It is critical that this oversight be completely divested of any interests within the pharmaceutical industry, beyond the reach of lobbyists and political influence. Not, you’ll readily agree, an easy ask in the world we currently occupy. Two things need to occur, preferably globally, to ensure our survival as a species is not compromised by the never-ending quest for profits and industry glory. We need to create the oversight and pharma needs to be forced into legal compliance.

And these things need to happen soon!

Where does the danger lie?

Contrary to the populist nonsense circulating on social media and right-wing conspiracy websites, mRNA vaccines don’t pose a risk to our DNA. At least not yet. The current slew of mRNA vaccines is unable to engage the mechanisms required to alter our DNA. It’s a complex topic which I’ve tried to simplify in another article you can reference here if it’s of interest.

That isn’t to say, however, that all future development of mRNA technology will obey the same delivery paths or mechanisms of action, but for now, the mRNA vaccines, in their current forms, cannot interact with your DNA. You can happily get vaccinated without the risk of growing a tail.

The real danger currently lies with another branch of pharma that is going to be at the forefront of new medicines for a while to come as we rage an ongoing war against our most deadly enemy. The virus.

I am, of course referring to antivirals. drugs that are designed to deliver their payloads to and engage with our genetic machinery. While these medicines, take for instance the antivirals developed for AIDS, can be hugely effective and lifesaving, they pose a very real risk of interfering negatively with our genetic code, or DNA. Not all antivirals have this ability, but many do and many newer drugs undoubtedly will.

Not only our DNA is at risk here. Antivirals work by mutating the DNA of the virus they’re designed to attack. The risk exists that resulting mutations can create drug-resistant new strains or variants of a virus, and some experts believe insufficient data exist on drugs like Merck’s new antiviral to combat Covid, Molnupiravir, to allow the drug to be released into the market. The UK has recently approved the drug for use.

Currently, we have to accept the assurances of the pharmaceutical companies, the same companies that develop these drugs, that the treatments are, in fact, safe.

Read that sentence again. There is no world in which that statement makes logical, sane sense or fosters an environment of trust and transparency. We don’t self-police well and if you don’t understand why then drop by your local police precinct and ask them to explain it to you. We simply cannot be trusted, and when the stakes are as high as they are in the world of big pharma, even independent bodies struggle to maintain any autonomy.

What about Federal and Government bodies

Doesn’t the FDA look out for our safety, you ask? Technically, yes, however their admirable mission statements and what actually occurs in practice, are two totally different realities. Woefully understaffed departments, political pressure, pharma lobbyists, and staff, many of whom owe their training and loyalty to large pharma companies, having served as interns or former employees, oversee clinical trials and approval processes, all contributing to potential breakdowns in safety protocols.

The recent scandal involving a whistleblower and the falsification and fabrication of results from a company engaged in submitting Covid vaccine data highlights the problem. Complaints around possible breaches in protocols designed to protect the public are often simply ignored. Lack of resources and manpower are usually assigned the blame and this instance was no exception.

Despite this, systems like the FDA still offer the public a certain level of protection and if they fail, as callous as it may sound, a worst-case scenario results in a few hundred deaths. Until now, that is. Treatments that can affect our DNA work differently. They operate silently and can take years, even decades before we are faced with the consequences. Genetic mutations may be passed on to descendants rather than affecting the patient directly.

Without wanting to sound melodramatic, the biggest challenge we will face in the coming decades will be ensuring the integrity of our human DNA. The reason is simple.

Antiviral medications work. There are very few effective mechanisms to combat viruses and antivirals are one of our best hopes to interfere with the virus’s interaction with our cells. Now, mRNA technology has also entered the fray, and will, undoubtedly stray into the world of DNA before long. It’s a sensible place to go if you’re looking to cure all that ails humanity.

While targetted DNA treatments may benefit the patient of the future, we need to ensure now that in our haste to produce profits, we don’t throw the baby out with the bathwater. Oversight is required.

If not governments, where do we turn?

Does the World Health Organization (WHO) still hold enough credibility globally to be entrusted with a task like this? It’s a difficult question to answer. They botched the Covid response spectacularly, erring on the side of cautious statements when they could have closed the whole planet down in days, buying us time to contain the virus.

They failed to address flawed policies on aerosolized particles when presented with new evidence that contradicted 50-year-old flawed science, evidence that affected how the virus was being distributed. The list goes on, and yet, what other option are we left with?

Only the WHO is placed in a position to engage globally with all pharmaceutical companies. New treatments in development or undergoing clinical trials that target our DNA or may, in any remote fashion, risk contaminating our DNA, would require full WHO approval prior to having a license granted for taking the treatment to market.

It’s by no means a clean or perfect solution, but it would offer a starting point. A place that we could look to and say with confidence, we are doing something to ensure we don’t accidentally self-destruct as a species. A hugely embarrassing and eminently avoidable scenario, but only if we take action to avoid it.

Don’t blame the Tech

Our levels of technology are expanding exponentially, allowing us a deeper and more complex understanding of diseases and viruses on a cellular level. Nanotechnology enables us to deliver microscopic particles to cells, that even five years ago, were only pipe dreams, dreamt by molecular biologists with a vision of what the future might hold. The wonders that await us in the next decade could very well change the face of medicine forever.

Eradication of cancer and other genetic conditions are now real possibilities thanks to technologies like mRNA treatments. Antivirals may very well finally achieve the unthinkable, a world free of influenza. It’s heady times for the industry, exciting times and times for great fortunes to be made, gambled, and lost. Therein lies the biggest danger.

