PDSB - PDS Biotech shares gain 12% after PDS0101 triple combo data in HPV+ malignancies

PDS Biotechnology (PDSB) jumps 11.7% premarket after announcing results from Phase II triple combination study of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.An overall objective response rate of 71% (10/14) in patients with refractory HPV16-associated cancers was seen with 1 complete response (anal cancer) and 9 partial responses (3 cervical cancer, 2 vulvar/vaginal cancer, 2 anal cancer, 2 oropharyngeal cancer).90% of these of these responses are ongoing after a median 5 months of follow up (9/10). These reported data validate the preclinical studies published by the NCI demonstrating that the mechanisms of action of the three immunotherapies which involve potent in-vivo HPV16-specific killer and helper T-cell induction with effective T-cell tumor infiltration, blocking of immune checkpoints as well as targeting of TGF-? resulted in superior tumor regression.Bintrafusp alfa is being jointly developed by Merck  KGaA and GlaxoSmithKline; NHS-IL12 is being developed by Merck  KGaA.The abstract summarizing interim data has been accepted for

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PDS Biotech shares gain 12% after PDS0101 triple combo data in HPV+ malignancies