PDSB - PDS Biotech stock soars 14% as PDS0101 shows promise vs HPV-positive cancers in interim trial data

PDS Biotechnology ( NASDAQ: PDSB ) stock rose ~14% on Oct. 11 after the company reported interim data from a phase 2 trial of PDS0101-based triple combination therapy in advanced human papillomavirus (HPV)-positive cancers.

The company said the study is evaluating PDS0101 in combination with two investigational immune-modulating agents – M9241 and bintrafusp alfa owned by Merck KGaA ( OTCPK:MKGAF ) ( OTCPK:MKKGY ) – in recurrent or metastatic HPV-positive cancers in patients who have failed prior therapy.

About 66% (19/29) of HPV 16-positive checkpoint inhibitor  (CPI) refractory patients in the group were alive at a median follow up of 16 months. Historically, this group has a median overall survival of 3 months to 4 months, the company said in an Oct. 11 press release.

PDS added that 48% (24/50) of patients experienced Grade 3 treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 AEs. There were no grade 5 treatment-related AEs.

The company noted that data for HPV 16-positive CPI naïve patients continue to appear encouraging: 75% (6/8) of CPI naïve patients were alive at a median of 25 months of follow up, and 38% (3/8) of responders had a complete response.

"Importantly, these results affirm the decision to explore this novel combination for the treatment of CPI refractory patients, who have no approved standard of care, and support development of a combination therapy to address the significant unmet need," said PDS President and CEO Frank Bedu-Addo.

The company noted that the triple combination is being studied in CPI-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers.

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