Sen. Bernie Sanders is once again keeping drug makers in check, suggesting that people living with cancer are being preyed on by greedy interests.

On Monday, Sanders demanded a Department of Health-led investigation into a proposal to grant a company with an exclusive patent license for cancer treatment and methods, produced with public resources and a potential conflict of interest.

The sexually transmitted infection Human papillomavirus (HPV) can lead to six types of cancer and most cervical cancer, the National Cancer Institute (NCI) reports. It can be dormant for years or cause genital warts or worse. Last month, National Institutes of Health (NIH) proposed granting Kingston, New Jersey-based Scarlet TCR a patent for a T-cell therapy for HPV, which has undergone a Phase I trial and has a Phase II trial scheduled to conclude in 2025.

There’s no cure for HPV, but drug developers are examining T-cell therapies to combat HPV and the cancers it leads to, including Scarlet TCR. Sometimes they’re gene-engineered. (CBD is also being explored for its potential to inhibit cervical cancer cells.) 

There’s a problem though. The patent proposal and the company’s ties to an ex-government employee and other inconsistencies were revealed in an Oct. 18 report by The American Prospect. The NIH quietly applied to be granted “an exclusive patent for a cancer drug, potentially worth hundreds of millions or even billions of dollars, to an obscure company staffed by one of its former employees,” The American Prospect reports.

Sanders, chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, demanded a probe of the patent proposal in an Oct. 23 letter to Christi Grimm, who is inspector general of the U.S. Department of Health and Human Services. The HELP committee also announced Sander’s open letter on Oct. 23.

Sanders suggested the NIH is allowing a company to take advantage of a life-saving cancer drug.

“I am growing increasingly alarmed that not only has the NIH abdicated its authority to ensure that the new drugs it helps develop are reasonably priced, it may actually be exceeding its authority to grant monopoly licenses to pharmaceutical companies that charge the American people, by far, the highest prices in the world for prescription drugs,” Sanders wrote. “One particularly egregious example has recently been brought to my attention that I believe demands your immediate attention.”

Sanders argued that the NIH should be doing more to lower the cost of drug therapy.

“There does not appear to be anything reasonable and necessary about granting a monopoly for a treatment that was invented, manufactured and tested by the NIH, is already in late stage trials and could potentially enrich a former NIH employee who was one of the major government researchers of this treatment,” Sanders wrote. “Based on current law and the best interest of U.S. taxpayers who paid for this cancer therapy, it would seem to make more sense for the NIH to offer non-exclusive licenses so that multiple manufacturers can produce this important cancer therapy at reasonable and affordable prices. The apparent abuse of the system by the NIH with respect to the exclusive patent license for this cancer therapy is so egregious that it has been characterized as a ‘how-to-become-a-billionaire program run by the NIH.’”

“If accurate,” Sanders wrote, “that would be absolutely unacceptable. The NIH should be doing everything within its authority to lower the outrageously high price of prescription drugs. It should not be granting a monopoly on a promising taxpayer-funded therapy that could cost hundreds of thousands of dollars for cancer patients in a way that appears to exceed its statutory authority.”

The American Prospect story pointed out that the NIH offering an exclusive license for a cancer treatment to a company with no website or SEC filings staffed by a former NIH employee

More Ethical Drug Research

There is historical precedence on life-saving drugs or therapies that didn’t need a patent: On Jan. 23, 1923, Sir Frederick G. Banting, James B. Collip, and Charles Best, discoverers of insulin, were awarded U.S. patents on insulin and the methods used. They all sold these patents to the University of Toronto for $1 each. Banting said, “Insulin does not belong to me, it belongs to the world.” 

While things have changed and the price of insulin skyrocketed, new efforts are being made by the drug’s top three makers to make insulin affordable once again.

When the polio vaccine was found to be 90% effective, its discoverer wasn’t in it for the money. On April 12, 1955, Edward R. Murrow asked Jonas Salk who owned the patent to the polio vaccine. “Well, the people, I would say,” Salk responded. “There is no patent. Could you patent the sun?”

In today’s pharmaceutical world, some of those values are lost.

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The company, CaaMTech, first received a patent in support of the research in 2021. An article published Wednesday on the website Greenstate explains that the company “develops pharmaceutical drugs for mental health conditions like depression and obsessive-compulsive disorder,” and is now “researching the therapeutic value of psilocybin in combination with cannabinoids.”

“Through their research, CaaMTech has isolated derivatives of psilocybin, cannabinoids, and terpenes,” Greenstate explained.

In the 2021 announcement of the patent, CaaMTech founder and CEO, Dr. Andrew Chadeayne said that the company’s “goal from Day 1 has been to capture as much of CaaMTech’s scientific innovation as possible in our intellectual property portfolio as we develop the next generation of psychedelic drugs.”

“The allowance of our first patent application has given a shot of energy to the team that has worked diligently over these past four years to bring it to the finish line,” Chadeayne said in the announcement. “With hundreds of applications still to prosecute, this is a great start.”

