two of the best biotechs on AIM, both with proven ability to develop commercially attractive small molecules, both with significant deals in the bag, strong leadership teams and big names at the helm.
AIM is increasingly inefficient when it comes to valuations. Poorly run lifestyle companies with no scientific capabilities and/or failed products which should have folded years ago are being kept afloat for years by retail investors buying into the hype or just looking for the quick trade, whereas credible and truly innovative bios are serioiusly undervalued resulting in massive dilution at each raise.
The decision now for retail investors is obviously whether to sell or hold. Redx has the backing of some top quality life science specialist funds who will all be looking to exit at some stage and of course there's the Redmile CLNs which from memory are due to be redeemed later this year. I guess either a NASDAQ listing or the outright sale of the Company is eventually the likely road of travel for Redx. I will continue to hold as I'm happy to be in for the long haul and try to ride the coattails of those specialist funds but am fully aware of the implications.
Whatever way you look at it, these delistings are a real loss to AIM and biotech retail investors.
Article below is well worth a read. It explains the role of BTK inhibitors for the treatment of B cell cancers in a way that's easy to understand and why intolerance and resistance to treatment as well as side effects meant that more selective inhibitors were required.
The article then goes on to give a history of the development of Pirtobrutinib from its creation in Redx's labs through to acquisiton by Loxo and Lilly and FDA approval. It includes an interview with Nicholas Guisot, who heads up drug discovery at Redx and also Lilly's Jake Van Naarden who acknowledges that the drug was 'exceptionally difficult to deliver chemically'.
Good coverage for Redx highlighting its ability through highly complex chemistry to create best in class small molecules and make a real difference to patients' lives.
'Noncovalent BTK inhibitors like pirtobrutinib offer people with CLL a lifeline when covalent BTK inhibitors no longer work. “I’ve seen many patients that really benefited from that treatment option,” Abdel-Wahab says. What’s more, pirtobrutinib is taken as a pill at home and has few side effects. Before the drug was available, patients whose disease had become resistant to a covalent BTK inhibitor were left with treatments that had to be given as infusions and required an inpatient stay. “So it’s kind of a big deal,” he says'
https://cen.acs.org/pharmaceuticals/drug-development/battle-B-cell-cancers-drugmakers/102/i10
Lofas,
It's a regulatory RNS, management have no choice.
Konar,
The RNS says they were appointed on 3rd October 2023 so I think we have to assume that's the date of their permanent appointment. Interestingly there is no mention of them prior to the December fundraise but every RNS issued since January lists them at the end as joint broker along with Panmure and Stifel. That's how we became aware of their appointment and what triggered the discussion on this bb back in early February - have copied my post from 5th Feb below:-
'Bermudashorts
Posted in: SCLP
Posts: 12,586
Price: 11.625
No Opinion
RE: Directorate change5 Feb 2024 09:13
Ee
Regarding the composition of the Board, it will be interesting to see but Sally's departure has no impact on Audit/Remuneration/Nominations committees so they don't have to replace her and can probably quite comfortably continue as they are. I still think at some stage it would be good to have a CFO on the board.
As for WG Partners, I know they acted as joint bookrunner in last placing, but they're not listed on Scancell's website as joint broker and I understood the appointment of a broker had to be notified. Unless I've missed that announcement, they simply seem to have appeared at the bottom of RNS's as joint broker.'
Yes, has been discussed this here previously, not exactly a surprise - if you check you'll see that WG are down as joint broker on every RNS issued for the last few months. Scancell still need to update their website and while they're at it they could also have a look at updating the Directors' Share Options section and the name of their auditors.
As for why today? I expect they're just tidying up loose ends as they approach the financial year end.
Bob,
I don't need to bother Lindy Durrant. In your 13.59 You've stated that combining CPIs with SCIB1+ will extend the patent life of the CPI by 10 years and that simply isn't the case. I've tried my best to explain why.
For the sake of clarity, any other party wanting to use Scancell's tech to extend the patent life of their mAbs will have to license the Avidimab platform and pay for it - it doesn't come for free as an added bonus with a cancer vaccine that is showing an 85% response rate in combination. It's an important distinction for any newbies looking in.
