Covid-19 roundup: Inovio nabs $3 million and a development partner for its vaccine that's still on partial hold; Slaoui proposes halving Moderna vaccine doses as distribution lags
With its vaccine candidate finally in Phase II, Inovio is bagging $3 million in a partnership deal with Advaccine Biopharmaceuticals Suzhou to develop and commercialize the candidate in Greater China.
Advaccine and Inovio shook hands on a deal for exclusive rights to develop, manufacture and commercialize the candidate, INO-4800, in Mainland China, Hong Kong, Macao and Taiwan. In addition to $3 million upfront, Advaccine is sweetening the deal with up to $108 million in milestone payments. In return, it stands to earn a “high single-digit percentage” of annual net sales in each region within Greater China. The company is also licensing its plasmid manufacturing process to Inovio, with the right to sublicense to Inovio’s manufacturing partners.
The news comes about a month after Inovio began dosing patients in the Phase II portion of a Phase II/III trial, which was slapped with a partial clinical hold back in September. The Phase III portion is still on hold, due to remaining questions about the device that will be used to deliver the shot directly to the skin. According to a statement, it plans on answering those remaining questions in the Phase II.
A few weeks ago, Inovio tapped Japan’s Kaneka Eurogentec as a manufacturing partner to hit its goal of producing hundreds of millions of doses. Kaneka is tasked with filling the role of Korean contract manufacturer VGX, which Inovio is in a legal standoff with. Tthe company remains optimistic, though it hasn’t had a product candidate approval in over 40 years. — Nicole DeFeudis
Slaoui proposes halving Moderna vaccine doses as distribution lags
As Covid-19 vaccine distribution lags behind projections, there has been much debate about how to increase inoculations over the last couple weeks. And on Sunday, OWS chief Moncef Slaoui gave his two cents.
Slaoui proposed cutting the Moderna vaccine dose in half to potentially allow more people access to the shots, he said on Face the Nation. He cited data from the biotech’s clinical trials that showed adults aged 18 to 55 who received two 50 μg doses showed an “identical immune response” to the standard of two 100 μg doses.
During the interview, Slaoui was pressed on what the federal government could do to help the states speed up vaccinations and said halving the Moderna doses was a potential alternative compared to spreading out the doses longer than originally planned in their late-stage trials.
“If we leave people a month, two months, three months with maybe incomplete immunity, waning immunity, maybe even the wrong kind of immune response induced, that is then corrected by the second dose,” Slaoui told Face the Nation. “Changing the decisions made, the choices made … without any data I think would not be responsible.”
Should the FDA decide to move forward with this plan, the two immunizations would still occur 28 days apart. Slaoui said OWS is in discussions with the agency and Moderna over whether implementing this proposal would be possible. Moderna won an EUA for its Covid-19 vaccine last month for the 100-μg doses, the same dosage level used in their Phase III study.
Getting shots in arms has proved a challenging task as vaccine rollout has started. Federal projections had aimed to distribute 20 million doses by the end of 2020 as recently as last month, but only 4.2 million Americans had received their first shots as of Saturday, per the CDC. Those numbers are likely higher in actuality given reporting lags, however.
The obstacles have launched a debate among health officials over the best way to accelerate distribution. With a new, more contagious coronavirus variant spreading, the UK has already announced plans to delay the second dose of the Pfizer/BioNTech and AstraZeneca vaccines — the latter of which is not yet authorized in the U.S.
According to the country’s Joint Committee of Vaccination and Immunization, this decision was made based on data showing the first Pfizer shot can grant partial immunity and that longer intervals between AstraZeneca shots can provide stronger immunity. The plan has some backers to emulate the plan in the US, given the supply constraint and new mutation.
I've been thinking about the debate of delayed vs. immediate 2nd dose for some time
Over past week, have become convinced that getting all doses out now is better
Its NOT a no-brainer
Reasonable people can (and do!!) disagree
So here's why my thinking evolved
— Ashish K. Jha, MD, MPH (@ashishkjha) January 3, 2021
UCSF department of medicine chair Robert Wachter and Brown University School of Public Health dean Ashish Jha vouched for a US version of the plan in an op-ed in the Washington Post on Sunday, writing in part:
Hundreds of thousands of people are being infected and thousands are dying every day. Any high-risk person who isn’t vaccinated today could be infected tomorrow and die in a month. But we are holding back half of the doses in reserve for people to get their second shots. That slows things down.
But there still doesn’t appear to be a consensus on the matter, as some top American officials are opposed to the deferred shot method.
“I would not be in favor of that,” NIAID chief Anthony Fauci told CNN on Friday. “We’re going to keep doing what we’re doing.”
A helpful thread about immune correlates from an expert on the topic. Highly relevant for bridging vaccines to new populations, studying modified vaccine formulations, and evaluating new vaccines once we can no longer run placebo-controlled trials. https://t.co/vD2SZGKcRp
— Natalie E. Dean, PhD (@nataliexdean) January 4, 2021
— Max Gelman
FDA rejects Relief Therapeutics and NeuroRx’s bid for an EUA
The FDA shot down last week an emergency use application for half-century-old aviptadil in Covid-19, which Swiss biotech Relief Therapeutics and their US partner NeuroRx submitted back in September based on a study in which only 21 patients were treated.
The partners announced Sept. 23 that they filed for an EUA based on a case-control study with 21 patients in the treatment arm and another group who received maximal standard-of-care treatment in the same ICU. NeuroRx came under fire earlier that month after Politico reported the company tapped a Republican congressman with close ties to its CEO and a history of mask skepticism to their Data and Safety Monitoring Board.
Upon filing, NeuroRx announced that patients in the treatment arm had “demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters.” Susan Ellenberg, a former FDA reviewer and a biostatistician at the University of Pennsylvania Perelman School of Medicine, told Endpoints that an EUA based on such limited data could be possible, but only if the evidence was overwhelming.
“The FDA did not agree to grant EUA, as applied for in September,” NeuroRx CEO Jonathan Javitt said in a statement.
Relief’s $RLFTF stock plunged on the news, falling from about 40 cents on Dec. 29 to 31 cents on Dec. 30.
Javitt cushioned the bad news by adding the partners had completed enrollment in a 165-patient Phase IIb/III trial, with topline data expected in late January or early February. At the end of November, the partners announced a 72% survival rate in more than 175 patients with critical Covid-19, respiratory failure and a severe comorbidity who were studied through an expanded access protocol in the US. Of the 90 patients who had reached a 28-day follow-up, 72% survived.
Javitt announced the companies will continue to work with the FDA, which “will promptly review the forthcoming data” from the Phase IIb/III. — Nicole DeFeudis
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