Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19.
The SARS-CoV-2 virus continues to shut down society and spread across the world, with the latest numbers from the World Health Organization indicating 332,935 confirmed cases and 14,510 deaths across 189 countries. The U.S. now has the third highest number of cases, 31,573, behind China and Italy.
On the first day of Bio-Europe Spring 2020, a virtual meet-up focused on Combatting Coronavirus – direct from the individual homes and private offices of six panelists, instead of from a stage at a Parisian conference center – indicated a delicate balance between frustration and hope for both short-term and long-term solutions to beat down the most disruptive pandemic in the past century.
“This is a great opportunity to show that as an industry we’re really the good guys. We can maybe save the world. I think the world is counting on us,” said George Yancopoulos, president and chief scientific officer of Tarrytown, N.Y.-based Regeneron Inc., which is working on both an interleukin-6 (IL-6) agent to address current critical care patients, as well as human monoclonal antibodies developed using its Velocisuite technologies.
The pandemic has delayed clinical trials, closed schools and colleges, sent millions of students and professionals to work remotely from their homes, and shuttered non-essential clothing stores and other retail outlets that do not sell basic life-sustaining products, such as food, all in an effort to flatten the curve, to essentially reduce the number of critically infected people at one time so as to alleviate the overwhelming burden that COVID-19 can and has placed on global health care systems.
“I don’t think there’s any alternative to extreme social distancing if we don’t want the hospitals to collapse,” said Otello Stampacchia, founder of Boston-based Omega Funds, who emphasized the powerful role that diagnostics can play in managing the progression of patients that go into hospitals. “It is incredibly hard to switch on capacity in [intensive care units] and hospitals. The workload that this will bring to the health care system is unbearable. I’ve seen this directly in Milan, which is when the fatality rate climbs like crazy.”
Italy has reported 59,138 confirmed cases and the highest number of deaths in the world – 5,476 total – while across the ocean there are “frolicking fools in Palm Beach that don’t understand the severity of this,” Stampacchia said.
Industry response to prevent and treat
While a vaccine against COVID-19 is seen as the ultimate solution, safety data and the subsequent manufacturing needed to supply the world are major barriers. While dozens of companies are working to deploy their technologies, the likelihood of having a safe, effective vaccine is probably 18 months away. In the meantime, several therapeutics are “being tried in almost 349 trials around the world,” said panel moderator Phyllis Arthur, vice president of infectious diseases and diagnostics policy at the Biotechnology Innovation Organization (BIO).
Whether through the actual infection or through a vaccine, “in 18 to 24 months, I believe most of the world will be seropositive,” said Stephane Bancel, CEO of Cambridge, Mass.-based Moderna Therapeutics Inc., which is developing a messenger RNA (mRNA) vaccine against COVID-19.
The vaccine was finished on Feb. 7 and dosing in Seattle with the first subjects occurred on March 16.
“We are working with the FDA to see if we can start a phase II in the spring. That would be based on the safety in the phase I,” Bancel said. “Potentially, in the fall, we could use emergency use to protect health care workers and people at high risk.”
Janssen Pharmaceuticals began working on its recombinant adenoviral vector vaccine produced using the human PER.C6 cell line once the first reports came out of China.
Candidates are being tested in preclinical models and the company expects to manufacture material for a phase I trial to start by the end of summer or the beginning of autumn, said Hanneke Schuitemaker, the global head of viral vaccine discovery and translational medicines at Johnson and Johnson’s Janssen.
“When the sequence was released and it became clear this was a betacoronavirus, our degree of alarm went up,” said Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), which partnered with both Moderna and Tubingen, Germany-based Curevac AG on their mRNA vaccines. CEPI expects to have a portfolio of about 10 vaccine development projects.
“I think everybody agrees” that developing vaccines, Regeneron’s Yancopoulos said, “is really one of the most important activities the whole ecosystem could take on because it could very well be the final answer to this.”
But companies like Regeneron may offer more near-term solutions, with one approach harnessing Ebola and MERS efforts to develop an antibody-based treatment using its mouse model.
