Member Info for Marcus134

The delta for the iSCIB1+ 77% PFS (at 20 months) is calculated by subtracting the benchmark 43% PFS reported for the Standard of Care (SoC) at the same time point.

The 20-Month Calculation

The 34-percentage point delta is derived as follows:

iSCIB1+ PFS (20 months): 77%

Standard of Care (SoC) PFS (20 months): 43%

Calculated Delta:

+34 percentage points

Comparison of Maturing Data

As the Phase 2 SCOPE trial progressed, the reported delta widened because the iSCIB1+ group showed greater durability than the historical control:

Milestone Snapshot iSCIB1+ PFS SoC PFS Resulting Delta

16-Month Data 74% 50% +24 points

20-Month Data 77% 43% +34 points

5-Year PFS: Results from the CheckMate 067 trial showed a 5-year PFS rate of 36%.

6.5-Year PFS: Updated results showed a rate of 34%.

Scancell`s PFS is not dropping after 20 months......AMAZING

Based on data as of April 2026, the combination of iSCIB1+ plus Ipi/Nivo showed a major advantage over historical Ipi/Nivo benchmarks:

Regimen PFS Rate @ 20 Months Source

iSCIB1+ + Ipi/Nivo 77% Scancell (2026)

Ipi/Nivo (Standard) 43% CheckMate 067 (Benchmark)

PFS Delta +34% Improvement Clinical Trial Vanguard

The Delta should continue to rise further.

The PFS delta between iSCIB1+ and the Ipi/Nivo benchmark is widening over time because the "drop-off" seen with standard therapy isn't happening at the same rate for the iSCIB1+ group.

📈 Why the Gap is Widening

In melanoma, standard Ipi/Nivo usually shows a steep decline in the first 6–12 months as patients develop resistance. iSCIB1+ is showing a "durable plateau," which is the "holy grail" of immunotherapy.

🚀 Factors Sustaining the Delta

Memory T-Cells: Because iSCIB1+ is a vaccine, it creates long-lived "memory" T-cells. This provides a constant surveillance system that prevents the cancer from rebounding after the initial checkpoint inhibitors (Ipi/Nivo) have done their job.

Broader Target: By targeting multiple melanoma antigens (gp100 and TRP-2), it is harder for the tumor to "hide" via antigen escape, which is a common cause of late-stage relapse in standard care.

⏱️ The "Survival Tail"

If this trend continues into the Phase 3 trial (starting H2 2026), the delta could become even more significant in Overall Survival (OS) data.

The FDA looks for a "substantial improvement."

A 34% delta in PFS is already massive; if it translates to a similar gap in OS, Breakthrough Therapy Designation becomes almost certain.

Worth a listen for anyone who missed this.

The killer CD8 T Cells are getting rid of these tumours

in EXTREMELY ADVANCED Melanoma patients.

https://youtu.be/5BOh9m5CYsg?t=767

Panmure Liberum holds its 'buy' rating and 32p target as FDA fast-track status adds regulatory momentum to compelling trial data.

Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF, FRA:SCP) shares rose 5.3% to 13.69p on Tuesday as the cancer immunotherapy developer delivered a double dose of positive news.

In one announcement, it weighed in with FDA Fast Track Designation for its lead drug iSCIB1+ and updated clinical data showing its advantage over the current standard of care continues to widen.

The progression-free survival (PFS) figure, which measures the proportion of patients whose cancer has not worsened within a given period, reached 77% at 20 months in the target patient group.

The broker, which acts as corporate broker to Scancell, maintained its 'buy' rating and 32p target price, implying more than 130% upside from Tuesday's price.

$3 - $9 billion potential market for iScib-1 alone.

Based on recent oncology data, several trials in 2025 and early 2026 have reported ~40% or greater improvements in progression-free survival (PFS) over standard of care (SoC), leading to stopped or accelerated trials.

Will the FDA deem it unethical to deny the Ipi Nivo arm iScib-1 if/when the data is repeated in phase 3?

