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Https://breakingthenews.net/Article/Sanofi-to-acquire-Dynavax-for-dollar2.2B/65399538

Dynavax Technologies focuses on vaccines and therapeutics that leverage Toll-like receptor (TLR) stimulation rather than traditional DNA vaccination approaches. Their technology utilizes CpG 1018, a synthetic oligonucleotide (a short segment of DNA) designed to activate TLR9, which induces a strong Th1-polarized immune response. While they do not have a marketed, pure "DNA vaccine" (where DNA encodes the antigen), they use this immunostimulatory DNA as an adjuvant for recombinant protein vaccine

T stem cells normally undergo asymmetric cell division (left) whereby one daughter cell becomes a long-lived memory T cell. When autophagy is disrupted, both daughter cells inherit old mitochondria (red) and become effector T-cells

boosting autophagy before or during T stem cell division, it may be possible to enhance the generation of memory cells—the backbone of long-term immunity and vaccine effectiveness

https://www.genengnews.com/topics/translational-medicine/autophagy-regulated-mitochondrial-inheritance-impacts-asymmetric-cell-division-and-t-cell-fate/?utm_content=362922521&utm_medium=social&utm_source=twitter&hss_channel=tw-31484145

The strength of Scancell`s vaccine;

AvidiMab® is a proprietary platform developed by Scancell designed to enhance the potency and durability of immune responses. When applied to cancer vaccines like iSCIB1+, it specifically improves the generation and quality of memory T cells.

Mechanism of Action

AvidiMab enhances the T-cell response through several key mechanisms:

Receptor Clustering: It promotes the clustering of receptors on the surface of target cells, which increases the "avidity" (total binding strength) of the interaction between the vaccine-induced T cells and the tumor.

High-Avidity Selection: Research indicates that the technology preferentially selects for and maintains high-avidity T cells within the memory pool. These high-avidity cells are more sensitive to low levels of tumor antigens, making them more effective at long-term surveillance.

Prolonged Memory: By increasing the magnitude and breadth of the immune response, AvidiMab-enhanced products provide better long-term protection and more robust immunological memory compared to earlier generations.

iSCIB1+ is an advanced cancer vaccine developed by Scancell that stimulates a potent and durable immune response against melanoma. A key component of its efficacy is the generation of antigen-specific memory T cells, which help prevent cancer recurrence by maintaining long-term immune surveillance.

Key Characteristics of iSCIB1+ Memory T Cells

Persistent Immune Response: iSCIB1+ is designed to create a "memory" in the immune system, allowing it to recognize and attack melanoma cells long after the initial treatment.

High Magnitude Response: Clinical data from 2025 indicates that patients who mount a high-magnitude T-cell response to iSCIB1+ experience significantly better tumor control (73% vs. 13% for non-responders).

Dual Epitope Activation: Patients showing clinical benefits often exhibit a memory T-cell response to both gp100 and TRP2 epitopes, which are key markers targeted by the vaccine.

Broader Targeting: iSCIB1+ is an enhanced version of the earlier SCIB1 vaccine; it includes more melanoma-specific epitopes and targets a wider range of HLA types, potentially benefiting up to 80% of melanoma patients.

Upfront, development, regulatory and commercial milestone payments could potentially total $1.06 billion

https://www.fiercebiotech.com/biotech/ipsen-continues-adc-push-1b-deal-simceres-preclinical-lrrc15-targeting-asset

Ipsen is eyeing the launch of SIM0613’s first phase 1 trial in the second half of next year.

Simcere’s clinical-stage pipeline has been in demand in 2025, with AbbVie kicking off the year by securing a trispecific antibody from the company in a $1 billion biobucks deal. The candidate, dubbed SIM0500, targets GPRC5D, BCMA and CD3 and was already in phase 1 trials for multiple myeloma in the U.S. and China.

