Moderna Inc (MRNA) Quote

On the topic of IL-12, CTMX used its PROBODY tech and MRNA's tech, creating an mRNA therapeutic encoding a masked IL-12, designed to be selectively activated within the tumour microenvironment https://cytomx.com/wp-content/uploads/AACR_poster_Mar2025.pdf

https://x.com/DiedSuddenly_/status/1933721666086973590/photo/1 $MRNA

Good writing: https://nataninvesting.substack.com/p/natans-notes-3-will-mrna-survive?utm_source=share&utm_medium=android&r=2a9ilx&triedRedirect=true

RFK Jr. went on national TV and spouted egregious, dangerous falsehoods about vaccines. As a parent and infectious diseases doctor, I couldn't stay silent. @FoxNews might not fact-check him, but I will. I've reviewed the trials. I've catalogued them. I have receipts. 🧵 https://t.co/la6VmJk4Ww— Jake Scott, MD (@jakescottMD) June 13, 2025

He lies about vaccine safety every day. Vaccine makers — are silent. They let it happen. Cowards. And yes, I’m talking about Merck, Pfizer, GSK, Sanofi, J&J. The biopharma industry acts like this is not their problem. It is! It’s time to stop the bullshit and defend vaccine… https://t.co/1lpp2WktHg— Adam Feuerstein ✡️ (@adamfeuerstein) June 12, 2025

Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease

https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-RSV-Vaccine-mRESVIA-in-Adults-Aged-1859-at-Increased-Risk-for-RSV-Disease/default.aspx

MRNA: 🤔
mRESVIA (mRNA-1345)

» PDUFA: June 12, 2025

» RSV in high-risk adults aged 18–59

» BLA

See the roundtable participants? Can you find anyone working on mRNA stuff? I can find several of them who are familiar with DC vaccine.

https://www.fda.gov/vaccines-blood-biologics/workshops-meetings-conferences-biologics/cell-and-gene-therapy-roundtable-06052025

FDA Cell and Gene Therapy Roundtable
June 5, 2025
Roundtable Participants



Jeff Allen, PhD
Present and CEO
Friends of Cancer Research

Ron Bartek
Co-founder and President
Friedreich's Ataxia Research Alliance

Allyson Berent, DVM, DACVIM
Chief Scientific Officer
Foundation for Angelman Syndrome Therapeutics
Co-Director
Angelman Syndrome Biomarker and Outcome Measure

Catherine Bollard, MBChB, MD
Senior Vice President and Chief Research Officer
Director, Center for Cancer and Immunology Research
Professor of Pediatrics and Immunology
Children's National and The George Washington University

Thomas Cahill, MD, PhD
Founder and Managing Partner
Newpath Partners

Andrew M. Cameron MD, PhD
Director
Department of Surgery
The Johns Hopkins University School of Medicine

Paula Cannon, PhD
Distinguished Professor of Microbiology and Immunology
Keck School of Medicine
University of Southern California

Terence R. Flotte, MD
Professor, Provost, Dean of UMass Chan Medical School
President, American Society of Gene and Cell Therapy

Charles A. Gersbach, PhD
John W. Strohbehn Distinguished Professor
Department of Biomedical Engineering
Director, Center for Advanced Genomic Technologies
Duke University

Bambi Grilley, RPh, CCRC, CCRP, CIP, RAC
Director, Clinical Research and Early Product Development
Center for Cell and Gene Therapy
Professor, Pediatrics
Baylor College of Medicine
Chief Regulatory Officer
International Society for Cell & Gene Therapy

Timothy Hunt, JD
Chief Executive Officer
Alliance for Regenerative Medicine

Carl H. June, MD
Richard W. Vague Professor in Immunotherapy
Department of Pathology and Laboratory Medicine
Director Center for Cellular Immunotherapies
Director, Parker Institute for Cancer Immunotherapy
Perelman School of Medicine
University of Pennsylvania
Smilow Center for Translational Research

