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The once booming COVID market is now in a tough spot, with few companies experiencing the same success as early in the pandemic. One recent setback was Pfizer’s Paxlovidone. It didn’t work Measures against long COVID and Moderna Plans are on hold Building an mRNA manufacturing facility in Kenya Billions of dollars in funding blamed Revenues fall due to declining COVID vaccine sales.
Despite the market downturn, some companies still see potential to gain an edge, either with combo shots or next-generation preventatives for underserved patient populations. Clinical-stage Geovax Labs, for example, is busy developing a COVID vaccine candidate called GEO-CM04S1 that is designed to target high-risk immunocompromised patients.
And the company Recently received A BARDA Project NextGen grant to study a Phase 2 candidate vaccine in healthy patients compared to an approved vaccine.
“We think we may be able to move faster by developing a vaccine that addresses populations that are perceived to be underserved by the currently approved vaccines.”
Geovax’s COVID candidate vaccine differs “significantly” from approved vaccines in several ways, said Geovax Chairman, President and CEO David Dodd: While other COVID vaccines only induce neutralizing antibody responses and require frequent booster shots to combat new strains, Geovax’s dual-antigen candidate vaccine also induces T-cell-based immunity by combining the traditional spike protein with an additional nucleocapsid protein.
“What we’ve been able to demonstrate in the clinical setting is that we’ve demonstrated protective immunity from the original Wuhan strain all the way up to Omicron XBB.1.5 without any reconstitution (of the vaccine),” Dodd said. “This means we’re demonstrating a much broader range of protective immunity than we’ve seen before.”
Dodd said the Geovax candidate appeared to be more durable than potential rivals, demonstrating protective immunity for eight to 12 months. Approximately twice as long This is similar to other vaccines that only induce an antibody response.
Major vaccine companies are focusing on combo vaccines, Including Modernahas just presented some encouraging data. Late-Stage Research The company is developing a combination COVID/influenza vaccine, and Dodd thinks Geovax could compete in that space as well: Because the company’s platform can encode multiple antigens, it may be “ideal for making combination vaccines,” Dodd said.
Filling the lingering COVID gap
People with immunodeficiencies This accounts for a large proportion of severe COVID-19 cases and hospitalizations, and the Geovax vaccine Over 300 million people worldwide Dodd says patients have a weakened immune system that makes their bodies less responsive to antibody stimulation.
“Right now, there are tens of millions of people in the United States who are living with the pandemic because the vaccine didn’t work,” he said. “That’s what makes our vaccine so different and so valuable.”
GeoVax is conducting two Phase 2 clinical trials. Currently in progress The company is conducting research in blood cancer patients, but it is not the only company targeting COVID prevention in immunocompromised patients.
AstraZeneca Just Announced The company announced positive results from a Phase 3 trial of its long-acting antibody, Sipavivert, achieving the trial’s primary endpoint in preventing COVID-19 infection in immunocompromised patients.
And in March, Inivid received FDA emergency use authorization as a pre-exposure prophylaxis for COVID-19. It is called Pengarda It was developed for immunocompromised patients.
However, these two examples are not traditional vaccines as they do not induce an immune response but instead deliver antibodies directly to the patient.
Expanding the focus
In addition to targeting immunocompromised patients, GeoVax is studying its technology in the broader population.
GeoVax will use the BARDA grant to sponsor a Phase 2b study of 10,000 healthy participants comparing the efficacy, safety and immunogenicity of GEO-CM04S1 to FDA-approved mRNA COVID-19 vaccines.
The company is also conducting a Phase 2 trial of GEO-CM04S1 as a booster dose of the COVID vaccine in healthy volunteers.
Dodd said the BARDA program will last about three years, but he thinks there may be an “expedited pathway for registration” possible elsewhere.
“We think we may be able to move more quickly by developing a vaccine that addresses populations that are perceived to be underserved by the currently approved vaccines,” he said.
