PDSB - PDS Biotechnology Corp (PDSB) - Phase 2 Interim Analysis in HPV Shows Strong Response Rate
PDS Biotech presented the first analysis from the Phase 2 trial testing PDS0101 in HPV16+ (human papilloma virus 16 positive) cancers. The data presentation was from the first 25 patients out of the target enrollment of 56 patients. The trial enrolls patients who have failed first-line treatments but were naïve to checkpoint inhibitors as well as those who had become refractory to checkpoint inhibitor treatment.PDS0101 is a triple combination therapy containing Versimue, the bifunctional checkpoint inhibitor bintrafusp, and Il-12 as an immune cytokine. This combination is intended to allow the immune system to recognize the tumor cell, then activate both CD4+ helper and CD8+ killer T-cells for a potent and durable immune response. Survival for patients who tested HPV16+ was 89% compared with 57% for HPV16- patients. This shows the contribution of PDS0101 in the triple combination.The ORR (objective response rate) in all patients was 55.5% with compared with expectations of 5% to 12%. The group that was did not have previous checkpoint inhibitors treatment showed 88.3% ORR, with while the refractory patients showed a 41.7% ORR. Tumor reduction (30% by RECIST) was 83% and 58% in the two groups.CD4+ and CD8+ cells showing HPV16 specific killer T-cells, resulting in improved response rates and survival. Accrual in the trial continues with 89% (16 out of 18 patients) alive at 8 months. Adverse events were consistent with expectations for the categories of drugs used. We expect these data to help patient enrollment toward completion of the trial, current expected in early 2022.While the number of patients was small, the high response rate and median survival show clinically meaningful improvements over the current treatments. In addition, the trial design was able to demonstrate the effect of PDL0101 in the triple combination, which we believe gives proof of concept for the core technology. We reiterate our Outperform rating and price target of $17 per share. Read More >>