German biotechnology firm CureVac is in talks with large drugmakers about a partnership to help market and distribute its prospective vaccine against the COVID-19 virus, its chief executive told Sueddeutsche Zeitung.
CureVac, backed by Microsoft founder and billionaire Bill Gates, listed on the Nasdaq stock market on Friday, raising $213 million.
Asked whether CureVac was in talks with larger pharmaceutical partners, CEO Franz-Werner Haas told the paper: “Yes. We are in talks. We cannot go it alone.”
CureVac which raised funds at the top end of its indicated price range of between $14 and $16 per share, will have further financing rounds going forward, Haas told the paper.
On the cost of a future CureVac vaccine, Haas said 10 euros ($11.8) to 15 euros should be realistic. He did not specify whether that was per dose or per treatment course.
The United States has struck a deal for an experimental vaccine developed by Pfizer and partner BioNTech for about $40 per treatment course. Moderna’s prospective two-dose regimen would cost between $64 and $74 per person.
Like many biotechs the group pushed on into phase III after a phase II failure; remarkably, the strategy has worked.
The failure four years ago of Seres’s bacterial formulation SER-109 threatened to end mounting exuberance over microbiome therapeutics. But the company pressed on into phase III, and that trial’s unexpected success yesterday could reawaken this field.
It has certainly reawakened Seres’s share price, which had crashed 70% on the 2016 disappointment. After drifting further for the next few years the stock yesterday surged 389% to value Seres at $1.7bn. This is quite the turnaround, and Seres is now gunning for a quick US regulatory filing, which it hopes will result in the first ever marketed microbiome therapeutic.
The development is curious for a number of reasons, the most obvious being that biotechs that insist on initiating pivotal development despite unconvincing or negative mid-stage data usually suffer punishing phase III failures.
A second is that the company had a backup compound, SER-262, which unlike SER-109 was synthetically designed and thought by some to be far more promising. But in the event SER-262 flunked a phase I Clostridium difficile infection trial two years ago, and ended up being abandoned, leaving remaining investor attention on SER-109.
Enough for approval?
Yesterday Seres said the SER-109 pivotal study, also in C difficile and called Ecospor III, had met its primary endpoint, reducing recurrence of infection at eight weeks by 30.2 percentage points versus placebo.
The overall risk of recurrence was cut by 83%, with a p value of <0.001, which despite being tested at a one-sided level looks impressive. Importantly, the FDA had apparently told Seres that a single study would suffice for approval as long as the upper bound of its hazard ratio range fell below 0.833; this value has come in at 0.51.
Seres had initiated Ecospor III after reviewing why SER-109 might have failed in phase II. Possible reasons ranged from manufacturing problems through clinical site variability to even a mix-up of trial samples. Ultimately Ecospor III tested a 10-fold higher SER-109 dose than had been used in phase II.
SER-109 is an oral formulation of purified, donor stool-derived, Firmicute bacteria spores, designed to germinate, repopulate the microbiome and inhibit germination and growth of C difficile. Seres says this is more convenient, less risky and better characterised than faecal transplant, though only a head-to-head trial can prove this.
Safety
Should Seres investors sitting on a fourfold gain be aware of any stumbling blocks? One is that, at just 105 subjects exposed to the SER-109 phase III dose, Seres’s safety database is about 200 patients short.
The group hopes that this requirement can be met through a post-marketing commitment, but at worst it will have to dose and analyse these extra subjects in an open-label phase before approval. Another is Seres’s funding requirement: second-quarter cash was $64m, enough to last only a year.
Then there is the competition. Among the numerous industry projects that aim to restore patients’ microbiome health is Ferring’s RBX2660, which is also in development for C difficile, and whose pivotal trial should read out imminently.
Ferring had acquired this through its 2018 takeover of Rebiotix, something that could soon look like a very smart move.