Donald B. Kohn, MD
Distinguished Professor:
- Microbiology, Immunology and Molecular Genetics
- Pediatrics, Hematology/Oncology
- Molecular and Medical Pharmacology
University of California, Los Angeles



Brett Kopelan, MA
Executive Director
The Dystrophic Epidermolysis Bullosa Research Association of America

David Liu, PhD
Richard Merkin Professor and Director of the Merkin Institute for Transformative Technologies in Healthcare
Director of the Chemical Biology and Therapeutic Sciences Program
Core Institute Member and Vice-Chair of the Faculty, Broad Institute
Investigator, Howard Hughes Medical Institute
Thomas Dudley Cabot Professor of the Natural Sciences and Professor of Chemistry & Chemical Biology, Harvard University

Jayme Locke MD, MPH
Vice President, Medical Development Xenotransplantation
United Therapeutics

Crystal Mackall, MD
Ernest and Amelia Gallo Family Professor of Pediatrics and Medicine
Founding Director, Stanford Center for Cancer Cell Therapy
Director of the Parker Institute for Cancer Immunotherapy
Stanford University

Rachel McMinn, PhD
Founder and CEO
Neurogene

Sean J. Morrison, PhD
Investigator, Howard Hughes Medical Institute
Director, Children's Research Institute at UT Southwestern
University of Texas Southwestern Medical Center
Dallas, Texas
Chair of Public Policy Committee
International Society for Stem Cell Research

Terry Pirovolakis
CEO & Founder
Elpida Therapeutics

Vinayak Prasad, MD, MPH
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

Michelle Rengarajan, MD, PhD
Physician-Scientist and Attending Endocrinologist
Massachusetts General Hospital
Instructor in Medicine
Harvard Medical School

Shengdar Q. Tsai, PhD
Associate Member, Department of Hematology, St. Jude Children's Research Hospital
Co-chair, Steering Committee of NIH Somatic Cell Genome Editing Consortium

Fyodor Urnov, PhD
Professor of Molecular Therapeutics at University of California, Berkeley
Scientific Director at Innovative Genomics Institute

Nicole Verdun, MD
Super Office Director
Office of Therapeutic Products
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

More like

Gaslighting
Throwback to liberals wanting to GAS everyone that refused the COVID vaccine..

👀 pic.twitter.com/CLyFj1hB90— American AF 🇺🇸 (@iAnonPatriot) June 2, 2025

mRNA vaccines modified to include cytokine IL-12 enhance T cell response

https://medicalxpress.com/news/2025-06-mrna-vaccines-cytokine-il-cell.html

Thanks.

Breakthrough vaccine could eradicate breast cancer, shows 75% immune response in trial

https://nypost.com/2025/06/07/us-news/breakthrough-vaccine-could-eradicate-breast-cancer-by-2030/

$ANIX

Moderna at Jefferies Conference: Strategic Growth and Challenges:

https://www.investing.com/news/transcripts/moderna-at-jefferies-conference-strategic-growth-and-challenges-93CH-4083646

What is it about parasites and cancer

Other than

https://needtoknow.news/wp-content/uploads/2024/10/Patient-cured-is-a-customer-lost.jpg

Red clover, green walnut hull extract and

Sweet wormwood, which has the same action as Ivermectin

Getting rid of parasites and cure cancer using natural ingredients - Dr Bryan Ardis

Tumors don't have chance to adapt if DCs can present hundreds of tumor-associated antigens to immune system.

Cancer cells can mutate in real time to evade treatment as well [1,2]. In this, 17% innately have HLA LOH [3], but other papers put it (much) higher.

Also, many TAAs are self-antigens. As a result of negative selection, to prevent autoimmunity, any T-cell that is able to target a TAA will express a TCR with a low affinity. But TCRs with high affinity (for TAAs) are required for efficient antitumour immunity [4]. This is why ADAP (and other companies) do what they do.

The current issue is that with massive t-cell infiltration into tumor site comes tumor-associated macropahges which can be depleted by CSF1R inhibitor.

