PDSB - PDS Biotechnology Corp (PDSB) - Phase 2 HPV Trial With PDS0101 Reaches Enrollment Milestone
Phase 2 Enrollment Is On Schedule. PDS Biotechnology has announced that the National Cancer Institute (NCI) Phase 2 trial testing PDS0101 in a triple-therapy regimen has reached the target patient enrollment in one of its two treatment arms. This trial is testing PDS0101 in combination with two immune modulating drugs in HPV-associated cancers.PDS0101 Is Being Tested With Immune Modulators To Improve Response. PDS0101 (Versamune-HPV16) uses the PDS Versamune technology with the HPV-16 antigen. It was designed to activate immunological pathways, stimulating an immune response against cancer cells with the human papilloma virus antigen. The trial is testing PDS0101 with two other immune modulating drugs (the bifunctional checkpoint inhibitor bintrafusp, and the immune cytokine IL-12) in HPV-associated cancers.Trial Design Has Two Arms. The trial is enrolling patients with metastatic or recurrent HPV-associated cancers, and divides the patients according to prior treatment. One arm includes patients that have progressive disease after two courses of chemotherapy, including a checkpoint inhibitor (checkpoint refractory). The second arm includes patients who have progressive disease after one course of chemotherapy but have not been treated with a checkpoint inhibitor (checkpoint naïve).Enrollment Continues As One Arm Has Met Target Patient Accrual. PDS has reported that the checkpoint refractory arm has reached its target enrollment of 30 patients. The checkpoint naive arm has enrolled 15 patients. The trial will continue enrolling patients in both arms until the target of 56 patients is reached. Endpoints are designed to show benefits in overall response, tumor shrinkage, and survival, as well as improvements with checkpoint inhibitor therapies.Conclusion: We see the completion of enrollment an indication that the trial is on schedule to report data in mid-2022. Previous data presented at the ASCO meeting in June 2021 from the first 25 patients showed a high response rate and improved median survival, with meaningful benefits over current treatments. We reiterate our Outperform rating and price target of $22 per share. Read More >>