Member Info for WeTookPelham

To quote Wildforce's perfectly put post "...I certainly would not have a long term, significant holding in anything I wasn’t very confident about ? " I could not agree more.

And yet we keep seeing posts by apparent long term (and large) holders where they are riddled with doubt? Also as WF says, it makes no sense.

Violindog, you're a prime example of this, surely it's time you sold up if holding is causing you this much stress? You must be in profit now, no? Genuine point I'm trying to make, not a dig. Is your sanity worth it?

Obviously there risks as with all investments but the company seems to be lining up for something major (one way or another).

But to all of the doubters if you have no conviction, it's simple, just don't hold any shares, there goes your doubts and stresses.*

(*Assuming they were genuine to begin with)

Violindog you should read Inan's response on the other side about what you posted. I have to agree unfortunately, you really do post some very misguided things IMO.

On a similar vein...

https://www.reuters.com/legal/transactional/big-pharma-ma-set-mega-year-patent-expiries-drive-deal-urgency-2026-05-01/

@Marcus134 - Excellent post as ever. What is it from?

Excellent find/research JohnnyB1.

(Apologies if already posted, but interesting timing with yesterdays presentation perhaps?)

https://www.fiercepharma.com/pharma/girding-against-keytruda-cliff-merck-splits-oncology-standalone-business-unit

https://www.reuters.com/business/healthcare-pharmaceuticals/merck-create-separate-cancer-business-offset-keytruda-patent-loss-wsj-reports-2026-02-23/

Apologies if already posted?

https://www.linkedin.com/posts/jack-shuang-hou-75314a2b3_clears-ind-advanced-activity-7421537068834582529-nkBG

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

"🚨🧬 Scancell: FDA #Clears #IND for Phase 3 iSCIB1+ Trial (#Cancer #Vaccine #Trial) in #Advanced #Melanoma (PFS Surrogate Endpoint)

A meaningful regulatory milestone for active cancer immunotherapy: Scancell Holdings plc announced U.S. FDA clearance of its IND to launch a registrational global Phase 3 trial of iSCIB1+ Immunobody® in advanced melanoma, with progression-free survival (PFS) agreed as the surrogate endpoint.

This unlocks the pathway for a Phase 3 start in 2026.

Here’s why this stands out 👇

🧩 1️⃣ FDA-cleared registrational pathway = execution phase begins

IND clearance is more than “permission to study”—it’s the green light toward a pivotal-grade program design and a clearer regulatory roadmap.

📈 2️⃣ Phase 2 SCOPE signals a strong PFS lift vs real-world / historical benchmarks

In the 140-patient Phase 2 SCOPE trial, iSCIB1+ was evaluated with nivolumab + ipilimumab in previously untreated unresectable stage IIIB/IV melanoma.

Scancell highlights an interim ~24%-point PFS improvement versus real-world SoC and historic controls.

🎯 3️⃣ Smart trial design: responder enrichment + broad patient reach

Scancell reports identifying a selection marker to enrich Phase 3 for likely responders.

They’re advancing needle-free intramuscular iSCIB1+ in patients with selected HLA alleles, covering ~80% of melanoma patients — a practical way to scale impact without narrowing too hard.

🔥 4️⃣ Performance appears resilient across “tough” subgroups

Scancell notes the favorable PFS trend remains consistent across key subgroups including:

✅ PD-L1 low

✅ BRAF wildtype

✅ prior checkpoint inhibitor exposure

— populations typically associated with more challenging outcomes.

👤 @Dr Phil L’Huillier — CEO, Scancell Holdings plc emphasized that FDA clearance supports the program’s clinical benefit + safety, and the company is exploring financing options including partnering discussions for Phase 3.

💡 My takeaway

Melanoma is already one of the most immunotherapy-responsive cancers—but the bar is getting higher. The next wave isn’t just “another IO combo”… it’s precision immune activation with durability, ideally with a clean safety profile and scalable manufacturing.

