David Meyer Oxley

Biotechnology professional tweets are strictly my own. #ADC, #bispecifics, #multivalent design in oncology

[David Meyer Oxley @CellularMedici2]

https://t.co/zI2pKkxzOL

[David Meyer Oxley @CellularMedici2]

Agree. A complement to blocking the sensor: restore the brain’s own clearance. Activating ABCC1 (MRP1) efflux clears amyloid-β and moderates upstream cGAS-STING inflammation, lowering Aβ, inflammation & p-tau together. Oral, non-immunogenic. (We’re building this at https://t.co/IK9yUvRqHh.)

[David Meyer Oxley @CellularMedici2]

@Billb1962bBoy @LoriMills4CA42 @bullishbruk Wisdom that should be amplified. Blocking that butthead is healthy.

[David Meyer Oxley @CellularMedici2]

@LoriMills4CA42 @bullishbruk That’s easy; he is or represents the short position. It’s his MO.

[David Meyer Oxley @CellularMedici2]

Eric, thank you for this very helpful framework calling for biomarker-directed, immunome-aware immunotherapy directed at the minimal residual disease setting or curative window in solid tumor disease. It maps directly onto a personalized, whole-tumor-derived autologous platform that is further along than most contemporary reviews reflected in your mRNA and peptide programs sponsored by Moderna, BioNTech, Genentech and Roche:

OncoVAX, an autologous tumor-derived cancer vaccine immunotherapy in the MRD setting of solid tumors. The randomized Phase III (Vermorken et al., Lancet, n=254) outcomes in resected Stage II colon cancer showed a 61 % reduction in recurrence (95 % CI 18 to 81, p=0.011) and significantly prolonged (15 years) recurrence-free interval from three induction doses plus one 6-month booster of the patient's own irradiated tumor cells plus BCG. No chemo, no ICI. Safe, potent and durable intervention. Commonsense.

This personalized approach leverages the patient's own resected tumor, irradiated and combined with BCG to train the patient’s immune system to the complete antigen landscape, including subclonal neoantigens that in silico prediction cannot pre-specify. From tumor resection to outpatient vaccination within 60 hours, compared with the roughly 2-month neoantigen-to-vial cycle described for personalized mRNA.

OncoVAX is directly responsive to the biomarker question you raise. Long-term retrospective biomarker stratified analysis (de Weger et al., Clin Cancer Res 2012;18(3):882, doi:10.1158/1078-0432.CCR-11-1716) showed the benefit concentrates in microsatellite stable Stage II disease, which represents more than 80% of post-resected Stage II population with MSS, NO, MO T3 disease that do not respond to neoadjuvant chemo, or ICI. This is exactly the unmet need that the 40-year-old watch-and-wait strategy, including surgery, chemo, and ICIs, leaves behind.

OncoVAX holds FDA authorization to proceed with a 550-patient Special Protocol Assessment and Fast Track-designated pivotal trial (NCT02448173). This registration-enabled pivotal is 1:1 RCT in resected Stage II colon cancer, with disease-free interval as the primary endpoint. This is registration ready, not hypothesis generating.

Your framing of drug development that is moving from chasing metastatic disease to prevention in the minimal residual disease setting of solid tumor disease is exactly the framing OncoVAX has occupied since the first NCI Director in Frederick, Mike Hanna, and his team designed for OncoVAX, which is now close to a BLA pathway and patient access to an affordable, potent, and durable colon cancer recurrence prevention tool.

Including completed Phase III autologous whole tumor cancer vaccine immunotherapy makes your landscape more complete and the patient menu broader. We are sharing more at ASCO in Chicago and at BIO26 in SD. We welcome an offline discussion if you care.

Humbly,
David
[email protected]
Frederick, Maryland

[David Meyer Oxley @CellularMedici2]

Thank you for this comprehensive survey; one mechanistic category is absent and worth understanding on its own terms:

Autologous, truly personalized, whole-tumor derived cancer vaccine immunotherapy in the adjuvant curative window. Completed Phase III data, NCI origin, and an FDA-authorized 550-patient registration-enabled pivotal trial with SPA and Fast Track designations pending enrollment.

