Member Info for Marcus134

Maybe Phil was very smart and playing it cool. The only people who matter are big pharma who are convinced enough to put up the dollars.

Maybe less is more because of what is going on in the background.

When he mentioned post translational modifications, no-one enquired further.

We know that Scancell has cracked high avidity, cross-presentation, correct targets and is getting good results in advanced cancer.

Https://www.businesswire.com/news/home/20260223744889/en/Gilead-Sciences-to-Acquire-Arcellx-to-Maximize-Long-term-Potential-of-Anito-cel

"memory T-cell response phenotype," which is characterized by the ability to rapidly recall and produce effector molecules to destroy cancer cells, as seen in patients with spontaneous remission

Cross-presentation, if other cells express the ImmunoBody protein and

secrete it, APCs can uptake the secreted protein and present the epitopes

via both MHC class I and II pathways.

This dual presentation is the key driver for priming naïve CD8+ T-cells (via MHC I)

and activating CD4+ helper T-cells (via MHC II), which support CTL expansion and

memory. This results in the generation of high-avidity, polyclonal CD8+ and CD4+

T-cell responses with strong cytotoxic potential. These T-cells in turn can

recognise and kill tumour cells presenting the target antigen. The inclusion of

helper epitopes enhances the durability, magnitude, and memory of the response.

The outcome is stronger, longer-lasting immune responses with higher-quality Tcells, improved memory formation, and better tumour targeting compared to immunotherapies that only stimulate CD8+ T-cells.

Deal activity in cancer vaccines is re-accelerating after a prolonged period of limited partnering, reflecting renewed confidence in the modality as clinical data and platform maturity improve. The c $1.25bn BioNTech acquisition of German mRNA vaccine developer CureVac in December 2025 is a clear inflection point. This follows earlier large platform alliances such as BioNTech-Genentech and Moderna-Merck and signals that large pharma now views cancer vaccines as a core long-term pillar of IO. For the broader sector, the transaction raises the strategic value of companies with validated antigen-selection technologies, combination data with checkpoint inhibitors and scalable manufacturing infrastructure, and points to a more competitive partnering and M&A environment.

Cancer vaccines are transitioning from a historically high-risk modality to a combination-driven, platform opportunity, supported by randomised clinical validation in the adjuvant and MRD settings. The shift to neoantigen targeting, genetic delivery and PD-1 synergy materially improves probability of success and commercial scalability. Earlier-line positioning expands patient populations and treatment duration, while recent large-scale transactions signal renewed big pharma appetite. Companies with biomarker-led development, checkpoint-combination data and scalable manufacturing are therefore best placed to secure premium partnering and valuation re-rating.

Https://www.fiercebiotech.com/biotech/fda-accepts-filing-moderna-flu-vaccine-after-swift-u-turn

The FDA has accepted Moderna’s revised influenza vaccine filing days after controversially refusing to review the original submission, putting the biotech on track to win approval in time for the 2026-27 flu season

I do not think there will be a problem with the FDA for Scancell`s vaccines.

16 Oct 2025 — The FDA has granted fast track designation to EO2463

EO2463 Is an innovative cancer peptide therapeutic vaccine

10 Sept 2025 — The FDA has granted Fast Track designation to the cancer vaccine GLSI-100

30 Apr 2025 — FDA-approved vaccines include BCG for bladder cancer, sipuleucel-T for prostate cancer, and T-VEC for melanoma, each with unique mechanisms and applications.

Six cancer vaccines were approved in China

Re Moderna;

The letter from FDA vaccine director Vinay Prasad, MD, MPH, said the agency doesn't consider the application to contain an "adequate and well-controlled trial" because it didn't compare the new shot to "the best-available standard of care in the United States at the time of the study." Prasad's letter pointed to some advice FDA officials gave Moderna in 2024, under the Biden administration, which Moderna didn't follow.

A pre-specified interim data read-out would be typical in a registrational oncology trial, and if included this could potentially be used to seek accelerated approvals whilst the trial runs to completion.

https://www.trinitydelta.org/research-notes/abundant-development-opportunities-in-immuno-oncology/

Https://www.fiercebiotech.com/biotech/lilly-innovent-pen-88b-collab-moves-beyond-traditional-licensing

IScib-1

Is immediately available, off - the -shelf. Patients get benefit earlier.

Data is at least as good if not better and may improve further with the new dosing regimen.

Bigger profits for big pharma as it is NOT PERSONALISED, cheap to produce and store

UK CVLP is supporting Scancell.

I envisage the CEO of a big pharma company who licenses iScib-1 making an appearance on the same program at some stage in the future highlighting iScib-1`s advantages.

IScib-1

Is immediately available, off - the -shelf. Patients get benefit earlier.

Data is at least as good if not better and may improve further with the new dosing regimen.

Bigger profits for big pharma as it is NOT PERSONALISED, cheap to produce and store

UK CVLP is supporting Scancell.

I envisage the CEO of a big pharma company who licenses iScib-1 making an appearance on the same program at some stage in the future highlighting iScib-1`s advantages.

Https://www.foxbusiness.com/video/6388759241112

Acral and Mucosal Melanoma (AM & MM) Market

Disease Profile: Acral (palms, soles, nailbeds) and mucosal (nasal, oral, genital) melanomas are distinct, aggressive, and often diagnosed late. While rare in Caucasians (1-3% of cases), they constitute 42%–65% of cases in Asian populations

The global uveal melanoma treatment market is a niche but rapidly evolving sector of oncology, valued at approximately US\(1.2toUS\) 1.5 billion in 2024. It is projected to reach US$ 2.5 billion by 2034–2035, growing at a steady CAGR of roughly 5.9% to 7.1%

The market for rare melanomas—specifically Acral, Uveal, and Mucosal subtypes—is a niche but rapidly expanding segment of the global melanoma therapeutics market, which is projected to reach approximately $10.26 billion by 2030.