CD163hi macrophages are resistant to CSF-1(R) targeted therapies, and drive both primary and secondary immune resistance. We know that clinical trials testing CSF-1(R) targeted therapies have shown poor results to date, and that CSF-1R+ macrophages can be positively associated with response [5].

The CD163hi macrophage issue is so minor in comparison of massive and sustainable t-cell infiltration triggered by DCVax-L.

High frequency of CD163hi macrophages correlates with higher risk of relapse, predicts poor response to ICI, and poor survival across different (sub)types of cancer.

CD163hi macrophages were also infiltrating two progressing lesions in the patient I talked after she received tens of billions of TCR-T cells (plus an anti-PD-1).

Refs:
1 https://www.nejm.org/doi/full/10.1056/NEJMoa1609279
2 https://aacrjournals.org/cancerimmunolres/article/10/8/932/707173/Adoptive-Cellular-Therapy-with-Autologous-Tumor
3 https://aacrjournals.org/cancerdiscovery/article/11/2/282/2772/Somatic-HLA-Class-I-Loss-Is-a-Widespread-Mechanism
4 https://academic.oup.com/cei/article/180/2/255/6422173
5 https://jitc.bmj.com/content/10/5/e003890

Good writing$

$MRNA

Tumors don't have chance to adapt if DCs can present hundreds of tumor-associated antigens to immune system. The current issue is that with massive t-cell infiltration into tumor site comes tumor-associated macropahges which can be depleted by CSF1R inhibitor. The CD163hi macrophage issue is so minor in comparison of massive and sustainable t-cell infiltration triggered by DCVax-L.

As said, CD163hi macrophages are able to suppress T-cells, even large numbers (billions upon billions) after adoptive transfer. A second progressing lesion (smaller) in the same patient contained a neutrophil infiltrate as well as CD163hi macrophages showing that tumours don't rely on one mechanism (of suppression) - they adapt.

Moderna will not and should not be the one that Merck will pin its future on.

BTW, did you see Baker Brothers investing anything related to mRNA stuff?

You need to digest all the papers I presented to you. IOVA has pretty dire future. Don't even think about there is a BO from Merck. It is a pipe dream. Merck has seen much better.

Why should he? You can't. Maybe dstock should practice what he preaches.

I don't have time for lengthy nonsense. Make it short. Can you read something and condesne it in words every lay person can understand?

You should know that CD163 only accounts for small population and they cannot suppress massive number of t-cells.

Based on the literature CD163hi macrophages are able to suppress T-cells.

In this paper, two HLA-matched patients with metastatic pancreatic ductal adenocarcinoma were treated with a TCR-T cell therapy (the TCRs came from a patient who responded to TIL therapy) [1].

In one patient, who had lung mets only, experienced a durable partial response after receiving 16.2 billion TCR-T cells. Looking into why therapy was more successful, one reason was due to the phenotype of the T-cells (CD45RO+CD103+CD69+CD49a+, so memory and tissue-resident).

However, after about a year, she showed slow progression. Dr. Tran has gone on to give more info at different medical/scientific conferences. She got a second infusion of TCR-T cells (that were more potent) plus an anti-PD-1. Looking at efficacy, at three months she had stable disease (~25% reduction by RECIST) and a six month scan showed stable disease as well. There were regressions of some lesions, but when comparing the scans (three months vs. six months) there was some growth in other lesions. At time they were thinking about the next steps.

Looking at two progressing lesions, the first genetically expressed the HLA and targeted antigen. It contained transduced T-cells as well, with the cells preferentially expressing TIM3, TIGIT, CD25 and IL7RA, suggestive of antigen encounter. It also displayed a high infiltration of non-transduced T-cells and CD163hi macrophages, often intimately co-localised with each other, both with the transduced and non-transduced T-cells.