If you review the cohort 3 chart we should continue improving over SOC.

28th April 2026

Scancell Holdings plc

Scancell receives FDA Fast Track Designation for iSCIB1+ in advanced melanoma and provides data update from its SCOPE Phase 2 study

Potent and durable efficacy with iSCIB1+ of 77% progression free survival (PFS) at 20 months, in combination with ipilimumab and nivolumab, demonstrated in the Phase 2 SCOPE trial; more PFS and additional early overall survival (OS) data expected in H1 2027

Initiation of the registrational Phase 3 trial with iSCIB1+ in advanced melanoma anticipated in H2 2026

Scancell Holdings plc (AIM: SCLP), the developer of active immunotherapies to treat cancer, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead ImmunoBody® iSCIB1+ for the treatment of advanced melanoma.

Dr Phil L'Huillier, CEO of Scancell, said: "This designation is a major achievement for Scancell and important recognition not only of the potential of iSCIB1+, but also of the significant need for new and improved treatment options for patients with advanced melanoma. We are very pleased with how the Phase 2 SCOPE data is maturing and are advancing plans for a global registrational Phase 3 trial, which we expect to initiate in the second half of 2026."

Progression free survival (PFS) has matured positively, reaching 77% at 20 months in the target population1. This widens the lead of iSCIB1+ over PFS reported with ipilimumab plus nivolumab alone of 43% at 20 months, now representing a 30+ percentage point improvement over standard of care (SoC).[2]

The Fast Track Designation is granted for investigational therapies that show advantage over available treatments, such as superior effectiveness, and provides the process to expedite review of drugs for serious conditions, with the aim of getting effective therapies to patients faster. The designation enables frequent engagement to ensure alignment on development plans, enhance development predictability and support a more efficient path through clinical development. Moreover, Fast Track Designation brings eligibility for Accelerated Approval, Priority Review and Rolling Review.

Additional PFS data and early OS data from the Phase 2 SCOPE study are expected in H1 2027.

Preclinical data ,

the biotech claimed the findings showed the “superior efficacy profile” of AJ1‑11095 when compared to Jakafi

To get its hands on both Ajax and AJ1‑11095, Lilly has signed a deal that could reach $2.3 billion

https://www.fiercebiotech.com/biotech/lilly-continues-ma-streak-23b-deal-next-gen-jak-inhibitor-biotech-ajax

https://www.ajaxtherapeutics.com/

You may know more than this Burble as I googled this info;

2005–2016: The London Beginnings (AIM)

Verona was founded in 2005 around a research program at King’s College London. The research involved Sir David Jack (former head of R&D at GSK) and Professor Clive Page, centering on finding a novel mechanism for chronic obstructive pulmonary disease (COPD).

2006 Listing: To secure early capital, the company went public on the AIM (the London Stock Exchange’s junior market) via a reverse merger.

The Role of AIM: The London junior market was instrumental during Verona's formative years. It provided the equity liquidity and cash needed to advance pre-clinical and early Phase 1 and Phase 2 clinical trials for its lead compound, ensifentrine.

2017: The Nasdaq Dual-Listing

By 2016, the company needed to fund massive, highly expensive Phase 3 clinical trials. Traditional UK and European investors at the time were largely viewed as too risk-averse to support late-stage clinical trials of that scale.

The IPO: In April 2017, Verona pulled off its initial public offering on the Nasdaq under the ticker VRNA. It raised around $80 million by issuing American Depositary Shares (ADS).

Dual-Listed Era: For a little over three years, Verona maintained a dual listing. Its primary shares traded on London's AIM while its ADSs traded in the US on the Nasdaq.

✂️ 2020: Leaving London Behind

By 2020, the center of gravity for Verona’s stock had shifted entirely to the United States. Following a massive $200 million funding round that was overwhelmingly supported by specialist US healthcare funds, trading volume and ownership moved aggressively across the Atlantic.