The omitted dataset: OncoVAX pivotal Phase III (Vermorken et al., The Lancet, n=254) in resected Stage II colon cancer. 61% reduction in recurrence (95% CI 18 to 81, p=0.011) and significantly prolonged recurrence free interval from three induction doses plus one 6 month booster of the patient's own irradiated tumor cells. No chemo.

Mechanism is distinct from mRNA and peptide neoantigen platforms. Leverages the patient's entire resected tumor, rendered non-tumorigenic by irradiation together with an immune stimulant called BCG to present the patient’s immune system with the full polyclonal antigen landscape, including subclonal neoantigens that in silico prediction cannot pre-specify. Two day manufacturing, no LNP, and no SAEs.

The clinically important refinement is the long term biomarker stratified; de Weger et al., Clin Cancer Res;18(3):882, doi: 10.1158/1078-0432.CCR-11-1716). In the OncoVAX cohort follow-up, the benefit was concentrated in microsatellite-stable Stage II disease, which comprises the vast majority (80% +) of early-stage tumors cold tumors that do not respond to checkpoint inhibitors. Durable RFI separation persisted on long-term Kaplan Meier follow-up.

Regulatory standing. OncoVAX holds FDA Special Protocol Assessment and Fast Track designation. The confirmatory pivotal trial ACTIVE (NCT02448173) is a 550 patient 1:1 RCT in resected Stage II colon cancer, disease free interval as the primary endpoint. Registration ready, not hypothesis generating.

The new wave of mRNA and peptide cancer vaccines is being introduced to a public and a clinical community that has lived through the COVID LNP mRNA experience. A non-mRNA, non-peptide, non-nanoparticle modality with three decades of randomized data, strong safety profile and autologous components deserves a visible place on the menu.

Your central framing of interception, the curative window, and moving immunotherapy earlier is exactly the framing this modality has occupied with an origin story at NCI under the directorship of Mike Hanna.
The new wave of mRNA OncoVAX holds FDA Special Protocol Assessment and Fast Track designation. The confirmatory pivotal trial ACTIVE (NCT02448173) is a 550-patient 1:1 RCT in resected Stage II colon cancer, with disease-free interval as the primary endpoint. Registration ready, not hypothesis generating.ting.erating.on the menu.

[David Meyer Oxley @CellularMedici2]

Interesting seeing cancer vaccines suddenly framed as a breakthrough frontier when the National Cancer Institute was involved in developing and advancing autologous vaccine strategies decades ago.

OncoVAX phase III data in resected stage II colon cancer demonstrated a 61% reduction in recurrence risk, with durable benefit extending out to ~15 years after essentially a one-time adjuvant treatment approach. Yet instead of becoming a priority platform, the field largely pivoted toward chronic high-cost therapeutics.

Patients deserve to know that effective cancer immunotherapy did not begin with today’s mRNA narratives or venture-funded hype cycle.

Some of the most compelling recurrence-prevention data in oncology came from individualized tumor-cell vaccines designed to generate the required polyclonal response needed to prevent metastatic spread before it starts, not simply treat late-stage disease after recurrence.

[David Meyer Oxley @CellularMedici2]

https://t.co/kElj4AqntG

[David Meyer Oxley @CellularMedici2]

Cancer is a heterogeneous disease. A solid tumor is not one clump of identical cells. It is a population of thousands of genetically distinct clones and subclones, each presenting a distinct antigenic profile, each evolving in real time to evade the immune system.

As Trump 47 Administration leader, Dr. Ben Carson said during his tenure as Chairman at the Maryland-based small business, Vaccinogen, A heterogeneous disease must be treated with commonsense heterogeneous therapy, which is why I chose to join Vaccinogen.

The Big Pharma homogeneous drug development strategy is why more than 50 cancer vaccines have failed over the past three decades. Every one of them aimed at a single curated target — one antigen, one peptide panel, one engineered epitope. Nature builds tumors that defeat any one weapon. And nature has been winning that fight for 30 years.

