The U.S. government continues to end contracts related to the $5 billion Project NextGen initiative, this time terminating funding for an Atlanta biotech’s lead COVID-19 vaccine program that’s currently being tested in a mid-stage trial.
The Biomedical Advanced Research and Development Authority (BARDA) has axed a Project NextGen (PNG) award for GeoVax Labs, effective April 11, the Georgia company said in an April 16 release. The funding was for GEO-CM04S1, a phase 2b multi-antigen COVID-19 vaccine designed to protect individuals who aren’t sufficiently shielded by vaccines currently on the market.
“While the recent HHS/BARDA Stop Work Order action was disappointing and surprising, our commitment to protecting vulnerable populations remains unchanged, and our clinical momentum is strong in support of our ongoing phase 2 GEO-CM04S1 programs,” GeoVax President and CEO David Dodd said in the release.
Despite the stop work order, GeoVax said it “remains committed to the critical medical need addressed by GEO-CM04S1.” The biotech will continue to work on two other ongoing, mid-stage COVID studies for its investigational vaccine, Dodd told Fierce Biotech.
In June 2024, the government granted GeoVax $24.3 million to run a 10,000-participant, randomized, phase 2b study to compare the efficacy, safety and immunogenicity of GEO-CM04S1 against an approved mRNA COVID-19 vaccine.
Under the contract, GeoVax had the chance to collect up to $45 million in total, with BARDA inking a separate $343 million deal for a CRO to execute the study. The financing comes from the federal government’s Project NextGen, which was designed to accelerate a pipeline of next-gen COVID-19 vaccines and therapeutics to address waning immunity and resistance.
"The BARDA funding pursuant to Project NextGen was mostly earmarked for incremental spending, with a large portion going directly to the external clinical research organization to conduct the clinical trial," Dodd told Fierce. "Given the structure of the award, the financial impact to GeoVax is estimated at less than $750,000 annually, toward reimbursement of existing personnel and overhead costs. GeoVax therefore does not anticipate any significant changes to its ongoing operations resulting from the contract termination."
GEO-CM04S1 was the only multi-antigen/polyvalent COVID-19 vaccine candidate being tested under Project NextGen, according to the biotech.
GeoVax’s asset is still being evaluated in two trials. One is testing the shot as a booster vaccine among patients with chronic lymphocytic leukemia, and the other is weighing it as a booster for healthy adults who have previously received an approved Pfizer or Moderna mRNA vaccine.
So far, the data suggest that the vaccine provides a more robust immune response, increased durability and protective immunity for patients with depleted immune systems, according to GeoVax.
A data readout from the healthy adult booster study is still anticipated this year, the biotech said.
HHS and BARDA did not return Fierce's request for comment.
The scenario echoes the recent experience of Vaxart, a California-based company that laid off 10% of its staff in March after the government ordered the biotech to stop work on a trial of its investigational COVID-19 vaccine pill.
The trial was being funded by up to $456 million under Project NextGen and had completed enrollment of an initial tranche of 400 patients in November. Following the order, a 90-day window commenced where Vaxart will learn whether the directive will be canceled, extended or the project itself will be terminated, Lo said at the time.
Earlier in the year, rumors swirled that HHS was reevaluating a $590 million contract for avian influenza mRNA vaccines that the Biden administration had struck with Moderna.
Since President Donald Trump entered his second term, his administration has delivered several mixed messages regarding vaccines, including by appointing known vaccine skeptic Robert F. Kennedy Jr. to lead the HHS. More recently, vaccine advocate Peter Marks, M.D., Ph.D., former director of the FDA’s Center for Biologics Evaluation and Research, told the Associated Press that he was pushed out after trying to block Kennedy from unfettered access to a federal vaccine safety database.
As for Geovax, the biotech has other candidates in its pipeline, including an mpox/smallpox vaccine that is expected to enter clinical testing this year.
Beyond infectious diseases, GeoVax touts a mid-stage cancer candidate dubbed gedeptin. The FDA has granted gedeptin an orphan drug tag in advanced head and neck cancer patients, with a phase 2 study anticipated to test the asset in combination with an immune checkpoint inhibitor.
The Georgia-based business is also advancing continuous cell line manufacturing for MVA-based vaccines, which is designed to improve vaccine self-sufficiency and supply resilience.
Editor's note: This article was updated to properly reflect which COVID trials are impacted by the BARDA decision.