Member Info for Marcus134

FDA approves Moderna’s updated COVID-19 vaccines targeting new variant

Ella Day | September 1, 2025

Kasdog,

yes , a blast from the past! Dr. Varawalla will be wanting billions for Scancell too ;-)

Protherics, Acambis, Peptide Therapeutics, Cenes

She was Senior Vice President and Head of Clinical Development, BTG International.

In late November 2018 Boston Scientific announced it would acquire BTG for $4.2 billion

No and not off-the-shelf, but the new data will be interesting to see. I don`t think anything matches Scancell atm.

Looking forward to Modi-1 in RCC , H&N and iScib-1 updates over the next four months.

Plus hopefully Sc129 news.

Phase IIb trial data has shown that the personalized mRNA cancer vaccine mRNA-4157 (V940) when combined with Merck's KEYTRUDA (pembrolizumab) significantly reduced the risk of recurrence or death by 49% and distant metastasis or death by 62% in patients with high-risk, resected stage III/IV melanoma compared to KEYTRUDA alone. These positive results from a median follow-up of approximately three years (34.9 months) are from the KEYNOTE-942/mRNA-4157-P201 study and led to the initiation of larger Phase 3 studies for melanoma and non-small cell lung cancer.

Https://www.biospace.com/press-releases/moderna-announces-data-to-be-presented-at-esmo-congress-2025Presentation #1515MO: Clinical Outcomes and PD-L1 Expression Analyses from a Trial of mRNA-4359 Plus Pembrolizumab in Checkpoint Inhibitor-Resistant/Refractory (CPI-R/R) Melanoma

Mini Oral Presentation: October 17, 2025

Presentation #3135eTiP: INTerpath-011: Phase 2 study of intismeran autogene (V940/mRNA-4157) plus bacillus Calmette-Guérin (BCG) versus BCG alone for high-risk (HR) non-muscle-invasive bladder cancer

Presentation #1684TiP: Intismeran autogene (V940/mRNA-4157) + pembrolizumab versus pembrolizumab alone as first-line therapy for advanced melanoma: the phase 2 INTerpath-012 study

Https://www.ndm.ox.ac.uk/news/researchers-granted-ai-supercomputing-award-to-accelerate-cancer-vaccine-work

https://ir.genmab.com/news-releases/news-release-details/genmab-receives-fda-breakthrough-therapy-designation-rinatabart

https://ir.genmab.com/news-releases/news-release-details/genmab-participate-fireside-chat-morgan-stanley-23rd-annual

What is the secret behind Modi's phenomenal success?

https://www.quora.com/What-is-the-secret-behind-Modis-phenomenal-success-Can-anybody-who-work-hard-rise-like-him

The FDA is approving vaccines.

GSK 5-in-1 meningitis vaccine recommended in US

On 14 February 2025, the US Food and Drug Administration (FDA) approved GSK's MenABCWY vaccine

FDA Fully Approves Moderna's COVID-19 Vaccine

16 Jul 2025 — Spikevax Moderna expects to have an updated version of the vaccine ready for the 2025-26 virus season

A safe and effective cancer vaccine will be fine.

Vulpes and Redmile are all-in. Scancell is talking with Pharma, the data is excellent. It is just a waiting game.

we are all ****ed off with the sp but it will change when the inevitable deals arrive. how much data does big pharma want before making a move is the question.

Https://www.fiercepharma.com/pharma/beone-bags-885m-royalty-deal-amgen-lung-cancer-drug-imdelltra

Hi Chester, just noticing your post. I think Scancell is up to speed on the latest FDA statement about OS (overall survival). That 5 year data on resected patients will hopefully do no harm.

It looks like Avidimab has helped produce that superior 81% PFS from 4 - 11 months with iScib.

I remember Holloway saying Avidimab was like people holding arms to stop them from falling off a slippery rock (prolonged antibody target occupancy).

AvidiMab® promotes receptor clustering thereby improving immune signalling.

Promotes non-covalent Fc-Fc interactions of target-bound antibodies

Facilitates receptor clustering, improved target occupancy, reduces antibody off-rate

Increases direct killing of anti-glycan antibodies and improves efficacy of agonist antibodies

We have data from Covidity plus,

SEA-CD40 (Seagen) is in Phase II trials for advanced solid tumours. AvidiMab was used in the Fc region (Exhibit 5) in an IgG1 format, with key residues from murine IgG3 transferred into the human SEA-CD40 IgG1 Fc region. The results for iSEA-CD40 showed higher Fc-Fc self-association, slower off-rate and improved binding to CD40, and better functional affinity than original SEA-CD40. These findings of better performance were also seen in other immune models that rely on clustering and/or increased residence time for activity.

Scancell also used it on 88 and 129

https://pmc.ncbi.nlm.nih.gov/articles/PMC7611157/

sialyl-di-Lewisa -targeting i129G1 mAb via introduction of these selected residues into 129hIgG1, converting it into a direct cell killing mAb with enhanced avidity and significant in vivo tumor control

SC129 is in lead candidate selection and targets sialyl-di-Lewisa, with high selectivity for pancreatic tumours (74%), gastric cancers (50%) and colorectal cancers (36%). Lewis-based glycans are attractive as they have a very limited distribution on normal tissues and are over-expressed in cancers that occur in epithelial cells. Preclinical testing has shown strong binding affinities for the targeted tumour cells (pancreatic and gastric), with very limited binding to normal tissues.