There is one cancer vaccine in America today built on a different principle. It is called OncoVAX®. It is made from the patient's own resected tumor and presents the complete antigenic landscape — the full malignant population — to the patient's own immune system. A heterogeneous, personalized therapy for a heterogeneous, personalized disease.

This is not a foreign idea. The scientific lineage traces directly to the National Cancer Institute. Dr. Michael G. Hanna, Jr., the first appointed Director of the NCI Frederick Cancer Research Center under President Nixon's War on Cancer, has advanced this NCI-originated program for more than 40 years. It is American science, built in America, for American patients.

The randomized Phase III evidence, published in The Lancet (Vermorken et al.):

• 254 Stage II/III colon cancer patients, randomized to surgery alone vs. surgery + OncoVAX®
• 61% reduction in recurrence risk in the Stage II subgroup (95% CI 18–81; p = 0.011)
• Validated at 15-year follow-up by de Weger et al., Clinical Cancer Research — hazard ratio 0.57 in the microsatellite-stable Stage II subgroup (p = 0.027)
• A simple and low-cost personalized cancer recurrence prevention medicine delivered in the outpatient setting. No serious treatment-related adverse events.

This is the most durable solid-tumor recurrence-prevention outcome ever recorded in a Phase III dataset.

Now look at who needs it. More than 80% of Stage II colon cancers in this country are microsatellite-stable. For these patients:

• costly and toxic PD-1 / CTLA-4 checkpoint blockade does NOT work — the tumor microenvironment is immunologically "cold"
• Adjuvant FOLFOX / CAPOX chemotherapy delivers <5% absolute disease-free survival benefit and ZERO overall survival benefit
• Engineered neoantigen mRNA vaccines lack the antigenic breadth to address tumor heterogeneity and have no longer term safety reported. This is especially important following the COVID mRNA vaccines developed by Big Pharma
• There is ZERO FDA-approved adjuvant immunotherapy

>80% of newly diagnosed Stage II patients are sent home to wait and watch. 25–35% will recur within five years as Stage IV metastatic disease. Most will not survive.

Colon cancer is now the leading cause of cancer death in Americans under 50. Three out of four cases in younger adults are caught at an advanced stage. These are not your grandparents' patients — these are working professionals in their 30s and 40s, with families, with futures.

The path forward is already built. OncoVAX® holds an FDA Special Protocol Assessment and Fast Track designation for a 550-patient pivotal trial (NCT02448173). The trial is operationally ready for first-patient enrollment in 2026. Manufacturing is U.S.-based and FDA-authorized. A Data Safety Monitoring Board interim is pre-specified for accelerated BLA potential by 2029.

American-developed. American-manufactured. NCI-originated. FDA-authorized. Ready to enroll patients in 2026.

This is what common-sense medicine looks like: a heterogeneous, personalized weapon for a heterogeneous, personalized disease. Built in Frederick, Maryland. Grounded in the NCI's own four-decade scientific record. Aligned with every priority of the NCI Cancer Vaccine Roadmap, the MAHA agenda, and the MFN America-First framework.

The patients deserve this choice. The data support it. The American manufacturing and clinical infrastructure already exists. The only thing missing is the decision.

@realDonaldTrump @POTUS @SecKennedy @FDA_KyleD @NCIDirector @theNCI @NIHDirector_Jay @DrOzCMS @HHSGov @SusieWiles47 @WhiteHouse @VP @JDVance @RapidResponse47 @elonmusk

#MAHA #MFN #ColonCancer #CommonSenseMedicine #CancerVaccine #AmericaFirst

[David Meyer Oxley @CellularMedici2]

@NCIDirector @RobertKennedyJr @NIHDirector_Jay @realDonaldTrump @DonaldJTrumpJr @EricTrump

For decades, oncology economics have rewarded treatments costing hundreds of thousands of dollars per patient annually, while transformative “one-and-done” immunotherapy platforms have received little federal attention or funding.

