A local startup wants $20 million to develop what its founder says is a promising, T Cell-based Covid-19 vaccine - designed to work with Pfizer's jab, enhancing its effectiveness and extending it for years.
But its founder says having been knocked back by our Government, he's now looking for funds overseas.
Covid-19 Vaccine Corporation (CVC) co-founder and chief executive Dr Robert Feldman says the funds would allow his company to move to clinical trials and apply for local and US FDA approval by the end of this year.
Feldman says he held "extensive discussions" with the Government, only to be knocked back in his request for $20m (CVC has received a number of smaller tranches of funding, including $488,000 in 2020 from MBIE's Covid Innovation fund and $399,000 through Crown agency Callaghan Innovation).
MBIE international science partnerships manager Simon Rae said the funding request had not reached a formal stage. An analysis carried out by the MBIE-funded VAANZ (more on which below) found CVC's vaccine was "not one of the top candidates".
More, regardless of the panel's verdict, there were just not enough funds in the kitty to cover CVC's request.
"There are not government funds that can support a $20m clinical trial," Rae said.
"As part of the Covid-19 vaccine strategy, MBIE funded Vaccine Alliance Aotearoa New Zealand (VAANZ) $12m to develop vaccine capability in Aotearoa New Zealand."
VAANZ is a consortium of research organisations led by the Malaghan Institute, the University of Otago and Victoria University of Wellington.
The Herald requested updates from Feldman, Covid-19 response Minister Chris Hipkins and various government agencies, on March 23 - the day that Scott Morrison's Government earmarked A$2 billion for a new vaccine product facility in Victoria, which will be able to produce 25 million doses per year of Moderna's vaccine from 2024, with a ramp up to 100 million doses per year for future pandemics.
The Ministry of Health and Hipkins' office both referred questions to MBIE.
Immunologist and life sciences veteran Feldman formed CVC in April 2020.
He raised $5m from a Pledge Me campaign, plus backing from richlister Guy Haddleton (recently seen pumping money into cannabis and supercomputing) who is now the largest shareholder with a 16 per cent stake.
Douglas Pharmaceuticals managing director Jeff Douglas came onboard as chairman, while Fonterra offered logistical support, and the University of Queensland, the University of Auckland and Scion as research partners.
Existing investors have recently tipped in another $2m, but Feldman says they are now "maxed out". (Haddleton declined comment.)
Feldman says while a local development drive was his first preference, having been knocked back by the Government he will now seek the $20m offshore.
CVC has developed proprietary antigens designed to induce what is known as a cytotoxic T Cell immune response, Feldman says. This type of immune response primes the immune system to specifically kill only those cells that have become infected with virus - as opposed to today's Messenger RNA (or mRNA) vaccines made by Pfizer, Moderna and others, which are focused on inducing antibodies that prevent entry of the SARS-CoV-2 into cells.
Feldman says his CVC is not trying to replace mRNA vaccines, but rather to work with them and amplify their effectiveness and dramatically increase the longevity of their protection. He says it will help us deal with future variants.
"Nature provided us with the ultimate stress test with Omicron," he says. In computer simulations, CVC's vaccine had close to 100 per cent effectiveness against the Covid-19 variant. Would that translate into real life? Feldman says human clinical trials are necessary to confirm the results.
Just not right
Leaving aside the merits of CVC's approach, Feldman says "It's just not right" that our Government's dedicated vaccine research funds top out at $12m, and that more general R&D funding, such as that provided through Callaghan Innovation, have not been available to his startup beyond an initial round of seed money.
"If you look around the world, other governments have put large amounts of money into vaccine development and those countries have benefited from it. If you have technology that's interesting, that has potential, then the Government should fund it."
Beyond the Australian Government's A$2b commitment to a new vaccine facility, Feldman says Canada, the UK, China and India have all benefited from major government funding to support local vaccine manufacturing and R&D programmes.
MBIE's Rae told the Herald, "VAANZ set up an independent vaccine advisory group, including international experts, to make recommendations on external candidates that could be developed through VAANZ, and developed vaccine candidates.
"In 2020, MBIE and Callaghan Innovation also funded CVC for early-stage research and development on a Covid-19 vaccine candidate using microbead display technology - $488,000 from MBIE's Covid Innovation Acceleration Fund and $395,000 through Callaghan Innovation.
"CVC have not applied formally to any other MBIE funds. MBIE received an additional request for financial support from CVC in August 2020.
"This was not made as an application to a funding round. MBIE directed CVC to explore a collaboration with VAANZ.
"We understand that VAANZ included CVC's candidate in its assessment of possible vaccine candidates and VAANZ's independent vaccine advisory group advised that it was not one of the top candidates," said Rae.
"It was always understood that taking candidates through clinical trials to manufacture would need to be funded outside of government, given the high costs of clinical trials.
"There are not government funds that can support a $20m clinical trial, outside of general innovation support such as that provided by Callaghan Innovation.
"This sort of investment would need to demonstrate a credible path through even more expensive later-stage trials, which in turn would require the support of a major pharmaceutical company, or an international organisation such as the Coalition for Epidemic Preparedness Innovations (CEPI).
"CEPI in particular has funded a number of promising Covid-19 vaccine candidates, and has continued to do so, particularly where these offer clear advantages over existing vaccines, for instance in providing broad protection against betacoronaviruses."