President Donald Trump invited a German-based biotech venture, CureVac, to the White House to make a deal earlier this month. As it turns out, CureVac does research and development into the coronavirus differently and may be on to something powerful, involving a novel way to develop a COVID-19 vaccine. According to some sources, to the shock of some, the prospective deal included a monopolistic position on the vaccine IP—for America only—which not surprisingly incensed Germans and others in Europe. Should science and more importantly medicine be developed and controlled only for one national interest? Or is this just a logical extension of how biotech deals are done today? TrialSite News looks into CureVac as U.S. officials are in somewhat of a challenging position as no real vaccine on this side of the “Pond” is forecast for at least a year if not 18 months. 

As always, TrialSite News attempts to break things down in a fair and balanced way—summarize the events, identify the players and drill into the facts to inform the reader—in a condensed and abbreviated format as our reader’s time is precious.

This news is primarily originating from overseas press and very reputable physician contacts in the UK and Germany. From what we know, President Trump attempted to secure the German scientists’ work exclusively and would pay “large sums” to get this prospective vaccine into the United States—and exclusively for America. On the other hand, today CureVac works extensively with the German health ministry which clearly, has its own national interest in mind.  Is Trump merely more open, obvious and uncomfortably candid about such considerations? Of course, all of this is, to some extent, speculation.

Who is CureVac?

Founded back in 2000 by Florian von der Mulbe and Ingmar Hoerr, the biopharma venture specializes in the prophylactic and therapeutic application of messenger RNA. They have accumulated decades of experience and expertise developing and optimizing this versatile molecule for medical purposes. They use mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases. They apply their proprietary approach to a number of therapies and rare diseases. They do have a competitor, of sort, in the U.S. called Moderna, which has been profiled by TrialSite News.

What do they Do?

The possibilities of mRNA are “unlimited,” according to CureVac. After all, as a molecule found within all forms of cellular life, messenger RNA (mRNA) is central to biology itself. It quite literally finds itself into the messenger between DNA (the body’s genetic blueprint) and proteins (the molecules responsible for the structure-function and regulation of the body), reports the German-based biotech.

CureVac has spent years researching the topic of how to overcome the instability of mRNA molecules. After analyzing millions of naturally occurring sequences, they have developed what they claim to be “incomparable insight into the endogenous RNA language.” 

Hence, they have developed an extensive proprietary nucleotide sequence library, affording CureVac scientists the ability to assemble the different elements of the mRNA puzzle for select, and targeted therapeutic use has less reliance on additional chemical modifications in the RNA. 

Thus, individual CureVac products are considered tailored molecular creations supporting the customization of “the 5’ and 3’ untranslated regions and the open reading frame to ensure translation of the mRNA sequence produces the ideal levels of protein creation in the body.” What results: “a packaged product specifically optimized for different indications.” See their pipeline for how this scientific know-how and proprietary capability is put to use in the research and development process.

CureVac Vaccine Work

As it turns out CureVac has a competitor in the mRNA field in the form of Cambridge, MA-based Moderna. Both companies are developing mRNA vaccines on technology that facilitates the rapid development of a vaccine derived from pure genetic code.  Relationships with the NIH and recent funding from the Center for Epidemic Preparedness https://cepi.net/supported immediate engagement into prospective vaccines.  Although Moderna is moving a mRNA-based COVID-19 vaccine into clinical trials first CureVac may have been at this process a longer time.

Background and Parallelism with Moderna

While studying at the University of Tübingen in the 1990s, he uncovered the promise of RNA—not only could it be effective as a building block for therapies and vaccines but it could be easier to produce. At the same time, Katalin Kariko and Drew Weissman (University of Pennsylvania) were working on RNA research efforts, which eventually led to the technology licensed to Moderna and BioNTech—also exploring a COVID-19 vaccine.

Where are they located?

Based in Tübingen, Germany, they have sites in Frankfurt, Germany, and Boston, USA.

Who has funded them?