Former NCI Director Dr. Mike Hanna pioneered the only polyclonal cancer immunotherapy platform through Vaccinogen — a program that our 47 Administration’s own Dr. Ben Carson knows well from his time as Vaccinogen chairman prior to his presidential campaign.

Colon cancer patients deserve access to shovel-ready, low-cost, durable recurrence-prevention therapy with strong long-term safety data and published Phase III outcomes — Vaccinogen’s OncoVAX, which demonstrated a 61% reduction in recurrence and 15 years of durability as published in The Lancet and positioned to begin a pivotal trial in 2026 if you select OncoVAX for your stage 1 platform selection for PPP that you announce in June with a Frederick, Maryland based small business.

Yet your NCI’s new $200 million cancer vaccine initiative appears heavily weighted toward mRNA and peptide technologies that remain controversial and very early-stage in oncology, with no long-term safety and durability data compared with more established autologous immune-based approaches, like commonsense OncoVAX.

At the same time, major pharmaceutical mRNA platforms are increasingly being recommended and prioritized based on far less oncology-specific data, despite ongoing unanswered questions regarding long-term durability, safety, and other mRNA-associated unknowns that still warrant careful scientific scrutiny.

Americans deserve a transparent and scientifically rigorous review of all credible cancer technologies — especially those with the potential to dramatically reduce both metastatic disease burden and overall healthcare costs.

The question you should ask is: “Which platform gives patients the proven late clinical stage data generated best chance at durable survival and prevention of recurrence and is the therapy commonsense, cost effective, addressing an unmet need and safe!

If federal agencies knowingly sideline credible small-business innovations like Vaccinogen in favor of politically connected mRNA platforms from Moderna or BioNTech without a fair scientific review, the American people will rightly view it as a profound failure of public trust that demands DOJ scrutiny and accountability.

[David Meyer Oxley @CellularMedici2]

Patients deserve access to low-cost treatments that could prevent cancer spread for 15+ years, not just expensive drugs designed to chase metastatic disease after it appears. Today’s oncology system rewards therapies costing hundreds of thousands per patient each year, while potential long-duration or one-time treatment approaches receive little serious evaluation. And yet, sadly, your HHS looks the other way when the solution is right at the end of your nose.

A fraction of that cost could potentially fund durable cancer prevention strategies and transformative “one-and-done” therapeutic platforms. Yet no one within your @HHS appears willing to rigorously investigate these possibilities. Americans deserve an honest review of all credible cancer technologies — not just the ones that fit the current pharmaceutical business model.

[David Meyer Oxley @CellularMedici2]

Big Pharma will not develop medicines to prevent the spread of cancer for one reason: they make far more money chasing it after it spreads. FACT.

My small business generated Phase II and Phase III clinical trial outcomes showing OncoVAX cuts the recurrence of colon cancer by 61%, with a durable benefit extending beyond 15 years from a single course of four outpatient shots. Highly effective, low-cost world-class medicine that does the job.

OncoVAX is common-sense medicine:
✅ Great for the patient.
✅ Good for the healthcare system.
✅ Great for the American taxpayer.
❌ Bad for Big Pharma cash flow and shareholder dividend schedules.

And that is why America has not stopped the spread of cancer. Not because we don't know how. Because Big Pharma balance sheets cannot survive a one-and-done cure. CEOs who run the world’s largest drug development companies would have to change the way that they think about drug development, and their multi-million dollar pay packages would suffer from the change.

The science of solid tumor cancer is not complicated. Train the patient's own immune system to see the entire cancer landscape and it will destroy the residual disease the surgeon left behind. Solid tumors are heterogeneous, meaning the cancer is far more than the visible mass on the scan. As Dr. Ben Carson once famously said, "You can’t treat a heterogeneous disease with homogeneous medicine." Single-target drugs will never cure cancer, no matter how sophisticated.

That is the entire story of late-stage cancer in America. And it is exactly the asymmetry that President @realDonaldTrump's MFN order and @SecKennedy's MAHA agenda were built to end.

But no one with a science degree or an MD inside this @WhiteHouse, or on the @WHFraudTF, gives the question two seconds of attention. FACT @SusieWiles47.

