Weekly Rundown: HHS pulls COVID-19 vaccine funding mid-trials

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HHS pulls COVID-19 vaccine funding mid-trials

Last week, vaccine and immunotherapy biotechnology company GeoVax announced that the Center for the Biomedical Advanced Research and Development Authority (BARDA) had terminated their Project NextGen award. This award was supporting the development of GeoVax’s next-generation COVID-19 vaccine (GEO-CM04S1), which is currently in Phase 2 trials being tested as a protective vaccine for immunocompromised stem cell transplant patients, as a booster shot for people with chronic lymphocytic leukemia, and as a booster for healthy adults. GeoVax Chief Executive Officer and Chairman David Dodd said in a press release, “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.” Endpoints News reported this week that CastleVax and Vaxart also received stop work orders for their Project NextGen awards. – Stephanie DeMarco

A new therapeutic target for aggressive pancreatic cancer

Scientists have identified PIKfyve — a lipid kinase critical for lysosome function — as a promising therapeutic target for pancreatic ductal adenocarcinoma (PDAC), a highly aggressive cancer with a five-year survival rate of just 13 percent (1). PDAC is the most common form of pancreatic cancer, accounting for over 90 percent of diagnoses. The cancer develops from the cells lining the pancreatic ducts, which carry digestive enzymes into the main pancreas and from there into the small intestine. Using a genetically engineered mouse model, researchers at the University of Michigan showed that PIKfyve is essential for PDAC growth. When they inhibited PIKfyve, the cancer cells compensated by activating the KRAS-MAPK signaling pathway, which triggered the expression of a distinct set of genes and metabolic changes that increased lipid production. However, when the researchers blocked both PIKfyve and the KRAS-MAPK pathway simultaneously, it led to the complete elimination of PDAC tumors in several mouse models of the disease. The finding positions PIKfyve inhibition as a highly promising and potentially fast-tracked therapeutic option for treating pancreatic cancer. – Dika Ojiakor

Bristol Myers Squibb schizophrenia drug fails as add-on therapy

Bristol Myers Squibb announced that its new FDA-approved schizophrenia drug, Cobenfy, hit a setback in the Phase 3 ARISE trial. The trial aimed to test whether the drug could be effective as an add-on treatment in adults with schizophrenia who are already taking atypical antipsychotic drugs but whose symptoms are not well controlled. The recent results showed that Cobenfy was not significantly different from a placebo in improving symptoms. In a press release, Bristol Myers Squibb included commentary from Husseini Manji, a psychiatrist at the University of Oxford, who said, “When patients are already receiving treatment, demonstrating additional statistical benefit becomes inherently more difficult. … Although Cobenfy did not demonstrate a statistically significant improvement as an adjunctive treatment in this trial, the data are encouraging, showing a noteworthy improvement for the majority of patients in the trial, as well as a tolerable safety profile.” As a monotherapy, multiple clinical trials showed that the drug — which is the first non-dopamine based therapeutic for schizophrenia in 70 years — is safe and effective at treating the condition (2). Researchers are also testing Cobenfy to treat symptoms associated with Alzheimer’s disease, autism spectrum disorder, and bipolar disorder. – Allison Whitten

Pharma invests in US-based manufacturing as tariffs loom

As the threat of tariffs on pharmaceuticals looms, some pharma companies have announced large-scale investments in US-based manufacturing. On Tuesday, Roche said that the company would invest $50 billion in the United States over the next five years. That investment would go toward building new research and development (R&D) facilities, new manufacturing centers, and expanding existing manufacturing sites. Regeneron also announced on Tuesday that through their partnership with Fujifilm, they would double their manufacturing capability in the US, investing more than $3 billion. They join other pharma companies — including Novartis, Johnson & Johnson, and Eli Lilly — in their new investments in US-based R&D and manufacturing. – Stephanie DeMarco

NIH cuts landmark study on women’s health

Leaders at the Women’s Health Initiative (WHI) announced this week that the NIH plans to drastically reduce — or potentially eliminate — funding for the WHI’s long-running study on women’s health. The WHI, launched in 1991, is the first and largest NIH program focused specifically on women’s health. The study set out to develop strategies for preventing heart disease, breast and colorectal cancer, and osteoporosis in postmenopausal women — chronic conditions that are the major causes of death in older women of all races and backgrounds. In a press release, WHI leaders stated that the NIH will end contracts supporting the initiative’s regional centers in September 2025, noting that “while written notification has yet to be received, investigators have been advised to expect formal confirmation soon.” These cuts are likely to disrupt ongoing studies and data collection and will severely limit the program’s ability to produce new insights into the health of older women — one of the fastest-growing populations in the US. – Dika Ojiakor

Editor's note: After the Weekly Rundown went to press, the Trump administration announced that it would be restoring funding to the WHI, NPR reported.

Combining antibody-drug conjugate with immunotherapy shows success

Gilead Sciences announced that the use of their antibody-drug conjugate, Trodelvy, combined with the immunotherapy drug Keytruda led to significantly improved progression-free survival in patients with inoperable metastatic triple-negative breast cancer with PD-L1-expressing tumors, compared to Keytruda and chemotherapy. The early results are based on the Phase 3 ASCENT-04 study, although Gilead did not report specific numbers for now. In the press release, Dietmar Berger, Chief Medical Officer at Gilead, said, “These findings are the first to show the transformative potential of an antibody-drug conjugate combined with an immuno-oncology agent in early treatment lines of metastatic breast cancer.” – Allison Whitten

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