“Strong patent protection and fundamental research give our drugs the foundational support that they need to proceed through clinical trials and become FDA-approved medicines,” he added. “‘Compositions and methods comprising a psilocybin derivative’ covers (among other subject matter) the synergistic modulatory effects of cannabinoids on the activation of serotonin receptors when administered in conjunction with a serotonin agonist. In simpler terms, CaaMTech has shown that cannabinoids work synergistically with psychedelic tryptamines in producing their effects. In doing so, CaaMTech has demonstrated the potential for two drugs once declared by the United States Federal Government to have ‘no known medical value’ to treat some of the world’s most challenging mental health issues.”

The announcement said that “notice of allowance [from the the US Patent and Trademark Office (USPTO)] is a watershed moment for CaaMTech’s intellectual property division, which has filed in excess of one hundred additional patent applications since the application was filed in 2017.” 

“Allowance is the final hurdle of examination before a patent is issued,” the announcement said.

Since the approval of that patent in 2021, Greenstate reports that “CaaMTech has shared findings related to 4-PrO-DMT as a novel synthetic alternative to psilocybin, among other things.” 

“Separate efforts may supplement this work, like the research survey from SABI Mind covering myriad topics, like the general acceptance or disregard for synthetic alternatives to compounds like psilocybin. These steps, alongside policy work, create wider access lanes for patients seeking trustworthy, science-based psychedelic therapies,” the outlet reported.

Developing the compound will not be easy. As MJBizDaily explained, there are “serious obstacles to creating a combo compound.”

“Cannabinoids and psychedelics act on different receptors in the brain. Cannabinoids such as THC binds primarily to the CB1 cannabinoid receptor; CBC binds primarily to the CB2 receptor. Psychedelics such as psilocybin bind primarily to 5-HT2A serotonin receptors,” the outlet reported.

“But there has been research showing that the cannabinoid CBD can bind to serotonin, and that, when serotonin is joined with a CB2 cannabinoid receptor, the resulting combination can do things that neither receptor can do on its own…Buoyed by the potential of the combo compound, the medical cannabis community is growing increasingly excited. For example, cannabis combined with psychedelics has been found to shrink tumors significantly in breast cancer.”

CaaMTech, based in Issaquah, Washington, bills itself as “the foremost drug discovery and lead optimization company focused on engineering psychedelic drugs that meet the standards of modern medicine.”

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A Canadian biotech company says that it is ready to initiate commercial production of psilocybin mushrooms. Core One Labs Inc., which is based in Vancouver, is “set to begin commercial production of its clinical-grade psilocybin at a Good Manufacturing Practices (GMP) facility in January 2023,” according to Benzinga.

The outlet reported that the company’s chief executive officer, Joel Shacker, “explained that the company is on course with the initial phase of testing its commercial capabilities for high-grade psilocybin.”

“We anticipate positive results regarding Core One’s commercial capabilities and quickly moving towards commercialization of our products; a milestone we anticipated will attract potential investors and please our current shareholders,” Shacker said.

In October, Core One announced that it was “nearing good manufacturing practices (GMP) production of its psychedelic compounds, as the Company has progressed its negotiations with a certified facility and is developing a detailed plan to provide high quality and affordable psychedelic medicine to properly licensed clinics and distributors.”

The company said at the time that its goal was to “create pharmaceutical grade psychedelic products for patients to treat a range of diseases including, anxiety, depression, addictions, Parkinson’s and other mental health and neurological disorders.”

“By partnering with a GMP production facility, our plan is to start with manufacturing psychedelic compounds and putting them in an easy to take format for patients, such as capsules. This can be done for Core One’s proprietary API grade psilocybin as well as other compounds the Company has been testing. As Core One’s drug pipeline progresses, we plan to create our own drug formulations that can also be manufactured at these GMP facilities,” the company said in the announcement in October. “GMP is a pillar of the quality assurance process that seeks to ensure that products are manufactured in a consistent manner that meets or exceeds mandated safety and quality standards.”

Benzinga reports that, along with beginning psilocybin production next month, Core One “intends to advance market production of its other Active Pharmaceutical Ingredient (API) psychedelic compounds towards eventually manufacturing and supplying them to licensed medical clinics and professionals, researchers and treatment development companies across Canada and other countries as well.”

The company “has developed and filed a patent for a novel psilocybin production system using engineered bacteria through its subsidiary company Vocan Biotechnologies,” in addition to already holding “four provisional patents for the development of psychedelic-based pharmaceutical formulations that target neurological and mental health disorders under its subsidiary Akome Biotech as well as three provisional patents for additional synthetic technologies for psilocybin and psilocin production methods under subsidiary Awakened Biosciences.”

The moves by the company come at a time when Canadian leaders are revising laws and regulations surrounding psilocybin. In October, the Province of Alberta began regulation of the use of psychedelic drugs for people in therapy, a first for a Canadian jurisdiction and a decision that Core One hailed as “groundbreaking.”

“Alberta’s new regulations would require medical directors to apply for a license before treating patients with psychedelics for mental health disorders. A psychiatrist would have to oversee any treatment, according to the regulations taking effect in January 2023. Health professionals could not charge money for the drugs, and a qualified professional must only give patients the drug at a medical facility – unless the person is in palliative care,” the company said in October. “This significant step being taken by a Canadian government body is groundbreaking, and the Company foresees this as the beginning of a complete paradigm shift in Canada.”

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