In May 2025, GSK acquired the Phase III-ready drug efimosfermin alfa (BOS-580) from Boston Pharmaceuticals for a potential $2 billion, aiming to treat steatotic liver diseases (SLD) like MASH, with an upfront $1.2 billion and up to $800 million in milestones, adding this promising, monthly-dosed FGF21 analogue to its liver disease pipeline for a potential 2029 launch

Novartis paid Arvinas an upfront $150 million in April 2024 for exclusive global rights to develop and commercialize ARV-766, a promising protein degrader for castration-resistant prostate cancer (CRPC), with potential milestones exceeding $1 billion

SL paid Dutch biotech VarmX $117 million for an exclusive option to acquire the company, focusing on VarmX's Phase 3-ready blood clotting treatment, VMX-C001, which acts as a "coagulation bypass agent" to prevent bleeding in patients needing anticoagulant reversal, with CSL also funding development and potential billions in milestone payments. This strategic deal gives CSL the right to buy VarmX outright

Key Trends in 2025 Pharma Platform Deals:

Focus on Platforms, Not Just Assets: Companies are buying entire platforms (e.g., J&J's RIPTACs, Repertoire Immune Medicines' DECODE platform) for novel drug discovery.

AI & Next-Gen Modalities: Deals target AI in drug discovery (AstraZeneca/Tempus) and advanced therapies (cell, gene, TPDs).

Combating the Patent Cliff: Major acquisitions (Merck, Pfizer, Roche) aim to replace future lost revenue from blockbuster drugs like Keytruda.

Increased Deal Values: Average deal sizes are rising, with some hitting multi-billion dollar valuations, notes Pharmaceutical Technology.

Notable 2025 Examples:

Johnson & Johnson ($3bn): Acquired Halda Therapeutics for its RIPTAC platform for small-molecule cancer drugs.

Merck ($9.2bn): Acquired Cidara Therapeutics, bolstering its respiratory pipeline ahead of Keytruda patent loss.

Pfizer: Gained rights to SSGJ-707 (bispecific antibody) for up to $6.2B and re-entered the obesity market with the Metsera deal ($7.3B).

Roche ($3.5bn): Acquired 89bio to strengthen its metabolic disease portfolio.

Genmab ($8bn): Acquired Merus to expand its oncology platform.

AstraZeneca & Partners: Partnering on AI platforms for novel drug target discovery.

How much for iScib-1 on phase 2 data?

How much for the Immunobody platform?

How much for Modi-1?

How much for Moditope platform?

How much for Glymab Therapeutics, another platform ?

Avidimab

This PFS benefit most likely

reflects the AvidiMab®

modification made to iSCB1+

Scancell Holdings PLC

(

AIM:SCLP,

OTC:SCNLF

)

View Price & Profile

Is Scancell nearing 'significant value crystallisation point'?

Last updated: 14:00 12 Dec 2025 GMT, First published: 13:59 12 Dec 2025 GMT

Scancell Holdings PLC -

There's been an odd reaction to some encouraging news from Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF), with the shares barely flickering this week.

The company updated the market with more supportive data from a trial of its drug for people with hard-to-treat melanoma, a common skin cancer.

Panmure Liberum said it hopped on a call after the latest stats drop and left the conversation extremely heartened by the feedback.

Scancell gave a broad-brush overview of plans for its lead asset iSCIB1+, which is being readied for a phase III trial. This is the final hurdle before approval, although it tends to be a clinically arduous and expensive process, particularly for smaller research and development firms.

That stage, however, is also when interest from big pharma tends to crystallise into investment, with deep-pocketed blue-chips often picking up the bill to push a promising drug towards sign-off.

Value building

Deals tend to come in the form of licensing agreements where upfront and milestone payments are agreed, and in certain cases, these can prove transformational.

Panmure, in its note, was not getting too carried away but told clients: “Significant value is building, with the potential to crystallise in the near term if a partnership is concluded.”

The broker is a buyer of the stock up to 32p. The current price is less than a third of that target.

Scancell will host a presentation on the SCOPE data, followed by a Q&A with management, on 11

December at 14:00 GMT. Please click here to register for the call.

Details of the ESMO IO oral and poster presentation

Title: SCOPE, phase 2 clinical trial with off-the-shelf DNA plasmid vaccine in first line advanced

melanoma with check point inhibition

Presenter: Professor Heather Shaw, Medical Oncology, Mount Vernon Cancer Centre, University

College London

Time: Thursday December 11, 11:50 GMT

Our rNPV valuation is £382m, or 37p/share, with further upside potential from iSCIB1+ progress and the expected news flow from the Moditope platform and GlyMab portfolio.