It is not technology, in and of itself, that poses the risk, but rather what we choose to do with it, and given our history as a species, we know we cannot leave that to chance.

The post Does Pharma Need Independent DNA Oversight? appeared first on Medika Life.

• U.S. Government will support the scale-up of INOVIO’s proprietary intradermal DNA delivery device CELLECTRA® 3PSP to deliver INOVIO’s COVID-19 vaccine
• INOVIO to report on interim U.S. Phase 1 clinical trial results in late June
• INOVIO preparing for U.S. Phase 2/3 efficacy study to begin this summer

DATE OF RELEASE: June 23, 2020 

PLYMOUTH MEETING, Pa./PRNewswire/ — INOVIO (NASDAQ:INO) today announced it has received $71 million funding from the U.S. Department of Defense (DoD) to support the large-scale manufacture of the company’s proprietary CELLECTRA^® 3PSP smart device and the procurement of CELLECTRA^® 2000 devices, which are used to deliver INO-4800 directly into the skin.

CELLECTRA^® 3PSP is designed to deliver INO-4800 directly into the skin, where the vaccine prompts the body’s immune system to drive a robust immune response. Interim results of U.S. Phase 1 clinical studies of INO-4800 will be available later this month. A Phase 2/3 efficacy trial is planned to begin this summer (July/August).

The DoD contract, from the JPEO-CRBND-EB through funding provided by the Defense Health Program, builds upon two separate prior $5 million grants from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI), to accelerate the testing of CELLECTRA^® 3PSP. Initial development of this next generation CELLECTRA^® 3PSP smart device began in 2019 with $8.1 million in funding from the medical arm of the U.S. Defense Threat Reduction Agency’s Medical CBRN Defense Consortium.

Dr. J. Joseph Kim, INOVIO’s President and CEO, said, “INOVIO is very pleased to receive this significant funding from the U.S. Department of Defense to continue our rapid scale-up capacity for our breakthrough DNA medicines delivery device CELLECTRA^®. We look forward to working closely with DoD, JPEO-CBRND and JPL-CBRND-EB to provide much needed protection to DoD personnel and their families through development of a safe and effective vaccine against COVID-19. This next generation smart device leverages the efficacy delivery and safety track record of an earlier version that has received CE mark certification and has been used in clinical trials to safely dose more than 2,000 patients in over 7,000 administrations of INOVIO’s DNA medicines. The current DoD contract further supports INOVIO’s large-scale production of devices and arrays to deliver potentially hundreds of millions of doses of INO-4800 next year to combat the global COVID-19 pandemic.”

CELLECTRA^® 3PSP is a small, portable, hand-held, user-friendly device that runs on “AA” batteries. The device is designed to function reliably in challenging environments and can be stockpiled in large quantities without maintenance, characteristics that are critical in a pandemic situation. INOVIO’s San Diego device manufacturing facility has produced initial quantities of the device, while also showing that the design and scale-up of the manufacturing processes can be transferred to contract manufacturers in order to further increase supply.

About the JPEO-CBRND

The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is the Joint Service’s lead for development, acquisition, fielding and life-cycle support of chemical, biological, radiological and nuclear defense equipment and medical countermeasures. As an effective acquisition program, we put capable and supportable systems in the hands of the service members and first responders, when and where it is needed, at an affordable price. Our vision is a resilient Joint Force enabled to fight and win unencumbered by a chemical, biological, radiological, or nuclear environment; championed by innovative and state-of-the-art solutions. JPL-CBRND Enabling Biotechnologies (EB) is an organization established for the purpose of providing medical solutions, during a crisis, against future threats.

About INO-4800

INO-4800 is INOVIO’s DNA vaccine candidate being developed to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 was designed using INOVIO’s proprietary DNA medicine platform rapidly after the publication of the genetic sequence of the coronavirus that causes COVID-19. INOVIO has extensive experience working with coronaviruses and is the only company with a vaccine in Phase 2 development for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).

INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not require to be frozen in transport or storage, which are important factors when implementing mass immunizations.

About INOVIO’s DNA Medicines Platform

INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the DoD. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

INOVIO’s DNA medicines deliver optimized plasmids directly into cells intradermally or intramuscularly using INOVIO’s proprietary hand-held smart device called CELLECTRA^®. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device is designed to ensure that the DNA medicine is efficiently delivered directly into the body’s cells, where it can go to work to drive an immune response. INOVIO’s DNA medicines do not interfere with or change in any way an individual’s own DNA. The advantages of INOVIO’s DNA medicine platform are how fast DNA medicines can be designed and manufactured, the stability of the products which do not require freezing in storage and transport, and the robust immune response, safety profile, and tolerability that have been demonstrated in clinical trials.

With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

About INOVIO

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Specifically, INOVIO’s lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Department of Defense (DOD), GeneOne Life Science/VGXI, HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards “W” designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com.

CONTACTS:

This press release contains certain forward-looking statements relating to our business, including our plans to develop DNA medicines, our expectations regarding our research and development programs, including the availability and timing of data from the company’s ongoing Phase 1 clinical trial of INO-4800 and the company’s plans and ability to outsource manufacturing of its delivery devices to contract manufacturers. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, our ability to secure adequate third-party manufacturing resources for the production of our product candidates, including the transfer of necessary processes, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

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