Biopharma execs highlight regulatory collaboration, call for increased manufacturing, data sharing

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Executives at biopharmas developing vaccines and therapeutics to treat COVID-19 provided updates on clinical timelines, the positive impact of regulatory collaboration and the need to dramatically expand manufacturing capacity in order to respond more quickly to future pandemics.

The comments came during a live virtual panel at the BIO-Europe Spring conference on Monday.

George Yancopoulos, president and CSO of Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), noted how cooperation with regulators has helped Regeneron accelerate both the development of new mAb therapies against COVID-19 and the start of a Phase II/III trial of IL-6 inhibitor Kevzara sarilumab to treat late-stage patients.

Yancopoulos said once anecdotal reports started coming out of China about the potential use of IL-6 inhibition in severe COVID-19 patients, Regeneron knew it needed to generate placebo-controlled data to better characterize the potential for efficacy. “Everybody recognized that we needed controlled data; we couldn’t just rely on anecdotal reports. So we got together with FDA, we got together with BARDA who has been a partner with us on all these efforts, starting with Ebola and MERS efforts and now in this effort. The governor of New York, Governor Cuomo, came in and said, ‘Whatever you guys need, we need to test this.’

“And the New York State Health Commissioner Howard Zucker stepped in and gave us access to all the great New York medical institutions,” Yancopoulos said. “It was a great example of all of us coming together, and in record time setting up our treatment study.”

“Within a few short weeks we may know whether we have a safe and effective treatment for these critical patients.”

George Yancopoulos, Regeneron

On March 16, Regeneron started the Phase II/III trial of Kevzara to treat COVID-19. Yancopoulos said the trial is enrolling rapidly, with 40-50 patients already; data could be available within weeks. “Within a few short weeks we may know whether we have a safe and effective treatment for these critical patients,” he said.

According to, the primary completion date for the trial is March 2021. A Phase III study that started Monday of Actemra tocilizumab, an IL-6 inhibitor from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY), is expected to be completed in December.

Yancopoulos added that FDA worked around the clock to get the Phase II/III protocol reviewed, including a call from FDA Commissioner Stephen Hahn offering to help.

“In this setting [FDA] have been nothing but incredible,” he said. “When we were getting our protocol reviewed to get the IL-6 receptor study going as soon as possible, they were as motivated as we were, because they want to see controlled data. They were on the phone talking with us in the middle of the night, all weekend working 24/7 just like our team was.

“The same thing at the highest levels. Just yesterday I got a call from Steve Hahn, the head of the FDA, saying, ‘What can we do to help? You guys are bringing along some of the most important near-term opportunities here. How can I help make sure we do the right thing, but there’s no barriers, there’s no artificial reasons to slow things down and we move things as quickly as possible?’”

The same collaborative response from regulators was echoed by Hanneke Shuitemaker, global head of viral vaccine discovery and translational medicine at the Janssen Pharmaceuticals unit of Johnson & Johnson (NYSE:JNJ).

She said J&J has received invitations for expanded review of their COVID-19 vaccine program from FDA, EMA and the U.K.’s MHRA. “It is really great to see their proactive attitudes with which they want to help us to proceed,” she said.

Accelerating development

Stéphane Bancel, the CEO of Moderna Inc. (NASDAQ:MRNA), detailed how the biotech was able to accelerate development of its COVID-19 vaccine mRNA-1273, which started an NIH-led Phase I trial on March 16.

Contrasting some media reports, Bancel said Moderna did conduct animal testing as part of the preclinical development for mRNA-1273. But what helped accelerate the timeline was the decision to manufacture non-GMP grade material and send it to both Moderna and NIH labs for initial animal testing while GMP material was made and underwent quality control.

“One priority of critical importance is open access to data and data sharing so that we can all learn from each other.”

Hanneke Shuitemaker, Janssen

He added that the preclinical package was aided by the fact that Moderna’s vaccines are all largely the same structure, but with a different antigen sequence. Some degree of extrapolation could be done from preclinical data from the company’s MERS vaccine, which has been in development with NIH for the past two years, along with clinical safety data from other vaccines.

Shuitemaker said J&J has accelerated its COVID-19 vaccine program such that immunogenicity testing is ongoing and a candidate vaccine will likely be selected by the end of the month, with a clinical trial starting by the end of summer or early autumn. She added that J&J has a 1,000-liter commercial manufacturing facility that could produce 300 million doses per year; the pharma could seek to increase manufacturing capacity if the vaccine were needed for worldwide distribution.

Biggest needs

The panelists said some of the biggest needs will be manufacturing capacity and continued open access to new data.

Bancel said that while it took Moderna only 42 days to go from obtaining the viral sequence to starting a clinical trial, the rate-limiting step will be building manufacturing capacity to produce the vaccine.

“How does the world equip itself with the right infrastructure?” he said. “The plant we are using right now, which we are in the process of scaling up, is a development plant. So can you make millions of vials a month? Yes. Can you make 150 million a month? No.”

He said governments should partner with organizations such as The Coalition for Epidemic Preparedness Innovations (CEPI) to better prepare for the next time a vaccine must be developed and manufactured rapidly. “We want to be working with and partnering with authorities so this can become a reality,” he said. “Governments spend billions of dollars on nuclear weapons with the hope of never using them, just in case. So it would not be crazy for the world to partner and put a few billion dollars to build a couple large manufacturing facilities that could respond in weeks.”

Shuitemaker said one of the biggest needs was for all stakeholders to continue to share data in real time with open access for all. “One priority of critical importance is open access to data and data sharing so that we can all learn from each other,” she said. “I want to emphasize that it is not a competition of companies against each other, but it is really a competition against this virus and for the benefit of public health.”

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