As for the second progressing lesion (smaller), it contained a neutrophil infiltrate as well as CD163hi macrophages. Based on this, they are trying to further characterise what (neo)antigens might be recognised by the non-transduced T-cells in one of the progressing lesions. In addition, undertaking single-cell transcriptomics of infusion products and peripheral blood samples, and deeper molecular studies on tumour sections.

Merck makes the collaboration with Moderna look so real just like Merck signed the deal with Daiichi on three ADCs.

The first deal was in 2016. Under the terms of the agreement, MRK made an upfront cash payment to MRNA of $200 million. That was expanded in 2017 and amended in 2018, before MRK exercised its option to jointly develop and commercialise MRNA's vaccine in 2022. For the latter, MRK paid MRNA $250 million upfront. Now additional trials are planned.

Targeting for several neoantigens may have efficacy for a certain percentage of hot tumors.

MRNA's vaccine encodes up to 34 patient-specific neoantigens.

But it lacks of efficacy in treating cold tumors.

Autogene cevumeran (which encodes up to 20 patient-specific neoantigens), jointly developed by BNTX and RHHBY's Genentech, continues to show poly-specific T-cell responses and delayed tumour recurrence in patients with resected pancreatic ductal adenocarcinoma [2].

Based on the data, a randomised PhII trial is ongoing. Other randomised PhII trials, including in adjuvant CRC are ongoing as well.

If I am not mistaken, the trials between Merck and Moderna only target hot tumor.

So far, but MRNA's CEO has talked about testing the vaccine in ''cold'' tumours, including resected pancreatic ductal adenocarcinoma.

Refs:
1 https://www.nejm.org/doi/full/10.1056/NEJMoa2119662
2 https://www.nature.com/articles/s41586-024-08508-4

$MLTX $MRK Merck held talks to buy Swiss biotech MoonLake Immunotherapeutics for more than $3bn

https://www.ft.com/content/5899ea69-e5fe-49f1-8ada-79f26c9254d8

Merck Stock’s Ticking Keytruda Time Bomb

https://www.forbes.com/sites/greatspeculations/2025/06/02/merck-stocks-ticking-keytruda-time-bomb/

$MKR

For now, it looks very real. IMO, that's exactly the impression Merck wants. If Merck can abandon something after spending $1.6b, Merck can abandon Moderna.

On May 14, 2025 - Merck & Co., Inc. filed a 13F-HR form disclosing ownership of 2,308,190 shares of Moderna, Inc. (US:MRNA) valued at $65,437,186 USD as of March 31, 2025. The entity filed a previous 13F-HR on February 14, 2025 disclosing 2,308,190 shares of Moderna, Inc.. This represents a change in shares of 0.00% during the quarter. The current value of the position is $61,305,526 USD.

https://fintel.io/so/us/mrna/merck

it's written on the wall

Never say it's impossible. Everything is possible.

https://www.fiercebiotech.com/biotech/seagan-puts-16b-merck-partnered-adc-back-burner

GREAT : Requests for #BioShield to @cssifm has been incredible - a desperate need. Team working hard to respond to every #Cancer request. Each page represents a single patient request, now in the 1000s, working w/ FDA on Expanded Access @DrMakaryFDA @RobertKennedyJr @realDonaldTrump pic.twitter.com/DX4gaH91p1— Dr. Pat Soon-Shiong (@DrPatSoonShiong) May 30, 2025

$IBRX

$MRNA it's impossible

mNEXSPIKE becomes Moderna's third FDA-approved product


https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-COVID-19-Vaccine-mNEXSPIKE/default.aspx

You should know that CD163 only accounts for small population and they cannot suppress massive number of t-cells.

Merck makes the collaboration with Moderna look so real just like Merck signed the deal with Daiichi on three ADCs.See the comparison between Neoadjuvant PD1 inhibitor treatment and Moderna neoantigen therapy? Tell me which one has better results. Targeting for several neoantigens may have efficacy for a certain percentage of hot tumors. But it lacks of efficacy in treating cold tumors. If I am not mistaken, the trials between Merck and Moderna only target hot tumor.

