2021 forecast: Targeted delivery, oral vaccines and mRNA 2.0: The next generation of drugs and prophylactics in the fight against COVID-19

29 December 2020

Fraiser Kansteiner / FiercePharma

As the chapter closes on the first year of the COVID-19 pandemic, drugmakers are hard at work bolstering the defenses mounted in 2020—and they're looking at new formulations and delivery methods to bring vaccines and therapies to more people around the world. 

Can follow-up shots ease the harsh cold chain requirements for mRNA vaccines? Could supplies be extended with a vaccine that works at one dose rather than two? And could COVID-19 meds be improved by targeting the site where the disease hits hardest?

These are just a few of the questions driving drugmakers and research institutions as they toil away on the next generation of coronavirus meds and vaccines. 

Take Germany’s CureVac, which says its mRNA vaccine, CVnCoV, can last for months above the subzero temperatures most shots in its class require. CureVac’s candidate, which advanced to phase 2b/3 in December, remains stable for up to three months when refrigerated and lasts up to 24 hours at room temperature, the company has said—a far cry from Pfizer’s prophylactic, which must be stored at minus 94 degrees Fahrenheit. That stability would give CureVac an edge over Moderna’s vaccine, too.

The company in November laid out plans to boost capacity to upward of 300 million vaccine doses in 2021. If its shot snares approval, CureVac's cold chain edge could help its shot reach far-flung areas inaccessible to the current mRNA crop.

Meanwhile, Pfizer itself is working on temp-stable options that could be ready as early as next year. "For the COVID-19 disease, I think we'll roll out next year a vaccine in powder format," Pfizer's chief scientist, Mikael Dolsten, M.D., Ph.D., told Business Insider last month. The second-generation version "could be just for refrigeration," providing at least "one simplification" over the current formulation. 

Drugmakers like Merck & Co. and Johnson & Johnson are homing in on another major hurdle: efficiency. Both companies are testing vaccines that could work after one dose, rather than two, which would stretch supplies to cover more patients. J&J’s adenovirus hopeful, still in phase 3, can also last up to three months refrigerated, or up to two years frozen. J&J in late December said it expects interim data in January and an FDA filing in February. Merck and Themis, meanwhile, are developing a one-dose option using the biotech's virus vector-based platform.

Plus, Merck has an oral vaccine in its sights. With IAVI, the pharma giant is advancing a second viral vector vaccine that would be delivered as a pill—far easier to distribute and administer than the usual shot. The program, which entered phase 1 in November, has ginned up $38 million in U.S. funding.

California's ImmunityBio recently showed its own viral vector tablet—when paired with a primer injection—boosted levels of anti-spike protein antibodies in nonhuman primates. It now plans to kick off a phase 1 study of the oral vaccine, which also boasts room-temp stability. 

ImmunityBio and Merck aren't alone, either. Vaxart also has an oral candidate in the clinic, aiming to deliver data next year, and Altimmune's single-dose intranasal candidate is due for results in the first quarter. The University of Hong Kong, meanwhile, got a thumbs-up to run human trials of its nasal spray vaccine in September.

On the therapeutic front, drugmakers following this year's lead with trials of repurposed meds, specialized biologics and experimental therapies previously reserved for diseases like cancer. Others still are tapping targeted delivery with inhaled drugs and nasal sprays to strike COVID-19 where it deals the most damage. 

Antibodies make up the majority of the treatments authorized so far, but they're infused treatments—and that hurdle has hampered their rollouts in the real world. Enter Eureka Therapeutics, which is developing a nasal spray antibody, hoping that targeting the airway—where inhaled viral droplets enter the body—could defend against disease. The company recently showed its candidate, InvisiMask, could protect mice against SARS-CoV-2 pseudovirus for at least 10 hours.

Meanwhile, Regeneron has new delivery plans for its antibody cocktail, authorized in late November. The biotech teamed up with gene therapy pioneer Jim Wilson and the University of Pennsylvania to develop it as a nasal spray, planning to tap adeno-associated virus tech, traditionally used in gene therapies, to position its antibody duo as a prophylactic.

Others, like Melbourne, Australia's Starpharma and researchers at the University of Texas (UT) at Austin, are tapping novel delivery methods for Gilead's approved antiviral, Veklury, also known as remdesivir. Starpharma has developed a long-acting, water-soluble version that could potentially be administered as a subcutaneous injection, which could tee up fewer treatments and push the antiviral into the outpatient setting. 

Scientists at UT Austin are tapping thin-film freezing technology to develop a powdered formulation of Veklury for use in an inhaler, enabling the treatment to target the disease directly in the lungs. And Gilead itself wasted little time pursuing options to improve its COVID-19 med; the company in July kicked off a phase 1b study testing the safety of inhaled Veklury in 60 healthy volunteers in the U.S.—a bid to snare clearance for the treatment in patients with less severe disease. 

Plus, mRNA has more to offer beyond pandemic vaccines—according to Kernal Biologics, a self-professed "mRNA 2.0" company. Instead of dosing patients with antibodies or drugs against COVID-19, the company wants to provide them with mRNAs that could turn their cells into drug factories. Kernal's pandemic candidate isn't yet cell-specific, but the biotech hopes to home in on lung cells to deliver its treatment where the virus causes the most damage. 

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