The Stat: By September 2020, about 93% of Verona’s shares were held as ADSs and 98% of all trading volume over the prior six months took place on the Nasdaq.

The Delisting: To eliminate the redundant costs and administrative burden of maintaining two public listings, Verona officially delisted from London's AIM on October 30, 2020.

🏆 The Climax: FDA Approval and $10 Billion Buyout

Consolidating on the Nasdaq allowed Verona to act like a typical heavily funded American biotech.

The Breakthrough: Verona secured FDA approval for its COPD drug, Ohtuvayre (ensifentrine), in June 2024.

The Mega-Exit: After proving the drug's success in clinical trials and making massive headway in the commercial market, global titan MSD (Merck & Co.) acquired Verona for $10 billion in an all-cash deal that closed in October 2025.

Verona's move remains the definitive case study for British biotech companies looking to leverage London for early growth before tapping into the massive capital of New York to finance late-stage blockbusters.

A triplet regimen comprising Merck’s Welireg and PD-1 blockbuster Keytruda and Eisai’s Lenvima flopped in a Phase 3 renal cell carcinoma trial.

Merck and Eisai are looking at an investigational regimen of three FDA-approved therapies for the treatment of renal cell carcinoma. Tuesday, however, a late-stage readout found that the three-drug combo showed no significant survival benefit.

HTTPS://www.biospace.com/drug-development/merck-eisais-keytruda-triplet-fails-to-improve-survival-in-kidney-cancer?utm_campaign=33719445-2026%20%7C%20Daily%20Social&utm_content=376048231&utm_medium=social&utm_source=twitter&hss_channel=tw-21793154

A little encouragement for Scancell holders.

Kelonia Therapeutics went from

November 2020: Valued at $13.5 million

April 2022: Raised $50 million in a Series A round, bringing its valuation to slightly above $100 million.

April 2026: Final deal price of $7 billion (total potential value).

Pipeline;

Clinical Progress: In early 2026, the FDA cleared Kelonia (in-vivo Car T) to begin Phase 1 safety trials for its lead program targeting multiple myeloma.

Pre-clinical CD19/BCMA biCAR Oncology & Autoimmune

Pre-clinical Undisclosed Oncology

There is a glaring disparity in Scancell`s valuation.

April 2026, Eli Lilly and Company is in advanced talks to acquire Kelonia Therapeutics for more than $2 billion.

two pre-clinical, one recruiting in phase I

https://keloniatx.com/pipeline/#pipeline

Https://investor.natera.com/governance/board-of-directors/person-details/default.aspx?ItemId=3d81b239-c4ea-4ac4-959b-5295b6a0949e

https://scancell.co.uk/about-us/

On the regulatory front, Replimune failed for a second time to secure approval for its advanced melanoma therapy RP1, as the FDA held its ground, requesting a Phase 3 trial that CEO Sushil Patel indicated in a statement last week “will not be viable.”

Great to see the consideration for Nasdaq which will hopefully raise our market cap substantially.

David brings valuable investor engagement and strategic financing expertise, including Nasdaq listing experience that will help guide the company as we explore a potential listing in the US.’

Factors Influencing the Deal Price

Probability of Success (PoS): A Phase 3 asset generally has a 60% to 65% chance of reaching approval. A positive Phase 3 readout can cause an instant, violent "re-rating" of the company's value.

Therapeutic Area: Oncology, cardiovascular-metabolic (e.g., GLP-1s), and CNS treatments currently command the highest premiums.

Asset Scarcity: Large pharma companies facing "patent cliffs"—the loss of exclusivity on older drugs—are currently spending billions to replenish their pipelines, driving up prices for Phase 3 assets

iScib-1 is such a huge improvement over SOC (standard of care), very safe, very long patent life, very profitable.