Https://youtu.be/E4SCw6kFU20

https://www.trinitydelta.org/research-notes/latest-scope-data-confirm-durable-improvement/

the latest data from the phase ii scope trial in advanced melanoma will be presented at esmo io. cohort 1 (scib1) and cohort 3 (iscib1+) evaluate the addition of scib1/iscib1+ to double checkpoint inhibitors (cpis) nivolumab and ipilimumab, now considered soc (standard of care). highly promising data to date, which could redefine soc, has already prompted the selection of next generation iscib1+ for the registrational phase iii trial being planned.

pfs (progression free survival) is a key study metric: cohort 1 (n=41) is 55% at 26 months; cohort 3 in the target hla population (n=39) is 74% at 16 months; cohort 3 in the non-target hla patients (n=10) is 20% at 14 months; and the combined cohort result is 60% at 26 months. pfs is derived from ******-meier survival curves, which are a downward sloping step graph, hence will decrease over time and are the reason a figure is tied to a time point. the favourable pfs remains consistent across subgroups analysed including pd-l1 status, braf status and prior checkpoint inhibitor exposure.

the equivalent orr (objective response rate) are: 63% for cohort 1; 56% for cohort 3 (target population); 20% for cohort 3 (non-target); and 60% for the combined cohorts. similarly, dcr (disease control rate, ie tumour shrinkage or stable disease) is: 83% for cohort 1; 79% for cohort 3 (target group); 40% for cohort 3 (non-target); and 81% for the combined cohorts (target group). for context, these compare positively with cpi doublet therapy (ipilimumab/ nivolumab), which reported an orr of 50% and dcr of 63% in checkmate-067 and 48% and 58% respectively in the real-world setting.

these durable responses are also supported by os (overall survival) data at 26 months from cohort 1 of 77%, a 14% improvement over soc of 63%. the combination of these strong results, coupled with the desire to maintain the clearly building momentum, has resulted in the decision to curtail cohort 4 and focus management resources on progressing the phase iii programme.

discussions with the fda and other regulatory agencies on the design of the registrational trial for iscib1+ in advanced melanoma are reported as being positive, with agreed guidance on dose, manufacturing, and clinical end points (pfs is expected to be the primary end point). active discussions are continuing with potential partners, with management assessing its options.

trinity delta view: the data from the scope study of scancell’s “off the shelf” cancer vaccine scib1/iscib1+ continue to show a clinically meaningful and commercially relevant improvement over currently achievable treatments. the safety and tolerability also remain attractive, with the iscib1+/cpi combination comparable to soc alone. positive discussions with regulatory authorities mean investor attention will now focus on the design, timing, and, importantly, funding of the pivotal phase iii regi

$6.55 to $39.40 in one day!

Capricor announced positive top-line results from its pivotal Phase III HOPE-3 trial evaluating deramiocel, the company’s investigational cell therapy for the treatment of (DMD).

“HOPE-3 delivered strong and definitive evidence that deramiocel can meaningfully improve the course of Duchenne muscular dystrophy

We're seeing T-cell responses in 72% of patients to both TRP-2 and gp100. Why do I emphasize that? Well, that means because we're seeing T-cells to both of those epitopes that reduces the likelihood of immune escape. So it gives the prospect of a longer-term immune control. use that as a selection tool to select for patients into the Phase III that we know will respond. This basically enhances the chances of success. And it's very, very rare that you have a selection marker for an I-O therapy.

For iSCIB1+, we're seeing the progression-free survival, the PFS at a level of 78% in our target population. If you compare this to historic doublet checkpoints or standard of care, that's around 46%. So there's a whopping difference that we're seeing here.

GlyMab Therapeutics,to me, there's a little gold mine there

I'm pleased how Modi is going. We are seeing benefit in patients from Modi. highly anticipated clinical data from Modi is anticipated in Q4 in renal cell carcinoma in combination with the checkpoint inhibitors

we believe we have the right data set to generate partnering interest.

So is it safe to assume that you're confident in either a partnership or financing before that trial starts or the randomized study start?