A top member of Russia’s Health Ministry ethics council, Professor Alexander Chuchalin, has resigned over the quick review process for the world’s first approved COVID-19 vaccine, dubbed Sputnik V after the USSR’s satellite program.
Citing medicine’s guiding principle to “do no harm,” he tried to block the nod on safety grounds, accusing two leading doctors, the Gamaleya Research Centre for Epidemiology and Microbiology’s Professor Alexander Gintsburg and the Russian Army’s top virologist Professor Sergey Borisevich, of flouting medical ethics in the process.
The data supporting the approval was generated from only 38 volunteers from the military.
In an interview with the scientific journal Nauka/Zhizn, he said, “In the case of a drug or vaccine, we, as ethical reviewers, would like to understand, first of all, how safe it is for humans. Safety always comes first. How to evaluate it? The vaccines that are being created today have never been used in humans, and we cannot predict how a person will tolerate it. It is impossible to determine this without weighing all the scientific facts. Therefore, our #1 task is to extract scientific data based on evidence-based medicine in order to understand that the action performed by scientists will not harm a person. It is vital to know the effect of the vaccine in the longer term. The fact is that there are a number of biological substances that do not manifest themselves immediately, but only after a year or two.”
Aims to accelerate development and commercialization of dry powder forms of niclosamide as a new potential treatment for COVID-19
Agreement provides for UNION therapeutics’ potential payment of development, regulatory and sales-related milestone payments of up to $210 million as well as tiered royalties
AstraZeneca said on Friday it had agreed with the European Union to supply up to 400 million does of its potential COVID-19 vaccine, taking the British drugmaker’s global supply target to 3 billion doses of the vaccine for the novel coronavirus.
The agreement, terms of which were not disclosed, builds on an earlier agreement in June between AstraZeneca and Europe’s Inclusive Vaccines Alliance spearheaded by Germany, France, Italy and the Netherlands.
“With production in our European supply chain soon to be started, we hope to make the vaccine available widely and rapidly, with the first doses to be delivered by the end of 2020,” AstraZeneca Chief Executive Officer Pascal Soriot said.
Vietnam has registered to buy a Russian COVID-19 vaccine, state television reported on Friday, as it fights a new outbreak after going several months with no local cases.
Russia said on Wednesday it would roll out the world’s first COVID-19 vaccine within two weeks, rejecting the concerns of experts who said it should not have been approved before completing large-scale trials.
“In the meantime, Vietnam will still continue developing the country’s own COVID-19 vaccine,” state broadcaster Vietnam Television (VTV) said, citing the Ministry of Health.
Vietnam has signed up for 50 million-150 million doses of the vaccine, Tuoi Tre newspaper reported. Some will be a “donation” from Russia, Tuoi Tre said, with Vietnam paying for the rest.
Vietnam will also buy vaccines from Britain, where it has a partnership to develop a homegrown vaccine with the University of Bristol, the health ministry said in a statement.
The ministry did not say when it expected to receive the vaccines, or how much they would cost. It was not clear which vaccine Vietnam intended to buy from Britain.
Last month, the ministry said Vietnam would have a homegrown vaccine available by the end of 2021.
Vietnam was lauded for suppressing an earlier outbreak through aggressive testing, contact-tracing and quarantining, but it is now racing to control infections in multiple locations linked to the popular tourist city of Danang, where a new outbreak was detected on July 25.
Vietnam has reported a total of 929 infections, with 21 deaths. Prime Minister Nguyen Xuan Phuc has said the risk of wider contagion is very high, and that the next few days are critical.
Authorities placed Hai Duong, a city of half a million people east of the capital, Hanoi, under lockdown for 15 days on Friday after three cases were detected there, the government said.
The head of Vietnam’s coronavirus taskforce, Vu Duc Dam, said on Friday that Vietnam now had no choice but to “live safely with the virus”.
“We are implementing the anti-virus measures of a poor country, so everyone has to stay alert and know how to protect themselves from the virus,” Dam said, according to state media.