David Schilansky is a seasoned pharma and biotech executive and is currently concluding his role as Chief Executive Officer of Ariceum Therapeutics and commencing as Venture Partner and Entrepreneur-in-Residence at Redmile Group. He was previously CEO and co-founder of Home Biosciences from 2020 to 2025, which created three biotech companies (One Biosciences, Sequantrix and Apikal Therapeutics). From 2011 to 2019, he co-headed DBV Technologies, leading its IPOs on Nasdaq and Euronext, raising a total of more than $1 billion. Prior to that, he held several leadership roles in finance, including Group CFO at Ipsen.

IScib-1 alone could generate $3 - 9 Billion

iSCIB1+ with CPIs*

Advanced

melanoma

Phase 3 start H2 26

ImmunoBody Platform

INDICATION PRECLINICAL

* Ipilimumab + nivolumab or pembrolizumab

Neo/Adjuvant

Planned development subject to financing

Additional opportunity

iSCIB2+ NY-ESO-1 Solid Tumours

iSCIB3+ Ovarian

iSCIB4+ ND PDAC, NSCLC,

MSS CRC

iSCIB1+ Melanoma 1L Metastatic

(registrational) ✓

Neoadjuvant/Adjuvant

Uveal, Acral, Mucosal

Brain cancer Glioblastoma

iSCIBx

(ImmunoBody®) Solid tumours PDAC, Ovarian, CRC, others

Modi-1 HNSCC Phase 2 ✓ future, Phase 2b/3

RCC Phase 2 ✓ future, Phase 2b/3

Antibodies

GTL134TCAB SCLC FIH 2027 NSCLC

GTL27, SLAN Solid tumours Gastrointestinal, Ovarian, other

SC129 / SC2811 Additional

development milestones

Https://x.com/bradloncar/status/2044026206001975347?s=20

Recent M&A News in Pharmaceuticals & Biotechnology SectorPharma M&A is surging in early 2026, with over $47 billion in deals announced in Q1, driven by Big Pharma's need to replenish pipelines before major patent expiries. Key trends include a focus on obesity treatments (GLP-1), antibody-drug conjugates (ADCs), and vertical integration, with high-value acquisitions by firms like Merck and Eli Lilly signaling a strong, strategic market.

Key 2026 M&A Drivers and Trends

High-Value Deal Spree: Following a strong Q4 2025, 2026 began with intense activity, including multiple billion-dollar-plus transactions, indicating a "return of confidence" and a "new rulebook" for strategic acquisitions.

Patent Cliff Urgency: Companies are under immense pressure to replace revenue from blockbuster drugs facing exclusivity losses by 2030, driving demand for ready-to-market or late-stage assets.

Key Focus Areas: Major acquisitions are targeting:

Obesity/GLP-1: Continued high demand for next-gen treatments.

Oncology & ADCs: Antibody-drug conjugates remain a top priority.

Immunology/Rare Diseases: Continued interest in specialized, high-margin therapeutic areas.

Big Pharma Appetite: Merck, Eli Lilly, and Biogen have led with major acquisitions (e.g., Terns Pharmaceuticals, Centessa Pharmaceuticals).

Strategic Shift: Deals are increasingly focused on securing specialized platforms, production capabilities, and de-risked, late-stage assets rather than just massive, company-altering mergers.

2026 Market Outlook

Analysts believe the surge is not a "false alarm" and that the momentum is likely to continue throughout 2026. Despite challenging macroeconomic conditions, the high volume of cash available (over $1.5Tn in potential capacity) and the need for innovation suggest a robust environment for biotech acquisitions.

I did a quick search, correct if wrong and I`m sure there were many raises etc.

Based on research from the Edison Group, Verona Pharma's market capitalization was approximately £31 million as of July 26, 2016. At that time, the share price was listed at 3.05p.

Merck pulled off its $10 billion buyout of Verona Pharma in 2025

https://www.fiercepharma.com/pharma/its-10b-buyout-verona-merck-was-lone-ranger

I agree Moonparty

Https://x.com/proactive_x/status/2039619034879017063?s=20