They have raised considerable money from dievini Hopp Biotech holding and the Bill & Melinda Gates Foundation.  According to Crunchbase, CureVac has raised a total of $382.2 million over 7 funding rounds.

Most recently they were granted $8.3 million by the Coalition for Epidemic Preparedness Innovations in January to build a solution based on its low-dose vaccine technology.

Partnerships

CureVac has entered into a number of collaborations with multinational corporations and organizations such as Boehringer Ingelheim (the world’s largest privately held drug company), CRISPR Therapeutics and the Bill & Melinda Gates Foundation. CureVac has been linked with the German health ministry and the Paul Ehrlich Institute, a research institution and medical regulatory organization and part of the German health ministry.

When did the recent meeting occur?

Ex-CEO Daniel Menichella met Trump, VP Mike Pence, members of the White House Coronavirus Task Force and senior representatives of pharma and biotech companies to discuss a vaccine at the White House on March 2. Apparently, it was during this meeting that the Trump deal points were put forth.

What happened Next?

Daniel Menichella was abruptly replaced by the Board chairman Ingmar Hoerr (co-founder) just nine days after the DC meeting with Trump and the drug makers. In a statement by the company, they avoided any mention of the meeting but there is speculation that at least one of the reasons was for how the meeting unfolded—but this cannot be verified. Perhaps it was just time for a change?

What is the Vaccine status?

CureVac has apparently narrowed down candidates and are now selecting the best two to move to clinical trials. The company hopes to have an experimental vaccine in production and ready by June or July of 2020 and thereafter seek approval from regulators (e.g. European Medicines Agency, or if Trump wins, the U.S. Food and Drug Administration).

What else is novel about this prospective COVID-19 vaccine?

According to one of the co-founders, von der Muelbe: “These minimal dosages that we have achieved put us in a position here in Tübingen to produce up to 10 million doses per (production) campaign.” Note that a campaign or production cycle lasts several weeks and, consequently, von der Muelbe reported, “More than one dose may be required to immunize a person, but one campaign would still serve several million people,” reported the Daily Mail.

Is it appropriate to attempt to monopolize a prospective COVID-19 cure?

Well first, core principles and values, as well as the Hippocratic Oath should be considered. Taken by all physicians, there is just a baseline of ethical standard that physicians—and by extensions those that produce medicine—should uphold and commit to: drugs are made for all peoples. Sure, there are access issues and that is a matter of the political and economic incentive system. Certainly, biotech deals carve out territories (including ones based on nation state all the time) but here we are talking about a virus that has the potential to kill millions around the world. 

Social Democrats in places like Germany (their Left) are up in arms. According to Karl Lauterbach, a senior lawmaker and professor of health economics and epidemiology, “The exclusive sale of a possible vaccine to the USA must be prevented by all means. Capitalism has limits.”

On the other hand, although Germany has developed and evolved a solid and accessible health system for most people there under current conditions that particular vaccine would be governed by German and by extension European authorities.

Would they ensure access to a free and dynamic market for patients in North America? Would licensing terms for places like the U.S. be fair and rational, given the severity and imminent menace of the situation? How much would it cost? How quickly could units be produced and shipped overseas? 

Local social democratic structures helps those locally but not necessarily vast segments of peoples around the world unless dynamic, competitive markets operate. Perhaps this latter point was Trump’s underlying motivation?

What is the German/European response?

The Germany government seeks to ensure the vaccine development (as well as active substances against the coronavirus) stay in Europe. According to CureVac, the German government is “intensive exchange with the company” according to NBC News

Conclusion

TrialSite News will monitor carefully. This is a race to help humanity (health, society and economy), and this means all countries and all people—regardless of national origin, ethnicity, religion, and the like. Although compensation is a key driving incentive, government payers (including those in the U.S.) will do what is right to ensure as many people as possible secure access to quality vaccines. 

That of primary importance, all governments should collaborate with national, regional, and local authorities to support innovative, pragmatic preventive schemes and, in parallel, simultaneously support a dynamic, healthy, and robust global market for vaccines that affords the greatest access to all people.

Source: DailyMail

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