Bob,
Combining iSCIB1+ with a checkpoint inhibitor has no impact on the patent of the CPI. As you say, the patent life of SCIB1 was extended by enhancing it with Avidimab but that doesn't mean in turn it extends the patent of any mAbs used in combination.
Avidimab is a technology developed by Scancell which involves modifying the Fc region of a monoclonal antibody to increase avidity and promote direct killing ability and has the potential to be applied to any mAb. The mAb would need to be re-engineered with the Avidimab modifications and it's this that extends the patent life.
In short, if developers of checkpoint inhibitors or indeed any other mAbs want to extend the patent life of their product, combining with iSCIB1+ won't do it - they'd have to pay to license Avidimab.
Bob
That's not quite right. iSCIB1+ doesn't extend the patent life of the CPIs.
Chester,
IMO the most important near term news is that recruitment to the SCIB1 clinical trial is complete and top line results for stage 2 of the SCIB1 study are as good as stage 1.
Bojo,
I agree.
Anyone with even the most basic level of research here will know that the whole liquid biopsy field is an emerging market at the cutting edge of science. The eventual size and value of that market depends entirely on the information CTCs are able to provide and whether or not it is clinically useful. The only way to establish that is through development of assays and processes to enable that information to be extracted.
As you know, following a huge amount of intensive r&d work, Angle have created and recently launched an immunofluorescence staining kit and HER2 assay. Remembering that every single breast cancer patient should have HER2 testing it makes absolute commercial sense as part of the launch to present at such a high profile conference. You only have to look at the international press coverage over the last couple of days to appreciate the attention this conference is attracting not least due to some big phase 3 read outs including Merck's Keynote 756 and Roche's IMpassion030 trials.
So we have new products being launched to top experts and big pharma at a conference being closely watched by industry media. Let's give credit where credit it due and welcome this for the positive step that it is.
Hadley,
I think it may have been Keytruda rather than Yervoy. Updated results from Merck's Keynote 756 trial were presented yesterday at the European Breast Cancer Conference in Milan. The trial is investigating Pembrolizumab (Keytruda) in combination with chemo in the neoadjuvant (before surgery) and adjuvant (after surgery) setting in early breast cancer. The study is showing that Keytruda may benefit a much wider group of patients - good news for Merck and other anti PD-1 developers and excellent news for patients.
https://event.eortc.org/ebcc14/2024/03/20/ebcc-14-news-new-data-show-pembrolizumab-improves-breast-cancer-outcomes-regardless-of-age-or-menopausal-status/
Konar,
Agreed, Sally Adams is the most likely candidate although you'd have thought she'd have exercised her 8.5p options rather than 10p. I'm assuming it's been rounded to 10p on the form but refers to the 10.5p options because as far as I know Scancell have never issued any options with an exercise price of 10p to any directors although I guess they could have issued them to other key staff or suppliers/collaborators/partners.
Haven't been able to keep up with the bb recently and I suspect this has already been posted, but I was researching another stock today and came across the Immuno-Oncology Summit taking place in London on 24th and 25th April. This is from the agenda:-
'Clinical Update on the DC Targeting Melanoma Vaccine, SCIB1 and The Modi-1 Vaccine Targeting Citrullination
Lindy Durrant, BSc, PhD, Professor, CEO, Scancell Ltd.
SCIB1 a DC targeting DNA vaccine gives at impressive 85% response rate in combination with ipilimumab and nivolumab in advanced melanoma. Citrullination occurs in stressed tumor cells and makes an excellent target for a universal cancer vaccine. Modi-1 targeting citrullination is currently in phase II clinical trial'
It's interesting that this follows hot on the heels of AACR where Lindy will be presenting SCIB1 results but neither conference featured on the recent RNS. I assume we'll be getting another RNS in due course outlining any conferences Lindy is attending and look forward to seeing whether that also includes ASCO.
https://www.immuno-oncologyeurope.com/cancer-vaccines#