The Phase 3 trial from PDS Biotech for HPV16-positive cancer proves encouraging, showing better survival and a strong outlook for the biotech sector.

PDS Biotechnology Corporation led the Phase 3 trial for head and neck squamous cell carcinoma (HNSCC) caused by HPV16, which has reported promising results. The study presented during ASCO’s annual meeting, called VERSATILE-003, found that recurrent/metastatic HNSCC patients had a median overall survival (mOS) of 30 months.

The biotech company designed Versamune® HPV (PDS0101) to stimulate T cell activity against HPV16 protein-expressing tumors. Out of 53 patients enrolled in the trial in the US and Europe, there were long-lasting responses to the drug and no additional safety problems found.

Regardless of falling 53% on its stock in a year, PDS Biotech holds steady confidence with analysts giving it ‘buy’ calls and predicting shares to rise to $4.50 to $13.00. The FDA has encouraged the use of companion diagnostics to see which patients are likely to benefit from this drug.

PDS Biotech reported in the first quarter of 2025, they had less overall loss; less money spent on research and development, and still had $40 million in cash. Pfizer is adding to its pipeline by working on a flu vaccine that works on a wide range of flu strains and earlier forms of cancer drugs. This keeps it a major player in biotech.

B.Riley Securities analysts are positive that PDS Biotech is heading in the right direction and can grow strongly. As biotech firms find it challenging to maintain cash resources, PDS Biotech’s effort with targeted immunotherapies shows how they are helping improve cancer therapy.