If the President knew this, heads would roll. The indifferent senior healthcare policy staffers, too busy attending pharma cocktail parties around the swamp, too worried about offending the same Big Pharma lobbyists the President himself just put on notice, would finally have to make something happen. And for the first time in the history of America's war on cancer, patients would actually receive common-sense medicines at prices every American could afford.

FACTS. But sadly, cowards don’t like them. And shortimers in the 47 Administration couldn't care less. @hubermanlab, @LauraLoomer, @elonmusk, @america

[David Meyer Oxley @CellularMedici2]

Big Pharma doesn't develop medicines to prevent the spread of cancer for one reason: they make far more money chasing it after it spreads. FACT!

My small business generated a Phase III clinical trial outcome showing that OncoVAX reduces the recurrence of colon cancer by 61% at 5.3 years, with a durable benefit extending beyond 15 years from a single course of four outpatient shots.

OncoVAX is common-sense medicine:

✅ Good for the patient.
✅ Good for the healthcare system.
✅ Good for the American taxpayer.
❌ Bad for Big Pharma cash flow and shareholder dividends.

And this is why we have not stopped the spread of most cancers in America. Not because we don’t know how but because of the profits that letting it spread reward to those with business models focused on making money from patients and not curing disease. FACT!

That is the entire story of late-stage cancer in America. And it is exactly the asymmetry that President @realDonaldTrump's MFN order and @SecKennedy's MAHA agenda were built to end. But, no one with a science degree or MD degree in this @WhiteHouse, or @WHFraudTF gives the question two seconds of time and attention. FACT!

If the President knew this, heads would rolls, indifferent senior staffers too worried about pissing off big drug development would make stuff happen to change it and for the first time in the history of cancer killing, patients would experience commonsense medicines at prices all could afford.

FACTS

[David Meyer Oxley @CellularMedici2]

And the same group of public and private sector actors are pushing mRNA vaccines for cancer! Right under the nose of HHS @SecKennedy while he acknowledges the harms of the COVID mRNA.

I have a front row seat on a public-private sector advisory committee who are engineering a $200 m giveaway to big pharma!

I'm watching it play our and no one is trying to prevent it. Total taxpayer scam👎

[David Meyer Oxley @CellularMedici2]

And the same group of public and private sector actors are pushing mRNA vaccines for cancer! Right under the nose of HHS @SecKennedy while he acknowledges the harms of the COVID mRNA.

I have a front row seat on a public-private sector advisory committee who are engineering a $200 m giveaway to big pharma!

I'm watching it play our and no one is trying to prevent it. Total taxpayer scam👎

[David Meyer Oxley @CellularMedici2]

And the same group of public and private sector actors are pushing mRNA vaccines for cancer! Right under the nose of HHS @SecKennedy while he acknowledges the harms of the COVID mRNA.

I have a front row seat on a public-private sector advisory committee who are engineering a $200 m giveaway to big pharma!

I'm watching it play our and no one is trying to prevent it. Total taxpayer scam👎

[David Meyer Oxley @CellularMedici2]

Well said! And the same group of public and private sector actors are pushing mRNA vaccines for cancer! Right under the nose of HHS @SecKennedy while he acknowledges the harms of the COVID mRNA.

I have a front row seat on a public-private sector advisory committee who are engineering a $200 m giveaway to big pharma!

I'm watching it play our and no one is trying to prevent it. Total taxpayer scam👎

[David Meyer Oxley @CellularMedici2]

And the same group of public and private sector actors are pushing mRNA vaccines for cancer! Right under the nose of HHS @SecKennedy while he acknowledges the harms of the COVID mRNA.

I have a front row seat on a public-private sector advisory committee who are engineering a $200 m giveaway to big pharma!

I'm watching it play our and no one is trying to prevent it. Total taxpayer scam����

[David Meyer Oxley @CellularMedici2]

America-First Cancer Policy: Why Are We Still Paying to Chase Cancer Instead of Stop It?

