What has become of S’pore’s US$220 mil investment in Arcturus Therapeutics’ COVID-19 vaccine?

Singapore had earlier aimed to secure the first doses of Arcturus Therapeutics’ COVID-19 vaccine, with its total investment amounting to about US$220 million (S$290 million).

Arcturus had agreed with the Economic Development Board (EDB) to commence developing the vaccine — referred to as ARCT-021 — in November last year.

Of the US$220 million committed by the EDB, an upfront limited-recourse loan of US$45 million was allocated to supporting the manufacturing process of the vaccine. This includes purchasing the relevant equipment, materials and services.

Under the agreement, the loan is to be repaid through royalties on future ARCT-021 commercial sales.

However, a caveat to the loan repayment is that Arcturus will not have to repay the loan if its vaccine is not approved by the regulatory authority.

Arcturus and the EDB also agreed to terms that providing the EDB with the right to preorder up to US$175 million worth of ARCT-021, with shipments expected to begin in the first quarter of this year.

It was reported that the American biopharmaceutical firm had collaborated with Duke-NUS Medical School in Singapore to develop ARCT-021.

Speaking to CNN in May last year, Arcturus Therapeutics’ CEO Joseph Payne revealed that the Singapore government and Duke-NUS Medical School approached the company last January.

“We’ve made great progress with them and you’re right Singapore is a small country. There are only about five or six million people in that country. We’re definitely looking to make more impact outside of Singapore with this vaccine,” he noted.

The vaccine, which uses RNA (mRNA) technology to provoke an immune response to fight the virus, was expected to be shipped early this year.

The clinical trials for ARCT-021 were approved in July last year, in which Arcturus and Duke-NUS had proceeded with 106 participants age between 21 to 80 years old.

Of those, 78 participants received a single dose of the vaccine. 36 participants were injected with two doses, while the remaining 28 received a placebo dose, the latter of which is given to one group in clinical trials in place of the investigational vaccine.

CNBC reported that 77 participants who had received a single dose had developed positive results. Arcturus also claimed that there have been no serious adverse events deemed to be treatment-related.

Duke-NUS Medical School’s Professor Ooi Eng Eong –- who co-developed the vaccine with Arcturus –- noted that the Phase ½ study results and preclinical data indicate that ARCT-021 leads to “a potent immune response to SARS-CoV-2”, and demonstrates a “differentiated biological profile”.

“This differentiates this investigational vaccine from many other COVID-19 vaccines in development,” Prof Ooi, who is also a member of Arcturus’ Vaccine Platform Scientific Advisory Board, told The Straits Times.

Thus, it was believed that ARCT-021 could be effective as a single dose, as compared to Pfizer and Moderna which require two doses to be effective.

“Not only is it a potential single shot and a very low dose, but you combine that with the ease of manufacturing this vaccine. It means that we can make a significant impact in millions of people,” said Mr Payne.

The Singapore government has already set aside more than S$1 billion for COVID-19 vaccines.

The first vaccine it approved was Pfizer-BioNTech’s vaccine, followed by Moderna’s COVID-19 vaccine, which expected to arrive in March.

Singapore has also made advanced purchase agreements with China’s Sinovac vaccine, but the Health Sciences Authority (HSA) noted that more data is still pending to ensure its safety.

“Beyond Sinovac, we continue to look at other options, and so that search for other vaccine options continues. We are not stopping at just three vaccines,” said Education Minister and co-chair of the COVID-19 multi-ministry taskforce Lawrence Wong on 19 Feb.

The development of Arcturus’ COVID-19 vaccine, however, was hardly reported by the mainstream media in Singapore despite the city-state having aimed to secure the first doses of ARCT-021.

Arcturus previously fired CEO Joseph Payne for misconduct but took him back

It is worth noting that Arcturus’ current CEO Joseph Payne was previously fired from the RNA medicines company in February 2018 for misconduct.

Mr Payne co-founded the company and is the largest shareholder in Arcturus with a 13.7 per cent stake.

“We have uncovered multiple instances where Mr Payne attempted to deceive, manipulate and lie to our shareholders, partners and other stakeholders,” said Arcturus.

The company had also filed a lawsuit against Mr Payne, which outlined his misconduct, poor judgment and bad decisions during his tenure in Arcturus. He was also alleged of putting his own interests before the company.

“Mr Payne’s misconduct and breach of fiduciary duties necessitated his termination and we believe this lawsuit is necessary to protect Arcturus’ rights and interests, as well as the interests of our shareholders and our other stakeholders,” it stated.

In response, he denied Arcturus’ assertion and claimed that four board members – namely Stuart Collinson, Craig Willet, Daniel Geffken, and David Shapiro – had conspired against him.

Mr Payne had also demanded to hold an extraordinary general meeting to trade out the four board members with new faces – namely Magda Marquet, Peter Farrell, Andrew Sassine and James Barlow.

As a result, the company has voted in favour of his plans and dropped the lawsuits.

It noted that the settlement agreement included “mutual releases of all parties and the agreement by the company and Joseph E. Payne to terminate all pending litigation”.

In May 2018, Arcturus reinstated Mr Payne as President and CEO of the company and named Peter Farrell as chairman of the company’s new board of directors.

“With the litigation behind us, the team is 100 per cent committed to developing our pipeline of novel RNA therapeutics, to strengthening and advancing all of our pharmaceutical partnerships and to creating value for our shareholders,” he said.

Analysts lost confidence in Arcturus’ vaccine

Arcturus’ data from the Phase ½ trial demonstrated that the vaccine produced neutralising antibodies after a single dose, but it was found that the neutralising antibodies were at lower levels than rival vaccine candidates.

As such, analysts claimed that they have lost confidence in the potential of ARCT-021 to protect recipients against the deadly coronavirus, with some even downgraded Arcturus to ‘Market Perform’ – from ‘Outperform’.

This is despite Arcturus saying that it will be looking for optimal dosing levels to begin a global Phase 3 trial in the second quarter of this year.

“While this latest dataset does not completely impair single-shot ARCT-021, which may provide protection against COVID-19 infection in Phase 3, the lack of SARS-CoV-2 neutralising antibody (Nab) titers at or above levels seen in convalescent sera reduces our confidence that ARCT-021 will be able to achieve competitive levels of vaccine efficacy with single-shot dosing,” Raymond James told 24/7 Wallst.

Stocks for the company has also dropped to a new low over the past few days.

Arcturus set to conduct Phase 2 trial for vaccine

Arcturus had earlier announced that it received approval from HSA to conduct its Phase 2 study of ARCT-021 in Singapore.

The company announced in January that the trial will be conducted in the United States, after the US Food and Drug Administration (FDA) approved Arcturus’ application for the investigational new drug (IND) allowance.

“Allowance of the IND [investigational new drug] for our ARCT-021 Phase II clinical study represents an important milestone for the programme and we look forward to starting to screen study participants at US and Singapore clinical sites very soon,” said Arcturus Therapeutics’ chief medical officer Steve Hughes.

The company aims to have about 600 participants in the Phase 2 study, in which 450 of them will be injected with ARCT-021, while 150 individuals will receive a placebo.

Additionally, early interim safety and immunogenicity analysis will also be conducted to select the dose for the Phase 3 study which slated to take place in the second quarter of this year.

“Our prior clinical results show that ARCT-021 administration results in humoral and cellular immunogenicity, and we are encouraged by an increasing body of evidence highlighting the potential importance of T cells in providing protection against SARS-CoV-2 infection and COVID-19.

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