I'd say so, Ed. So yes, we are confident. We have the bulk of the data. We are in active conversations

The actual study of funding the study we will evaluate our options following the active conversations we're having with partners right now. So based on those conversations, based on their feedback as well as the confirmation from the regulators that we've got the right study design, we will come back and update you on what that right financing will be.

with this data set and our push on regulatory conversations, we're very confident that we will have serious conversations about partnering and partnering in the broader sense. And also possibilities around investment further.

https://seekingalpha.com/article/4822076-scancell-holdings-plc-scnlf-q4-2025-earnings-call-transcript

Https://scancell.co.uk/wp-content/uploads/2025/09/Scancell-Financial-Year-End-2025-Results.pdf

Upcoming Milestones

• Additional iSCIB1+ SCOPE data & regulatory discussions in Q4 2025

• Modi-1 clinical data in RCC in combination with CPI in Q4 2025

• Partnering & out-licensing & further financing assessment

Clear Path to Substantial Markets with Multiple Value Driver

• iSCIB1+ could set the new benchmark in advanced melanoma

• Modi-1 showing early efficacy in multiple tumour types

• Glymabs Therapeutics established providing strategic optionality

Science and Technology Secretary Liz Kendall said: “This vital deal will ensure UK patients get the cutting-edge medicines they need sooner, and our world-leading UK firms keep developing the treatments that can change lives.”

Business and Trade Secretary Peter Kyle said the deal “guarantees that UK pharmaceutical exports – worth at least £5 billion a year – will enter the US tariff-free”.

https://uk.finance.yahoo.com/news/uk-us-agree-zero-tariff-153900403.html

We’re looking forward to seeing more data from these studies at hashtag#ESMOImmuno25 in London next month.

Dr. Nermeen Varawalla brought RIVIA on stage at hashtag#SITC25 while presenting new data from one of their Phase 2 cancer vaccine trials.

We’ve followed Scancell’s team and their tireless work on SCOPE and ModiFY studies since last year, when Dr. Nermeen first met Rivia at hashtag#ESMOImmuno24.

RIVIA will be there too! Reach out if you’d like to hear how modern biotechs like Scancell are using unified Trial Intelligence to run their trials more efficiently and move faster.

Well another excellent post on MacMillan from a Modi-1 patient . Very encouraging.

Exactly Burble, and validate two platforms, Moditope and Immunobody.

Modi-2 and iScib-2 are locked and loaded.

I don`t think PD-1 CTLA-4 has been approved for Ovarian and TNBC so Scancell is pushing on with RCC and Head & Neck.

If the results are good then perhaps big pharma will pay for the CPIs to trial that combination.

Bermuda,

as you know, the quality of the T Cells is vital too. PD-1 to help prevent exhaustion also blocking CTLA-4 , the "brakes" are released, which can unleash the immune system to fight the cancer more effectively.

https://academic.oup.com/discovimmunology/article/2/1/kyac011/6874811

Hopefully we see some good results with Modi-1 with Ipi/Nivo in RCC within a few weeks.

Next steps for iSCIB1+ on the horizon Scancell is pioneering the next generation of immunotherapies, addressing hard to treat cancers. Its two distinct platforms, ImmunoBody and Moditope, are designed to overcome immune evasion, target tumour-specific vulnerabilities, and generate durable anti-tumour responses. ImmunoBody is the most advanced, with data from the Phase II SCOPE study of SCIB1/iSCIB1+ in combination with CPIs in advanced melanoma showing meaningfully improved outcomes across all key metrics. Upcoming FDA discussions will define the design and format of the potentially registrational study.

Modi-1 CPI combo data due in Q425 Results from the Phase I/II ModiFY trial RCC cohort, exploring Modi-1 with double CPIs, are expected in Q425. Similarly to SCIB1/iSCIB1+, the Modi-1/doublet CPI combination could be highly synergistic. Doublet CPI is SoC for advanced RCC and ModiFY data should establish whether the addition of Modi-1 could bring potential improvements in the first-line setting.

GlyMab Therapeutics provides strategic optionality Establishment of GlyMab Therapeutics as a wholly owned Scancell subsidiary will separate the antibody and immunotherapy platforms into independent corporate entities. This reflects the reality that each will need distinct scientific expertise and strategic direction, and are likely to have different funding needs and attract different investors/partners.

Valuation of £382m ($477m), or 37p/share; cash through to Q326 iSCIB1+ is the most important contributor (worth >50%) and together with the platform, our model suggests ImmunoBody is worth £215m/$269m. This could increase to £346m/$432m when the iSCIB1+ registrational trial starts next year, with derisking events including further data, regulatory feedback, and securing trial funding.

Thanks 127.

It will be nice to see that 37p target reviewed upwards with positive news.