The @FDA_KyleD just approved a Roche drug called Tecentriq for bladder cancer patients whose disease has come back at a molecular level after surgery.

The trial that earned FDA approval enrolled 250 patients. The benefit was modest: patients on the drug went 9.9 months before their cancer was detectable again, versus 4.8 months on placebo. To get that benefit, patients receive a year of hospital-based intravenous infusions that carry serious side effects, including the immune system attacking their own organs. The list price exceeds $200,000 per patient per year.

Roche is a Swiss company. American patients and American taxpayers will pay the highest price in the world for that drug, while patients in Switzerland, Germany, and the United Kingdom pay a fraction of what we do for the very same molecule. That is exactly the rip-off President Trump and Secretary Kennedy have said is over.

The One-Way Partnership Secretary Kennedy Called Out

For forty years, the deal between Washington and Big Pharma worked like this: the American taxpayer funded basic science through the National Institutes of Health. The American patient paid the highest drug prices on earth. The American taxpayer subsidized cheap drugs for Europe, Canada, Japan, and Australia. The profits went to a handful of multinational corporations, many of them headquartered outside the United States. This is the low-IQ deal-making that U.S. government bureaucrats of old made quietly with Big Pharma — exactly what we elected President @realDonaldTrump to put a stop to. And he is.

@SecKennedy and his common-sense leadership team have built on that order with seventeen voluntary MFN pricing agreements, the launch of TrumpRx for direct-to-consumer purchasing, and a December 1, 2025 trade agreement with the United Kingdom that raises what the UK pays for new American medicines by 25%. This is what happens when you apply common sense to public policy.

That is the new deal. This is a good deal. This is what winning can look like when you elect high-IQ, no-BS leaders and let them loose to MAGA. Americans stop overpaying. Foreign nations stop free-riding. And the savings get put back into the American patient.

But there is a second half of this fight that has not yet been joined, and it is the more important half.

The MAHA Question Nobody Is Asking Yet, But President Trump!

MAHA is not just about ingredients in food, dyes in cereal, or fluoride in water. Secretary Kennedy has framed the mission as ending the chronic disease epidemic in America. Cancer is the second-leading cause of death in this country, and colon cancer is now the leading cause of cancer death in Americans under 50 years old.

Why Not Target Cancer Prevention Over Chasing Costly and Toxic Metastatic Disease

So the MAHA question for cancer is the same question MAHA asks about every other chronic disease: why is the entire legacy system built to treat cancer after it spreads instead of preventing it early when we can? That's as illogical and low-IQ as noticing your bedroom on fire and deciding to wait until the entire second floor is engulfed before calling the fire department.

How Solid Tumor Cancer Care Actually Works Today

If you are diagnosed with an early-stage solid tumor — colon, breast, lung, kidney — here is the playbook your oncologist follows. It has not changed in forty years.

Wait-and-Watch.

A surgeon removes the tumor that they can see. A pathologist looks at the tissue. If your lymph nodes are clean and there is no obvious spread, you are sent home. You get a scan once a year. You become part of the wait-and-watch patient cohort.

As a result of this failed wait-and-hope strategy, roughly 1 in 3 of you with early-stage cancer will have your cancer come back within 2–5 years. By the time it does, it has usually spread to the liver or the lungs. At that point, treatment from Big Pharma costs a fortune, the side effects are brutal, and most patients do not survive.

That's the failed watch-and-wait strategy of Big Pharma and low-IQ science: chasing the fire once the entire second floor is ablaze, when it could have been avoided.

What Wait-and-Watch Actually Costs American Families

A study published in October 2025 in a peer-reviewed American Association for Cancer Research journal looked at real U.S. insurance claims data from 2017 through 2023. In the first year alone after diagnosis, medical charges for patients whose colon cancer had already spread were $353,255. For patients whose cancer had not yet spread, the figure was $182,000. Nearly double. That was just year one.