They are correctly focusing on Immunobody until a deal is secured. Moditope and the Glymabs look amazing as well.

The Immunobody platform......

iScib x

Brain cancer ( Gioblastoma)

Pancreatic (PDAC)

Colorectal (CRC)

(Ovarian) and others.

Also iScib-1 is now listed at Adjuvant/Neo Adj, Acral, Uveal, Mucosal Melanoma.

Moditope - 1, Modi-2 numerous

SC134- SCLC Lung

SC27 gastro, ovarian, others

sc129 pancreatic (genmab)

Sc2811 ""

GlyMab Therapeutics, we continue our partnering and strategic discussions with the preclinical portfolio of antibodies targeting these novel glycans.

data on Modi-1 in the first half of this year

breakthrough designation for iSCIB1+probably a 2- or 3-month process. So we should have an outcome on that fairly quickly.

IND clearance, an important catalyst for both the conversations we're having with pharma and mid-caps, the strategics, but also with investors.

We are in active conversations on the partnering side.

This is a blockbuster market, and we've got multiple assets.

Modi-1

We're now looking for a PFS readout, which will happen over this quarter, this half year. And then that could well be a driver subject to that data to a potential licensing opportunity and non-diluting financing for the company. That's certainly how Sath and I think about the opportunity.

quietly confident of our capabilities to be able to dual list

The new rules of biopharma M&A: 4 trends driving dealmaking this year

By Gabrielle Masson Jan 28, 2026 5:00pm

The new rules center on securing platforms and production means

Next up are ADCs, which have been fueling a spike in oncology dealmaking

https//www.fiercebiotech.com/biotech/new-rules-biopharma-ma-4-trends-driving-deal-making-year#:~:text=The%20new%20rules%20center%20on,ahead%20of%20the%20competition%3F'%E2%80%9D

Callum Scott (Senior Vice President and Head of Development, Scancell) will address the role of potency testing across the cancer vaccine development lifecycle, highlighting the intersection of technical feasibility, regulatory expectations, and commercial considerations.March 24–25, 2026

https://www.insights.bio/vaccine-insights/journal/article/3722/nextgen-biomed-2026

Jan 20, 2026 12:03 PM Eastern Standard Time

Immunomic Therapeutics Announces FDA Clearance of IND Application for a UNITE®-Based Self-Amplifying RNA Vaccine for Triple-Negative Breast Cancer, to Be Studied Alone and in Combination with Keytruda

A pre-specified interim data read-out would be typical in a registrational oncology trial and, if included, this could potentially be used to seek accelerated approvals while the trial runs to completion.

active discussions with potential partners known to be underway.

https://www.trinitydelta.org/research-notes/fda-clears-global-phase-iii-trial-for-iscib1/

However, it seems the area still attracts investors. IO Biotech’s announcement came on the same day as the seed round of another cancer vaccine-focused company, Infinitopes. IO’s trajectory could serve as a cautionary tale until we know more about the next steps of its strategic reevaluation

https://www.prnewswire.com/news-releases/infinitopes-expands-seed-financing-to-35-million-to-accelerate-clinical-development-of-precision-cancer-vaccine-302665634.html

Iscib-1 avidimab memory t cells

In 2026, iSCIB1+ represents Scancell's advanced second-generation DNA cancer vaccine for melanoma, utilizing the AvidiMab® platform to significantly improve the induction of long-lasting memory T cells.

AvidiMab® Enhancement of Memory T Cells

The AvidiMab® technology specifically modifies the Fc region of the vaccine-encoded antibody to increase its avidity (binding strength) to antigen-presenting cells (APCs) like dendritic cells.

100-Fold Potency Increase: By targeting high-affinity Fc receptors (CD64) on APCs, AvidiMab® enhances the direct and cross-presentation of tumor antigens, resulting in up to 100 times greater T cell potency compared to standard DNA vaccines.

Memory Induction: Clinical data from 2025 and 2026 show that these high-avidity T cells not only kill existing tumor cells but are characterized by a memory T cell phenotype, ensuring deep and prolonged clinical responses.

Broadened Population: While the original SCIB1 vaccine reached only 40% of patients, iSCIB1+ is engineered with additional epitopes to trigger memory T cell responses in 80% to 100% of the melanoma population.

Clinical Efficacy in 2026

Updated results from the Phase 2 SCOPE trial (as of early 2026) highlight the durability provided by these memory responses:

Improved Survival: Patients receiving iSCIB1+ in combination with checkpoint inhibitors showed a 78% progression-free survival (PFS) at 11 months, compared to 46% for standard-of-care doublet therapy alone.

Antigen-Specific Response: 72% of patients mounted a strong T cell response to multiple melanoma antigens (gp100 and TRP2), which directly correlated with tumor shrinkage and a "memory recall" effect that prevents recurrence.

Biomarker Selection: Response can now be predicted using a patient's HLA class I alleles, allowing for a precision-medicine approach in the upcoming 2026 registrational trials.

Delivery and Future Outlook

Needle-Free Delivery: iSCIB1+ is typically administered using a spring-powered needle-free device (like PharmaJet), which optimizes DNA uptake in the skin/muscle to seed memory T cells.

Registrational Phase: Following successful FDA feedback, Scancell is moving iSCIB1+ into late-stage Phase 3 development in 2026.