It is not a matter of 50/50 partnership. If Merck terminates the partnership, Moderna's future becomes dire.Let's see if this will happen in one year or two.

BTW, it is a good idea to picture the scenario that Merck will decouple with Moderna sometime soon.

Under the current collaboration, the two companies share the costs and any potential profits equally under the collaboration—a true 50/50 partnership.

Can DCVax-L activate NK cells to eliminate cancer cells

Even if true, cancer cells can shed MICA/B as a mechanism to evade immune surveillance [1]. They can also downregulate NKG2DLs [2-3]. On top of this, TGF-b signaling converts NKs into (intermediate) type 1 innate lymphoid cells [4]. I could go on.

Can we expect a cure for cancer once CSF1R inhibitor is included?

There are TAM (sub)populations that are either less sensitive or resistant to CSF-1(R) targeted therapies. In this paper, they show that CD163hi macrophages are resistant to CSF-1 targeted therapy, and drive both primary and secondary resistance [5]. High frequency correlates with higher risk of relapse [6], predicts poor response to ICI [7], and poor survival [8-12].

BTW, it is a good idea to picture the scenario that Merck will decouple with Moderna sometime soon.

Additional trials testing MRNA's personalised neoantigen vaccine with MRK's Keytruda are planned.

Refs:
1 https://pubmed.ncbi.nlm.nih.gov/33363734/
2 https://molecular-cancer.biomedcentral.com/articles/10.1186/s12943-019-0956-8
3 https://www.mdpi.com/2072-6694/12/12/3827
4 https://www.nature.com/articles/ni.3800
5 https://jitc.bmj.com/content/11/3/e006433
6 https://pubmed.ncbi.nlm.nih.gov/32082570/
7 https://www.cell.com/cell/fulltext/S0092-8674(16)30215-X
8 https://wjso.biomedcentral.com/articles/10.1186/s12957-021-02299-y
9 https://www.nature.com/articles/bjc2014446
10 https://bmccancer.biomedcentral.com/articles/10.1186/1471-2407-12-306
11 https://www.oncotarget.com/article/15736/text/
12 https://www.oncotarget.com/article/20244/text/

Which makes you think it is huge?

Can DCVax-L activate NK cells to eliminate cancer cells? Sure can. See those Tscm cells activated by DCVax-L? These cells are essential for immune memory.

Those CD14 monocytes will differentiate into macrophages once seeping into tumor tissue and the macrophages will suppress t-cells. But CSF1R inhibitor will prevent the differentiation. Can we expect a cure for cancer once CSF1R inhibitor is included?

BTW, it is a good idea to picture the scenario that Merck will decouple with Moderna sometime soon.

This is so Huge, Anktiva Cancer Treatment/Cure, No more Burning Radiation, No more Rat Poison Chemo, this has got to be a Top subject FDA Every Day....

$IBRX
Unlike conventional treatments including chemotherapy and radiation that kill and suppress natural killer immune cells and thus paradoxically catalyze further spread, the BioShield protects and activates the immune system’s natural killer cells and T cells to restore immune function and prolong life.


https://www.biospace.com/press-releases/immunitybio-saudi-arabias-ministry-of-investment-kfshrc-and-kaimrc-sign-strategic-memorandum-of-understanding-to-launch-cancer-bioshield-platform-in-the-middle-east

Moderna to Present at Upcoming Conferences in June 2025

Jefferies Global Health Care Conference, on Thursday, June 5th at 10:30am ET

Goldman Sachs 46th Annual Global Healthcare Conference, on Wednesday, June 11th at 8:40am ET

https://investors.modernatx.com/news/news-details/2025/Moderna-to-Present-at-Upcoming-Conferences-in-June-2025/default.aspx

