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Inovio-Confirms-Frontrunner-Status

 

Inovio Pharmaceuticals Inc. has gained a bad reputation with many biotech investors, being seen as a company which in recent years has pledged to develop vaccines against a string of novel virus outbreaks – MERS, Zika and Ebola - but failed to deliver on its promises.

But now the company is a frontrunner in the race to develop a COVID-19 vaccine, and has just entered Phase I trials – so can it come good when the stakes are so high?

This week Inovio became the third company to commence first-in-human trials of a COVID-19 vaccine, just behind the record-breaking performance from US rival Moderna and China’s CanSino Biologics, who both initiated their respective Phase I trials on 16 March after barely three months development time.

Moderna and Inovio have a lot in common – neither company has ever brought a medicine to market before, and both are pioneering innovative technologies – messenger RNA in Moderna’s case, while Inovio is using a DNA platform.

Both saw their share prices surge after teaming up in January with the Coalition for Epidemic Preparedness Innovation (CEPI) to develop COVID-19 vaccine candidates – though Moderna currently has a market cap ten times bigger at $10.53bn.

That most likely reflects investor wariness of Inovio, which has been around for nearly 40 years without bringing a drug to market, and has suffered numerous setbacks in a variety of mid-stage trials in recent times.

Inovio’s share price rocketed on the day its CEO Dr Peter Kim told President Trump at a 2 March meeting of biopharma execs at the White House that it had already developed a COVID-19 vaccine candidate.

The aggressive short-seller Citron Research responded to the claim on Twitter, saying Kim’s claim to have produced its candidate in three hours was "ludicrous and dangerous” and accused Inovio of using “serial stock promotion” for years.

Inovio hit back on Twitter, dismissing Citron Research as a third-party that had "demonstrated a lack of understanding of the science behind DNA medicines." 

Nevertheless, its stock crashed back after Citron’s intervention, and there is even a class action lawsuit filed by a Boston law firm claiming the company misled investors.

But this came on 6 April, the very same day Inovio began dosing its first volunteers in its Phase I trial of its vaccine INO-4800.

 

A Speedy First Step

This means Inovio has taken the first step towards proving the doubters wrong, but it still has a lot to prove. The company now expects to have initial safety data from 40 volunteers in the trial by the late summer, and is preparing to move swiftly into Phase II trials to prove its efficacy.

Asked about the skepticism around the company, CEO Dr Peter Kim to Scrip: “Everybody's entitled to their opinion. and we welcome the skepticism and as long as [its] constructive and rational.”

He added: “When CEPI funded us, their aspiration was that we could start within 16 weeks and you know we over-delivered on that aspiration. So we are very excited. But we also realise this is just a step in a very involved process of getting a vaccine tested for safety, immunogenicity and then eventually efficacy and approval for this vaccine to be used in the field. But we're very happy about how far we have come in a very short time.”

Displaying confidence in Inovio’s platform, he says he is looking forward to Inovio’s vaccine being judged against the other frontrunner candidates  - which also include J&J and Sanofi  - within the next 12-18 months.

“We [will be able to] put everything on the table and compare the safety, immune responses, efficacy and all of the other important aspects of vaccine development, and vaccine attributes in a very clear, cross comparable basis.”

This time, it is not just Inovio which is self assured, CEPI also has confidence in the company, based on what is now a longstanding partnership against novel viruses. CEPI’s $9m grant for INO-4800 came after Inovio produced successful proof-of-concept data for a MERS vaccine produced last year.

That data showed the candidate was well-tolerated (no vaccine associated serious adverse events), while seroconversion and T-cell responses reached 94% and 76% respectively after three vaccinations, and the responses were durable in one year of follow-up.

In addition, The Bill and Melinda Gates Foundation has also given the company its backing, with a $5m grant to accelerate development of its proprietary Cellectra smart device which administers the vaccine through the skin.

Pharma analysts also see huge potential in Inovio’s technology, which instead of the traditional approach of using an inactivated version of the virus itself to create a vaccine, instead delivers a DNA molecule within a cell, known as a plasmid, directly into a patient’s cells. Once inside the cell, the plasmids are used by the cell's own machinery to generate antigens against the virus.

In a recent research note, analysts at Bernstein identified Inovio's DNA platform as very promising, including ways in which it could sidestep some of the problems seen in conventional vaccines, and hurdles which might trip mRNA vaccines.

The plasmids are administered intradermally using its Cellectra delivery device. This uses a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter – a technique which overcomes a key limitation of mRNA and other DNA approaches.

The technology also has a benefit at the level of distribution to patients in the field, as the molecule is stable enough to be stored without a cold chain, unlike mRNA and traditional vaccines.

Despite its speed in reaching this Phase I trials, Dr Kim is not putting a timeline on when its vaccine could gain US FDA approval and reach a broad number of patients, though this won't be any earlier than 12 months from now.

Dr Kim says that commentators and journalists are entitled to speculate about which coronavirus vaccine will gain approval first, and which might prove more effective and durable, but says its clear that several vaccine candidates will need to be successful in order for the world to conquer COVID-19.

“At the end of the day, it's going to require multiple vaccines to come through the finish line. Even Bill Gates himself talked about publicly supporting seven or eight different vaccines, knowing that one or two will be critical to come to the finish line to help fight this pandemic."

Applauding the work of the other companies working in the field, Kim added: “I think is very important that we collectively fight our battle against this pandemic and help to control this because, you know, we can't go on as a society the way it's been going for the last couple of months.”

Beyond efficacy, one of the biggest challenges for any COVID-19 vaccine developer is manufacturing at a global scale. Inovio is already working on its plans, aims to produce 1m doses of the vaccine by the end of 2020 to perform further clinical trials or for emergency use. 

However the company has confirmed it will need additional help to produce more if successful, and will also need further financial backing. The receptiveness of investors will be very much influenced by those initial safety and efficacy results, which could have a big impact on Inovio's long term fortunes, as well as the fight against COVID-19.

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