2024-01-26 18:59:32 ET
Summary
- Preliminary efficacy results from phase 1/2 Mayo Clinic study, using PDS0101 + KEYTRUDA to treat patients with Oropharyngeal cancer, expected in Q2 2024.
- The global oral cancer treatment market is expected to reach $2.74 billion by 2030.
- It is said that nearly 80% to 90% of all oropharynx tumors are HPV-positive.
- Initiation of phase 3 VERSTILE-003 study, using PDS0101 + KEYTRUDA to treat patients with recurrent or metastatic head and neck squamous cell carcinoma, expected Q1 of 2024.
PDS Biotechnology ( PDSB ) was able to submit an IND to begin its phase 3 VERSATILE-003 study, using PDS0101 + KEYTRUDA to treat patients with recurrent or metastatic head and neck squamous cell carcinoma [HNSCC]. I briefly spoke about this in a prior Seeking Alpha article entitled " PDS Biotechnology: Interim Data Reinforces Push Towards Phase 3 Study ". Since then, it has been able to receive guidance from the FDA on a proposed design of a late-stage trial. With this feedback, it anticipates that it will begin the VERSATILE-003 study in Q1 of 2024. The thing is that while the company continues to make progress on this late-stage program, there is another catalyst to look forward to....
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PDS Biotechnology: Advancement Of PDS0101 Continues With Expansion Data