It is clear that information sources

Are highly correlated with public opinion

Are the sources themselves

Responsible for forming public opinion

Or

Could the direction of causation be the inverse

With people seeking out sources

That conform to their preexisting biases

Irreconcilable documentary

I got it. I do wish I hadn’t. Had a blip on my EKG that was either vaccine related or covid. It corrected itself. I got two shots of Moderna and what I do think it caused is papular urticaria that I cannot get rid of. It’s subsided almost entirely from when it first came up but…— Michelle (@BFL_Michelle) May 22, 2025 $MRNA

Next-generation COVID-19 vaccine: Moderna shared pivotal safety, immunogenicity and relative vaccine efficacy data for its next-generation COVID-19 vaccine (mRNA-1283) at the Advisory Committee on Immunization Practices meeting in April 2025. The Company filed for regulatory approval of mRNA-1283 with the FDA using a priority review voucher in 2024. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 31, 2025.

Respiratory syncytial virus (RSV) vaccine: The Company recently shared positive Phase 3 data for its RSV vaccine (mRNA-1345) in high-risk adults aged 18-59 at the ESCMID 2025 Global Congress. Moderna filed for regulatory approval of mRNA-1345 for high-risk adults with the FDA using a priority review voucher in 2024. The FDA has assigned a PDUFA goal date of June 12, 2025.

What we know about the safety, efficacy of mRNA vaccines amid recent scrutiny

Infectious disease experts told ABC News that mRNA and mRNA vaccines have been studied for decades, the vaccines are safe and effective, and that the shots were instrumental in saving lives during the COVID-19 pandemic.

“Here’s the bottom line: mRNA vaccines for COVID, according to estimates from Yale School of Public Health, saved 3.2 million lives,” Dr. Peter Hotez, a professor of pediatrics and molecular virology at Baylor College of Medicine in Houston, told ABC News.

“So instead of 1.2 million Americans who lost their life because of COVID, it would have been a 4.4 million,” he added. “So, I think it's unfortunate that anti-vaccine activists target mRNA vaccines like they do, but it is a good technology.”

https://abcnews.go.com/Health/safety-efficacy-mrna-vaccines-amid-recent-scrutiny/story?id=122068940

They are developing a next generation anti-PD-L1 t-haNK cell line equipped with inducible safety switch features to remove the need for irradiation. Also, modifications that could limit rejection after infusion, as well as cytokine-induced memory-like expansion.

Personally, I think they should have switched some years ago to developing iPSC-derived CAR (and/or TCR) cell therapies. One benefit of using iPSCs is that the cell lines can be differentiated into any cell type of the body.

Neoantigen enriched biomimetic nanovaccine for personalized cancer immunotherapy

https://www.nature.com/articles/s41467-025-59977-8

Has the company survived on OTC for almost ten years while reaching one milestone after another? Dilution is the least thing that we should care about. All we need to care about is whether the technology is truly revolutionary.

BTW, is it a small thing that an OTC company will give a presentation at such a prestigious conference at NYAS? You would agree that George Zavoico should have much better foresight about $NWBO than most people in biotech business, would you not?

https://events.nyas.org/event/cbf0a499-91ad-45b2-bd87-c5a81fe38810/agenda



https://events.nyas.org/event/cbf0a499-91ad-45b2-bd87-c5a81fe38810/summary

there is a problem, little cash attracts dilution!

Data don't lie! I don't trust people. I only trust data.

$NWBO "bright future"

Company intends to submit Biologic License Application (BLA) for the indication of reversal of lymphopenia in patients receiving standard-of-care chemotherapy and/or radiation and for the treatment of locally advanced or metastatic pancreatic cancer which includes the first-in-class CAR-NK (PD-L1 t-haNK)

https://www.onclive.com/view/nogapendekin-alfa-inbakicept-car-nk-wins-fda-rmat-designation-for-lymphopenia-reversal-in-metastatic-pancreatic-cancer

https://immunitybio.com/immunitybio-receives-fda-rmat-designation-for-anktiva-and-car-nk-for-the-reversal-of-lymphopenia-in-patients-receiving-standard-of-care-chemotherapy-radiotherapy-and-in-treatment-of-multiply-rel/

$home run