“We’ve actually produced these highly potent human antibodies from this mouse model in record time,” Yancopoulos said, adding that the antibodies, which target the Spike protein, would be scaled up and ready to move into human trials by June and could potentially act as a prophylactic passive vaccine available to health care workers and other people at risk by the end of the summer.
An even more near-term opportunity, he said, is the company’s anti-inflammatory rheumatoid arthritis drug, Kevzara, an IL-6 antibody.
While Foster City, Calif.-based Gilead Sciences Inc.’s remdesivir is currently available in the U.S. for compassionate use, it did not work in the Ebola setting, Yancopoulos said, and the only product found recently with “remarkable benefits and effects” against COVID-19 in testing by Chinese researchers was Basel, Switzerland-based Roche Holding AG’s Actemra (tocilizumab), another IL-6 drug for rheumatoid arthritis.
Regeneron was able to start testing of its IL-6 drug in the U.S. and has already enrolled at least 40 patients, with data available in a few weeks as to whether it is a safe and effective treatment for critical patients.
“If we can solve that, that’s really going to impact so many aspects of the situation because maybe people won’t have to fear as much getting sick,” Yancopoulos said.
Other IL-6 candidates in development for COVID-19 include Hemel Hempstead, U.K.-based Eusa Pharma Inc.’s siltuximab and London-based Tiziana Life Sciences plc’s TZLS-501.
Cooperation, money and better preparation needed
To support the immediate needs for diagnostics, treatments and vaccines, the panelists highlighted a wish list that included open access and data-sharing and a manufacturing capacity that can quickly scale up to meet global requirements, as well as the financial investment needed from government and other investors.
“Governments spend billions of dollars on nuclear weapons with the hope of never using them, but just in case,” Bancel said. “So it wouldn’t be crazy for the world to put a few billion dollars into manufacturing that could respond in weeks” to a pandemic like COVID-19.
While investors “are absolutely shell-shocked by this” and the reaction to the public markets has “paralleled the downcycle of the Great Depression,” Stampacchia said, “we need to move beyond the short-term kind of thinking here, and I do think every investor I know is asking, ‘How can we help?’”
Both Yancopoulos and Schuitemaker credited the FDA and other regulatory agencies with working around the clock to support industry in finding meaningful solutions.
“Without losing their rigor on their processes,” Schuitemaker said, “it’s really great to see their proactive attitudes with which they want to help us proceed.”
James Greenwood, president and CEO of BIO, laid out two initiatives that BIO put in place as a response to the pandemic: the Coronavirus Collaboration Initiative, involving 45 companies working with U.S. health authorities to collaborate and share resources; and the creation of the website, hub.bio.org, “where already companies are posting what they need and don’t have and other companies are posting what they have and are willing to share.”
But Greenwood expressed frustration with politicians, pointing out that five years ago the organization formed the Bipartisan Commission on Biodefense, which is co-chaired by former U.S. Secretary of Homeland Security and Pennsylvania Governor Tom Ridge and former Sen. Joe Lieberman to heighten government awareness of weaknesses and to provide recommendations so the country would be prepared for things like COVID-19.
“For five years, we have been telling the Congress and the administration and the previous administration that it is not if there is a pandemic, but when,” Greenwood said. “Importantly, we said the Medicare program should reimburse hospitals so that those hospitals can pay for and stockpile the things that they would need for a pandemic. That didn’t happen, tragically, so we are where we are.”
Now that the crisis is going to cost “literally trillions of dollars,” Greenwood questioned whether Congress will do what is needed for the future, considering its members are “too frequently cynical about our industry,” assuming that COVID-19 was an opportunity for biopharma companies to shut out or gouge patients with exorbitant prices for treatments.
“The exact opposite is the truth,” Greenwood said. “We came to the rescue and we came to the rescue with all of the best motives.”
BioWorld has tracked companies that are developing therapeutics, vaccines and diagnostics, which are at about 80, 45 and 75, respectively, not including numerous partners that are involved.
BIO-Europe Spring will continue through Friday in its virtual format.