SC134 is undergoing functional analysis and targets fucosyl GM1, with an initial focus on small cell lung cancer (SCLC). Fucosyl-GM1 is known to be expressed in up to 90% of SCLC and, unlike many other lung cancer antigens, has little or no expression in normal tissues.

SC88 is in lead candidate selection and targets Lewisacx with a view to addressing colorectal cancer. The cell-based studies again showed highly specific target binding with little off-target effects.

SC2881, is a checkpoint modulator undergoing target validation for glycolipid stage-specific embryonic antigen 4 (SSEA4) on human and mouse T stem memory cells. It could have clinical value in many solid tumours.

More to come.

primed killer cd4 t cells infiltrate the tme where they initially encounter citrullinated or ****citrullinated peptides expressed on the surface of apcs which stimulates release of interferon gamma (ifnγ), which induces local inflammation and upregulation of mhc-ii on tumour cells. tumour cells typically create an anti-inflammatory microenvironment, where mhc ii expression is not upregulated, to evade the immune system.

the secretion of ifn-ϒ and the resultant inflammation could alter the nature of the tme, effectively converting “cold” tumours into “hot” ones, and so make a tumour visible to other elements of the immune system. hence, moditope stimulates the production of killer cd4 t cells which overcome the immune suppression induced by tumours, allowing activated t cells to seek out and kill tumour cells that would otherwise remain hidden from the immune system.

immune checkpoint inhibitors (icis) "release the brakes" on t cells, allowing them to attack cancer cells more effectively

ctla-4 blockade removes a barrier to initial t cell activation, allowing more t cell clones to become active.

pd-1 blockade revives t cells that have become unresponsive (quiescent or exhausted) in the tumor environment.

“We want to ensure as many eligible NHS patients as possible have access to these vital trials, which is why we are working with a range of industry partners as more studies get up and running to ensure patients are fast-tracked to a vaccine that could transform lives.”

Grandfather of 4 Paul Thomas, 63, from New Milton, Hampshire, was first diagnosed with advanced skin cancer in 2017, and the disease kept returning following treatment.

Last year Paul, who owns a window cleaning business, was given the opportunity to be part of the SCOPE skin cancer vaccine trial which is now part of the NHS Cancer Vaccine Launchpad.

He said: “I feel so lucky to be put on the trial. Thankfully I was still quite fit and since I’ve been on it, my tumours have all shrunk. Every time I go for a scan they seem to be shrinking, which is really exciting.

“I’m really hoping for total eradication of my cancer, as opposed to being put in remission and I’m feeling optimistic. The care I’ve had so far has been fantastic and the team that have looked after me have been superb, along with amazing support from my family, I’m so thankful.”

https://www.england.nhs.uk/2025/04/skin-cancer-patients-fast-tracked-access-revolutionary-nhs-cancer-vaccine-trial/

Mirror, 14 Apr 2025

"This isn't just another clinical trial – it's a beacon of hope for patients facing advanced melanoma and a testament to our commitment to harness the most innovative treatments in our fight against cancer."

The first skin cancer patients are expected to be referred next month after the NHS partnered with UK life sciences firm Scancell to widen access. Around 17,500 people are diagnosed with skin cancer every year, and around 2,300 die from the disease.

People with advanced conditions will be fast-tracked into trials of the new melanoma injection, known as iSCIB1+ (Immunobody). Keir Starmer has hailed the breakthrough, saying the innovation is "nothing short of lifesaving".

Https://www.fiercebiotech.com/biotech/krystal-discontinues-melanoma-trial-after-fdas-replimune-rebuff-stat

Like Krystal’s drug, Replimune’s asset is delivered via injection and is engineered using the herpes virus. Both were also being studied in combination with Bristol Myers Squibb’s checkpoint inhibitor Opdivo, with Krystal testing KB707 in combination with Merck’s Keytruda as well.

In June, the FDA denied Replimune’s approval application, which leveraged phase 1/2 data from 140 patients who had previously progressed on a PD-1 drug. Replimune reported an objective response rate of 32.9%.

Https://www.fda.gov/regulatory-information/search-fda-guidance-documents/approaches-assessment-overall-survival-oncology-clinical-trials

Scib-1 in resected patients achieved a five-year overall survival (OS) of 87.5% .

OS is now one of the main things that the FDA is looking for.

https://www.biospace.com/fda/fda-looks-to-raise-survival-bar-for-cancer-drug-approvals-in-new-draft-guidance?utm_campaign=5458739-2025%20%7C%20Daily%20Social&utm_content=344037262&utm_medium=social&utm_source=twitter&hss_channel=tw-21793154

Patients enrolled in SCOPE remain in the study for two years, so survival data (OS and PFS) will continue to be monitored. We expect an update on PFS, with longer follow-up, in Q425, as well as potential initial OS data, in addition to early data from Cohort 4 which is examining intradermal administration (PharmaJet’s Tropis) and an accelerated dosing regimen.

A reminder, near term, partnering and funding

https://youtu.be/RZ8yA1XJseY?t=1329