A peer-reviewed review published in November 2025 confirmed that the drugs we use after cancer spreads, most of them branded products from the same multinationals President Trump just brought to the MFN negotiating table, are now the single biggest cost driver in late-stage colorectal cancer, and the bill climbs every year as more patients are diagnosed too late, after the kitchen fire has burned out the entire second floor and the water trucks are just being paid to prevent the neighbor's place from being torched.

In January 2026, the Colorectal Cancer Alliance, the largest U.S. nonprofit in this disease, announced that colon cancer is now the leading cause of cancer death in Americans under 50 years old. Three out of four cases in younger adults are caught at an advanced stage. Most will not survive. This isn't your grandparents’ disease; these are young working professionals in their prime earning years, dating, getting married, starting families, who suddenly must confront the potential loss of a 35+ year future and instead, focus on a t-minus 5 year time horizon.

Said bluntly: Wait-and-watch is the most expensive cancer strategy America has, and the American patient pays for it twice. Once at the pharmacy counter for late-stage drugs priced at international markups. Once at the funeral.

Imagine seeing a small kitchen fire on your stovetop and deciding to walk past it, go upstairs, and wait to see if it is out in the morning. The fire is small. The smoke alarm has not gone off yet. By the time it does, the house is in flames, the response costs a hundred times what the extinguisher would have cost, and the outcome is no longer in your control. No homeowner accepts that. No insurance company underwrites it.

But the failed 40-year-long wait-and-watch strategy is the standard of care for one out of three American colon cancer patients today. This doesn't make sense and lacks common sense. But this failed cancer policy makes billions for multinational pharma whose drugs spray water on an out-of-control house fire that will destroy the entire home. That is because it is not in their economic interest to prevent the fire in the first instance.

A Different Way, Designed by Common Sense and Made in America

Treat-to-prevent. A company called Vaccinogen spent several decades building a different kind of cancer medicine, not a foreign-priced drug to chase cancer after it spreads, but an American medicine designed to stop the spread before it happens.

Here is how it works. When the surgeon removes the tumor, a piece of that tissue is shipped to a U.S. manufacturing facility. The patient's own tumor cells are processed and combined with a low-cost immune priming agent that the FDA approved for bladder cancer more than thirty years ago. The result is delivered back to the patient as four outpatient shots over six months. The shots train the patient's own immune system to recognize and destroy the microscopic cancer cells, the invisible marbles, that the surgeon could not see.

It is, in plain terms, a personalized cancer medicine made from the patient, for the patient, manufactured in America. That's called common-sense medicine. And the completed randomized Phase III clinical data confirm this.

The medicine is called OncoVAX. OncoVAX takes aim at something called the minimal residual disease (MRD) setting in Stage II colon cancer, where roughly eight out of ten newly diagnosed Stage II patients for whom there is currently no FDA-approved medicine. That’s stupid, bad for patients, but good for Big Pharma.

What the Clinical Trials Actually Showed

A randomized Phase III trial enrolled 254 MRD Stage II colon cancer patients. Half got surgery alone. Half got surgery plus OncoVAX. The results were published in The Lancet, one of the most widely recognized medical journals on the planet and arguably the hardest to pass peer review.

The OncoVAX patients had a 61% lower risk of their cancer coming back. Roughly 80% of OncoVAX patients were cancer-free at five years. The durable effects of a single course of treatment persisted 15 years later. No cancer drug on the market, foreign or domestic, has ever demonstrated American-made OncoVAX durability. There were no serious treatment-related side effects. The full course of treatment was four outpatient shots and not a year of in-hospital toxic infusions with companion serious adverse events, and not a $200,000-per-patient-per-year cost burden on taxpayers.

Where Things Stand With The FDA

Unlike Roche’s drug, which the FDA just approved from a single, 250-patient trial, OncoVAX must now prosecute a second 550-patient study with a built-in early-stopping rule. If the new data look like the old data, patients could see approval as early as 2029.