If iSCIB1+ can reproduce Phase 2 durability signals in a registrational Phase 3 setting, this could become a real platform validation moment for off-the-shelf active immunotherapy.

#Melanoma #Immunotherapy #CancerVaccines #CheckpointInhibitors #ClinicalTrials #FDA #Biotech #Oncology #DrugDevelopment

https://lnkd.in/gYF64hcc"

Lol...Did no-one think to look at Locky's posting history?

"Posts(All Time): 1"

"Last Post :22nd Jan 2026"

"Member Since 10th Apr 2025"

So our new visitor's first ever and only post is about funding?

Lol...yeah ok.

@locky - mission accomplished...debate started in earnest, doubt's created etc etc.

P.S. where have you vanished to? ;)

Https://www.emarketer.com/content/fda-shifts-one-trial-approvals--setting-new-standard-drug-reviews

RE FDA, I'm not sure if this was specifically mentioned on here?

Any connection RE today's presentation?

Fair enough CP, we'll have to take your word for it I guess, like everyone else on here. It's just that (IMO) your posts come across as subtle deramping, a bit like our erratic, emotional instrument playing canine friend.

Are you holding any shares here CrustyPete?

The complainers/moaners have a simple solution to end their complaining. They never seem to consider it though. Funny that.

Https://www.youtube.com/watch?v=izcdXTldpz8

Scancell CEO Phil L'Huillier and CFO Sath Nirmalananthan will be attending the hashtag#LondonLifesciencesWeek, taking place November 16-21.

This range of conferences, networking events, and public engagements focuses on innovation, investment, and the growth of life sciences companies across the UK. It’s centred around the Jefferies Global Healthcare Conference in London.

During the week, our Head of Business Development Mandeep Sehmi will be attending the LSX Investival Showcase 2025.

Please let us know if you would like to schedule a meeting during the week.

https://lifesciencesweek.london/

hashtag#Conference hashtag#Investing hashtag#LifeSciences hashtag#Biotech hashtag#Cancer hashtag#CancerFree hashtag#Oncology

@RR - Eh?

Lol...indeed RW.

"...No Rob, Just seems to be a continuous seller/sellers over a long period and especially why at this later stage In Sclp's Trials history?."

@Dracula1 - No comment on the strong buying so far this week?

From two days ago on Linkedin, I saw this and then realised CW had picked up on it also, very bullish by Phil L'Huillier IMO:

"...It’s the right time to take a good look at what we are doing at Scancell.

Our lead program, iSCIB1+ in combination with checkpoints is showing a whopping 😮 PFS of 69% at 22 months (n=72).

Compare this to ipi/nivo in checkmate 067 at mPFS of 11.5m. We have also scheduled the EOP2 with FDA and have a phase 3 design and plan mapped out.

Kudos to the Scancell team that have executed so swiftly on the back of our positive data to submit reg docs to multiple regulators to accelerate the next phase of development."

But re-posting as importantly this ties in (IMO )with your most recent posts @botski & @Chester18 RE:

"...Could be way off but could Glymab Thera actually be a defensive move, protecting us from a low ball offer for the whole entity?"

"...It’s always prudent to show you have a strategy combined with a financial plan to go it alone, all the way to full approval and commercialisation. Scancell have even ensured the manufacturing is firmly established."

Yes great posts by chilltime over the over sides, definitely worth a read, very well thought out IMO.

Intriguing Ai response CW- "✅ Bottom line: Partnership or acquisition is far more likely than a cheap raise. With Redmile & Vulpes holding ~50%, dilution makes little sense. Big pharma knows what’s at stake — especially as combination therapies become the key to defending revenue post-patent cliff."

@KonarA - Seconded...as per TF's post, a fantastic point, well made.

"There are definitely deals in the works - and they seem to be very far-advanced….indeed near-term."

Correct me if I've misinterpreted, but a couple of posters mentioned this years final results have come sooner than previous years, and the implication being that this might be because of said potential deal news timelines?