Two San Diego biotech companies are speeding ahead on potential COVID-19 vaccines. But for many in the industry, going fast isn’t an option right now.
The fallout from the coronavirus has hit the region’s biotech cluster in the form of clinical trial disruptions, difficulties attracting venture capital, and certain drug research being suspended.
Downstream, some patients face delays in accessing medicines. As a high-profile example, hospitals have postponed infusions of a San Diego-hatched treatment for a muscle disease.
San Diego’s life sciences sector employs nearly 65,500 people and generates $39.4 billion in local economic impact, per a report last year from Biocom. The hub, routinely ranked as the third largest in the nation, has grown in recent years thanks to an infusion of venture capital and significant drugs hitting the market.
Now, a new reality is setting in.
“It’s gonna be rough sledding for a little while,” said Jay Lichter, who heads a constellation of biotechs as part of COI Pharmaceuticals in La Jolla.
An increasingly common story is unfolding at one of those companies, which Lichter didn’t name. A clinical trial assessing the firm’s drug will probably end early because some patients stopped showing up for fear of contracting COVID-19.
If ceased, the trial would fall short of its patient enrollment target, but Lichter said the existing patient data should be enough to move forward. Still, it’s a tough-to-navigate situation that’s widespread in the industry, Lichter said.
Among other drugmakers, patient dropoff has occurred earlier in clinical testing, causing spotty and unusable data.
“There are certain studies that will be rebooted, essentially, when the crisis abates,” said Gary Firestein, director of UC San Diego’s Altman Clinical and Translational Research Institute. The institute’s mission includes running clinical testing.
Clinical trials act as the proving grounds of life sciences. Without patient data, biotechs can’t land that next round of funding, move to the next stage of testing or – if far enough along –request regulatory approval.
As a worst-case scenario, promising research ends up in scientific purgatory, helping neither investors nor patients.
There are also impediments to getting new trials up and running, with reluctant patients — especially those with compromised immune systems — declining to join. That affects patients eager to enroll, who might see a trial as a last hope.
Testing sites highlight safety precautions. UC San Diego’s Altman Clinical and Translational Research Institute screens new patients for symptoms like cough and fever, and it operates trials out of a clinic that’s separate from the health system’s hospital.
“It’s a lower flow of patients,” Firestein said. “The intensity of exposure I think is considerably less than waiting in line at Costco for paper towels.”
In a sign of far-reaching clinical trial issues, large pharmaceutical Eli Lilly — which has a San Diego footprint — recently postponed the start of new clinical trials and suspended enrollment in most ongoing studies. Trials underway with completed enrollment will continue.
Recognizing the challenges, the U.S. Food and Drug Administration this month said it’s open to trial modifications in certain cases, and the agency recommended phone calls or virtual visits with patients when appropriate.
Beyond testing, some biotechs fear a cash crunch in a few months with investors taking a wait-and-see approach in choppy economic waters. It marks a reversal from investors eagerly hopping into the space in recent years. Since 2015, venture capital investment in San Diego life sciences has steadily climbed, according to data from property investment firm JLL.
Biotechs rely on investor support as most don’t have commercial products. To extend cash runway, some firms with multiple drug programs are pausing riskier ones.
“Early-stage companies are trying to find money in any way, shape or form,” said David Crean, a managing director of Objective Capital Partners who advises biotechs on financial decisions.
In addition, analysts warn of COVID-19 disrupting the availability of certain treatments, whether due to supply chain problems or overwhelmed hospitals being unable to administer therapies.
Some hospitals have postponed infusions of a treatment for spinal muscular atrophy, a rare disease that attacks nerve cells in the spinal cord, making breathing, walking and head control difficult. The medicine, called spinraza, was born in the labs of Carlsbad’s Ionis Pharmaceuticals.
Jon D’Angelo, who has the disease, said his quarterly infusion hasn’t been delayed. But fear of that happening outweighs trepidation over stepping in a hospital right now.
Near the end of each treatment cycle, he becomes tired and loses strength.
“Some of us already notice declines at the end of a four-month period. Going beyond — five months, six months, maybe longer — then we start to see even more declines,” said 31-year-old D’Angelo, who lives in North Carolina and works in employee benefits.
D’Angelo, who uses a wheelchair and has personal care attendants, said his quality of life shot up thanks to spinraza, which became commercially available in 2017. Even his voice got stronger.
Amid hospitals postponing, he made clear that he doesn’t hold ill will toward Ionis or Biogen. Massachusetts-based Biogen markets the treatment and said in a statement it would work with health systems to provide access to the therapy.
Despite slowing in the life sciences industry, Inovio Pharmaceuticals and Arcturus Therapeutics say they’re working around the clock on COVID-19 vaccines.
“We haven’t so far had any impacts on our timelines,” said Kate Broderick, senior vice president of research and development at Inovio.
It took Inovio’s San Diego lab only three hours to concoct an experimental vaccine. The process involved running a genetic profile of the virus that Chinese researchers shared online in January through the company’s algorithm.
Inovio this year received $14 million in grants to speed up its vaccine, slated to enter testing in humans next month. But experts caution that COVID-19 vaccines, if successful, might not be available to the wider public for at least a year.
The Singapore Economic Development Board awarded $10 million to San Diego-based Arcturus to develop a vaccine for Singapore, it was announced earlier this month. If the effort pans out, the company would also seek approval to market the vaccine elsewhere.
Arcturus’ vaccine is designed to be effective at low doses, meaning the company believes a single manufacturing batch could vaccinate large numbers of people. CEO Joseph Payne said the company is a few months away from starting testing in humans.
The heavy lifting of biotech can’t be done from a home office. Experiments must be carried out in a lab, with special technology, equipment and protective gear. But with coronavirus spreading, biotechs and academic institutions have ordered many employees to do what they can from home, like data analysis and planning new experiments.
San Diego-based Scripps Research in a statement said it’s winding down “all but the most critical scientific and administrative operations” at its La Jolla and Florida campuses.
Scripps is still pressing ahead on COVID-19 research, including probing how the virus spreads and infects the body, and efforts to identify which existing drugs could be repurposed to fight the virus.
Likewise, Sanford Burnham Prebys Medical Discovery Institute in La Jolla closed its campus to non-essential personnel. The institute has joined in the hunt for already-developed drugs that may inhibit coronavirus.
Adding to uncertainty, several biotechs said it’s unclear if scientists must work from home under California Gov. Gavin Newsom’s March 20 order restricting non-essential movements.
Trade group Biocom has pushed the state to “make it clear that necessary life science employees who work at research and development companies, along with life science supply chain employees, are exempt from the stay-at-home order,” it said in a statement.
“The work that these companies are doing in research is an ongoing and cost-intensive process,” said Biocom CEO Joe Panetta in an email. “It can’t simply be switched off or you have to start over again in many cases and you lose precious investment in time.”
Ionis, the company that developed spinraza, said it strongly encourages employees to work from home. For those deemed necessary in the lab, Ionis pared back onsite hours.
“We have not seen significant impact on any of our research activities or our clinical trials or other operations at this time,” the company said in a statement.
Elsewhere, life sciences startups are being more careful with cash.
“With the capital markets being as uncertain as they are, this signals some pretty scary times ahead,” said Dawn Barry, the president of startup LunaDNA in San Diego. “As an early-stage company, this is a race of time and resources.”
In a difficult funding landscape LunaDNA sees its platform as a potential salve to clinical trial disruption. The company reimburses users for sharing their health data for research.