Here is why this is a low-IQ, dumb approach: the second trial is projected to cost roughly $100 million and take four to five years from start to finish. During that wait, American colon cancer patients keep being sent home to wait and watch. And why would FDA approve a cancer medicine from a single non-randomized trial for a Big Pharma that will chase metastatic disease, but require a second trial from an American small business that delivered exceptional clinical outcomes from a randomized Phase III trial with more patients — a trial that clearly demonstrates we can prevent recurrence with common-sense medicine that lasts more than 15 years and costs the taxpayer a fraction, and I mean a fraction, of the cost of the drug approved to chase metastatic disease?

Why The Math Should Bother Every American

The FDA just granted Priority Review and approval to a $200,000-per-year Swiss drug that delays bladder cancer recurrence by five months in a 250 patient single trial. That is appropriate when it is the best available science. No quarrel with that decision.

But the same agency requires a $100 million, four-to-five-year confirmatory trial for an American-made medicine that, in a randomized 254-patient Phase III study published in The Lancet, cut colon cancer recurrence by 61%, delivered durable benefit measured in decades, costs a fraction of late-stage care, and produced no serious side effects?

One drug (Roche) chases the disease after it spreads, at a price set in Basel. The other (Vaccinogen, Inc.’s OncoVAX) was designed to stop it from spreading, at a price that can be set in America.

Guess which one moved faster through the system. As a businessman, when there is an equal playing field in drug development, I am confident that American innovators in science will end the flawed Big Pharma rip-off of the past and usher in real innovation that means cancer is no longer a death sentence. I would know, OncoVAX is my small business's common-sense approach, whose team believes in putting out a small kitchen fire with common sense rather than walking past it to head to bed and hoping that it is out in the morning.

My story is the asymmetry MAHA was built to fix. This is the one-way partnership President Trump's MFN order was built to end.

Two Simple Things This Administration Could Do Right Now, Consistent With MFN and MAHA

One. Approve OncoVAX following the same rules that were applied to the Big Pharma Roche drug.

Two. Include OncoVAX in the @NCIDirector's new cancer initiative. NCI and the Foundation for the NIH launched a national cancer roadmap in March 2026. Its stated priorities are "shovel-ready" projects, prevention of cancer recurrence, and stopping the spread.

OncoVAX checks every one of those boxes, well beyond any of the Big Pharma mRNA drugs being championed by the multinational sponsors behind them. Putting OncoVAX in the first stage of demonstration projects would deploy federal capital alongside the American manufacturing and clinical infrastructure already in place, the kind of America-First investment that MFN and MAHA were designed to enable.

Bottom Line

Prevention is cheaper than chasing cancer. Putting out a small kitchen fire is cheaper than waiting for the entire home to be engulfed before you take action. The peer-reviewed math says so. The patient outcomes say so. Common sense says so. And it is exactly the kind of medicine the MAHA and MFN agenda were built to deliver: made in America, priced for Americans, designed to stop cancer before it bankrupts families and ends lives.

For forty years, the American cancer ecosystem has moved with priority and speed for late-stage drugs that cost six figures a year, that are often manufactured abroad, and that extend life by months. It has moved slowly on early-stage prevention medicines, even ones with fifteen-year durability, four outpatient shots, no serious side effects, and a scientific lineage that traces back to the National Cancer Institute itself. This is common-sense medicine when applied to common-sense science.

That asymmetry is the policy question. Not whether the FDA is biased. Not whether any one company is the villain. The question is whether the agencies, under the leadership of President Trump, Secretary Kennedy, and Administrator Oz, use the tools they already have — MFN pricing, real-world evidence pathways, the NCI cancer roadmap — to give American patients a real choice before the disease comes back, instead of after.

The days of Americans paying the world's highest prices for late-stage chase-the-cancer medicine, while the cure-it-early medicine sits in a regulatory holding pattern, should be over.

The patients deserve that choice. The data support it. The American infrastructure exists. The only thing missing is the decision.

@realDonaldTrump @POTUS @SecKennedy @DrMakaryFDA @NCIDirector @SusieWiles47 cc: @WhiteHouse @VP @JDVance @NIHDirector_Jay @DrOzCMS @theNCI @HHSGov @RapidResponse47 @elonmusk
#MAHA #ColonCancer #CommonSenseMedicine